title: Randomized, Multicenter, Double-Blinded, Phase IV Study Evaluating the Efficacy (as measured by Sustained Virological Response) and Safety of 360 µg Induction Dosing of Pegasys in Combination with Higher Copegus Doses in Treatment-naïve Patients with Chronic Hepatitis C Genotype 1 Virus Infection of High Viral Titer and Baseline Body Weight Greater than or Equal to 85 kg

acronym: PROGRESS

lead_sponsor: F. Hoffmann-La Roche Ltd


title: A Rollover Protocol to allow continued access to Tivozanib (AV-951) for subjects enrolled in other Tivozanib Protocols

source: euctr

lead_sponsor: AVEO Pharmaceuticals, Inc.

study_type: Interventional

status: Completed

lead_sponsor_type: industriel

status_simplified: Completed


title: A MULTINATIONAL, RANDOMIZED, OPEN-LABEL, PHASE 3 STUDY OF SUNITINIB MALATE VERSUS SORAFENIB IN PATIENTS WITH ADVANCED HEPATOCELLULAR CARCINOMA

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


title: Randomized phase III study comparing vinflunine-gemcitabine and gemcitabine-carboplatin combinations in patients ineligible to cisplatin with advanced or metastatic urothelial carcinoma.

lead_sponsor: PIERRE FABRE MEDICAMENT

status: Prematurely Ended

status_simplified: Unknown


title: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

lead_sponsor: Pfizer limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK


title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group, Event-Driven Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects with Idiopathic Pulmonary Fibrosis (IPF)

acronym: ARTEMIS

lead_sponsor: Gilead Sciences Incorporated


title: Efficacy of once weekly exenatide long acting release and once daily insulin glargine in patients with Type 2 diabetes treated with metformin alone or in combination with sulphonylurea.

acronym: GWBR(a)

lead_sponsor: Eli Lilly and Company


title: A randomized double blind phase III trial of pazopanib versus placebo in patients with soft tissue sarcoma whose disease has progressed during or following prior therapy.

acronym: PALETTE

lead_sponsor: GlaxoSmithKline Research & Development Limited


title: A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Subjects With WHO or ISN Class III or IV Nephritis Due To Systemic Lupus Erythematosus


title: AMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension

acronym: AMBITION


title: A multicenter, randomized, double-blind, double-dummy, placebo- and active-controlled study to assess the efficacy, safety and tolerability of taspoglutide (RO5073031) compared to sitagliptin and placebo in patients with type 2 diabetes mellitus inadequately controlled with metformin.

lead_sponsor: F.Hoffmann-La Roche Ltd


title: Multinational, multicentre, prospective, open-label, uncontrolled clinical trial to assess the efficacy and safety of Autologous Cultivated Limbal Stem Cells Transplantation (ACLSCT) for restoration of corneal epithelium in patients with limbal stem cell deficiency due to ocular burns

acronym: HOLOCORE

lead_sponsor: Chiesi Farmaceutici S.p.A.


title: A PHASE III RANDOMIZED, DOUBLE-BLIND STUDY OF SUNITINIB (SU011248, SUTENT®) VERSUS PLACEBO IN PATIENTS WITH PROGRESSIVE ADVANCED/METASTATIC WELL-DIFFERENTIATED PANCREATIC ISLET CELL TUMORS

lead_sponsor: Pfizer Inc.


title: A Randomised, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Sevelamer Carbonate Tablets Dosed Three Times a Day in Hyperphosphatemic Chronic Kidney Disease Patients Not on Dialysis

lead_sponsor: Genzyme Europe BV


title: MRX-503: An Open-label Extension Study to Evaluate the Long-term Safety and Efficacy of Maralixibat in the Treatment of Subjects with Progressive Familial Intrahepatic Cholestasis (PFIC)

lead_sponsor: Mirum Pharmaceuticals Inc.

status: Ongoing

status_simplified: Ongoing


title:
A Multi-center, Double-blind, Randomized, Placebo Controlled Study to Assess the Efficacy and Safety of NTRA-2112 on Intestinal Malabsorption due to GI Immaturity in Preterm Infants.

 Étude multicentrique, en double aveugle, randomisée et contrôlée par placebo visant à évaluer l'efficacité et la tolérance du NTRA-2112 sur la malabsorption intestinale due à une immaturité du système digestif chez des nourrissons prématurés.

acronym: A Study to Assess the Efficacy and Safety of NTRA-2112 in Preterm Infants

lead_sponsor: Nutrinia


title:
An Open-label Extension Study to Evaluate Long-term Efficacy and Safety of A4250 in Children with Progressive Familial Intrahepatic Cholestasis Types 1 and 2 (PEDFIC 2)

 Étude d'extension en ouvert évaluant l'efficacité et la sécurité à long terme de l'A4250 chez des enfants atteints de cholestase intrahépatique progressive familiale de types 1 et 2 (PEDFIC 2)

lead_sponsor: Albireo AB


title: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of ST-0529 in Subjects with Moderately to Severely Active Ulcerative Colitis

lead_sponsor: Sublimity Therapeutics (Hold Co) Ltd.


title: An Open-Label, Long-Term Safety Study Including a Double-Blind, Placebo-Controlled, Randomized Withdrawal Period of TEV-50717 (deutetrabenazine) for the Treatment of Tourette Syndrome in Children and Adolescents

acronym: ARTISTS

lead_sponsor: Teva Branded Pharmaceutical Products R&D, Inc.


title: A Phase 2 Study of INCMGA00012 in Participants With Metastatic Merkel Cell Carcinoma

lead_sponsor: Incyte Corporation


title:
An exploratory maintenance trial evaluating the effect of BI 655064 in Lupus Nephritis patients who have achieved a meaningful response either at the end of 1293.10 or after an induction treatment outside of 1293.10

 Etude exploratoire de maintenance évaluant l’effet du BI 655064 chez des patients atteints de néphropathie lupique et ayant présenté une réponse significative soit à la fin de l’étude 1293.10 soit après un traitement d’induction en dehors de l’étude 1293.10

lead_sponsor: Boehringer Ingelheim France


title:
A PHASE 3 RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY INVESTIGATING THE EFFICACY AND SAFETY OF PF-04965842 AND DUPILUMAB IN COMPARISON WITH PLACEBO IN ADULT SUBJECTS ON BACKGROUND TOPICAL THERAPY, WITH MODERATE TO SEVERE ATOPIC DERMATITIS

 ÉTUDE DE PHASE III RANDOMISEE, MULTICENTRIQUE, EN DOUBLE AVEUGLE, A DOUBLE PLACEBO, CONTROLEE PAR PLACEBO, A GROUPES PARALLELES, VISANT A EXAMINER L’EFFICACITE ET LA SECURITE DU PF 04965842 ET DU DUPILUMAB PAR RAPPORT A UN PLACEBO CHEZ DES PATIENTS ADULTES ATTEINTS DE DERMATITE ATOPIQUE MODEREE A SEVERE, SOUS TRAITEMENT TOPIQUE DE FOND


title: A Randomized Open-Label Phase III Trial of MK-3475 versus Platinum based Chemotherapy in 1L Subjects with PD-L1 Strong Metastatic Non-Small Cell Lung Cancer

acronym: MK-3475 versus SOC in 1L Subjects with PD-L1 Strong Metastatic NSCLC

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


title: ASSURE: An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects with Primary Biliary Cholangitis (PBC)

acronym: ASSURE

lead_sponsor: CymaBay Therapeutics, Inc.


title: A Phase 3, Randomized, Open-Label Study of Nivolumab Combined with Cabozantinib or Nivolumab and Ipilimumab Combined with Cabozantinib versus Sunitinib in Participants with Previously Untreated, Advanced or Metastatic Renal Cell Carcinoma

lead_sponsor: Bristol-Myers Squibb International Corporation


title: A Phase III, Double-Blind, Placebo-Controlled, Multicenter, Randomized Study Of Pracinostat In Combination With Azacitidine In Patients ≥18 Years With Newly Diagnosed Acute Myeloid Leukemia Unfit For Standard Induction Chemotherapy

lead_sponsor: Helsinn Healthcare SA


title:
A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Safety and Efficacy of Avacopan (CCX168) in Patients with C3 Glomerulopathy

 Étude de phase 2, randomisée, en double aveugle, contrôlée contre placebo, évaluant la sécurité et l’efficacité de l’Avacopan (CCX168) chez des patients atteints de glomérulopathie à C3

lead_sponsor: ChemoCentryx, Inc.


title:
A Randomized, Double-blind Study To Evaluate the Efficacy
 and Safety of Cabozantinib (XL184) at 60 mg/Day Compared
 to 140 mg/Day in Progressive, Metastatic Medullary Thyroid
 Cancer Patients

acronym: EXAMINER

lead_sponsor: Exelixis, Inc.


title: A Phase III Open-Label Extension Study to Assess the Long-Term Safety and Efficacy of Idebenone in Patients with Duchenne Muscular Dystrophy (DMD) who completed the SIDEROS study

acronym: SIDEROS-E

lead_sponsor: Santhera Pharmaceuticals (Switzerland) Limited


title: Open-label, individual dose titration study to evaluate safety, tolerability and pharmacokinetics of riociguat in children from 6 to less than 18 years of age with pulmonary arterial hypertension (PAH)

acronym: PATENT-CHILD

lead_sponsor: Bayer Healthcare AG


title: A PHASE 3 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY OF THE ANALGESIC EFFICACY AND SAFETY OF THE SUBCUTANEOUS ADMINISTRATION OF TANEZUMAB (PF-04383119) IN SUBJECTS WITH CANCER PAIN PREDOMINANTLY DUE TO BONE METASTASIS RECEIVING BACKGROUND OPIOID THERAPY

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


title: A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Trial of Two Fixed Doses of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy in Children and Young Adults with Dravet Syndrome

lead_sponsor: Zogenix International Limited


title:
A Phase 3, Open-Label, Multicenter Study of ALXN1210 in Children and Adolescents with Atypical Hemolytic Uremic Syndrome (aHUS)

 Étude de phase III, en ouvert, multicentrique, évaluant l’ALXN1210 chez des enfants et des adolescents atteints du syndrome hémolytique et urémique atypique (SHUa)

lead_sponsor: Alexion Pharmaceuticals Incorporated


title: A PHASE III, OPEN-LABEL, EXTENSION TRIAL OF ECU-NMO-301 TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN PATIENTS WITH RELAPSING NEUROMYELITIS OPTICA (NMO)

lead_sponsor: Alexion Pharmaceuticals, Inc.


title: A phase II randomized, controlled, open-labeled (dose-blinded) dose finding study of the safety and efficacy of I-040202 in the treatment of patients with acute open tibial shaft fractures

lead_sponsor: Kuros Biosurgery AG


title: Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension.

lead_sponsor: MondoGEN AG


title: A Phase III, randomised, parallel group, double-blind, double-dummy, active comparator -controlled, multi-center study to assess the efficacy and safety of PGL4001 (ulipristal) versus GnRH-agonist (leuprorelin 3.75mg) for pre-operative treatment of symptomatic uterine myomas.

acronym: PEARL II, PGL4001 versus GnRH-agonist in uterine myomas

lead_sponsor: PregLem S.A.


title: A Phase 3, Randomized, Double-Blind, Multinational, Placebo-Controlled Study to Evaluate Efficacy and Safety of Teplizumab (MGA031), a Humanized, FcR Non-Binding, Anti-CD3 Monoclonal Antibody, in Children and Adults with Recent-Onset Type 1 Diabetes Mellitus

acronym: Protégé Encore

lead_sponsor: MacroGenics, Inc.


title: A double blind, randomized, placebo-controlled, parallel group, multicenter Phase 3 pivotal study to assess the safety and efficacy of 1mg/kg/day intravenous DP-b99 over 4 consecutive days versus placebo when initiated within nine hours of acute ischemic stroke onset

acronym: MACSI

lead_sponsor: D-Pharm Ltd.


title: Etude prospective, randomisée, en double aveugle versus placebo, internationale, groupe parallèle, évaluant l'efficacité et la sécurité d'un bolus I.V de tenecteplase en comparaison avec un traitement standard chez des patients normotensifs ayant une embolie pulmonaire aigue.

acronym: PEITHO

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

lead_sponsor_type: academique


title: An Open-labeled, Randomized, Parallel Group Trial of zalutumumab, a Human Monoclonal Anti-EGF receptor Antibody, in combination with Best Supportive Care, versus Best Supportive Care, in Patients with Non-Curable Squamous Cell Carcinoma of the Head and Neck who have failed standard platinum-based chemotherapy.

lead_sponsor: Genmab A/S


title: A 24-week, international, multi centre, randomised, double-blind, double-dummy, parallel group, phase IV clinical trial investigating changes in back pain in postmenopausal women with an osteoporosis related vertebral fracture(s) treated with either 100 µg PTH(1-84) daily or 70 mg alendronate weekly

acronym: RELIEF

lead_sponsor: Nycomed Danmark Aps


title: A double blind, within patient, placebo controlled trial to assess the efficacy of Juvista (avotermin) in conjunction with scar revision surgery for the improvement of disfiguring scars.

acronym: Juvista in scar revision surgery of disfiguring scars

lead_sponsor: Renovo Ltd


title: A Randomized, Double-blind, Placebo-Controlled, Multi-Center Study to Evaluate the Efficacy and Safety of Two Doses of Tramadol Hydrochloride Orally Disintegrating Tablets in Male Subjects with Premature Ejaculation.

lead_sponsor: Biovail Laboratories International SRL, c/o Biovail Technologies Ltd


title: A Phase III, Multicenter, Ramdomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Intramuscular Peramivir in Subjects with Uncomplicated Acute Influenza

acronym: The IMPROVE 2 Study

lead_sponsor: BioCryst Pharmaceuticals


title: A Phase III, randomized, double-blind trial of TMC278 75 mg q.d. versus efavirenz 600 mg q.d. in combination with a fixed background regimen consisting of tenofovir disoproxil fumarate and emtricitabine in antiretroviral-naïve HIV-1 infected subjects

acronym: ECHO Simplified Pill Regimen In Naive patients with TMC278

lead_sponsor: Tibotec Pharmaceuticals Limited


title:
A Phase 3, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept in Subjects with Active Crohn’s Disease (CD) who have had an Inadequate Clinical Response and/or Intolerance to Medical Therapy.
 Revised Protocol 01, incorporating Protocol Amendment 02 (Version 1.0, Date: 06-Dec-2006).

lead_sponsor: Bristol-Myers Squibb International Corporation


title: A multi-center, randomized, open label, controlled study to compare the Sustained Virological Response during treatment with Neoral or tacrolimus in maintenance liver transplant recipients treated with pegylated interferon and ribavirin for recurrent Hepatitis C

acronym: SUSTAIN

lead_sponsor: Novartis Pharma Services AG


title: IDH mutated 1p/19q intact lower grade glioma following resection: Wait Or Treat? IWOT – A phase III study

acronym: IWOT

lead_sponsor: European Organisation for Research and Treatment of Cancer


title:
A Phase 3, Randomized, Double-Blind, Multinational, Placebo-Controlled Study to Evaluate Efficacy and Safety of Teplizumab (PRV-031), a Humanized, FcR Non-Binding, anti-CD3 Monoclonal Antibody, in Children and Adolescents with Newly Diagnosed Type
 1 Diabetes (T1D)

 Étude clinique internationale de phase III, randomisée, en double insu, contrôlée contre placebo, évaluant l’efficacité et la tolérance du téplizumab (PRV-031), un anticorps monoclonal anti-CD3 humanisé, ne se liant pas au récepteur Fc, chez des enfants et des adolescents présentant un diabète de type 1 (DT1) nouvellement diagnostiqué

acronym: PROTECT

lead_sponsor: Provention Bio, Inc.


title:
A randomized, double blind, multicenter extension to CZPL389A2203 dose-ranging study to assess the short-term and long-term safety and efficacy of oral ZPL389 with concomitant or intermittent use of TCS and/or TCI in adult patients with atopic dermatitis (ZEST Extension)

 Protocole d’extension de l’étude CZPL389A2203, dose-réponse, multicentrique, randomisée, en double aveugle, évaluant à court terme et à long terme la tolérance et l’efficacité de ZPL389 par voie orale avec une utilisation concomitante ou intermittente de dermocorticoïdes et/ou d’inhibiteurs de la calcineurine topiques chez des patients adultes atteints de dermatite atopique (Extension de l’étude ZEST)

acronym: ZEST Extension

lead_sponsor: Novartis Pharma AG


title: A European randomised Phase 3 study to assess the efficacy and safety of TOOKAD® Soluble for low risk localised prostate cancer compared to Active Surveillance

lead_sponsor: STEBA BIOTECH SA


title:
A Phase 3, Multinational, Double-Blind, Randomized, Placebo-Controlled Study of MGL-3196 (resmetirom) in Patients With Non-Alcoholic Steatohepatitis (NASH) and Fibrosis to Resolve NASH and Reduce Progression to Cirrhosis and/or Hepatic Decompensation

 Étude de phase 3, internationale, en double aveugle, randomisée, contrôlée par placebo portant sur le MGL 3196 (resmétirom) chez des patients atteints d’une stéatohépatite non alcoolique (Non-Alcoholic Steatohepatitis, NASH) avec fibrose hépatique visant à faire disparaître la NASH et à diminuer la progression vers une cirrhose et/ou une décompensation hépatique

lead_sponsor: Madrigal Pharmaceuticals, Inc.


title: An Open-Label, Single-Arm, Phase 1/2 Study Evaluating the Safety and Efficacy of Ponatinib for the Treatment of Recurrent or Refractory Leukemias or Solid Tumors in Pediatric Participants

lead_sponsor: Incyte Biosciences International Sàrl


title: A Phase III Double-blind Randomised Study Assessing the Efficacy and Safety of Capivasertib + Fulvestrant Versus Placebo + Fulvestrant as Treatment for Locally Advanced (Inoperable) or Metastatic Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2−) Breast Cancer Following Recurrence or Progression On or After Treatment with an Aromatase Inhibitor (CAPItello-291)

lead_sponsor: AstraZeneca AB


title: A multicentre randomized, double-blind (sponsor open), placebo-controlled Phase 2 study to evaluate the safety, tolerability, efficacy, dose-response, pharmacokinetics and pharmacodynamics of repeat dosing of an anti-LAG3 cell depleting monoclonal antibody (GSK2831781) in patients with active ulcerative colitis

lead_sponsor: GlaxoSmithKline Research & Development Limited


title: An Open-Label Extension (OLE) Study to Evaluate the Efficacy and Safety of Nefecon Treatment in Patients With IgA Nephropathy Who Have Completed Study Nef-301

lead_sponsor: Calliditas Therapeutics AB


title: A Phase III Randomized, Open-label Study to Evaluate Efficacy and Safety of Pembrolizumab (MK-3475) in Combination with Axitinib versus Sunitinib Monotherapy as a First-line Treatment for Locally Advanced or Metastatic Renal Cell Carcinoma (mRCC) (KEYNOTE-426)

acronym: Pembrolizumab plus axitinib vs. sunitinib monotherapy in advanced/metastatic renal cell carcinoma

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


title:
A Compassionate Use Open-Label Study of Anti IL-5
 (Mepolizumab) Treatment in Subjects with Hypereosinophilic
 Syndrome

lead_sponsor: GlaxoSmithKline Resaearch and Development Ltd


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:
Prospective, randomized, controlled, double-blind, multicentre, multinational study on the safety and efficacy of 6% Hydroxyethyl starch (HES) solution versus an electrolyte solution in patients undergoing elective abdominal surgery

 Étude 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 bénéficiant d’une chirurgie abdominale non urgente

acronym: PHOENICS

lead_sponsor: B. Braun Melsungen AG


title: Open-label safety and tolerability of dabigatran etexilate mesilate given for 3 days at the end of standard anticoagulant therapy in successive groups of children aged 2 years to less than 12 years, and 1 year to less than 2 years.

lead_sponsor: Boehringer Ingelheim France


title: A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Apremilast in Children From 5 to Less Than 18 Years of Age With Active Juvenile Psoriatic Arthritis (PEAPOD)

lead_sponsor: Amgen Inc.


title:
A Non-Controlled, Open-Label, Multicenter, Study of Immune Tolerance Induction Performed with rFVIIIFc within a Timeframe of 60 Weeks in Severe Haemophilia A Patients with Inhibitors who have Failed Previous Immune Tolerance Induction Therapies

 Étude multicentrique, non contrôlée, en ouvert, évaluant l'immunotolérance induite par rFVIIIFc pendant une période de 60 semaines chez des patients atteints d'hémophilie A sévère sous inhibiteurs, n'ayant pas répondu à des traitements antérieurs d'immunotolérance

lead_sponsor: Swedish Orphan Biovitrum AB (publ)


title: A phase I/II study of Bosutinib in pediatric patients with Chronic Myeloid Leukemia who are resistant or intolerant to at least one prior Tyrosine Kinase Inhibitor therapy, ITCC-054/AAML1621

acronym: Bosutinib in pediatric CML

lead_sponsor: Erasmus MC


title: A RANDOMIZED PHASE III TRIAL COMPARING CONVENTIONAL-DOSE CHEMOTHERAPY USING PACLITAXEL, IFOSFAMIDE, AND CISPLATIN (TIP) WITH HIGH-DOSE CHEMOTHERAPY USING MOBILIZING PACLITAXEL PLUS IFOSFAMIDE FOLLOWED BY HIGH-DOSE CARBOPLATIN AND ETOPOSIDE (TI-CE) AS FIRST SALVAGE TREATMENT IN RELAPSED OR REFRACTORY GERM CELL TUMORS

acronym: TIGER

lead_sponsor: European Organisation for Research and Treatment of Cancer


title: A Phase IIIb, Randomized, Multicenter, Active-controlled, Parallel-group, Non-inferiority, Open-label Study Evaluating the Efficacy, Safety, and Tolerability of Switching to Long-acting Cabotegravir Plus Long-acting Rilpivirine administered every two months from a Bictegravir/emtricitabine/tenofovir alafenamide Single Tablet Regimen in HIV-1 Infected Adults who are Virologically Suppressed

acronym: PH3b, CAB LA+RPV LA vs BIK, IM Every 2Months, Non-inferiority, Efficacy&Safety in Participants HIV-1

lead_sponsor: ViiV Healthcare UK Limited


title:
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of AMX0035 Versus Placebo for 48-week Treatment of Adult Patients with Amyotrophic Lateral Sclerosis (ALS)

 Essai multicentrique de phase III, randomisé, en double aveugle, contre placebo, visant à évaluer la tolérance et l’efficacité de l’AMX0035 par rapport à un placebo, dans le traitement de patients adultes atteints de Sclérose Latérale Amyotrophique (SLA) sur une période de 48 semaines.

acronym: Phoenix

lead_sponsor: Amylyx Pharmaceuticals Inc.


title: A Phase 3 Randomized, Open-Label Clinical Study to Evaluate the Efficacy and Safety of Pembrolizumab plus Epacadostat, Pembrolizumab Monotherapy, and the EXTREME Regimen as First line Treatment for Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (KEYNOTE-669/ECHO-304)

acronym: Pembrolizumab plus epacadostat, and the EXTREME regimen as first line tre for R/M HNSCC

lead_sponsor: Incyte Corporation


title: A Multinational Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CCX282-B in Subjects with Moderate to Severe Crohn’s Disease

lead_sponsor: ChemoCentryx, Inc


title: A Randomized Phase 3 Multicenter Open-label Study to Compare the Efficacy of TAK-788 as First-line Treatment Versus Platinum-Based Chemotherapy in Patients With Non-Small Cell Lung Cancer With EGFR Exon 20 Insertion Mutations

acronym: TAK-788 as First-line Treatment Versus Platinum-Based Chemotherapy for NSCLC With EGFR Exon 20 Inser

lead_sponsor: Millennium Pharmaceuticals, Inc. Millennium Pharmaceuticals is a wholly owned subsidiary of Takeda Pharmaceutical


title: A Phase 3, Multicenter, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of AL001 in Individuals at Risk for or With Frontotemporal Dementia Due to Heterozygous Mutations in the Progranulin Gene

lead_sponsor: Alector Inc.


title:
An open-label, multi-center, roll-over study to assess long-term safety in patients with endogenous Cushing’s syndrome who have completed a prior Novartis-sponsored osilodrostat (LCI699) study and are judged by the investigator to benefit from continued treatment with osilodrostat

 Etude multicentrique, en ouvert et de poursuite du traitement afin d’évaluer la tolérance à long terme chez des patients atteints du syndrome de Cushing endogène ayant terminé une précédente étude Novartis portant sur l’osilodrostat (LCI699) et continuant à bénéficier du traitement par osilodrostat selon leur médecin-investigateur

lead_sponsor: Novartis Pharma AG


title: A Phase 3 Study Comparing Pomalidomide and Dexamethasone With or Without Daratumumab in Subjects With Relapsed or Refractory Multiple Myeloma Who Have Received at Least One Prior Line of Therapy With Both Lenalidomide and a Proteasome Inhibitor.

acronym: The APOLLO Study

lead_sponsor: European Myeloma Network (EMN)


title:
Long-term treatment of cancer associated VTE Optimal dose of apixaban API-CAT STUDY for APIxaban Cancer Associated Thrombosis

 Long-term treatment of cancer associated VTE Optimal dose of apixaban API-CAT STUDY for APIxaban Cancer Associated Thrombosis

acronym: API-CAT

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

status: Temporarily Halted


title:
Corticosteroids or clobazam for ESES syndrome: a European, multicenter,
 randomized, controlled clinical trial

acronym: RESCUE ESES: Randomized European trial of Steroids vs Clobazam Usage

lead_sponsor: University Medical Center Utrecht


title:
A Phase III Double-Blind, Randomised, Placebo-Controlled Study Assessing Efficacy and Safety of Capivasertib + Abiraterone Versus Placebo + Abiraterone as Treatment for Patients with De Novo Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) Characterised by PTEN deficiency (CAPItello-281)

 Etude de Phase III randomisée, en double-aveugle, et contrôlée par placebo évaluant l'efficacité et la tolérance  de capivasertib + abiratérone versus placebo + abiratérone chez des patients atteints d’un cancer métastatique de la prostate hormono-sensible (mHSPC) nouvellement diagnostiqué, caractérisé par un déficit en PTEN (CAPItello-281)

lead_sponsor: AstraZeneca AB


title: Open-label Uncontrolled Trial to Evaluate Pharmacokinetics, Pharmacodynamics, Safety, and Activity of Efgartigimod in Children From 2 to Less Than 18 Years of Age With Generalized Myasthenia Gravis

acronym: ADAPT JR

lead_sponsor: argenx BV


title:
A phase III trial evaluating the efficacy and safety of the house dust mite (HDM) sublingual immunotherapy (SLIT)-tablet in children and adolescents (5-17 years) with HDM allergic asthma

 Étude de Phase III évaluant l’efficacité et la bonne tolérance du comprimé d'immunothérapie sublinguale aux acariens (comprimé HDM-SLIT) chez des enfants et des adolescents âgés de 5 à 17 ans présentant un asthme allergique aux acariens de la poussière de maison.

lead_sponsor: ALK-Abelló A/S


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 Ulcerative Colitis

lead_sponsor: Celltrion, Inc.


title: A Phase 3, international, multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of glepaglutide in patients with short bowel syndrome (SBS)

acronym: Ease SBS 1 - Efficacy And Safety Evaluation of Glepaglutide in treatment of SBS

lead_sponsor: Zealand Pharma A/S


title: A Phase 2, Open-Label, 2-Cohort Study of INCB050465, a PI3Kδ Inhibitor, in Subjects With Relapsed or Refractory Marginal Zone Lymphoma With or Without Prior Exposure to a BTK Inhibitor.


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:
A Phase 3, Open-label, Randomized Study of Dato-DXd Versus Investigator’s Choice of Chemotherapy in Participants With Inoperable or Metastatic Hormone Receptor-Positive, HER2-Negative Breast Cancer Who Have Been Treated With One or Two Prior Lines of Systemic Chemotherapy (TROPION-Breast01)

 Etude de phase 3, randomisée, en ouvert, évaluant le Dato-DXd versus une chimiothérapie au choix de l’investigateur, chez des patients atteints d’un cancer du sein positif aux récepteurs hormonaux, HER2 négatif, de stade inopérable ou métastatique et ayant été préalablement traités  par une ou deux lignes de chimiothérapie systémique (TROPION-Breast01)


title:
Randomized, double-blind, phase 3 study of tucatinib or placebo in combination with ado-trastuzumab emtansine (T-DM1) for subjects with unresectable locally-advanced or metastatic HER2+ breast cancer (HER2CLIMB-02)

 Étude de phase 3, randomisée, en double insu, évaluant un traitement par tucatinib ou placebo en association à l’ado-trastuzumab emtansine (T-DM1) chez des patients atteints d’un cancer du sein HER 2 positif métastatique ou localement avancé non résécable (HER2CLIMB-02)

lead_sponsor: Seattle Genetics, Inc.


title: A Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of AG-120 in Combination with Azacitidine in Subjects ≥ 18 Years of Age with Previously Untreated Acute Myeloid Leukemia with an IDH1 Mutation

lead_sponsor: Agios Pharmaceuticals, Inc.


title: A Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101 and Plasma Cell Dyscrasia Treatment Versus Placebo and Plasma Cell Dyscrasia Treatment in Plasma Cell Dyscrasia Treatment-Naïve Patients with Mayo Stage IIIb AL Amyloidosis

lead_sponsor: Caelum Biosciences, Inc.


title: A Randomized, Double-Blind, Phase III Study of Pembrolizumab (MK-3475) plus Chemotherapy vs Placebo plus Chemotherapy for Previously Untreated Locally Recurrent Inoperable or Metastatic Triple Negative Breast Cancer – (KEYNOTE-355)

acronym: A Phase III Study of Chemotherapy ± Pembrolizumab in 1L Triple Negative Breast Cancer


title: A Phase 2a, Randomized, Double-blind, Placebo controlled, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of Belcesiran in Patients with PiZZ Alpha-1 Antitrypsin Deficiency

lead_sponsor: Dicerna Pharmaceuticals, Inc.


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)


title:
A DOUBLE-BLIND, PLACEBO-CONTROLLED, STUDY TO EVALUATE THE EFFICACY AND SAFETY OF 24 WEEKS TREATMENT WITH REN001 IN PATIENTS WITH PRIMARY MITOCHONDRIAL MYOPATHY (PMM)

 ÉTUDE EN DOUBLE AVEUGLE, CONTRÔLÉE CONTRE PLACEBO, VISANT À ÉVALUER L’EFFICACITÉ ET LA TOLERANCE D’UN TRAITEMENT DE 24 SEMAINES PAR REN001 CHEZ DES PATIENTS ATTEINTS DE MYOPATHIE MITOCHONDRIALE PRIMAIRE (MMP)

acronym: Phase 2b Safety and Efficacy Study of REN001 in Mitochondrial Myopathy

lead_sponsor: Reneo Pharma Ltd.


title:
A randomized phase III study of neoadjuvant chemotherapy followed by surgery versus surgery alone for patients with High Risk RetroPeritoneal Sarcoma

 Étude randomisée de phase III comparant une chimiothérapie néoadjuvante suivie d’une chirurgie et une chirurgie seule chez des patients atteints d’un sarcome rétropéritonéal à risque élevé

acronym: STRASS 2

lead_sponsor: European Organisation for Research and Treatment of Cancer


title: A Phase 3, Randomized, Double blind, Placebo controlled, Multicenter Study of Bendamustine and Rituximab (BR) alone Versus in Combination with Acalabrutinib (ACP 196) in Subjects with Previously Untreated Mantle Cell Lymphoma

lead_sponsor: Acerta Pharma BV


title:
High-Risk Neuroblastoma Study 2 of SIOP-Europa-Neuroblastoma (SIOPEN)
 Randomized, international and multicentric phase 3 study that evaluates and compares 2 treatment strategies in 3 therapeutic phases (induction, high-dose chemotherapy and radiotherapy) for patients with high-risk neuroblastoma.

 Etude internationale multicentrique de phase 3 randomisée qui évalue et compare 2 stratégies de traitement dans 3 phases thérapeutiques (induction, chimiothérapie à haute dose et radiothérapie) pour les patients atteints de neuroblastome de haut-risque.

lead_sponsor: Gustave Roussy


title: A Phase 3, randomized, double-blind, active controlled study to compare the efficacy and safety of ridinilazole (200 mg, bid) for 10 days with vancomycin (125 mg, qid) for 10 days in the treatment of Clostridium difficile infection (CDI).

lead_sponsor: Summit (Oxford) Limited


title:
A Phase 3, External Placebo-Controlled, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Patients with Neuromyelitis Optica Spectrum Disorder (NMOSD)

 Étude de phase 3, contrôlée par placebo externe, ouverte, multicentrique, visant à évaluer l’efficacité et la sécurité du ravulizumab chez des patients adultes présentant un trouble du spectre de la neuromyélite optique (NMOSD)

acronym: A Phase 3 Efficacy and Safety Study of Ravulizumab in Adult Patients with NMOSD

lead_sponsor: Alexion Pharmaceuticals, Inc.


title:
A Phase 3, Matrix Design, Partially Double-Blind, Randomized Study of the Efficacy and Safety of 50 mg Lonafarnib/100 mg Ritonavir BID with and without 180 mcg PEG IFN-alfa-2a for 48 Weeks Compared with PEG IFN-alfa-2a Monotherapy and Placebo Treatment in Patients Chronically Infected with Hepatitis Delta Virus Being Maintained on Anti-HBV Nucleos(t)ide Therapy (D-LIVR)

 Étude randomisée de phase III, avec un plan matriciel et partiellement en double aveugle, visant à évaluer l’efficacité et la sécurité d’emploi de 50 mg de lonafarnib et 100 mg de ritonavir administrés deux fois par jour pendant 48 semaines, associés ou non à 180 µg de peginterféron alfa-2a, en comparaison avec une monothérapie de peginterféron alfa-2a et un traitement par placebo chez des patients présentant une infection chronique par le virus de l’hépatite D et recevant un traitement d’entretien par nucléoside(tide) anti-VHB (Virus de l’hépatite B) (D-LIVR)

acronym: D-LIVR

lead_sponsor: Eiger BioPharmaceuticals, Inc.


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 Phase 3, INterVentional, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of DCC-2618 In Patients with AdvanCed Gastrointestinal Stromal TUmorS who have Received Treatment with Prior Anticancer Therapies

acronym: INVICTUS

lead_sponsor: Deciphera Pharmaceuticals, LLC


title:
An Open-Label Extension Trial to Assess the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy for Seizures in Patients with Rare Seizure Disorders Such as Epileptic Encephalopathies Including Dravet Syndrome and Lennox-Gastaut Syndrome

 Essai d’extension en ouvert visant à évaluer la sécurité d’emploi à long terme du ZX008 (chlorhydrate de fenfluramine) en solution buvable en tant que traitement adjuvant des crises convulsives chez des patients atteints de troubles convulsifs rares tels que des encéphalopathies épileptiques, y compris du syndrome de Dravet et du syndrome de Lennox-Gastaut

lead_sponsor: Zogenix International Limited


title: A Multicenter, Open-Label, Single- and Multiple-Dose, Dose-Finding Study, with an Optional Open-Label Extension to Assess the Safety, Tolerability, and Pharmacokinetics of Obeticholic Acid in Pediatric Subjects with Biliary Atresia

acronym: ObetiCholic Acid in Pediatric Subjects with BiliaRy AtrEsia (CARE)

lead_sponsor: Intercept Pharmaceuticals, Inc.


title: A Double-Blind Phase 3 Extension Trial Assessing the Long Term Safety and Efficacy of Glepaglutide in Patients with Short Bowel Syndrome (SBS)

acronym: EaseSBS 2 - Efficacy And Safety Evaluation of Glepaglutide in treatment of SBS

lead_sponsor: Zealand Pharma A/S


title: Prevention of Mortality with Long-Term Administration of Human Albumin in Subjects with Decompensated Cirrhosis and Ascites

acronym: PRECIOSA

lead_sponsor: Instituto Grifols S.A.


title:
A phase 3, multicenter, randomized, double-blind, placebo-controlled trial comparing the efficacy and safety of tafasitamab plus lenalidomide in addition to R-CHOP versus R-CHOP in previously untreated, high-intermediate and high-risk patients with newly-diagnosed diffuse large B-cell lymphoma (DLBCL)

 Essai de phase 3, multicentrique, randomisé, en double aveugle, contrôlé par placebo, visant à comparer l'efficacité et l'innocuité du tafasitamab plus lénalidomide en association avec la chimiothérapie R-CHOP par rapport à la chimiothérapie R-CHOP seule chez des patients à risque intermédiaire et à risque élevé présentant un lymphome diffus à grandes cellules B (LDGCB) récemment diagnostiqué n'ayant jamais été traités

acronym: frontMIND

lead_sponsor: MorphoSys AG


title:
A phase III, randomized, controlled, open-label, multicenter, global study of capmatinib versus SoC docetaxel chemotherapy in previously treated patients with EGFR wt, ALK negative, locally advanced or metastatic (stage IIIB/IIIC or IV) NSCLC harboring MET exon 14 skipping mutation (METΔex14)

 Etude internationale de phase III, multicentrique, randomisée, en ouvert, évaluant capmatinib versus docétaxel chez des patients atteints de cancer bronchique non à petites cellules, localement avancé ou métastatique, avec mutations responsables d’un saut de l’exon 14 de MET (METΔex14) et préalablement traités

lead_sponsor: Novartis Pharma AG


title: A Clinical Study to Evaluate the Safety and Effectiveness of NOVOCART® 3D plus Compared to Microfracture in the Treatment of Articular Cartilage Defects of the Knee.

lead_sponsor: TETEC – Tissue Engineering Technologies – AG


title:
A Long-term, Single-Arm, Open-label, Multicenter, Follow-on Trial of ARGX113-2006 to Evaluate Safety of Efgartigimod Administered Intravenously in
 Children With Generalized Myasthenia Gravis

acronym: ADAPT JR.+

lead_sponsor: argenx BV


title: A Phase 1/2, Open-Label, Multi-Center, First-in-Human Study of the Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity of TPX-0005 in Patients with Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 Rearrangements (TRIDENT-1)

lead_sponsor: Turning Point Therapeutics, Inc.


title: Effects of Plasma Exchange with Human Serum Albumin 5% (PE-A 5%) on Short-term Survival in Subjects with "Acute-On-Chronic Liver Failure" (ACLF) at High Risk of Hospital Mortality

acronym: APACHE


title:
A Phase 3 Randomized, Double-Blind, Controlled Study Evaluating FPA144 and Modified FOLFOX6 in Patients with Previously Untreated Advanced Gastric and Gastroesophageal  Cancer: Phase 3 Preceded by Dose-Finding in Phase 1

 Étude de phase III randomisée, menée en double aveugle, contrôlée contre placebo évaluant FPA144 et le FOLFOX-6 modifié chez des patients atteints d'un cancer gastrique ou gastro-œsophagien avancé n'ayant reçu aucun traitement antérieur : phase III précédée d'une recherche de dose en phase I

acronym: FIGHT

lead_sponsor: Five Prime Therapeutics, Inc.


title: A Phase 3, Randomized, Placebo-Controlled, Double-Blinded, Multicenter Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients with C3 Glomerulopathy or Immune-Complex Membranoproliferative Glomerulonephritis

acronym: VALIANT

lead_sponsor: Apellis Pharmaceuticals, Inc.


title: A PHASE III, RANDOMIZED, OPEN-LABEL STUDY OF PRALSETINIB VERSUS STANDARD OF CARE FOR TREATMENT OF RET-MUTATED MEDULLARY THYROID CANCER

lead_sponsor: F. Hoffmann-La Roche Ltd


title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-Controlled, Parallel-Group Study with an Open-Label Extension to Evaluate the Efficacy and Safety of Oral Rilzabrutinib (PRN1008) in Adults and Adolescents with Persistent or Chronic Immune Thrombocytopenia (ITP)

lead_sponsor: Principia Biopharma, Inc.


title: A randomised, double-blind, placebo-controlled, multicentre, Phase 3 study evaluating long-term efficacy and safety of lanifibranor in adult patients with non-cirrhotic non-alcoholic steatohepatitis (NASH) and fibrosis 2 (F2)/fibrosis 3 (F3) stage of liver fibrosis

lead_sponsor: Inventiva S.A.


title: A multi-center, open-label, uncontrolled, single-arm, extension study to determine the long-term safety and tolerability of oral lucerastat in adult subjects with Fabry disease

lead_sponsor: Idorsia Pharmaceuticals Ltd


title: A randomized phase 3 trial of fludarabine/cytarabine/gemtuzumab ozogamicin with or without venetoclax in children with relapsed AML

acronym: Venetoclax in children with relapsed AML

lead_sponsor: Princess Máxima Center


title:
SERENA-2: A Randomised, Open-Label, Parallel-Group, Multicentre Phase 2 Study Comparing the Efficacy and Safety of Oral AZD9833 versus Fulvestrant in Women with Advanced ER-Positive HER2-Negative Breast Cancer

 SERENA-2 : Étude de phase 2 multicentrique, randomisée, ouverte, à groupes parallèles comparant l'efficacité et l'innocuité de l'AZD9833 administré par voie orale par rapport au fulvestrant chez des femmes atteintes de cancer du sein avancé ER positif et HER2 négatif

lead_sponsor: AstraZeneca AB


title: A Randomized, Double-Blind, Placebo-Controlled, Two-Arm Parallel Group, Multi-Center Phase 3 Pivotal Trial to Investigate the Efficacy and Safety of Recombinant Human Alkaline Phosphatase for Treatment of Patients with Sepsis-Associated Acute Kidney Injury

lead_sponsor: AM-Pharma B.V.


title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Comparing Niraparib Plus Pembrolizumab Versus Placebo Plus Pembrolizumab as Maintenance Therapy in Participants Whose Disease has Remained Stable or Responded to First-Line Platinum-Based Chemotherapy with Pembrolizumab forStage IIIB or IV Non-Small Cell Lung Cancer

lead_sponsor: GlaxoSmithKline Research & Development Ltd.


title: A Phase 3 multicenter, randomized, double-blind, placebo-controlled, clinical study to assess the efficacy and safety of linzagolix in subjects with moderate to severe endometriosis-associated pain.

acronym: Edelweiss 3

lead_sponsor: ObsEva S.A.


title: Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of Fulvestrant (FASLODEX) with or without PD-0332991 (PALBOCICLIB) ± Goserelin in Women with Hormone Receptor-Positive, Her2-Negative Metastatic Breast Cancer Whose Disease Progressed after Prior Endocrine Therapy

lead_sponsor: Pfizer Inc 235 East 42nd Street, New York, NY10017


title: Open-Label, Single-Arm, Multicenter Study to Evaluate Long-Term Safety and Tolerability of Brivaracetam Used as Adjunctive Treatment in Pediatric Study Participants With Epilepsy

lead_sponsor: UCB Biopharma SRL


title:
A PHASE 3 TRIAL OF FIANLIMAB (REGN3767, ANTI-LAG-3) + CEMIPLIMAB VERSUS PEMBROLIZUMAB IN PATIENTS WITH PREVIOUSLY UNTREATED UNRESECTABLE LOCALLY ADVANCED OR METASTATIC MELANOMA

 Étude de phase III visant à évaluer le fianlimab (REGN3767, anti-LAG-3) + cémiplimab par rapport au pembrolizumab chez des patients atteints d’un mélanome localement avancé ou métastatique non résécable, antérieurement non traité

lead_sponsor: Regeneron Pharmaceuticals, Inc.


title:
An Open-Label, Multicenter, Outpatient Extension Study to Evaluate the Safety and Tolerability of Staccato Alprazolam in Study Participants 12 Years of Age and Older With Stereotypical Prolonged Seizures

 Étude d’extension en ouvert, multicentrique, en ambulatoire, visant à évaluer la sécurité d’emploi et la tolérabilité de Staccato alprazolam chez des participants à l’étude âgés de 12 ans et plus présentant des crises stéréotypées prolongées

status: Not Authorised


title:
A Double-Blind, Randomized, Placebo-Controlled, Multicenter, Outpatient, Parallel-Group Study to Assess the Efficacy and Safety of Staccato Alprazolam in Study Participants 12 Years of Age and Older With Stereotypical Prolonged Seizures

  Étude multicentrique, randomisée, en double aveugle, contrôlée par placebo, en ambulatoire, en groupes parallèles, visant à évaluer l’efficacité et la sécurité d’emploi de Staccato alprazolam chez des participants à l’étude âgés de 12 ans et plus présentant des crises stéréotypées prolongées


title: Randomized, double blind, placebo controlled study to evaluate the effect of dupilumab on airway inflammation through assessments of lung function, mucus plugging and other lung imaging parameters in patients with asthma

acronym: VESTIGE

lead_sponsor: Sanofi-Aventis Groupe


title: A double-blind randomized extension study to assess the long-term efficacy and safety of linzagolix in subjects with endometriosis-associated pain.

acronym: Edelweiss 3 extension


title: A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Odevixibat (A4250) in Children with Biliary Atresia Who Have Undergone a Kasai Hepatoportoenterostomy (BOLD)

lead_sponsor: Albireo 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)

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


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: 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


ipd_sharing: Undecided

status: Terminated

primary_purpose: Treatment

acronym: INFORMS

intervention_type: Drug

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

lead_sponsor: Novartis Pharmaceuticals

study_completion_date_type: Actual

type: EudraCT Number

design_allocation: Randomized

study_start_date_type: Actual

ReferenceType: derived

ReferenceCitation: Leppert D, Kropshofer H, Häring DA, Dahlke F, Patil A, Meinert R, Tomic D, Kappos L, Kuhle J. Blood Neurofilament Light in Progressive Multiple Sclerosis: Post Hoc Analysis of 2 Randomized Controlled Trials. Neurology. 2022 May 24;98(21):e2120-e2131. doi: 10.1212/WNL.0000000000200258. Epub 2022 Apr 4.

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. 2022 Mar;269(3):1663-1669. doi: 10.1007/s00415-021-10750-z. Epub 2021 Aug 15.

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.

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.

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.

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

enrollment_type: Actual

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

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

lead_sponsor: Abbott GmbH & Co. KG


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 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: 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, 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).


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


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


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: 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.


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: 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

lead_sponsor: Novartis Pharma Services AG


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

lead_sponsor: GlaxoSmithKline

design_allocation: Non-Randomized

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

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: 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 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


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 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 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 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


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


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 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


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 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: 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 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 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

lead_sponsor: Bristol Myers Squibb International Corporation


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: 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: 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 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.


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 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: 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 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 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

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


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.

lead_sponsor: Amgen Inc


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

lead_sponsor: Actelion Pharmaceuticals 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 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: 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

lead_sponsor: AstraZeneca AB


title: A multicenter, multinational, randomized, controlled, open label study, performed in children with thermal burns, to evaluate the efficacy and safety of NexoBrid as compared to standard of care (SOC) treatment

lead_sponsor: MediWound Ltd.


title:
A Two-Part Study of ZX008 in Children and Adults with Lennox-Gastaut Syndrome (LGS); Part 1: A Randomized, Double-blind, Placebo-controlled Trial of Two Fixed Doses of ZX008 (Fenfluramine Hydrochloride) Oral Solution as Adjunctive Therapy for Seizures in Children and Adults with LGS, Followed by Part 2: An Open-label Extension to Assess Long-Term Safety of ZX008 in Children and Adults with LGS

 Une étude en deux parties de ZX008 chez les enfants et les adultes souffrant du syndrome de Lennox-Gastaut (SLG): Partie 1: Essai randomisé, en double aveugle, contrôlé versus placebo de deux doses fixes de ZX008 (chlorhydrate de fenfluramine) en solution orale comme traitement d’appoint contre les crises épileptiques chez des enfants et des adultes souffrant de SLG; suivi de la Partie 2: Une étude d’extension en ouvert pour évaluer la sécurité à long terme de ZX008 chez les enfants et les adultes souffrant de SLG

lead_sponsor: Zogenix International Limited, a wholly owned subsidiary of Zogenix Inc.


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: 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: 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: 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: 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 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: 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


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

lead_sponsor: Merck KGaA


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: 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 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: 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


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


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 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:
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: 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"

lead_sponsor: Boehringer Ingelheim France


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.

lead_sponsor: Sanofi-Aventis Recherche & Développement


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

lead_sponsor: sanofi-aventis recherche & développement


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: 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 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 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, 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 trial comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin® in children with growth hormone deficiency

lead_sponsor: Novo Nordisk A/S


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:
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: 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 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: 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, 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 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

lead_sponsor: AstraZeneca AB


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.


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


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


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 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 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: 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: European Low and Intermediate Risk Neuroblastoma

acronym: LINES

lead_sponsor: INSTITUTO DE INVESTIGACION SANITARIA LA FE DE VALENCIA


title: Efficacy and Safety of Concizumab prophylaxis in patients with haemophilia A or B without inhibitors


title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Cabozantinib (XL184) in Subjects with Radioiodine-Refractory Differentiated Thyroid Cancer Who Have Progressed after Prior VEGFR-Targeted Therapy

lead_sponsor: Exelixis, Inc.


title: A Phase 3b, Double Blind, Randomized, Placebo Controlled, Multicenter Study Evaluating the Effect of Obeticholic Acid on Clinical Outcomes in Subjects with Primary Biliary Cirrhosis

lead_sponsor: Intercept Pharmaceuticals Inc.


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

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


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 46-week, Double-blind, Placebo-controlled, Phase 3 Study with a 6-week Randomized-withdrawal Period to Evaluate the Safety and Efficacy of Relamorelin in Patients with Diabetic Gastroparesis

 Étude de phase 3 d’une durée de 46 semaines, en double aveugle, avec une période de retrait randomisée de 6 semaines contrôlée par placebo évaluant la sécurité d'emploi et l'efficacité de la relamoreline chez des patients atteints de gastroparésie diabétique.

acronym:
Diabetic Gastroparesis Study with Randomized-withdrawal Period

 Étude de la gastroparésie diabétique avec une période d'arrêt randomisée

lead_sponsor: Allergan 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 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 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: 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: 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: 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 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 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: 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: 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

lead_sponsor: AstraZeneca AB


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

lead_sponsor: Pfizer Inc.


title: Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients

lead_sponsor: Merck Serono S.A. - Geneva


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 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 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 Randomized, Open-label Study of Ponatinib Versus Nilotinib in Patients with Chronic Myeloid Leukemia in Chronic Phase Following Resistance to Imatinib

 Étude randomisée menée en ouvert comparant le ponatinib au nilotinib chez des patients atteints de leucémie myéloïde chronique en phase chronique suite à une résistance à l'imatinib

acronym: OPTIC 2L

lead_sponsor: ARIAD 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 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


title: A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF THE EFFICACY AND SAFETY OF LENALIDOMIDE (REVLIMID®) AS MAINTENANCE THERAPY FOR PATIENTS WITH B-CELL CHRONIC LYMPHOCYTIC LEUKEMIA FOLLOWING SECOND-LINE THERAPY  (THE CONTINUUM TRIAL)

acronym: The Continuum trial


title: Efficacy and safety assessment of T4032 (unpreserved bimatoprost 0.01%) versus Lumigan® 0.01% in ocular hypertensive or glaucomatous patients.

acronym: In-SIGHT study

lead_sponsor: Laboratoires THEA