title: An open-label safety study of S-888711 in adult subjects with relapsed persistent or chronic immune thrombocytopenia with or without prior splenectomy

lead_sponsor: Shionogi USA, Inc.


title: A Phase III, randomized, double blind study of the safety and efficacy of GSK1349572 50 mg once daily to raltegravir 400 mg twice daily both administered with fixed-dose dual nucleoside reverse transcriptase inhibitor therapy over 96 weeks in HIV-1 infected antiretroviral therapy naïve adult subjects.

source: euctr

lead_sponsor: ViiV Healthcare UK Ltd

study_type: Interventional

status: Ongoing

lead_sponsor_type: industriel

status_simplified: Ongoing


title:
A Phase 2 Study of the Efficacy and Safety of ACP-196 in Subjects with Relapsed/Refractory CLL and Intolerant of Ibrutinib Therapy

 Etude de phase 2 visant à évaluer l'efficacité et la sécurité d'emploi de l'ACP-196 chez des patients atteints de LLC en rechute/réfractaire et présentant une intolérance au traitement par ibrutinib

lead_sponsor: Acerta Pharma, BV

status: Completed

status_simplified: Completed


title: A multicenter, randomized, double-blind, placebo-controlled, parallel-group study to investigate the efficacy and safety of S-888711 tablets administered once-daily for 42 days to adult subjects with relapsed persistent or chronic immune thrombocytopenia with or without prior splenectomy.


title: A randomized, double-blind, parallel group, placebo-controlled study to assess the efficacy and safety of two doses of oral microencapsulated grass pollen extract administered prior to and during the the grass pollen season

lead_sponsor: Curalogic A/S


title: Effect of strontium ranelate (2g per day) in the management of lower limb fractures with delayed-union or non union: an international open label study in patients with osteoporosis

lead_sponsor: Institut de Recherches Internationales Servier


title: A randomized, open-label clinical trial to identify predictive factors for controlled ovarian stimulation using a fixed daily dose of 200 IU of recombinant FSH in a GnRH antagonist regimen with or without oral contraceptive scheduling

lead_sponsor: NV Organon

status: Prematurely Ended

status_simplified: Unknown


title: A 48-Week, Multicenter, Randomized, Double-Blind, Parallel-Group Evaluation of the Comparative Efficacy, Safety, and Tolerability of Exelon® 10 and 15 cm2 Patch in Patients with Alzheimer’s Disease Showing Cognitive Decline during an Initial Open-Label Treatment Phase.

lead_sponsor: Novartis Pharma Services AG


title: Pregnancy and neonatal follow-up of ongoing pregnancies established after controlled ovarian stimulation in clinical trial 107012 for the development of Org 36286 (corifollitropin alfa)


title: A non-comparative open pilot trial to assess the safety and pharmacokinetics of up to three single doses of AERUMAB 11 in patients with ventilator associated pneumonia caused by serotype O11 P. aeruginosa

lead_sponsor: Kenta Biotech Ltd


title: Prospective Phase II Pilot study of Rabbit Antithymocyte globulin (ATG, Thymoglobuline®, Genzyme) with Ciclosporin for Patients with Acquired Aplastic Anaemia and comparison with matched historical patients treated with horse ATG and Ciclosporin

lead_sponsor: EBMT (European group for Blood and Marrow Transplantation)


title:
Randomized, subject and investigator blinded, placebo-controlled
 study to demonstrate the anti-inflammatory
 effect of fevipiprant (QAW039) in moderate-severe asthma
 patients with high sputum and blood eosinophils

 Etude randomisée contrôlée contre placebo, en double aveugle (patients et investigateurs), destinée à démontrer l'effet anti-inflammatoire du fevipiprant (QAW039) chez des patients
 atteints d’asthme modéré à sévère et présentant des taux élevés d’éosinophiles dans le sang et les expectorations

lead_sponsor: Novartis Pharma AG


title: "VASCULAR-TARGETED PHOTODYNAMIC THERAPY USING WST11 IN PATIENTS WITH LOCALISED PROSTATE CANCE"

lead_sponsor: STEBA BIOTECH NV


title: A Double-Blind, Placebo-Controlled, Parallel-Group, Multicentre, Multiregional, One Year Study to Assess the Efficacy and Safety of Twice Daily Oral Rifaximin Delayed Release Tablets for Induction of Clinical Remission with Endoscopic Response at 16 Weeks followed by Clinical and Endoscopic Remission at 52 Weeks in Subjects with Active Moderate Crohn’s Disease

lead_sponsor: Salix Pharmaceuticals, Inc.


title: A Phase IIb study to select a once daily oral dose of GSK1349572 administered with either abacavir/lamivudine or tenofovir/emtricitabine in HIV-1 infected antiretroviral therapy naïve adult subjects.

lead_sponsor: GlaxoSmithKline Research and Development Ltd


title: V0251 oral suspension efficacy and tolerance in vestibular neuritis. A randomised double-blind placebo controlled study

lead_sponsor: PIERRE FABRE MEDICAMENT -IRPF- PIERRE FABRE INNOVATION


title: Phase II efficacy and safety study of Dasatinib in Patients with Chronic and Accelerated Phase Chronic Myeloid Leukaemia Relapsing after Allogeneic Blood or Bone Marrow Transplantation


title:
An Open Label, 1-Year Trial, including a Double-Blind Placebo-Controlled Withdrawal Period, of Setmelanotide (RM-493), a Melanocortin 4 Receptor (MC4R) Agonist, in Early Onset POMC Deficiency Obesity due to Bi-Allelic Loss-of-Function POMC or PCSK1 Genetic Mutation

 Un essai ouvert d’1 an, incluant une période de retrait à double insu contre placebo, portant sur le setmélanotide (RM-493), un agoniste du récepteur 4 de la mélanocortine (MC4R), dans l’obésité par déficit en POMC d’apparition précoce due à une mutation biallélique associée à une perte de fonction des gènes POMC ou PCSK1.

lead_sponsor: Rhythm Pharmaceuticals, Inc.


title: FEIBA NF: A prospective, open-label, randomized, parallel study to evaluate efficacy and safety of prophylactic versus on-demand treatment in subjects with hemophilia A or B and a high titer inhibitor

acronym: FEIBA NF Prophylaxis Study

lead_sponsor: Baxter Innovations GmbH


title:
Neo-AEGIS (NEOadjuvant trial in Adenocarcinoma of the oEsophagus and oesophagoGastric Junction International Study): Randomised Clinical Trial of neoadjuvant and adjuvant chemotherapy (Modified MAGIC regimen) vs. neoadjuvant chemoradiation (CROSS protocol) in adenocarcinoma of the oesophagus and oesophago-gastric junction

 Neo-AEGIS (Essai international de traitement NEO-adjuvant dans les Adénocarcinomes de l’oEsophage et de la jonction oesoGastrique) : Essai randomisé  comparant la chimiothérapie néo-adjuvante et adjuvante (protocole MAGIC modifié de chimiothérapie péri-opératoire) versus la radio-chimiothérapie néo-adjuvante (protocole CROSS) dans les adénocarcinomes de l’oesophage et de la jonction oesogastrique.

acronym: Neo-AEGIS

lead_sponsor: ICORG


title: A Phase 1/2 Study of ARQ 092 (Miransertib) in Subjects with PIK3CA-related Overgrowth Spectrum and Proteus Syndrome

lead_sponsor: ArQule, Inc.


title: Immune Response to Influenza Vaccine in Subjects with B-cell Malignancies Treated with Idelalisib

lead_sponsor: Gilead Sciences, Inc.


title: A randomised, double-blind, double-dummy, placebo-controlled, parallel-group study to assess and compare efficacy and safety of an 8-week treatment with BI 54903 at doses of 22.7, 45.5, and 90.9 µg b.i.d. administered via Respimat® inhaler and fluticasone propionate HFA MDI 88 µg b.i.d. in patients with asthma inadequately controlled on SABA therapy.

lead_sponsor: Boehringer Ingelheim Pharma GmbH & Co. KG,


title: A Phase 1/2 Open-Label, Dose Escalation Study Investigating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ASP2215 in Patients with Relapsed or Refractory Acute Myeloid Leukemia

lead_sponsor: Astellas Pharma Global Development, Inc.


title:
A phase 2, double-blind, randomized safety and efficacy study of Glasdegib (PF-04449913) versus placebo in patients with Myelofibrosis previously treated with ruxolitinib.

 Etude de phase II, randomisée, en double aveugle, évaluant l'innocuité et l'efficacité du Glasdegib (PF-04449913) en comparaison avec un placebo chez des patients atteints de myelofibrose précedemment traités par ruxolitinib.

acronym: Glasdegib (PF-04449913)

lead_sponsor: Pfizer Inc. 235 East 42nd Street, New York, 10017


title: REDUCE - Multicenter, prospective, randomized study investigating the efficacy and safety of a reduced immunosuppressive therapy with tacrolimus once daily in comparison to standard triple immunosuppression in senior renal transplant recipients

acronym: REDUCE

lead_sponsor: Charité Universitätsmedizin Berlin

lead_sponsor_type: academique


title:
Double-blind, vehicle-controlled, randomized, multi-centre study to evaluate the efficacy and safety of LH-8 cutaneous solution in children and adolescents with moderate to severe scalp alopecia areata

 Étude multicentrique en double aveugle, contre placebo et randomisée, visant à évaluer l’efficacité et l’innocuité de la solution cutanée LH-8 chez les enfants et adolescents atteints d’une pelade du cuir chevelu modérée à sévère

lead_sponsor: Legacy Healthcare (France) SAS


title:
Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of BHV-3241 in Subjects with Multiple System Atrophy (M-STAR Study)

 Étude randomisée, en double aveugle, contrôlée par placebo, en groupes parallèles, visant à évaluer l’efficacité et la sécurité de BHV-3241 chez des patients atteints d’atrophie multisystématisée (étude M-STAR).

lead_sponsor: Biohaven Pharmaceuticals, Inc


title: A Phase 1/2 Study of Oral LOXO-305 in Patients with Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) or Non-Hodgkin Lymphoma (NHL)

lead_sponsor: Loxo Oncology, Inc.


title: RANDOMISED, PLACEBO-CONTROLLED, DOUBLE-BLIND EFFICACY STUDY  OF THE EMOLLIENT V0034CR IN ADDITION TO A MODERATELY POTENT CORTICOSTEROID IN THE ACUTE PHASE OF TREATMENT OF ATOPIC DERMATITIS IN INFANTS.

acronym: Not applicable

lead_sponsor: PIERRE FABRE MEDICAMENT


title: A Phase IIa, Multicenter, Double-Blind, Randomized, Active Comparator-Controlled Clinical Trial to Study the Efficacy and Safety of MK-0893 in Combination With Sitagliptin or in Combination With Metformin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control.

lead_sponsor: Laboratoires Merck Sharp & Dohme - Chibret


title: A Phase III Randomized, Double-blind, Placebo-controlled Multicenter Study in Adults to Determine the Safety, Efficacy, and Immunogenicity of AZD1222, a Non-replicating ChAdOx1 Vector Vaccine, for the Prevention of COVID-19

lead_sponsor: AstraZeneca AB


title: A phase III, randomized, double-blind, active-controlled, equivalence clinical trial to investigate the efficacy and safety of a single injection of 100 µg Org 36286 (corifollitropin alfa) to induce multifollicular development for controlled ovarian stimulation (COS) using daily recombinant FSH (recFSH) as a reference

acronym: Ensure

lead_sponsor: NV Organon


title: A multicenter, randomized, open label phase II trial evaluating the efficacy and safety of mFOLFOX7 plus weekly alternating sequential oral administration of BIBF 1120 250 mg twice daily and BIBW 2992 50 mg once daily (BB) versus mFOLFOX7 alone as first-line therapy in patients with metastatic colorectal cancer.

lead_sponsor: Boehringer Ingelheim France SAS


title: A Phase II Study of Oral Tamibarotene in Acute Promyelocytic Leukemia Patients Who Have Received Prior Therapy with ATRA and Arsenic Trioxide (STAR-1)

lead_sponsor: INNOVIVE Pharmaceuticals


title: A six-month double-blind, randomized, placebo-controlled study investigating the safety and tolerability of deferiprone in participants with Friedreich's ataxia

lead_sponsor: ApoPharma Inc.


title: An International, Randomized, Double-blind, Placebo-controlled, Phase 2 Study of AMG 479 with Exemestane or Fulvestrant in Postmenopausal Women with Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer

lead_sponsor: Amgen Inc.


title: AN INTERNATIONAL  PHASE III RANDOMISED TRIAL COMPARING  THE PROPOFOL CONSUMPTION DURING GENERAL ANAESTHESIA WITH XENON IN INSPIRATORY CONCENTRATIONS OF 50 % AND 70% AND TOTAL IV ANAESTHESIA ALONE IN ASA III PATIENTS WITH STABLE CORONARY HEART DISEASE

acronym: General anaesthesia with xenon

lead_sponsor: AIR LIQUIDE


title: A phase 2B, randomised, double-blind, placebo-controlled, parallel group, dose-ranging, multicentre study to investigate the efficacy, safety and tolerability of the mGluR5 negative allosteric modulator ADX10059 for the prevention of migraine

lead_sponsor: Addex Pharma SA


title: A RANDOMIZED PHASE III STUDY OF TEMOZOLOMIDE AND SHORT-COURSE RADIATION VERSUS SHORT-COURSE RADIATION ALONE IN THE TREATMENT OF NEWLY  DIAGNOSED GLIOBLASTOMA MULTIFORME IN ELDERLY PATIENTS

lead_sponsor: EORTC European Organisation for Research and Treatment of Cancer


title: A multicenter, randomized, double-blind, placebo-controlled parallel-group phase IIb study of the safety and efficacy of istaroxime over 24 hours at three doses in acute decompensated heart failure patients. The IGNITE Trial.

acronym: IGNITE Trial

lead_sponsor: Debiopharm S.A.


title: A longitudinal 2-year bone marrow study of eltrombopag olamine (SB-497115-GR) in previously treated adults, with chronic immune (idiopathic) thrombocytopenic purpura (ITP).

lead_sponsor: GlaxoSmithKline Research & Development Limited


title: A Phase IIb pilot study to assess the antiviral activity of GSK1349572 containing regimen in antiretroviral therapy (ART)-experienced, HIV-1-infected adult subjects with raltegravir resistance

acronym: VIKING

lead_sponsor: GlaxoSmithKline Research and Development Ltd


title: A Phase IIIb Double-Blind, Randomised, Placebo-Controlled Study of Patient Reported Outcomes in Friedreich’s Ataxia Patients after withdrawal from Treatment with Idebenone (PROTI Study)

acronym: PROTI

lead_sponsor: Santhera Pharmaceuticals (Switzerland) Limited


title: A Randomized, Open-Label, Active-Controlled, Parallel-Group, Multicenter Study to Determine the Safety and Efficacy of Albiglutide Administered in Combination With Insulin Glargine as Compared with the Combination of Insulin Glargine and Preprandial Lispro Insulin in Subjects With Type 2 Diabetes Mellitus

lead_sponsor: SmithKline Beecham Corporation (doing business as GlaxoSmithKline)


title: A multinational, multicenter, exploratory pharmacogenomics trial to test the importance of identified genetic markers, and potentially identify new markers of various ovarian responses to GONAL-f® treatment in women undergoing assisted reproduction technology (ART).

acronym: Pharmacogenomics trial of GONAL-f® in ART

lead_sponsor: Merck Serono International, A branch of Laboratoires Serono S.A.


title: A Phase IIa, Randomized, Double-Blind, Placebo- and Active-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of MK-6913 for the Treatment of Vasomotor Symptoms in Postmenopausal Women

lead_sponsor: Merck & Co., Inc.


title: A randomized, sham-injection controlled, double-masked, multicenter trial of microplasmin intravitreal injection for treatment of exudative age-related macular degeneration (AMD).

lead_sponsor: ThromboGenics NV


title: A randomised open-label study comparing the safety and efficacy of ritonavir boosted lopinavir and 2N(t)RTI backbone versus ritonavir boosted lopinavir and raltegravir in participants virologically failing first-line NNRTI/2N(t)RTI therapy: the SECOND-LINE study

acronym: SECOND-LINE

lead_sponsor: National Centre in HIV Epidemiology and Clinical Research


title: A prospective, multi-center, randomized, double-blind trial to assess the effectiveness and safety of 12 versus 30 months of dual antiplatelet therapy (DAPT) in subjects undergoing percutaneous coronary intervention (PCI) with either drug-eluting stent (DES) or bare metal stent (BMS) placement for the treatment of coronary artery lesions.

acronym: DAPT Study

lead_sponsor: HCRI


title: A randomized pre-surgical pharmacodynamics study to assess the biological activity of LEE011 plus letrozole versus single agent letrozole in primary breast cancer

lead_sponsor: Novartis Pharma AG


title: A Phase 3, Double-Blind, Double-Dummy, Multi-Center, Prospective, Randomized Study of the Efficacy and Safety of LCP-Tacro™ Tablets, Once Daily, Compared to Prograf® Capsules, Twice Daily, in Combination with Mycophenolate Mofetil for the Prevention of Acute Allograft Rejection in De Novo Adult Kidney Transplant Recipients

lead_sponsor: LifeCycle Pharma A/S


title:
A randomized phase 2 study comparing different dose-approaches of induction treatment (first cycle) of regorafenib in metastatic colorectal cancer (mCRC) patients.

 Une étude de phase 2 randomisée comparant différentes approches posologiques dans le traitement par induction (premier cycle) du régorafénib chez des patients adultes atteints d'un cancer colorectal métastatique (CCRm).

acronym:
RE-ARRANGE

 RE-ARRANGE

lead_sponsor: Grupo de Tratamiento de los Tumores Digestivos (TTD)


title:
Clinical Study in Previously Treated Children with Severe Haemophilia A to Investigate the Long-Term Immunogenicity, Tolerability and Efficacy of Human-cl rhFVIII

 Etude clinique chez des enfants atteints d’hémophilie A sévère et préalablement traités visant à étudier l'immunogénicité, la tolérance et l'efficacité à long terme de Human-cl rhFVIII

lead_sponsor: Octapharma AG


title: Randomised phase II trial of oral vinorelbine and cisplatin followed by maintenance with single agent oral vinorelbine versus gemcitabine and cisplatin followed by maintenance with single agent gemcitabine in first line Locally Advanced or Metastatic Non-Small-Cell Lung Cancer patients with squamous histological type

lead_sponsor: Pierre Fabre Medicament


title: Randomized multi-centre open-label non-inferiority phase 3 clinical trial for patients with a stage IV childhood renal tumour comparing upfront Vincristine, Actinomycin-D and Doxorubicin (VAD, standard arm) with upfront Vincristine, Carboplatin and Etoposide (VCE, experimental arm)

lead_sponsor: ASSISTANCE PUBLIQUE HÔPITAUX DE MARSEILLE


title: A Phase 2/3, Multicenter Randomized Study of Rituximab-Gemcitabine-Dexamethasone-Platinum (R-GDP) with or without Selinexor in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma (RR DLBCL)

lead_sponsor: Karyopharm Therapeutics Inc.


title: A Double-Blind, Placebo-Controlled, Parallel-Group, Multicentre, Multiregional, One Year Study to Assess the Efficacy and Safety of Twice Daily Oral Rifaximin Delayed Release Tablets for Induction of Clinical Remission with Endoscopic Response at 16 Weeks followed by Clinical and Endoscopic Remission at 52 Weeks in Subjects with Active Moderate Crohn’s Disease

lead_sponsor: Salix Pharmaceuticals, Inc.


title: Phase 2 randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety and efficacy of Reltecimod as compared to placebo in addition to standard of care in patients with sepsis-associated acute kidney injury (SA-AKI)

acronym: REAKT

lead_sponsor: Atox Bio


title: Phase II study for repeated dosing of the trifunctional bispecific  anti-HER-2/neu x anti-CD3 antibody ertumaxomab in patients with  HER-2/neu 1+ or 2+/FISH negative expressing advanced or metastatic  breast cancer (stage IIIb/IV) progressing after endocrine treatment

lead_sponsor: Fresenius Biotech GmbH


title:
A Phase 2 Multinational, Randomized, Double-blind, Parallel-group, 16-week Placebo-controlled Study with a 36–week Extension to Investigate the Use of Benralizumab for Patients with Moderate to Severe Atopic Dermatitis Despite Treatment with Topical Medications (The HILLIER Study)

 Étude de phase 2, internationale, randomisée, en double aveugle, en groupes parallèles, contrôlée par placebo, menée sur 16 semaines avec une période d’extension de 36 semaines, évaluant l’utilisation du benralizumab chez des patients atteints de dermatite atopique modérée à sévère et traités par des médicaments topiques (étude HILLIER)

acronym: HILLIER

lead_sponsor: AstraZeneca AB


title: A Phase I/II study of clofarabine in combination with cytarabine and liposomal daunorubicin in children with relapsed/refractory pediatric AML

acronym: CLARA-DNX

lead_sponsor: Hospices Civils de Lyon


title:
A phase II, multicenter, open-label, randomized-controlled trial evaluating the efficacy and safety of a sequencing schedule of cobimetinib plus vemurafenib followed by immunotherapy with an anti- PD-L1 antibody atezolizumab for the treatment in patients with unresectable or metastatic BRAF V600 mutant melanoma.

 Essai clinique multicentrique, ouvert et randomisé de phase II visant à déterminer l’efficacité et la sécurité d'une thérapie séquentielle à base de cobimétinib et de vémurafénib, suivie d’une immunothérapie par anticorps anti-PD-L1 atézolizumab pour traiter des patients présentant un mélanome inopérable ou métastatique avec mutation BRAFV600.

acronym:
ImmunoCobiVem

 ImmunoCobiVem

lead_sponsor: University Hospital Essen


title: A Randomized double-blind placebo-controlled multicenter Phase 3 study of efficacy and safety of AR-301 as adjunct therapy to antibiotics in the treatment of Ventilator-Associated Pneumonia (VAP) caused by S. aureus

lead_sponsor: Aridis Pharmaceuticals, Inc.


title: Efficacy and safety study of F373280 for maintenance of sinus rhythm after electrical cardioversion in patients with persistent Atrial Fibrillation and Chronic Heart Failure.

lead_sponsor: PIERRE FABRE MEDICAMENT


title: A pivotal, international, randomised, double-blind, efficacy and safety trial of sodium valporate in paediatric and adult patients with Wolfram Syndrome

acronym: Treat Wolfram

lead_sponsor: University of Birmingham


title: A proSpective randomized controlled trial comParing infliximAb-antimetabolites combination therapy to anti-metabolites monotheRapy and infliximab monothErapy in Crohn’s disease patients in sustained steroid-free remission on combination therapy.

acronym: GETAID 2014-3 SPARE

lead_sponsor: GETAID


title: A Seamless, Adaptive, Phase 2b/3, Double-Blind, Randomized, Placebo-controlled, Multicenter, International Study Evaluating the Efficacy and Safety of Belapectin (GR MD-02) for the Prevention of Esophageal Varices in NASH Cirrhosis.

acronym: NASH-RX

lead_sponsor: Galectin Therapeutics Inc.


title:
An Open Label, Non-Randomized, Multi-Center Extension Study to Evaluate the Long Term Safety and Efficacy of APL-2 in the treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH).

 ÉTUDE D’EXTENSION EN OUVERT, NON RANDOMISEE, MULTICENTRIQUE VISANT A EVALUER L’EFFICACITE ET LA SECURITE D’EMPLOI A LONG TERME DE L’APL-2 CHEZ DES PATIENTS ATTEINTS D’HEMOGLOBINURIE PAROXYSTIQUE NOCTURNE (HPN)

lead_sponsor: Apellis Pharmaceuticals, Inc.


title: A Phase 2, single-arm, pathologist-blinded study using liver biopsy specimens to assess copper concentration and histopathologic changes in patients with Wilson disease who are treated with ALXN1840 for 48 weeks followed by an extension treatment period with ALXN1840 for up to an additional 48 weeks

lead_sponsor: Alexion Pharmaceuticals, Inc


title: Treatment of chemo-refractory viral infections after allogeneic stem cell transplantation with multispecific T cells against CMV, EBV and AdV:  A phase III, prospective, multicentre clinical trial

acronym: Multivirus-specific T-cell transfer post SCT vs AdV, CMV and EBV infections (TRACE)

lead_sponsor: Klinikum der Universität München


title:
Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Determine the Efficacy and Safety of Vedolizumab in Prevention of Endoscopic Recurrence of Crohn's Disease in Patients with Ileo-colonic Surgical Resection and Ileocolonic Anastamosis : REPREVIO (recurrence prevention with Entyvio)

 Essai multicentrique contrôlé randomisé en double aveugle contre placebo étudiant l’efficacité et la tolérance du védolizumab en prévention de la récidive postopératoire de maladie de Crohn après résection-anastomose iléo-colique (REPREVIO)

acronym:
REPREVIO

 REPREVIO

lead_sponsor: Academic Medical Center Amsterdam


title: Open-Label, Phase 2 Study to Evaluate the Efficacy and Safety of CUDC-907 With and Without Rituximab in Patients With Relapsed/Refractory MYC-Altered Diffuse Large B-Cell Lymphoma

lead_sponsor: Curis, Inc.


title:
A Randomized, Open-label, Multi-center Phase III Study of Durvalumab and Tremelimumab as First-line Treatment in Patients with Unresectable Hepatocellular Carcinoma (HIMALAYA)

 Etude randomisée, en ouvert, multicentrique de phase III évaluant le Durvalumab et le Tremelimumab en 1ère ligne de traitement chez les patients atteints d’un carcinome hépatocellulaire non résécable (HIMALAYA)

acronym: HIMALAYA


title:
A Phase 2, Open-label, Multicenter, Randomized, Multidrug Platform Study of Durvalumab Alone or in Combination with Novel Agents in Subjects with Locally Advanced, Unresectable, Stage III Non-small Cell Lung Cancer (COAST)

 Étude de plateforme de phase 2, multicentrique, randomisée, en ouvert, utilisant plusieurs médicaments, visant à évaluer le durvalumab en monothérapie ou en association avec de nouveaux agents chez des sujets atteints de cancer du poumon non à petites cellules de stade III, localement avancé et non résécable (COAST)

acronym: COAST

lead_sponsor: MedImmune, LLC, a wholly owned subsidiary of AstraZeneca PLC


title: A Phase II, global, randomized study to evaluate the efficacy and safety of Danirixin (GSK1325756) co-administered with a standard-of-care antiviral (oseltamivir), in the treatment of adults hospitalized with influenza

acronym: GSK1325756, Phase 2, hospitalised Influenza Patients, RD, NAI co-administration, IV, PKPD

lead_sponsor: GlaxoSmithKline Research & Development Ltd


title: A Prospective, Randomized, Double-Blinded, Placebo-Controlled, Multinational, Multicenter, Parallel-group, Phase III Study to Evaluate the Efficacy and Safety of Apatinib plus Best Supportive Care (BSC) compared to Placebo plus BSC in Patients with Advanced or Metastatic Gastric Cancer (GC)

lead_sponsor: LSK BioPartners, Inc


title:
A Phase 3 trial of Setmelanotide (RM-493), a Melanocortin-4 Receptor (MC4R) Agonist, in Bardet-Biedl Syndrome (BBS) and Alström syndrome (AS) Patients with Moderate to Severe Obesity

 Étude de phase 3 portant sur la setmélanotide (RM-493), un agoniste du récepteur 4 de la mélanocortine (MC4R), dans le syndrome de Bardet-Biedl (SBB) et le syndrome d’Alström (SA) chez des patients atteints d’obésité modérée à sévère

lead_sponsor: Rhythm Pharmaceuticals, Inc.


title:
A Randomized, Open-Label Phase II/III Study With Dendritic Cells Loaded With Allogeneic Tumour Cell Lysate (PheraLys) in Subjects With Mesothelioma as Maintenance Treatment (MesoPher) After Chemotherapy.
 DENIM (DENdritic Cell Immunotherapy for Mesothelioma)

lead_sponsor: Amphera B.V.


title: An open-label study to provide berotralstat access to subjects with type 1 and 2 hereditary angioedema who were previously enrolled in berotralstat studies

lead_sponsor: BioCryst Pharmaceuticals Inc


title: An open label extension study to investigate the safety of cannabidiol (GWP42003-P; CBD) in children and adults with inadequately controlled Dravet or Lennox-Gastaut Syndromes

lead_sponsor: GW Research Ltd


title: Study to Assess the Safety of Cystadrops® in Pediatric Cystinosis Patients from 6 Months to Less Than 2 Years Old

acronym: SCOB2 (Study Cystadrops® Ophthalmic for Patients Below 2 years)

lead_sponsor: Recordati Rare Diseases


title:
SHAMAL: A Multicentre, Randomised, Open-Label, Parallel-Group, Active-Controlled, Phase IV Study to Assess the Reduction of Daily Maintenance ICS/LABA Treatment Towards Anti-Inflammatory Reliever Treatment in Patients with Severe Eosinophilic Asthma Treated with Benralizumab

 SHAMAL : Étude de Phase IV multicentrique, randomisée, menée en ouvert, avec groupes parallèles, contrôlée versus traitement actif, évaluant la réduction du traitement d’entretien quotidien par ICS/LABA en faveur d'un traitement anti-inflammatoire de crise chez des patients présentant un asthme éosinophilique sévère traités par benralizumab

acronym: SHAMAL

lead_sponsor: AstraZeneca AB


title:
Pragmatic, prospective, randomized, controlled, double-blind, multicentre, multinational study on the safety and efficacy of a 6% Hydroxyethyl starch  (HES) solution versus an electrolyte solution in trauma patients

 Étude pragmatique, prospective, randomisée, contrôlée, en double aveugle, multicentrique, internationale, visant à évaluer la sécurité et l’efficacité d’une solution d’hydroxyéthylamidon (HEA) à 6 % par comparaison avec une solution électrolytique chez des patients victimes de blessures traumatiques

acronym: TETHYS

lead_sponsor: B. Braun Melsungen AG


title:
A Randomised, Double-Blind, Vehicle-Controlled Phase 2 Study of Topically Applied INM-755 (cannabinol) Cream in Patients with Epidermolysis Bullosa.

 Étude de phase II, randomisée, en double aveugle et contre crème véhicule portant sur l’INM-755 (cannabinol) par voie topique chez des patients atteints d’épidermolyse bulleuse

lead_sponsor: InMed Pharmaceuticals Inc.


title: A Randomized, Parallel-Arm, Double-Blind, Placebo-Controlled Study with Open-Label Extension to Assess the Efficacy and Safety of Vatiquinone for the Treatment of Friedreich ataxia (MOVE-FA)

acronym: MOVE-FA

lead_sponsor: PTC Therapeutics, Inc.


title:
A subject-, investigator-, and sponsor-blinded, randomized, placebo-controlled, multicenter study to investigate efficacy, safety, and tolerability of VAY736 in patients with idiopathic pulmonary fibrosis

 Étude multicentrique, contrôlée par placebo, randomisée, pour laquelle les patients, les investigateurs et le promoteur sont en aveugle, visant à examiner l’efficacité, la sécurité d’emploi et la tolérance de VAY736 chez des patients atteints de fibrose pulmonaire interstitielle diffuse (FPID)

lead_sponsor: Novartis Pharma AG


title:
Phase II study examining the activity of L19-IL2 immunotherapy and stereotactic ablative radiotherapy in metastatic non-small cell lung cancer

 Étude de phase II portant sur la combinaison d’une immunothérapie L19-IL2 et d’une radiothérapie (stéréotaxique d'ablation) chez des patients atteints d’un carcinome pulmonaire non à petites cellules métastasé

lead_sponsor: Maastricht University Medical Centre


title: A randomized, double-blinded, phase III study of atezolizumab versus placebo in patients with late relapse of epithelial ovarian, fallopian tube, or peritoneal cancer treated by platinum-based chemotherapy and bevacizumab

acronym: ATALANTE : ATezolizumab and Avastin in LAte recurreNT diseasE

lead_sponsor: ARCAGY-GINECO


title: Randomized, multinational, double-blind study, comparing a high loading dose regimen of clopidogrel versus standard dose in patients with unstable angina or non-ST segment elevation myocardial infarction managed with an early invasive strategy

acronym: CURRENT

lead_sponsor: sanofi-aventis recherche et développement


title: A Comparison of Prasugrel and Clopidogrel in Acute Coronary Syndrome (ACS) Subjects with Unstable Angina/Non-ST-Elevation Myocardial Infarction (UA/NSTEMI) Who are Medically Managed - The TRILOGY ACS Study

acronym: Trilogy ACS

lead_sponsor: Eli Lilly and Company


title: A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Ulcerative Colitis

lead_sponsor: Millennium Pharmaceuticals, Inc.


title: A randomised double-blind placebo-controlled clinical trial investigating the effect and safety of oral semaglutide in subjects with early Alzheimer´s disease (EVOKE)

lead_sponsor: Novo Nordisk A/S


title:
An open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis

 Etude d’extension, multicentrique, en ouvert, à un seul bras évaluant la sécurité d’emploi, la tolérance et l’efficacité à long-terme de l’ofatumumab chez des patients atteints de sclérose en plaques récurrente.


title: Effects of ivabradine in patients with stable coronary artery disease without clinical heart failure. A randomised double-blind placebo-controlled international multicentre study.

acronym: SIGNIFY

lead_sponsor: Institut de Recherches Internationales Servier


title: A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Crohn’s Disease


title: A Randomized, Double-blind, Placebo-Controlled, Phase 2 Study of Cemiplimab Versus the Combination of Cemiplimab With ISA101b in the Treatment of Subjects With HPV16-Positive Platin-Resistant Oropharyngeal Cancer (OPC)

lead_sponsor: ISA Therapeutics B.V.


title:
A Randomized, Double-Blind, Controlled Phase 3 Study of Cabozantinib in Combination with Nivolumab and Ipilimumab versus Nivolumab and Ipilimumab in Subjects with Previously Untreated Advanced or Metastatic Renal Cell Carcinoma of Intermediate or Poor Risk

 Étude de phase 3, contrôlée, randomisée, en double aveugle, portant sur le cabozantinib en association au nivolumab et l’ipilimumab par rapport au nivolumab et à l’ipilimumab chez des patients présentant un carcinome à cellules rénales avancé ou métastatique non traité auparavant, à risque intermédiaire ou faible

lead_sponsor: Exelixis, Inc.


title:
A 12-week, multicenter, randomized, double-blind, parallel-arm, placebo-controlled study to assess the efficacy and safety of CSJ117, when added to existing asthma therapy in patients ≥18 years of age with severe uncontrolled asthma.

 Étude de 12 semaines, multicentrique, randomisée, en double aveugle, groupes parallèles, contrôlée versus placebo, visant à évaluer l’efficacité et la sécurité d’emploi du CSJ117, lorsqu’il est ajouté au traitement de l’asthme existant chez les patients âgés de ≥ 18 ans souffrant d’asthme sévère non contrôlé


title: A Phase III Study of Pembrolizumab (MK-3475) vs. Best Supportive Care as Second-Line Therapy in Subjects with Previously Systemically Treated Advanced Hepatocellular Carcinoma (KEYNOTE-240)

acronym: Phase III Study of MK 3475 + Best Supportive Care in Subjects with Advanced Hepatocellular Carcinoma

lead_sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.


title: Extended treatment protocol for subjects continuing to benefit from ibrutinib after completion of ibrutinib clinical trials

lead_sponsor: Pharmacyclics Switzerland GmbH


title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial to Evaluate the Efficacy and Safety of Oral BTK Inhibitor PRN1008 in Moderate to Severe Pemphigus

lead_sponsor: Principia Biopharma


title:
Phase 3 Open-Label, Multicenter Study of the Safety, Efficacy, and Pharmacokinetics of Intravenous Recombinant Coagulation Factor VIII Fc-von Willebrand Factor-XTEN Fusion Protein (rFVIIIFc-VWF-XTEN; BIVV001) in Previously Treated Patients ≥12 Years of Age With Severe Hemophilia A

 Étude de phase 3, en ouvert, multicentrique visant à évaluer l'innocuité, l'efficacité et la pharmacocinétique de l'association intraveineuse du facteur VIII de coagulation recombinant fusionné au fragment Fc-facteur de von Willebrand-protéine de fusion XTEN (rFVIIIFc-VWF-XTEN ; BIVV001) chez des patients ayant déjà été traités, âgés de ≥ 12 ans atteints d'hémophilie A sévère

lead_sponsor: Bioverativ Therapeutics Inc.


title: A Phase 3 Study of Itacitinib or Placebo in Combination With Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease

lead_sponsor: Incyte Corporation


title: A Phase 3, Randomized, Open-label Study to Compare Adjuvant Immunotherapy of Bempegaldesleukin Combined with Nivolumab Versus Nivolumab After Complete Resection of Melanoma in Patients at High Risk for Recurrence (PIVOT-12)

acronym: PIVOT - 12

lead_sponsor: Nektar Therapeutics


title:
A randomized, double-blind placebo-controlled, Phase 3 study of Debio 1143 in combination with platinum-based chemotherapy and standard fractionation intensity-modulated radiotherapy in patients with locally advanced squamous cell carcinoma of the head and neck, suitable for definitive chemoradiotherapy (TrilynX)

 Étude de phase 3, randomisée, en double aveugle, contrôlée par placebo, portant sur Debio 1143 associé à une chimiothérapie à base de platine et une radiothérapie conformationnelle par modulation d'intensité chez les patients atteints d’un carcinome épidermoïde à cellules squameuses de la tête et du cou localement avancé, pour lequel une chimioradiothérapie définitive est appropriée (TrilynX).

acronym: TrilynX

lead_sponsor: Debiopharm International S.A.


title:
A Phase 3, Randomized, Multi-center, Open-label Study of Trastuzumab Deruxtecan (T-DXd) versus Investigator’s Choice Chemotherapy in HER2-Low, Hormone Receptor Positive Breast Cancer Patients whose Disease has Progressed on Endocrine Therapy in the Metastatic Setting (DESTINY-Breast06)

 Étude de phase III, randomisée, multicentrique, en ouvert, comparant le trastuzumab déruxtecan (T-DXd) versus une chimiothérapie au choix de l'investigateur chez des patients atteints d’un cancer du sein RH+, avec faible expression de HER2, ayant progressé sous traitement endocrinien en contexte métastatique (DESTINY-Breast06)

lead_sponsor: AstraZeneca AB


title: A Randomized, Double-blind, Placebo-Controlled, Phase 3 Study  to Assess the Efficacy and Safety of Weekly Farletuzumab (MORAb-003) in Combination with Carboplatin and Taxane in Subjects with Platinum-sensitive Ovarian Cancer in First Relapse

lead_sponsor: Eisai Limited


title: Phase 3 Open-Label Randomized Study of Amonafide L-Malate in Combination with Cytarabine Compared to Daunorubicin in Combination with Cytarabine in Patients with Secondary Acute Myeloid Leukemia (AML)

lead_sponsor: Antisoma Research Ltd.


title: A Phase III Randomized Study of Oral Sapacitabine in Elderly Patients with Newly Diagnosed Acute Myeloid Leukemia

lead_sponsor: Cyclacel Limited


title: A Phase II multi-center, open label, randomized study to assess safety and efficacy of two different schedules of oral LDE225 in adult patients with relapsed/refractory or untreated elderly patients with acute leukemia

lead_sponsor: Novartis Pharma Services AG


title: A Randomized Parallel-Group, Placebo-Controlled, Double-Blind, Event-Driven, Multi- Center Pivotal Phase III Clinical Outcome Trial of Efficacy and Safety of the Oral sGC Stimulator Vericiguat in Subjects With Heart Failure With Reduced Ejection Fraction (HFrEF) - VerICiguaT Global Study in Subjects With Heart Failure With Reduced Ejection Fraction (VICTORIA)


title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of SCH 530348 in Addition to Standard of Care in Subjects With Acute Coronary Syndrome: Thrombin Receptor Antagonist for Clinical Event Reduction in Acute Coronary Syndrome (TRA•CER)

acronym: TRA•CER

lead_sponsor: Schering-Plough Research Institute, a division of Schering Corporation


title: Thiazolidinedione Intervention with vitamin D Evaluation (TIDE) A Multicenter Randomized Double-Blind Placebo-Controlled Trial of a Thiazolidinedione or Placebo and of Vitamin D or Placebo In People With Type 2 Diabetes at Risk For Cardiovascular Disease

acronym: TIDE

lead_sponsor: GlaxoSmithKline


title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of SCH 530348 in Addition to Standard of Care in Subjects With a History of Atherosclerotic Disease: Thrombin Receptor Antagonist in Secondary Prevention of Atherothrombotic Ischemic Events (TRA 2°P - TIMI 50)

acronym: TRA 2°P - TIMI 50

lead_sponsor: Schering-Plough Research Institute


title: Randomized placebo-controlled study to evaluate the safety and efficacy of adding tocilizumab (TCZ) to methotrexate (MTX) versus switching to TCZ (placebo controlled), with possible addition of other disease-modifying anti-rheumatic drugs (DMARDs), in patients with active rheumatoid arthritis who have inadequately responded to prior MTX treatment.

lead_sponsor: F Hoffmann-La Roche Ltd


title: A Phase 3 Extension, Multicenter, Double-blind, Parallel-Group, Long-term Safety and Tolerability Trial of Bapineuzumab (AAB-001, ELN115727) in Subjects With Alzheimer Disease Who Are Apolipoprotein E ε4 Noncarriers and Participated in Study 3133K1-3000-WW

lead_sponsor: Wyeth Research Division of Wyeth Pharmaceuticals Inc., Clinical Research and Development


title: A multi-centre, open-label, randomised, two-arm Phase III trial of bevacizumab plus chemotherapy versus chemotherapy alone in patients with platinum-resistant, epithelial ovarian, fallopian tube or primary peritoneal cancer.

acronym: AURELIA

lead_sponsor: F. Hoffmann-La Roche Ltd


title: An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn's Disease

acronym: CALM

lead_sponsor: Abbott GmbH & Co. KG


title: A Comparison of Prasugrel at the Time of Percutaneous Coronary Intervention (PCI) Or as Pre-treatment At the Time of Diagnosis in Patients with Non-ST-Elevation Myocardial Infarction (NSTEMI)  -  The ACCOAST Study

acronym: TADF

lead_sponsor: Eli Lilly


ReferenceType: derived

ReferenceCitation: Koch MW, Mostert J, Repovic P, Bowen JD, Strijbis E, Uitdehaag B, Cutter G. Smoking, obesity, and disability worsening in PPMS: an analysis of the INFORMS original trial dataset. J Neurol. 2021 Aug 15. doi: 10.1007/s00415-021-10750-z. [Epub ahead of print]

family: Koch

full_name: Marcus W. Koch

given: Marcus W.

sequence: first

family: Mostert

full_name: Jop Mostert

given: Jop

sequence: additional

family: Repovic

full_name: Pavle Repovic

given: Pavle

family: Bowen

full_name: James D. Bowen

given: James D.

family: Strijbis

full_name: Eva Strijbis

given: Eva

family: Uitdehaag

full_name: Bernard Uitdehaag

given: Bernard

family: Cutter

full_name: Gary Cutter

given: Gary

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Journal of Neurology

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ReferenceCitation: Koch MW, Mostert J, Zhang Y, Wolinsky JS, Lublin FD, Strijbis E, Cutter G. Association of Age With Contrast-Enhancing Lesions Across the Multiple Sclerosis Disease Spectrum. Neurology. 2021 Sep 28;97(13):e1334-e1342. doi: 10.1212/WNL.0000000000012603. Epub 2021 Aug 10.

family: Zhang

full_name: Yinan Zhang

given: Yinan

family: Wolinsky

full_name: Jerry S. Wolinsky

given: Jerry S.

family: Lublin

full_name: Fred D. Lublin

given: Fred D.

journal_name: Neurology

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

ReferenceCitation: Miller DH, Lublin FD, Sormani MP, Kappos L, Yaldizli Ö, Freedman MS, Cree BAC, Weiner HL, Lubetzki C, Hartung HP, Montalban X, Uitdehaag BMJ, MacManus DG, Yousry TA, Gandini Wheeler-Kingshott CAM, Li B, Putzki N, Merschhemke M, Häring DA, Wolinsky JS. Brain atrophy and disability worsening in primary progressive multiple sclerosis: insights from the INFORMS study. Ann Clin Transl Neurol. 2018 Jan 30;5(3):346-356. doi: 10.1002/acn3.534. eCollection 2018 Mar.

name: Queen Square MS Centre; UCL Institute of Neurology; London UK

family: Miller

full_name: David H. Miller

given: David H.

name: The Corinne Goldsmith Dickinson Center for Multiple Sclerosis; Icahn School of Medicine at Mount Sinai; New York New York

name: Biostatistics Unit; Department of Health Sciences (DISSAL); University of Genoa; Via Pastore 1 Genoa 16132 Italy

family: Sormani

full_name: Maria Pia Sormani

given: Maria Pia

name: Departments of Medicine, Clinical Research, Biomedicine and Biomedical Engineering; University Hospital; University of Basel; Basel Switzerland

family: Kappos

full_name: Ludwig Kappos

given: Ludwig

name: Department of Neurology; University Hospital Basel; Basel Switzerland

family: Yaldizli

full_name: Özgür Yaldizli

given: Özgür

name: The Ottawa Hospital Research Institute; University of Ottawa; Ottawa Ontario

family: Freedman

full_name: Mark S. Freedman

given: Mark S.

name: Multiple Sclerosis Center; University of California; San Francisco California

name: Brigham and Women's Hospital; Harvard Medical School; Boston Massachusetts

name: Center of Clinical Investigation; Salpêtrière Hospital APHP; University Paris 6; Paris France

name: Department of Neurology; Medical Faculty; Heinrich-Heine University; Düsseldorf Germany

name: Hospital Universitari Vall d'Hebron; Barcelona Spain

name: VU University Medical Center; Amsterdam The Netherlands

name: Novartis Pharmaceuticals Corporation; East Hanover New Jersey

name: McGovern Medical School; UTHealth; Houston Texas

journal_name: Annals of Clinical and Translational Neurology

repository_institution: Harvard University - Digital Access to Scholarship at Harvard (DASH)

evidence: oa repository (via OAI-PMH title and first author match)

repository_institution: University College London - UCL Discovery

repository_institution: University of California - eScholarship University of California

repository_normalized: California Digital Library - eScholarship

ReferenceCitation: Lublin F, Miller DH, Freedman MS, Cree BAC, Wolinsky JS, Weiner H, Lubetzki C, Hartung HP, Montalban X, Uitdehaag BMJ, Merschhemke M, Li B, Putzki N, Liu FC, Häring DA, Kappos L; INFORMS study investigators. Oral fingolimod in primary progressive multiple sclerosis (INFORMS): a phase 3, randomised, double-blind, placebo-controlled trial. Lancet. 2016 Mar 12;387(10023):1075-1084. doi: 10.1016/S0140-6736(15)01314-8. Epub 2016 Jan 28. Erratum in: Lancet. 2017 Jan 21;389(10066):254.

ReferenceCitation: Hartung HP, Aktas O. Bleak prospects for primary progressive multiple sclerosis therapy: downs and downs, but a glimmer of hope. Ann Neurol. 2009 Oct;66(4):429-32. doi: 10.1002/ana.21880.

title: Bleak prospects for primary progressive multiple sclerosis therapy: Downs and downs, but a glimmer of hope

ipd_sharing_description:
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

location_country:
Italy
United States
Sweden
Switzerland
Netherlands
Germany
Finland
France
Czechia
Poland
Hungary
Belgium
Australia
Spain
Turkey
Denmark
Canada
United Kingdom

title: A Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Comparing the Efficacy and Safety of 0.5mg Fingolimod Administered Orally Once Daily Versus Placebo in Patients With Primary Progressive Multiple Sclerosis and An Open-label, Single-arm Extension Study to the Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Comparing the Efficacy and Safety of0.5 mg FTY720 Administered Orally Once Daily Versus Placebo in Patients With Primary Progressive Multiple Sclerosis

summary: The purpose of this study is to evaluate whether FTY720 is effective in delaying MS disability progression compared to placebo in patients with PPMS. This was an open-label, single-arm extension study to a double-blind, randomized multicenter, placebo-controlled, parallel-group core study. The core study completed and eligible patients enrolled into the extension study at the next scheduled or unscheduled core study visit. All patients, regardless of their treatment in the core study, received fingolimod 0.5 mg in the extension study. The extension study was terminated early after the results of the core study became available showing that the study did not meet its primary endpoint which was defined as confirmed disability progression in this population


title: A Multicenter, Randomized, Double-Blinded Comparative Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Daptomycin Versus Active Comparator in Pediatric Subjects With Acute Hematogenous Osteomyelitis Due to Gram-Positive Organisms

lead_sponsor: Cubist Pharmaceuticals, Inc.


title: Extension study to the multicenter, open-label, randomized, controlled study CRAD001H2304 to evaluate the long-term efficacy and safety of concentration-controlled everolimus in liver transplant recipients


title: A Multicenter Study of  the Efficacy and Safety of the Human Anti-TNF Monoclonal Antibody Adalimumab as Maintenance Therapy in Subjects Requiring High Dose Corticosteroids for Active Non infectious Intermediate-, Posterior-, or Pan-uveitis


title: A Worldwide, Open Label, Clinical Trial to Examine the Long Term Safety and Tolerability of Rizatriptan in Pediatric Migraineurs for the Treatment of Migraine With or Without Aura

lead_sponsor: Merck & Co., Inc.


title: An International, Multicenter, Randomized, Double-Blind Study of Vorinostat (MK-0683) or Placebo in Combination with Bortezomib in Patients with Multiple Myeloma

lead_sponsor: Merck & Co., Inc


title: A Randomized Acceptability and Safety Study of Suboxone Induction in Heroin Users

lead_sponsor: Integrated Therapeutics Group Inc


title: A Phase 3, Multicenter, Randomized, Placebo-Controlled, Double-Blind Trial of AMG 706 in Combination With Paclitaxel and Carboplatin for Advanced Non-small Cell Lung Cancer

lead_sponsor: Amgen Inc


title: A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receiving concomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine.

acronym: Safinamide in IPD with motor fluctuations, as add-on to levodopa

lead_sponsor: Merck Serono S.A. - Geneva


title: A Phase III Randomized, Placebo-Controlled Clinical Trial to Assess the Safety and Efficacy of Odanacatib (MK-0822) to Reduce the Risk of Fracture in Osteoporotic Postmenopausal Women Treated With Vitamin D and Calcium

lead_sponsor: Laboratoires Merck Sharp & Dohme - Chibret


title:
A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose-Escalation and Dose-Confirmation Study to Evaluate the Safety and Efficacy of Rivaroxaban in Combination with Aspirin Alone or with Aspirin and a Thienopyridine in Subjects with Acute Coronary Syndromes  (39039039ACS2001)
 The ATLAS ACS TIMI 46 Trial (Anti-Xa Therapy to Lower cardiovascular events in addition to Aspirin with or without thienopyridine therapy in Subjects with Acute Coronary Syndrome)

acronym: The ATLAS ACS TIMI 46 Trial

lead_sponsor: Bayer HealthCare AG


title: Cilengitide in subjects with newly diagnosed glioblastoma multiforme and methylated MGMT gene promoter – a multicenter, open-label, controlled Phase III study, testing cilengitide in combination with standard treatment (temozolomide with concomitant radiation therapy, followed by temozolomide maintenance therapy) versus standard treatment alone.

acronym: CENTRIC

lead_sponsor: Merck KGaA


title: A Multicenter, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Long Term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects With Ulcerative Colitis


title: A Phase III, Observer-Blind, Randomized, Non-influenza Vaccine Comparator-Controlled, Parallel-Group, Multi-Country Study in Children Aged 6-35 Months to Assess the Safety and Efficacy of Abbott’s Candidate Quadrivalent Influenza Vaccine.

lead_sponsor: Abbott Biologicals B.V.

status: Not Authorised


title: A MULTICENTER, DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF LACOSAMIDE AS ADJUNCTIVE THERAPY IN SUBJECTS WITH EPILEPSY ≥4 YEARS TO <17 YEARS OF AGE WITH PARTIAL ONSET SEIZURES

lead_sponsor: UCB BIOSCIENCES, Inc.


title: A RANDOMIZED, OPEN-LABEL, MULTI-CENTER, ACTIVE-CONTROLLED, PARALLEL GROUP STUDY TO DETERMINE THE EFFICACY AND SAFETY OF THE REG1 ANTICOAGULATION SYSTEM COMPARED TO BIVALIRUDIN IN PATIENTS UNDERGOING PERCUTANEOUS CORONARY INTERVENTION

lead_sponsor: Regado Biosciences, Inc.


title: A Phase III, randomized, double-blind, placebo-controlled multi-center study of ASA404 in combination with paclitaxel and carboplatin as first-line treatment for locally advanced or metastatic (stage IIIb/IV) non-small cell lung cancer (NSCLC).

lead_sponsor: Novartis Pharma Services AG


title: A Phase 3, 12-Week, Double-Blind, Placebo-and Active-Controlled Efficacy and Safety Study of Preladenant in Subjects with Moderate to Severe Parkinson's Disease

lead_sponsor: Schering-Plough Research Institute, a division of Schering Corporation


title: A 12-week treatment, multi-center, randomized, parallel group, blinded, double dummy study to compare the efficacy and safety of Indacaterol (150 μg o.d.) delivered via a SDDPI with Tiotropium (18 μg o.d.) delivered via a HandiHaler®, in patients with moderate-to-severe COPD.


title:
A Multicenter, Open-Label Study to Evaluate the Long Term Efficacy, Safety, and Tolerability of
 Repeated Administration of Adalimumab in Subjects with Crohn's Disease

lead_sponsor: AbbVie Deutschland GmbH & Co. KG


title: A Worldwide, Randomized, Double Blind, Placebo-Controlled, Parallel Group Clinical Trial to Evaluate the Safety and Efficacy of Rizatriptan for the Acute Treatment of Migraine in Children and Adolescents


title: A Multicenter Study of the Efficacy and Safety of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects with Inactive Non-infectious Intermediate-, Posterior-, or Pan-uveitis

lead_sponsor: Abbott GmbH & Co. KG


title: A Randomized, Multicenter, Double-Blind, Group-Sequential Study to Evaluate the Efficacy, Immunogenicity, and Safety of a Single Dose of Merck 0657nI Staphylococcus aureus Vaccine (V710) in Adult Patients Scheduled for Cardiothoracic Surgery.

lead_sponsor: Laboratoires Merck Sharp and Dohme-Chibret


title: A phase III, double-blind, randomized placebo-controlled study, to evaluate the effects of RO4607381 on cardiovascular (CV) risk in stable CHD patients, with a documented recent Acute Coronary Syndrome (ACS).

lead_sponsor: F.Hoffmann-La Roche Ltd.


title: NAI114373: A Phase III international, randomized, doubleblind, double-dummy study to evaluate the efficacy and safety of 300 mg or 600 mg of intravenous zanamivir twice daily compared to 75 mg of oral oseltamivir twice daily in the treatment of hospitalized adults and adolescents with influenza.

lead_sponsor: GlaxoSmithKline Research & Development Limited


title: A Pivotal Trial to Determine the Efficacy and Safety of AP23573 when Administered as Maintenance Therapy to Patients with Metastatic Soft-Tissue or Bone Sarcomas

lead_sponsor: ARIAD Pharmaceuticals, Inc.


title:
IntReALL HR 2010
 International Study for Treatment of High Risk Childhood Relapsed ALL 2010

lead_sponsor: Charité - Universitätsmedizin Berlin


title: A Phase III, Randomized, Double-Blind, Active Comparator-Controlled Clinical Trial to Study the Safety, Tolerability, and Efficacy of Imipenem/Cilastatin/Relebactam (MK-7655A) Versus Piperacillin/Tazobactam in Subjects with Hospital-Acquired Bacterial Pneumonia or Ventilator-Associated Bacterial Pneumonia.

acronym: IMI/REL (MK-7655A) vs. PIP/TAZ in Treatment of Subjects with HABP/VABP.

lead_sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.


title: International Study for Treatment of Standard Risk Childhood Relapsed ALL 2010 - A randomized Phase III Study Conducted by the Resistant Disease Committee of the International BFM Study Group

acronym: IntReALL SR 2010

lead_sponsor: Charité - University Hospital of Berlin


title:
European Network of Paediatric Hodgkin Lymphoma Second International Inter-Group Study for Classical Hodgkin Lymphoma in Children and Adolescents (EuroNet-PHL-C2)

 EuroNet-PHL-C2.  Seconde Etude Internationale de l’inter-groupe des Lymphomes de Hodgkin Classiques de l’Enfant, de l’Adolescent et de l’Adulte jeune (EuroNet-PHL-C2)

lead_sponsor: JUSTUS LIEBIG UNIVERSITY OF GIESSEN


title: A Phase II/III Study of MK-0646 Treatment in Combination with Cetuximab and Irinotecan for Patients with Metastatic Colorectal Cancer

lead_sponsor: Laboratoires Merck Sharp & Dohme - Chibret


title: An International, Randomized, Double-Blinded, Phase 3 Efficacy Study of XL184 versus Placebo in Subjects with Unresectable, Locally Advanced, or Metastatic Medullary Thyroid Cancer

lead_sponsor: Exelixis, Inc.


title: A randomized, double-blind, placebo controlled, withdrawal study of flare prevention of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations


design_allocation: Non-Randomized

intervention_type: Drug

status: Terminated

lead_sponsor: GlaxoSmithKline

enrollment_type: Actual

primary_purpose: Treatment

location_country:
Belgium
Australia
Russian Federation
Denmark
Czech Republic
Taiwan
France
Japan
Poland
Norway
Argentina
Canada
Korea, Republic of
Chile
Netherlands
Bulgaria
Hungary
Germany
United Kingdom
Italy
Brazil
Israel
Spain
Turkey

study_completion_date_type: Actual

title: An Open-label Extension Study of the Long-term Safety, Tolerability and Efficacy of GSK2402968 in Subjects With Duchenne Muscular Dystrophy

summary: The purpose of this study is to explore long-term safety, tolerability and efficacy of GSK2402968 in DMD subjects who previously participated in either DMD114117 or DMD114044.


title: A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of CCX168 in Subjects with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated  Vasculitis on Background Cyclophosphamide or Rituximab Treatment

lead_sponsor: ChemoCentryx, Inc.


title:
Single dose, open label, uncontrolled, safety trial of intravenous administration of idarucizumab to paediatric patients enrolled from ongoing phase IIb/III clinical trials with dabigatran etexilate for the treatment and secondary prevention of venous thromboembolism.

 Etude de sécurité en ouvert et non contrôlée, de l’administration intraveineuse d’une dose unique d’idarucizumab à des patients pédiatriques participant aux essais cliniques de phase IIb/III avec le dabigatran étexilate pour le traitement et la prévention secondaire de la maladie thromboembolique

lead_sponsor: Boehringer Ingelheim France


title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis

acronym: A Phase 2 safety and efficacy study of Lenabasum in Cystic Fibrosis

lead_sponsor: Corbus Pharmaceuticals, Inc.


title: Apixaban Versus Acetylsalicyclic Acid (ASA) to Prevent Stroke in Atrial Fibrillation Patients Who Have Failed or are Unsuitable for Vitamin K Antagonist Treatment: A Randomized Double Blind Trial  + Administrative Letter to Protocol dated 10-Jul- 2007

lead_sponsor: Bristol Myers Squibb International Corporation


title: A Randomised, Double-Blind, Placebo-Controlled Study of the Safety and Tolerability of E5555, and its Effects on Clinical Events and Biomarkers in Patients with Non-ST-Segment Elevation Acute Coronary Syndrome

lead_sponsor: Eisai Limited


title: Study of Once-Daily Abacavir/Lamivudine versus Tenofovir/Emtricitabine, Administered with Efavirenz in Antiretroviral-Naive, HIV-1 Infected Adult Subjects

lead_sponsor: GlaxoSmithKline Research and Development Limited


title: A Study to Determine the Activity of SCH 717454 in Subjects With Osteosarcoma or Ewing’s Sarcoma That Has Relapsed After Standard Systemic Therapy.

lead_sponsor: Schering Plough Research Institute


title: A Phase III, Multicenter, Double-Blind, Randomized, Placebo- and Metformin-Controlled Clinical Trial to Evaluate the Safety and Efficacy of Sitagliptin in Pediatric Patients with Type 2 Diabetes Mellitus with Inadequate Glycemic Control

acronym: Sitagliptin Ped. Pts. Type 2 Diab. Mellitus Inadequate Glycemic Control

lead_sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. (hereafter referred to as the SPONSOR or Merck)


title: A Phase 3 Randomized Study of the Efficacy and Safety of Posaconazole versus Voriconazole for the Treatment of Invasive Aspergillosis in Adults and Adolescents (Phase 3; Protocol No. MK-5592-069)


title: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO DEMONSTRATE THE EFFICACY AND LONG-TERM SAFETY OF DUPILUMAB IN ADULT PATIENTS WITH MODERATE-TO-SEVERE ATOPIC DERMATITIS

lead_sponsor: Regeneron Pharmaceuticals, Inc.


title: A Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients With Moderately to Severely Active Crohn’s Disease

lead_sponsor: Celltrion, Inc


title: A 12-week, open label, multicenter, titration study, with a 9-month maintenance treatment extension, to demonstrate efficacy of SBR759 compared to sevelamer HCl in lowering serum phosphate levels in Chronic Kidney Disease patients on hemodialysis

lead_sponsor: Novartis Pharma Services AG


title: A One-Year, Randomized, Open-Label, Parallel-Arm, Phase III Long-Term Safety Trial, with Controlled Adjustment of Dose, of Multiple Doses of CG5503 PR* and Oxycodone CR in Subjects with Chronic Pain

lead_sponsor: Johnson & Johnson Pharamceutical Resarch & Development, L.L.C


title: A Randomised, Double-Blind, Placebo-Controlled, Multi-centre, Phase III Study of Post-Operative Adjuvant Lapatinib or Placebo and Concurrent Chemoradiotherapy Followed by Maintenance Lapatinib or Placebo Monotherapy in High-Risk Subjects with Resected Squamous Cell Carcinoma of the Head and Neck (SCCHN)

lead_sponsor: GlaxoSmithKline Research & Development Limited


title: A multi-center, randomized, double-blind, placebo and active controlled, parallel group, dose range study to evaluate the efficacy and safety of LCZ696 comparatively to valsartan, and to evaluate AHU377 to placebo after 8 week treatment in patients with essential hypertension

lead_sponsor: NOVARTIS PHARMA SERVICES AG


title: A Prospective, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of BAY 41-6551 as Adjunctive Therapy in Intubated and Mechanically-Ventilated Patients with Gram-Negative Pneumonia

lead_sponsor: Bayer Schering Pharma AG


title: A Multicenter Open-Label Study of the Long-term Safety and Efficacy of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects with Non-infectious Intermediate-, Posterior-, or Pan-uveitis

lead_sponsor: Abbott GmbH & Co. KG


title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Safety and Efficacy of Two Different Regimens of Mipomersen in Patients with Familial Hypercholesterolemia and Inadequately Controlled Low-Density-Lipoprotein Cholesterol

acronym: FOCUS FH

lead_sponsor: Genzyme Corporation and its Affiliates


title: Effects of ivabradine on plaque burden, morphology and composition in patients with clinically indicated coronary angiography. A randomised double-blind placebo-controlled international multicentre study.

acronym: MODIFY

lead_sponsor: Institut de Recherches Internationales Servier


title: A 52-week, Double Blind, Double dummy, Randomized, Multinational, Multicentre, 2-arm Parallel Group, active Controlled Clinical Trial of fixed combination of beclometasone dipropionate plus formoterol fumarate plus Glycopyrronium bromide administered via pMDI (CHF 5993) versus indacaterol/glycopyrronium (Ultibro®) via DPI in patients with Chronic Obstructive Pulmonary Disease

acronym: TRIBUTE

lead_sponsor: Chiesi Farmaceutici S.p.A.


title:
A randomized, double blind, placebo controlled multicenter dose ranging study to assess the safety and efficacy of multiple oral ZPL389 doses in patients with moderate to severe Atopic Dermatitis (ZEST trial)

 Etude dose-réponse, multicentrique, randomisée, en double aveugle, contrôlée par placebo, évaluant la tolérance et l’efficacité de doses multiples de ZPL389 par voie orale chez des patients atteints de dermatite atopique modérée à sévère (étude ZEST)

acronym: A study to assess the safety and efficacy of ZPL389 doses in patients with moderate to severe AD

lead_sponsor: Novartis Pharma AG


title:
A Phase 3, Randomised, Rater-Blinded, Multi-Centre Study to Evaluate the Efficacy and Safety of WTX101 Administered for 48 Weeks Versus Standard of Care in Wilson Disease Subjects Aged 18 and Older with an Extension Phase of up to 60 Months

 Étude multicentrique de phase III randomisée, en aveugle pour les évaluateurs, visant à évaluer l’efficacité et la sécurité du WTX101 administré pendant 48 semaines, par rapport au traitement standard, chez des patients atteints de la maladie de Wilson âgés de 18 ans ou plus avec une phase d’extension de 60 mois maximum

lead_sponsor: Wilson Therapeutics AB


title:
An open label, randomized Phase II study of BI 754091 alone or in combination with BI 836880 in patients with chemotherapy resistant, unresectable, metastatic squamous cell carcinoma of the anal canal

 Etude de phase II, randomisée, en ouvert, avec le BI 754091 seul ou en association avec le BI 836880 chez des patients atteints d’un carcinome épidermoïde métastatique du canal anal résistant à la chimiothérapie, non résécable

lead_sponsor: Boehringer Ingelheim


title: Paediatric Hepatic International Tumour Trial

acronym: PHITT

lead_sponsor: University of Birmingham


title:
A randomized, double-blind, placebo-controlled multicenter study of secukinumab to evaluate the safety, tolerability and efficacy up to 2 years in patients with active non-radiographic axial spondyloarthritis

 Étude multicentrique, randomisée, en double aveugle, contrôlée versus placebo, évaluant la sécurité d'emploi, la tolérance et l'efficacité jusqu'à 2 ans du sécukinumab chez des patients atteints d'une spondyloarthrite axiale non radiographique active


title: Phase II, Open Label, Single Arm Study Assessing the Clinical Benefit of SAR125844, Administered as Single Agent by Weekly Intravenous (IV) Infusion, for the Treatment of Patients with Advanced Pretreated Non-Small Cell Lung Cancer (NSCLC) Harboring MET Gene Amplification

lead_sponsor: Sanofi-aventis recherche & développement


title: Randomized, Global, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Vedolizumab IV for the Treatment of Primary Sclerosing Cholangitis, With Underlying Inflammatory Bowel Disease

lead_sponsor: Takeda Development Centre Europe, Ltd.


title:
A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine

 Étude de phase 3 randomisée, en double aveugle, contrôlée contre placebo, évaluant la sécurité  et l’efficacité de CCX168 (Avacopan) chez des sujets présentant une vascularite associée à des anticorps anti-cytoplasme des polynucléaires neutrophiles (ANCA) traités conjointement avec Rituximab ou Cyclophosphamide/Azathioprine

lead_sponsor: ChemoCentryx, Inc.


title: A StuDy EVAluatiNg the Long-Term EffiCacy and Safety of RalinEpag in Subjects with PAH via an Open-Label EXTENSION

acronym: ADVANCE-extension

lead_sponsor: Arena Pharmaceuticals, Inc.


title:
A Phase 2, Double-Blind, Randomized, Parallel-Group Study Evaluating the Efficacy, Safety, and Tolerability of Obeticholic Acid, Administered Alone or in Combination with Bezafibrate, in Subjects with Primary Biliary
 Cholangitis who had an Inadequate Response or who were Unable to Tolerate Ursodeoxycholic Acid

lead_sponsor: Intercept Pharmaceuticals, Inc.


title: A Phase 2b, Multicenter, Randomized, Open-label, Controlled, 3-Arm Study to Evaluate the Clinical Efficacy and Safety of SHP607 in Preventing Chronic Lung Disease Through 12 Months Corrected Age Compared to Standard Neonatal Care in Extremely Premature Infants

lead_sponsor: Premacure AB


title:
I6T-MC-AMAP
 A Phase 3, Multicenter, Open-Label Extension Study to Evaluate the Long-
 Term Efficacy and Safety of Mirikizumab in Patients with Moderately to
 Severely Active Ulcerative Colitis (LUCENT 3)

 I6T-MC-AMAP
 Étude d’extension de Phase 3, multicentrique, en ouvert visant à évaluer la sécurité et l’efficacité à long terme du mirikizumab chez les patients atteints de rectocolite hémorragique active modérée à sévère (LUCENT 3)

acronym: LUCENT 3

lead_sponsor: Eli Lilly and Company


title: A Phase 3 randomized, open label, multicenter study of isatuximab (SAR650984) in combination with lenalidomide and dexamethasone versus lenalidomide and dexamethasone in patients with high-risk smoldering multiple myeloma

lead_sponsor: Sanofi-Aventis Recherche & Développement


title: A phase I/II study of Inotuzumab Ozogamicin as a single agent and in combination with chemotherapy for pediatric CD22-positive relapsed/refractory Acute Lymphoblastic Leukemia

lead_sponsor: Erasmus Medical Center


title: A Long-term Access Programme for Subjects with Severe Asthma who Participated in a GSK-sponsored Mepolizumab Clinical Study

lead_sponsor: GlaxoSmithKline Research & Development Ltd


title: A Phase III Double-blind, Randomized, Placebo-Controlled Study assessing the Efficacy, Safety and Tolerability of Idebenone in Patients with Duchenne Muscular Dystrophy Receiving Glucocorticoid Steroids

acronym: SIDEROS

lead_sponsor: Santhera Pharmaceuticals (Switzerland) Limited


title: A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP).

acronym: RAISE

lead_sponsor: GlaxoSmithKline Research and Development Limited


title: A RANDOMIZED, PHASE 3 STUDY OF SUNITINIB IN COMBINATION WITH CAPECITABINE COMPARED WITH CAPECITABINE IN PATIENTS WITH PREVIOUSLY TREATED BREAST CANCER

lead_sponsor: Pfizer Inc.


title: A Randomized, Open-Label, Multicenter, Phase 2 Study to Evaluate the Safety and Efficacy of Lumiliximab in Combination with Fludarabine, Cyclophosphamide, and Rituximab Versus Fludarabine, Cyclophosphamide, and Rituximab Alone in Subjects with Relapsed Chronic Lymphocytic Leukemia

acronym: Lumiliximab in combination with FCR in the treatment of relapsed CLL

lead_sponsor: Biogen Idec Ltd


title: A randomized, double-blind phase 3 study of gemcitabine plus AG-013736 versus gemcitabine plus placebo for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer

lead_sponsor: Pfizer Inc, 235 East 42nd Street, New York, NY 10017, USA


title: A Multi-center, Randomized, Vehicle-Controlled Study to Assess the Efficacy and Safety of Adalimumab in Combination with Topical Treatment (Calcipotriol/Betamethasone) in Subjects with Moderate to Severe Psoriasis and Insufficient Response to Classic Systemic Treatment (BELIEVE)

acronym: BELIEVE

lead_sponsor: Abbott GmbH & Co. KG


title: A Randomized, Open-Label, Multinational Phase 3 Trial Comparing Amrubicin Versus Topotecan in Patients With Extensive or Limited and Sensitive or Refractory Small Cell Lung Cancer After Failure of First-Line Chemotherapy

lead_sponsor: Celgene Corporation


title: A randomized,  placebo-controlled, 2-arm parallel-group, multicenter study with a 24-week double-blind treatment period assessing the efficacy and safety of lixisenatide in patients with Type 2 diabetes insufficiently controlled with insulin glargine and metformin


title: A prospective, multi-center, double-blind, randomized, placebo-controlled, parallel-group study to assess the efficacy and safety of clazosentan in reducing vasospasm-related morbidity and all-cause mortality in adult patients with aneurysmal subarachnoid hemorrhage treated by endovascular coiling.

acronym: CONSCIOUS 3

lead_sponsor: Actelion Pharmaceuticals Ltd.


title:
Comparison of ARIXTRA™ in lower LImb Superficial Thrombophlebitis with placebO (CALISTO).
 An International, Multicentre, Randomised, Double-blind, Placebo-controlled, Two-parallel Group, Phase III Study to Evaluate the Efficacy and Safety of ARIXTRA (2.5 mg subcutaneously) for the Treatment of Patients with Acute Symptomatic Isolated Superficial Thrombophlebitis of the Lower Limbs to prevent Thromboembolic Complications

lead_sponsor: GlaxoSmithKline Research & Development Ltd.


title:
A multicenter study to evaluate long-term safety and tolerability of open label  sacubitril/valsartan in pediatric patients with heart failure due to systemic left ventricle systolic dysfunction who have completed study CLCZ696B2319 (PANORAMA-HF)

 Etude multicentrique, en ouvert, évaluant la tolérance et la sécurité d’emploi à long terme de LCZ696 (sacubitril/valsartan) chez des patients pédiatriques atteints d’insuffisance cardiaque due à une dysfonction ventriculaire gauche systolique ayant terminé l'étude CLCZ696B2319

lead_sponsor: Novartis Pharma AG


title: A Randomized, Open-label, Rater-Blinded, Active-Controlled, International, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Flexibly Dosed Esketamine Nasal Spray Compared With Quetiapine Extended-Release in Adult and Elderly Participants With Treatment-Resistant Major Depressive Disorder Who are Continuing a Selective Serotonin Reuptake Inhibitor/Serotonin-Norepinephrine Reuptake Inhibitor

acronym: ESCAPE-TRD

lead_sponsor: Janssen-Cilag International NV


title: Long term safety and tolerability of satavaptan in patients with cirrhosis of the liver that have been previously randomized and completed treatment in any of the phase III studies: EFC4492; EFC4493 or EFC6682: a double blind parallel group study comparing satavaptan at 5 to 10 mg daily versus placebo

lead_sponsor: sanofi-aventis recherche & développement


title: A randomised, double-blind, placebo controlled, multi-centre phase II study of atacicept in anti- TNF alfa-naïve patients with moderate to severely active rheumatoid arthritis and an inadequate response to methotrexate

acronym: Atacicept in anti-TNF alfa-naïve subjects with RA

lead_sponsor: Merck Serono International


title: A multicenter, double-blind, randomized, 12-month, placebo-controlled study to evaluate the lipid-lowering effect, safety and tolerability of AVE5530 25 mg/day and 50mg/day when added to ongoing stable statin therapy (HMG-CoA reductase inhibitors) in patients with primary hypercholesterolemia.


title: A Phase III, Randomised, Placebo-controlled, Double-blind Study to Assess the Efficacy and Safety of Once-daily Orally Administered ZD4054 10 mg in Non-metastatic Hormone-resistant Prostate Cancer Patients

lead_sponsor: AstraZeneca AB


title: A 52-WEEK MULTICENTER, OPEN-LABEL, RANDOMIZED, PARALLEL, TWO - ARM STUDY COMPARING EXUBERA® (INHALED HUMAN INSULIN) VS. HUMALOG® (INSULIN LISPRO), BOTH IN COMBINATION WITH INSULIN GLARGINE IN SUBJECTS WITH TYPE 1 DIABETES MELLITUS - PROTOCOL A2171035.

lead_sponsor: Pfizer Inc


title: A Pan-European, open label, randomised study comparing the efficacy and cost-effectiveness of Symbicort Maintenance and Reliever Therapy (Symbicort SMART) using a maintenance dose of Symbicort 160/4.5 micrograms of 1 or 2 inhalations twice daily in the treatment of persistent asthma. EUROSMART

acronym: EUROSMART


title: A Multicenter, Randomized, Double-Blind, Comparison Study of the Safety and Efficacy of a Once-Daily Dose of Tigecycline versus Ertapenem for the Treatment of Foot Infections in Subjects with Diabetes

lead_sponsor: Wyeth Research Division of Wyeth Pharmaceuticals Inc.


title: A 12 month, double blind, randomized, placebo-controlled trial evaluating the effect of BIBF 1120 administered at oral doses of 50 mg qd, 50 mg bid, 100 mg bid and 150 mg bid on Forced Vital Capacity decline during one year, in patients with Idiopathic Pulmonary Fibrosis, with optional active treatment extension until last patient out.

acronym: Effect of orally administered BIBF 1120 on FVC decline in IPF

lead_sponsor: Boehringer Ingelheim France SAS


title: The efficacy and safety of 2g strontium ranelate in the treatment of male osteoporosis. A prospective multicentre, international, double-blind, placebo-controlled study with a treatment duration of 2 years and the main study analysis after 1 year.

acronym: MALEO

lead_sponsor: Institut de Recherches Internationales Servier


title: A Randomized, Double-Blind Study Comparing the Safety and Efficacy of Once-Weekly Administration of Etanercept 50 mg, Etanercept 25 mg, and Placebo in Combination With Methotrexate in Subjects With Moderately Active Rheumatoid Arthritis Who Have Achieved an Adequate Response With Etanercept 50 mg Once Weekly and methotrexate

lead_sponsor: Wyeth Pharmaceuticals France


title: A multi-center, randomized, open-label, active-controlled study to compare the efficacy, safety and tolerability of taspoglutide (RO5073031) versus insulin glargine in insulin-naive type 2 diabetic patients inadequately controlled with metformin and sulphonylurea combination therapy.

acronym: EMERGE 5

lead_sponsor: F. Hoffmann-La Roche Ltd.


title: A Randomized Phase 3 Study of Tasisulam Administered as an Intravenous Infusion on Day 1 of a 28-Day Cycle vs. Paclitaxel as Second-Line Treatment in Patients with Metastatic Melanoma

lead_sponsor: Eli Lilly and Company


title: A Phase 3, Active (Warfarin) Controlled, Randomized, Double-Blind, Parallel Arm Study to Evaluate Efficacy and Safety of Apixaban in Preventing Stroke and Systemic Embolism in Subjects with Nonvalvular Atrial Fibrillation

acronym: ARISTOTLE

lead_sponsor: Bristol Myers Squibb International Corporation


title: A Multinational, Randomized, Double-Blind Study Comparing Aflibercept Versus Placebo in Patients Treated with Second-Line Docetaxel after Failure of One Platinum Based Therapy for Locally Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC)

acronym: VITAL


title: A Randomized Trial of Temsirolimus and Sorafenib as Second-Line Therapy in Patients With Advanced Renal Cell Carcinoma Who Have Failed First-Line Sunitinib Therapy

lead_sponsor: Wyeth Research Division of Wyeth Pharmaceuticals Inc. Global Medical Affairs


title: A 6 MONTH, PROSPECTIVE, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTIPLE CENTER TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF FRAGMIN IN THE TREATMENT OF CHRONIC NEUROISCHAEMIC FOOT ULCERS IN DIABETIC PATIENTS

lead_sponsor: Pfizer Inc, 235 East 42nd Street, New York, NY 10017


title: Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy

lead_sponsor: F. Hoffmann-La Roche Ltd


title: A 6 MONTH, PROSPECTIVE, OPEN-LABEL MULTIPLE CENTER EXTENSION TRIAL TO EVALUATE THE LONG TERM SAFETY AND SUSTAINED EFFICACY OF FRAGMIN IN THE TREATMENT OF CHRONIC FOOT ULCERS IN DIABETIC PATIENTS WITH PERIPHERAL ARTERIAL OCCLUSIVE DISEASE

lead_sponsor: Pfizer Limited, Ramsgate Road, Sandwich, Kent


title: RANDOMIZED, OPEN LABEL, PHASE III TRIAL OF CP-751,871 IN COMBINATION WITH PACLITAXEL AND CARBOPLATIN VERSUS PACLITAXEL AND CARBOPLATIN IN PATIENTS WITH NON-SMALL CELL LUNG CANCER

acronym: CP In Combo

lead_sponsor: Pfizer Inc 235 East 42nd Street New York, NY 10017


title: Multi center, double blind, randomized, placebo controlled, active reference, parallel group polysomnography study to assess the efficacy and safety of a 16 day oral administration of ACT 078573 in adult subjects with chronic primary insomnia.

lead_sponsor: Actelion Pharmaceuticals Ltd


title: A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of TAK-242 Versus Placebo in Subjects With Sepsis Induced Cardiovascular and Respiratory Failure

lead_sponsor: Takeda Global Research & Development Centre (Europe), Ltd.


title:
Apixaban for Prevention of Acute Ischemic Events - 2
 A Phase 3, Randomized, Double-Blind, Evaluation of the Safety and Efficacy of Apixaban In Subjects with a Recent Acute Coronary Syndrome

acronym: APPRAISE - 2

lead_sponsor: Bristol-Myers Squibb International Corporation


title: A phase 3, randomized, double-blind, double-dummy, parallel-group, multi-center, multi-national study for the evaluation of efficacy and safety of (LMW) heparin/edoxaban versus (LMW) heparin/warfarin in subjects with symptomatic deep-vein thrombosis and/or pulmonary embolism

acronym: Evaluation of edoxaban vs. warfarin in subjects with symptomatic venous thromboembolism (VTE)

lead_sponsor: Daiichi Sankyo Development Limited


title: A Long-term Assessment of Safety and Physical Function with AMG 108 Subcutaneous Monthly Treatment in Subjects with Rheumatoid Arthritis

lead_sponsor: Amgen Inc.


title: A Randomised, Double-blind, Parallel Group, Phase 3, Efficacy and Safety Study of AZD6140 Compared with Clopidogrel for Prevention of Vascular Events in Patients with Non-ST or ST Elevation Acute Coronary Syndromes (ACS) [PLATO – A Study of PLATelet inhibition and Patient Outcomes.]

acronym: PLATO

lead_sponsor: AstraZeneca AB


title:
A Phase 3, Randomized, Double-blind, Active-controlled (Enoxaparin 40 mg QD), Parallel-group, Multi-center Study to Evaluate the Safety and Efficacy of Apixaban in Subjects Undergoing Elective Total Knee Replacement Surgery.
 + Revised Protocol 01: Incorporates Amendment 02  dated 18-Apr-2007

acronym: The ADVANCE - 2 Study


title: A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis

lead_sponsor: Centocor BV


title: Study Title:  A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the safety, tolerability and efficacy of daily oral administration of laquinimod 0.6 mg in subjects with relapsing remitting multiple sclerosis (RRMS)

acronym: Allegro

lead_sponsor: Teva Pharmaceutical Industries Ltd


title: A PROSPECTIVE, RANDOMIZED TRIAL COMPARING THE EFFICACY OF ANIDULAFUNGIN AND VORICONAZOLE IN COMBINATION TO THAT OF VORICONAZOLE ALONE WHEN USED FOR PRIMARY THERAPY OF PROVEN OR PROBABLE INVASIVE ASPERGILLOSIS

lead_sponsor: Pfizer Inc., 235 East 42nd Street, New York, NY 10017


title: EuroNet-Paediatric Hodgkin's Lymphoma Group / First International inter-group study for classical Hodgkin’s lymphoma in children and adolescents

acronym: EURONET PHL C1

lead_sponsor: ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)


title: A randomized, double-blind, controlled phase III study of Stimuvax® (L-BLP25 or BLP25 liposome vaccine) in combination with hormonal treatment versus hormonal treatment alone for first-line therapy of post-menopausal women with estrogen receptor (ER)-positive and/or progesterone receptor (PgR)-positive, inoperable locally advanced, recurrent, or metastatic breast cancer STRIDE - STimulating immune Response In aDvanced brEast cancer

acronym: STRIDE

lead_sponsor: Merck KGaA


title: A Randomized Trial Comparing two therapies: Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET) or Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT) in Subjects with Type 2 Diabetes who were previously treated by basal insulin Glargine with either Metformin or Metformin and Sulfonylurea

acronym: GWDM or Etude 4B

lead_sponsor: Eli Lilly and Company Limited


title: A MULTICENTER, THREE ARM, RANDOMIZED, OPEN LABEL  CLINICAL STUDY TO COMPARE RENAL FUNCTION IN LIVER TRANSPLANT RECIPIENTS RECEIVING AN IMMUNOSUPPRESSIVE REGIMEN OF ADVAGRAF® (IMMEDIATELY OR DELAYED POST-TRANSPLANT) AND MMF WITH OR WITHOUT A MONOCLONAL ANTI-IL2R ANTIBODY (BASILIXIMAB)

acronym: Short Title: DIAMOND Study

lead_sponsor: Astellas Pharma Europe Ltd.


title: The efficacy and safety of a daily oral administration of S06911 (strontium ranelate 2g/vitamin D3 1000 IU fixed combination) on vitamin D insufficiency in the treatment of osteoporotic postmenopausal women and men. A prospective, international phase III study with a 6-month double-blind period to assess the efficacy and safety of a daily oral administration of S06911 versus S12911 (strontium ranelate 2g) and a 6-month open-labelled extension for a subgroup of patients to assess safety of a daily oral administration of S06911.

lead_sponsor: Institut de Recherches Internationales Servier


title: Effects of bosentan on morbidity and mortality in patients with Idiopathic Pulmonary Fibrosis - a multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, group sequential, phase III study

lead_sponsor: ACTELION PHARMACEUTICALS LTD


title: A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 76 week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE)

lead_sponsor: Human Genome Sciences, Inc.


title: A MULTICENTER, SINGLE-ARM, OPEN, CONVERSION STUDY FROM A CYCLOSPORINE (CyA) BASED IMMUNOSUPPRESSIVE REGIMEN TO A TACROLIMUS MODFIED RELEASE, FK506E (MR4), BASED IMMUNOSUPPRESSIVE REGIMEN IN KIDNEY TRANSPLANT SUBJECTS

acronym: CONCERTO

lead_sponsor: Astellas Pharma GmbH


title: A RANDOMISED, PHASE 3 STUDY OF DOCETAXEL IN COMBINATION WITH SUNITINIB VERSUS DOCETAXEL IN THE FIRST-LINE TREATMENT OF ADVANCED BREAST CANCER PATIENTS

lead_sponsor: Pfizer Limited.


title: A Multinational, Randomized, Double-Blind Study, Comparing the Efficacy of Aflibercept Once Every 2 Weeks versus Placebo in Patients Treated with Gemcitabine for Metastatic Pancreatic Cancer.

lead_sponsor: sanofi-aventis recherche & développement


title: A Phase III, Randomised, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of 10 mg ZD4054 in Combination with Docetaxel in Comparison with Docetaxel in Patients with Metastatic Hormone-resistant Prostate Cancer


title: OPEN-LABEL, NON-COMPARATIVE, STUDY OF INTRAVENOUS ANIDULAFUNGIN, FOLLOWED OPTIONALLY BY ORAL VORICONAZOLE OR FLUCONAZOLE THERAPY, FOR TREATMENT OF DOCUMENTED CANDIDEMIA/INVASIVE CANDIDIASIS IN INTENSIVE CARE UNIT PATIENT POPULATIONS

lead_sponsor: Pfizer Ltd


title: Open, randomized, multinational phase IIIb trial evaluating the activity and safety of cetuximab as 250 mg/m² weekly and 500 mg/m² every two weeks maintenance therapy after platinum-based chemotherapy in combination with cetuximab as first-line treatment for subjects with advanced non-small cell lung cancer (NSCLC)

acronym: NEXT


title: Multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose finding study to evaluate the efficacy, safety, and tolerability of three doses of ACT-128800, an oral S1P1 receptor agonist, administered for twenty-four weeks in patients with relapsing-remitting multiple sclerosis

lead_sponsor: Actelion Pharmaceuticals Ltd


title: A Phase 2, Open-Label, Randomized, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib Plus Pembrolizumab Versus Pemigatinib Alone Versus Standard of Care as First-Line Treatment for Metastatic or Unresectable Urothelial Carcinoma in Cisplatin-Ineligible Participants Whose Tumors Express FGFR3 Mutation or Rearrangement (FIGHT-205)

lead_sponsor: Incyte Corporation


title: A randomised, double-blind, placebo-controlled, multicentre prospective dose-finding Phase II/III study with atacicept given subcutaneously to subjects having recently experienced a flare of systemic lupus erythematosus (SLE)

acronym: Atacicept in generalised SLE Phase II/III

lead_sponsor: Merck Serono International SA, An affiliate of Merck KGaA, Darmstadt, Germany


title: A randomized, double-blind, parallel group, placebo controlled, multi center dose ranging study of solifenacin succinate (3 mg, 6 mg and 9 mg) in combination with tamsulosin OCAS 0.4 mg compared with solifenacin succinate monotherapy (3 mg, 6 mg and 9 mg) and tamsulosin OCAS 0.4 mg monotherapy in males with lower urinary tract symptoms (LUTS) associated with begnin prostatic hyperplasia (BPH) -  [SATURN]

acronym: SATURN

lead_sponsor: Astellas Pharma Europe B.V.


title: A Multicenter, Randomized, Double-Blind Study to Determine the Efficacy and Safety of the Addition of SYR-322 25 mg versus Dose Titration from 30 mg to 45 mg of ACTOS® Pioglitazone HCl in Subjects with Type 2 Diabetes Mellitus Who Have Inadequate Control on a Combination of Metformin and 30 mg of Pioglitazone HCl Therapy

lead_sponsor: Takeda Global Research & Development Centre (Europe) Limited,


title:
A Phase 3 Randomized, Double-blind, Parallel-group, Multi-center Study of the Safety and Efficacy of Apixaban for Prophylaxis of Venous Thromboembolism in Acutely Ill Medical Subjects During and Following Hospitalization.
 ADOPT: Apixaban Dosing to Optimize Protection from Thrombosis

acronym: ADOPT

lead_sponsor: Bristol Myers Squibb


title: A Twenty Eight –Week, Open-Label, Safety Study of Flibanserin 50 milligrams to 100 milligrams dailyin Premenopausal European Women With Hypoactive Sexual Desire Disorder

acronym: Magnolia

lead_sponsor: Boehringer Ingelheim France


title: Effect of Choline Fenofibrate (ABT-335 /SLV348) on Macular Edema Measured by Optical Coherence Tomography in Subjects with Diabetic Macular Edema - a one-year, Placebo-Controlled, Randomized Study

lead_sponsor: Fournier Laboratories Ireland


title: An Open-Label, Randomized Study To Evaluate The Radiographic Efficacy And Safety Of Enbrel™ (Etanercept) Added To Methotrexate In Comparison With Usual Treatment In Subjects With Moderate Rheumatoid Arthritis Disease Activity.

acronym: Extra

lead_sponsor: Wyeth Pharmaceuticals France


title: A Three-Month, Multicenter, Double-Masked Study Comparing the Safety and Efficacy of the Fixed Combination Travoprost + Brinzolamide Eye Drops, Suspension vs Travatan vs Azopt in Patients with Open-Angle Glaucoma or ocular Hypertension

acronym: Travoprost / Brinzolamide Fixed Combination vs. TRAVATAN and vs. AZOPT

lead_sponsor: Alcon Research, Ltd.


title: EFFICACY AND SAFETY OF ESLICARBAZEPINE ACETATE AS THERAPY IN PATIENTS WITH FIBROMYALGIA: A DOUBLE BLIND, RANDOMISED, PLACEBO CONTROLLED, PARALLEL GROUP, MULTICENTRE CLINICAL TRIAL

lead_sponsor: BIAL   Portela & Ca, S.A.


title: A MULTICENTER, RANDOMIZED, DOUBLE BLIND, CONTROLLED PHASE 3, EFFICACY AND SAFETY STUDY OF SUNITINIB (SU011248) IN PATIENTS WITH ADVANCED/METASTATIC NON SMALL CELL LUNG CANCER TREATED WITH ERLOTINIB

lead_sponsor: Pfizer Inc. - 235 East 42nd Street - New York - 10017


title:
A multi-center, randomized, double-blind, placebo-controlled, parallel group, phase III study to evaluate the efficacy and safety of LNP023 in primary IgA nephropathy patients

 Etude de phase III, multicentrique, randomisée, en double aveugle, en groupes parallèles, contrôlée par placebo, évaluant l’efficacité et la sécurité d’emploi de LNP023 chez des patients atteints de néphropathie primaire à IgA

lead_sponsor: Novartis Pharma AG


title: A prospective, multi-center, double-blind, randomized, placebo-controlled, parallel-group study to assess the efficacy and safety of clazosentan in reducing vasospasm-related morbidity and all-cause mortality in adult patients with aneurysmal subarachnoid hemorrhage treated by surgical clipping.

acronym: CONSCIOUS 2

lead_sponsor: Actelion Pharmaceuticals Ltd.


title: A Twenty-Four Week, Randomized, Double-Blind, Placebo-Controlled, Safety and Efficacy trial of Flibanserin 50 Milligrams Daily and 100 Milligrams Daily in premenopausal European Women With Hypoactive Sexual Desire Disorder

acronym: "Orchid"


title: A Phase III Prospective, Randomized, Double-Blind, Active-Controlled, Multi-Center, Superiority Study of Vernakalant Injection versus Amiodarone in Subjects with Recent Onset Atrial Fibrillation

lead_sponsor: Cardiome Pharma Corp.


title: Effects of a 10 or 15 mg single intravenous bolus of ivabradine versus placebo on heart rate control during a multislice computed tomography coronary angiography for the evaluation of coronary artery disease. A randomised, double blind, international, multicenter study.

lead_sponsor: Institut de Recherches Internationales Servier (I.R.I.S)


title: A Randomized Double Blind, Placebo Controlled Study Evaluating the Efficacy and Safety of Romiplostim Treatment of Thrombocytopenia in Subjects with Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS)

lead_sponsor: Amgen Inc


title: A Phase II/III Randomized Trial of Two Doses of MK-3475 (SCH900475) versus Docetaxel in Previously Treated Subjects with Non-Small Cell Lung Cancer

lead_sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., (Merck)


title: A Phase III Randomized Open-label Study of Single Agent Pembrolizumab vs Physicians' Choice of Single Agent Docetaxel, Paclitaxel, or Irinotecan in Subjects with Advanced/Metastatic Adenocarcinoma and Squamous Cell Carcinoma of the Esophagus that have Progressed after First-Line Standard Therapy (KEYNOTE-181)

acronym: Study of Pembrolizumab vs Docetaxel, Paclitaxel or Irinotecan in Subjects with Esophagus Carcinoma

lead_sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.


title: Phase II Trial of Pembrolizumab (MK-3475) in Subjects with Metastatic Castration-Resistant Prostate Cancer (mCRPC) Previously Treated with Chemotherapy

acronym: Phase  II  Trial  of  MK-3475  in  Subjects  with  mCRPC  with  Prior Chemotherapy


title: Multi-Centre, Multi-National, Open Label, Safety Study of Etripamil Nasal Spray for Patients with Paroxysmal Supraventricular Tachycardia

lead_sponsor: Milestone Pharmaceuticals Inc.


title:
A Phase III Randomized, Open-label, Multi-center, Global Study of MEDI4736 Alone or in Combination with Tremelimumab versus Standard of Care in the Treatment of First-line Recurrent or Metastatic Squamous Cell Head and Neck Cancer Patients

 Étude internationale de phase III, randomisée, en ouvert, multicentrique,
 comparant le MEDI4736 en monothérapie ou en association au
 tremelimumab versus une chimiothérapie conventionnelle, en première
 ligne de traitement, chez des patients atteints d'un cancer épidermoïde de
 la tête et du cou récurrent ou métastatique (KESTREL)

acronym: KESTREL

lead_sponsor: AstraZeneca AB


title: A Phase III Randomized Clinical Trial of Pembrolizumab (MK-3475) versus Paclitaxel, Docetaxel or Vinflunine in Subjects with Recurrent or Progressive Metastatic Urothelial Cancer

acronym: MK-3475 vs. paclitaxel, Docetaxel or vinflunine in metastatic urothelial cancer


title:
A Long-Term Follow-up Study to Evaluate the Durability of Virologic Response and/or Viral Resistance Patterns of Subjects With Chronic Hepatitis C Who Have Been Previously Treated with
 MK-5172 in a Prior Clinical Trial

lead_sponsor: Merck Sharp & Dohme Corp.


title: A Phase II, Open-label, Single-arm, Multicenter Study to Evaluate Efficacy and Safety of Pembrolizumab Monotherapy in Subjects with Advanced Recurrent Ovarian Cancer

acronym: Phase II Study of Pembrolizumab in Subjects with Advanced Recurrent Ovarian Cancer


title: A Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of oral cladribine in subjects with a first clinical event at high risk of converting to MS

acronym: ORAl CLadribine in Early MS (ORACLE MS) Trial

lead_sponsor: Merck Serono International


title: A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PHASE 3 STUDY OF SUNITINIB PLUS PREDNISONE VERSUS PREDNISONE IN PATIENTS WITH PROGRESSIVE METASTATIC HORMONE-REFRACTORY PROSTATE CANCER AFTER FAILURE OF A DOCETAXEL-BASED CHEMOTHERAPY REGIMEN

lead_sponsor: Pfizer Inc


title: A Randomized Open-Label Study to Evaluate the Safety and Efficacy of Denosumab and Monthly Actonel® Therapies in Postmenopausal Women Transitioned from Weekly or Daily Alendronate Therapy.


title: A 48-WEEK, DOUBLE BLIND, RANDOMIZED, MULTINATIONAL, MULTICENTRE, 2-ARM PARALLEL GROUP, REFERENCE TREATMENT CONTROLLED CLINICAL TRIAL OF “FIXED COMBINATION” BECLOMETHASONE DIPROPIONATE PLUS FORMOTEROL FUMARATE ADMINISTERED VIA pMDI (CHF 1535 FOSTER®) VERSUS FORMOTEROL IN PATIENTS WITH SEVERE CHRONIC OBSTRUCTIVE PULMONARY DISEASE

lead_sponsor: Chiesi Farmaceutici S.p.A.


title: A multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, Phase III study to assess the effects of ACT-064992 on morbidity and mortality in patients with symptomatic pulmonary arterial hypertension

acronym: SERAPHIN


title: RANDOMIZED, OPEN-LABEL, PHASE 3 TRIAL OF ERLOTINIB ALONE OR IN COMBINATION WITH CP-751,871 IN PATIENTS WITH ADVANCED NON-SMALL CELL LUNG CANCER OF NON-ADENOCARCINOMA HISTOLOGY

lead_sponsor: Pfizer Inc 235 East 42nd Street, New York, NY 10017


title: A multi-center, randomized, double-blind, placebo-controlled phase III trial comparing the efficacy of bevacizumab in combination with rituximab and CHOP (RA-CHOP) versus rituximab and CHOP (R-CHOP) in previously untreated patients with CD20-positive diffuse large B-cell lymphoma (DLBCL)

acronym: MAIN

lead_sponsor: F. Hoffmann-La Roche Ltd


title: A Randomized, Double-blind, Placebo-controlled Trial of Long-term (2-year) Treatment of Galantamine in Mild to Moderately-severe Alzheimer’s Disease

lead_sponsor: Janssen Cilag International NV


title: A multi-center, randomized, double-blind, parallel group study of the safety, disease remission and prevention of structural joint damage during treatment with tocilizumab (TCZ), as a monotherapy and in combination with methotrexate (MTX), versus methotrexate in patients with early, moderate to severe rheumatoid arthritis.

lead_sponsor: F. Hoffmann-La Roche Ltd.


title: A Multinational, Randomized, Double-blind Study, Comparing the Efficacy of Aflibercept Once Every 2 Weeks versus Placebo in Patients with Metastatic Colorectal Cancer (MCRC) Treated with Irinotecan  /  5-FU Combination (FOLFIRI) after failure of an oxaliplatin based regimen.

acronym: VELOUR

lead_sponsor: sanofi-aventis recherche & développement


title: An Open Label Extension Study Evaluating the Safety of Long Term Dosing of Romiplostim in Thrombocytopenic Subjects with Myelodysplastic Syndromes (MOS)


title: A 52-Week, Randomised, Double-Blind, Active-Controlled, Multi-Centre Phase IIIb/IV Study to Evaluate the Efficacy and Tolerability of Saxagliptin Compared to Glimepiride in Elderly Patients with Type 2 Diabetes Mellitus Who Have Inadequate Glycaemic Control on Metformin Monotherapy

acronym: Generation