title: A Phase 2 Rollover Protocol of Telaprevir (VX-950) in Combination with Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Subjects Enrolled in the Control Group (Group A) of Study VX06-950-106, VX05-950-104 and VX05-950-104EU Who did not Achieve or Maintain an Undetectable HCV RNA Level Through Sustained Viral Response

acronym: Rollover Study of Telaprevir (VX-950), Pegasys, and Copegus in Hepatitis C

lead_sponsor: Vertex Pharmaceuticals Incorporated


title: A Phase 2, Randomized, Open-label Study of Bosutinib Administered in Combination With Exemestane vs. Exemestane Alone as Second Line Therapy in Post-Menopausal Women with Locally Advanced or Metastatic ER+/PgR+/Her2- Breast Cancer

source: euctr

lead_sponsor: Wyeth Research Division of Wyeth Pharmaceuticals Inc.

study_type: Interventional

status: Completed

lead_sponsor_type: industriel

status_simplified: Completed


title: A randomised, double-blind, placebo controlled, multi-centre, exploratory, pilot, phase II trial of 150 mg atacicept given subcutaneously in combination with rituximab in subjects with rheumatoid arthritis.

acronym: Atacicept in combination with rituximab in subjects with rheumatoid arthritis

lead_sponsor: Merck Serono International


title: A 12-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension

acronym: FREEDOM-M

lead_sponsor: United Therapeutics Corporation


title: A TREATMENT PROTOCOL FOR PATIENTS CONTINUING FROM A PRIOR SU011248 PROTOCOL

lead_sponsor: Pfizer Inc.


title: A Multicenter, Open-Label Extension Study of WVE-210201 in Patients previously enrolled in WVE-DMDX51-001

lead_sponsor: Wave Life Sciences Ltd.

status_simplified: Unknown


title: Safety and efficacy study of TPV boosted with low dose ritonavir (TPV/r) 500 mg/200 mg BID in antiretroviral treatment experienced HIV positive patients with HCV or HBV co-infection, with a pilot evaluation of therapeutic drug monitoring (TDM).  An open-label, multicenter, multinational trial with randomisation to standard of care (SOC) or TDM TPV/r therapy

lead_sponsor: Boehringer Ingelheim France SAS


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

acronym: Pharmacogenomics trial of GONAL-f® in ART

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


title: Phase 3b, Randomized Trial of Revlimid® (Lenalidomide) Versus Placebo Maintenance Therapy Following Melphalan Prednisone Velcade® (Bortezomib) Induction Therapy in Newly Diagnosed Multiple Myeloma

acronym: ARUMM

lead_sponsor: Celgene Corporation


title: A 104 week, randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the efficacy of aliskiren on the progression of atherosclerosis in patients  with coronary artery disease when added to optimal background therapy

lead_sponsor: Novartis Pharma Services AG


title: A Phase 2 multicenter, randomized, placebo controlled, double-blind study to assess the safety and efficacy of CC-486 (oral azacitidine) in combination with pembrolizumab (MK-3475) versus pembrolizumab plus placebo in subjects with previously treated locally advanced or metastatic non-small cell lung cancer

status: Ongoing

status_simplified: Ongoing


title: Phase II randomized trial of MEK inhibitor AS703026 or placebo combined with gemcitabine in chemo-naïve metastatic pancreas cancer subjects

lead_sponsor: Merck Serono S.A. - Geneva


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

acronym: Not applicable

lead_sponsor: ApoPharma Inc.


title: Adults adminstered Venlafaxine and Eszopiclone Response to Treatment (AVERT): A 31-Week, Efficacy, Safety and Tolerability Study of Eszopiclone 3 mg Co-administered with Venlafaxine in Subjects with Major Depressive Disorder (MDD) and Co-existing Insomnia

lead_sponsor: Sepracor NV in care of Sepracor Inc.


title: A Non-inferiority Comparison of 35mg Delayed-release Risedronate, Administered Once-weekly Either Before or After Breakfast, and 5mg Immediate-release Risedronate, Administered Once-daily Before Breakfast, in the Treatment of Postmenopausal Osteoporosis as Assessed Over 2 Years; a Phase III, Multicenter, Double-Blind, Double-dummy, Randomized, Active-controlled, Parallel-group Study

acronym: Fantasia Phase III

lead_sponsor: Procter & Gamble Pharmaceuticals


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

lead_sponsor: Curalogic A/S


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

lead_sponsor: LifeCycle Pharma A/S


title: An international phase III randomised trial comparing in severe Exacerbations of Chronic obstructive pulmonary  disease the efficacy of Helium/Oxygen versus Air/Oxygen administered during spontaneous breathing and intermittent non-invasive ventilation. The E.C.H.O. ICU trial

acronym: ECHO ICU trial

lead_sponsor: Air Liquide


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

acronym: DAPT Study

lead_sponsor: HCRI


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

lead_sponsor: Shionogi USA, Inc.


title:
An Open-Label, Multinational, Phase 1/2 Study of the Safety and Dose Escalation of SHP648, an Adeno-Associated Virus Serotype 8 (AAV8) Vector Expressing FIX Padua in Hemophilia B Subjects

 Étude de phase I/II internationale en ouvert évaluant la sécurité d’emploi et l’escalade de dose du SHP648, un vecteur viral adéno-associé de sérotype 8 (AAV8) exprimant le facteur IX Padua chez des patients atteints d’hémophilie B

lead_sponsor: Baxalta Innovations GmbH

status: Prematurely Ended


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

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

lead_sponsor: Novartis Pharma AG


title: A randomised, double-blind, placebo-controlled, multi national, Phase III study of the efficacy and safety of 300 IR sublingual immunotherapy (SLIT), starting 2 months before the grass pollen season, administered as allergen based tablets once daily to patients suffering from grass pollen rhinoconjunctivitis (with or without asthma)

lead_sponsor: Stallergenes S.A.


title: GF-001001-00 cream.  A multicentre, randomised, double-blind, parallel, placebo-controlled phase II study to assess the efficacy and safety of 3 different doses of GF-001001-00 cream versus placebo cream applied 2 times daily for 7 days in the treatment of adult patients with secondarily-infected traumatic lesions.

lead_sponsor: Ferrer International, SA


title: A Phase II Clinical Trial of Pembrolizumab as Monotherapy and in Combination with Cisplatin+5-Fluorouracil in Subjects with Recurrent or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma (KEYNOTE-059)

acronym: A Phase II Study of Pembrolizumab in Subjects with Gastric Cancer

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


title:
A Multicenter, Phase 2 Study of Tesetaxel plus Three Different PD-(L)1 Inhibitors in Patients with Triple-Negative, Locally Advanced or Metastatic Breast Cancer and Tesetaxel Monotherapy in Elderly Patients with HER2 Negative, Locally Advanced or Metastatic Breast Cancer

 Étude multicentrique de phase 2 portant sur le tésétaxel et trois inhibiteurs différents du PD-(L)1 chez des patients atteints d’un cancer du sein triple-négatif, localement avancé ou métastatique et sur le tésétaxel en monothérapie chez des patients âgés présentant un cancer du sein HER2 négatif, localement avancé ou métastatique

lead_sponsor: Odonate Therapeutics, Inc.


title:
A Randomised, Double-Blind, Placebo-Controlled, Phase II Study to Assess the Efficacy and Safety of Orally Administered DS102 in Patients with Severe Acute Decompensated Alcoholic Hepatitis.

 Etude de phase II, randomisée, en double-aveugle, contrôlée contre placebo, évaluant l’efficacité et la tolérance du DS102 administré par voie orale chez des patients atteints d’hépatite alcoolique aiguë sévère

lead_sponsor: Afimmune


title:
A Phase II, Single Arm, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of MOR00208 Combined with Idelalisib in Patients with Relapsed or Refractory CLL/SLL Previously Treated with Bruton’s Tyrosine Kinase (BTK) Inhibitor.

 Étude de phase II, multicentrique, en ouvert, sur groupe unique visant à évaluer l’efficacité et la sécurité d’emploi du MOR00208 en association avec l’idelalisib chez les patients atteints de LLC/PLL récidivant ou réfractaire précédemment traité par l’inhibiteur de la tyrosine kinase de Bruton (BTK)

lead_sponsor: MorphoSys AG


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

lead_sponsor: EORTC European Organisation for Research and Treatment of Cancer


title: An International, Multi-Center, Double-Blind, Randomized, Phase III Trial of 90Y-Clivatuzumab Tetraxetan plus Low-Dose Gemcitabine Versus Placebo plus Low-Dose Gemcitabine in Patients with Metastatic (Stage IV) Pancreatic Adenocarcinoma Who Received at Least Two Prior Treatments (PANCRIT-1)

acronym: PANCRIT-1 (PANcreatic Cancer RadioImmunoTherapy Trial 1)

lead_sponsor: Immunomedics, Inc.


title: A Phase 2, Double-blind, Randomized, Placebo-controlled Multicenter Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Efficacy of JBT-101 in Cystic Fibrosis

lead_sponsor: Corbus Pharmaceuticals, Inc.


title: A Double-Masked, Randomized, Controlled, Multiple-Dose Study to Evaluate the Efficacy, Safety and Tolerability of QR-421a in Subjects with Retinitis Pigmentosa (RP) due to Mutations in Exon 13 of the USH2A Gene with Early to Moderate Vision Loss

acronym: Celeste

lead_sponsor: ProQR Therapeutics IV B.V.


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

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

lead_sponsor: Recordati Rare Diseases


title: A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of INCB054828 in Subjects With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma Including FGFR2 Translocations Who Failed Previous Therapy

lead_sponsor: Incyte Corporation


title: A multicenter study with an open-label Phase Ib part followed by a randomized, placebo-controlled, double-blind, Phase II part to evaluate efficacy, safety, tolerability, and pharmacokinetics of the DNA-PK inhibitor M3814 in combination with capecitabine and radiotherapy in participants with locally advanced rectal cancer

lead_sponsor: Merck KGaA


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

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


title:
Thyroid hormone analog therapy of patients with severe psychomotor retardation caused by mutations in the MCT8 thyroid hormone transporter: The Triac Trial.

 Behandeling met een schildklierhormoon analoog bij patiënten met psychomotore retardatie veroorzaakt door een mutatie in de MCT8 schildklierhormoon transporter: de Triac Trial.

acronym:
Triac Trial in MCT8 patients

 Triac Trial in MCT8 patiënten.

lead_sponsor: Centre Hospitalier de Toulouse

lead_sponsor_type: academique


title:
A Phase 3 Open-Label, Single-Arm Study To Evaluate The Efficacy and Safety of BMN 270, an Adeno-Associated Virus Vector–Mediated Gene Transfer of Human Factor VIII at a dose of 4E13 vg/kg in Hemophilia A Patients with Residual FVIII Levels ≤ 1 IU/dL Receiving Prophylactic FVIII Infusions

 Étude de phase 3 ouverte, à un seul bras, destinée à évaluer l’efficacité et la sécurité du BMN-270, un vecteur viral adéno-associé pour le transfert de gène du facteur VIII humain à une dose de 4E13 vg/kg chez des patients atteints d’hémophilie A ayant des taux de base de FVIII ≤ 1 UI/dl et recevant des injections de FVIII en prophylaxie

lead_sponsor: BioMarin Pharmaceutical Inc.


title: A Phase II randomised, placebo-controlled trial of vedolizumab with or without therapeutic HIV MVA vaccine in individuals who started antiretrovirals during primary or chronic infection

lead_sponsor: Inserm-ANRS


title: A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLEBLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CC-220 IN SUBJECTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS

lead_sponsor: Celgene Corporation


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

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

lead_sponsor: Maastricht University Medical Centre


title:
A Multi-Center, Randomized, Double-Blind, Placebo- and Active Comparator-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of BMS-986165 in Subjects with Moderate-to-Severe Plaque Psoriasis

 Étude de phase 3 multicentrique, randomisée, en double aveugle, contrôlée par placebo et par traitement comparateur actif, visant à évaluer l’efficacité et la sécurité d’emploi de BMS-986165 chez des sujets atteints de psoriasis en plaques modéré à sévère

lead_sponsor: Bristol-Myers Squibb Company


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

lead_sponsor: ArQule, Inc.


title:
A Phase 1/2 Study of ALKS 4230 Administered Subcutaneously
 as Monotherapy and in Combination With Pembrolizumab in
 Subjects With Advanced Solid Tumors
 (ARTISTRY-2)

 Étude de phase 1/2 sur l’ALKS 4230 administré par voie sous-cutanée en monothérapie et en association avec le pembrolizumab à des sujets présentant des tumeurs solides à un état avancé - ARTISTRY-2 (001)

lead_sponsor: Alkermes, Inc.


title:
A Phase 2 Randomized Study of the Efficacy and Safety of Acalabrutinib with Best Supportive Care Versus Best Supportive Care in Subjects Hospitalized with COVID-19

 Étude de phase 2 randomisée évaluant l’efficacité et la tolérance de l’acalabrutinib associé aux Meilleurs Soins de Support (Best Supportive Care - BSC) vs Meilleurs Soins de Support chez des patients hospitalisés infectés par le COVID-19

acronym: CALAVI

lead_sponsor: Acerta Pharma B.V.


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

acronym: REDUCE

lead_sponsor: Charité Universitätsmedizin Berlin


title: A Phase III Multicenter Open-Label Randomized Trial to Evaluate Efficacy and Safety of FOLFIRINOX (FFX) versus Combination of CPI-613 with modified FOLFIRINOX (mFFX) in Patients with Metastatic Adenocarcinoma of the Pancreas

acronym: PANC003 (also known as “AVENGER 500”)

lead_sponsor: Rafael Pharmaceuticals, Inc


title: A Phase IIb, randomized, double-blind, parallel-group study to assess the efficacy, safety, tolerability, and resistance profile of GSK3640254 in combination with dolutegravir compared to dolutegravir plus lamivudine in HIV-1 infected, treatment-naïve adults

acronym: DYNAMIC

lead_sponsor: ViiV Healthcare UK Limited


title: A Phase 1/2, Baseline-controlled, Non-randomised, Open-label, Single-ascending Dose Study of a Novel Adeno-associated Viral Vector (FLT190) in Patients With Fabry disease

lead_sponsor: Freeline Therapeutics Ltd


title:
PEACE (Pegzilarginase Effect on Arginase 1 Deficiency Clinical Endpoints): A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Efficacy and Safety of Pegzilarginase in Children and Adults with Arginase 1 Deficiency

 Étude PEACE (Pegzilarginase Effect on Arginase 1 Deficiency Clinical Endpoints [effets de la pegzilarginase sur les critères d’évaluation cliniques relatifs au déficit en arginase 1]) : Une étude de phase III, randomisée, en double aveugle, contrôlée contre placebo, visant à évaluer l’efficacité et la sécurité d’emploi de la pegzilarginase chez des enfants et des adultes présentant un déficit en arginase 1.

lead_sponsor: Aeglea Biotherapeutics, Inc.


title: A PHASE 1/2, OPEN-LABEL, DOSE-ESCALATION AND EXPANSION STUDY OF ENTRECTINIB (RXDX-101) IN PEDIATRICS AND YOUNG ADULTS WITH NO CURATIVE FIRST-LINE TREATMENT OPTION OR RECURRENT/REFRACTORY SOLID TUMORS AND PRIMARY CNS TUMORS

lead_sponsor: F. Hoffmann-La Roche Ltd


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

lead_sponsor: Amphera B.V.


title: A Phase 2 Dose Ranging Study to Evaluate the Efficacy and Safety of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE) With Inadequate Response to Standard of Care (SOC) Therapy

acronym: Safety and Efficacy of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE)

lead_sponsor: Amgen Inc


title:
EPITOPE OPEN-LABEL EXTENSION STUDY TO EVALUATE THE LONG-TERM CLINICAL BENEFIT AND SAFETY OF DBV712 IN PEANUT-ALLERGIC CHILDREN (EPOPEX)

 Étude d’extension en ouvert EPITOPE visant à évaluer le bénéfice clinique à long terme et la sécurité d’emploi du DBV712 chez des enfants allergiques à l’arachide (EPOPEX)

acronym: EPOPEX

lead_sponsor: DBV TECHNOLOGIES S.A.


title:
A randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics of orally administered GLPG3970 for 12 weeks in adult subjects with active primary Sjögren’s Syndrome

 Étude multicentrique, randomisée, en double aveugle, contrôlée contre placebo, visant à évaluer l’efficacité, la sécurité d’emploi, la tolérance, la pharmacocinétique et la pharmacodynamie du GLPG3970 administré par voie orale pendant 12 semaines chez des patients adultes atteints d’un syndrome de Gougerot-Sjögren primitif actif

lead_sponsor: Galapagos NV


title:
OXYTOCIN TREATMENT IN NEONATES AND INFANTS AGED FROM 0 TO 3 MONTHS WITH PRADER-WILLI SYNDROME: A STUDY OF THE SAFETY AND EFFICACY ON ORAL AND SOCIAL SKILLS AND, FEEDING BEHAVIOR OF INTRANASAL ADMINISTRATIONS OF OXYTOCIN VS. PLACEBO (PHASE III CLINICAL TRIAL)

 Traitement par ocytocine chez les nouveau-nés et les nourrissons âgés de 0 à 3 mois présentant un syndrome de Prader-Willi : étude de la tolérance et de l’efficacité sur les troubles de l’oralité, les interactions sociales et le comportement alimentaire d’administrations intra-nasales d’ocytocine versus placebo (Étude clinique de phase III)

acronym:
OTBB3

 OTBB3

lead_sponsor: University Hospital of Toulouse


title: A Double-Blind, Vehicle-Controlled, Randomized Withdrawal and Treatment Extension Study to Assess the Long-Term Efficacy and Safety of Ruxolitinib Cream in Participants With Vitiligo

acronym: TRuE-V LTE

lead_sponsor: Incyte Corporation


title: A Randomized, Open Label, Phase III Trial to Evaluate the Efficacy and Safety of Palbociclib + Anti-HER2 Therapy + Endocrine Therapy vs. Anti-HER2 Therapy + Endocrine Therapy after Induction Treatment for Hormone Receptor Positive (HR+)/HER2-Positive Metastatic Breast Cancer

acronym:
PATINA

 PATINA

lead_sponsor: Alliance Foundation Trials, LLC


title: A Randomized, Controlled, Open-label, Phase 2 Study of Cemiplimab as a Single Agent and in Combination with RP1 in Patients with Advanced Cutaneous Squamous Cell Carcinoma

lead_sponsor: Replimune, Inc.


title:
A Multicenter, Multinational Extension of Study PRV-031-001 to Evaluate the Long-Term Safety of Teplizumab (PRV-031), a Humanized, FcR Non-Binding, Anti-CD3 Monoclonal Antibody, in Children and Adolescents with Recent-Onset Type 1 Diabetes Mellitus

 Extension de l’étude PRV-031-001, multicentrique, internationale visant à évaluer la tolérance à long terme du teplizumab (PRV-031), un anticorps monoclonal anti-CD3 humanisé ne se liant pas au FcR, chez des enfants et des adolescents atteints de diabète de type 1 d’apparition récente

acronym: PROTECT Extension Study

lead_sponsor: Provention Bio, Inc.


title:
TEMOkids study (ORP-TMZ-I- b): A Population pharmacokinetic, acceptability and safety study for KIMOZO, a paediatric oral suspension of temozolomide

 Etude TEMOkids (ORP-TMZ-I- b): Etude de pharmacocinétique de population, d’acceptabilité et de sécurité d’emploi de Kimozo, suspension buvable pédiatrique de témozolomide

acronym:
TEMOkids study

 Etude TEMOkids

lead_sponsor: ORPHELIA Pharma


title: A PHASE II, MULTICENTER, OPEN-LABEL, SINGLE-ARM STUDY TO EVALUATE THE PHARMACODYNAMIC EFFECTS OF ONCE WEEKLY ADMINISTRATION OF GANTENERUMAB IN PARTICIPANTS WITH EARLY (PRODOMAL TO MILD) ALZHEIMER'S DISEASE


title: Randomized phase III trial on NIraparib-TSR-042 (dostarlimab) vs physician’s choice CHEmotherapy in recurrent, ovarian, fallopian tube or primary peritoneal cancer patients not candidate for platinum retreatment: NItCHE trial (MITO 33)

acronym: NItCHE

lead_sponsor: FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE


title: Randomised, double-blind, double-dummy, multicentre trial to evaluate the efficacy and safety of three different weekly dosages of calcifediol versus placebo in subjects with either vitamin D deficiency or insufficiency

acronym: WORFEROL

lead_sponsor: FAES FARMA S.A.


title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study: 5 Independent Sub-studies of Setmelanotide in Patients with POMC, PCSK1, LEPR, SRC1, SH2B1, and PCSK1 N221D Gene Defects in the Melanocortin-4 Receptor Pathway

acronym: Setmelanotide in patients with specific gene defects

lead_sponsor: Rhythm Pharmaceuticals Inc.


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

acronym: ATALANTE : ATezolizumab and Avastin in LAte recurreNT diseasE

lead_sponsor: ARCAGY-GINECO


title:
A 2-Stage (Open-Label Run-in followed by Randomized Withdrawal),
 Double-Blind, Placebo-Controlled, Phase 2 study of Setmelanotide in
 Patients with Specific Gene Defects in the Melanocortin-4 Receptor
 Pathway


title: An Umbrella Study of INCMGA00012 Alone and in Combination With Other Therapies in Participants With Advanced or Metastatic Endometrial Cancer Who Have Progressed on or After Platinum-Based Chemotherapy (POD1UM-204)


title:
A 52-Week Open-Label Extension Study of Pimavanserin in Children and Adolescents with Irritability Associated with Autism Spectrum Disorder (ASD)

 Étude de prolongation ouverte de 52 semaines évaluant la Pimavansérine chez les enfants et les adolescents atteints d’irritabilité associée au trouble du spectre de l’autisme (TSA)

lead_sponsor: Acadia Pharmaceuticals Inc.


title:
A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Pimavanserin for the Treatment of Irritability Associated With Autism Spectrum Disorder

 Étude de phase 2, randomisée, en double aveugle et contrôlée par placebo, visant à évaluer l’efficacité et l’innocuité de la Pimavansérine dans le traitement de l’irritabilité associée au trouble du spectre de l’autisme


title: Aldose Reductase Inhibition for Stabilization of Exercise capacity in Heart Failure (ARISE-HF): A Multicenter, Randomized, Placebo-Controlled Study to Evaluate the Safety and Efficacy of AT-001 in Patients with Diabetic Cardiomyopathy / Stage B Heart Failure at High Risk of Progression to Overt Heart Failure (Stage C Heart Failure)

acronym: ARISE-HF

lead_sponsor: Applied Therapeutics Inc.


title: A Phase 2, Open-Label, Single-Agent, Multicenter Study to Evaluate the Efficacy and Safety of INCB054828 in Subjects With Metastatic or Surgically Unresectable Urothelial Carcinoma Harboring FGF/FGFR Alterations


title:
Phase 1 / 2 Multicenter Study of the Safety, Pharmacokinetics, and Preliminary Efficacy of APL-101 in Subjects with Non-Small Cell Lung Cancer with c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors

 Étude de phase I/II multicentrique visant à évaluer la sécurité d'emploi, la pharmacocinétique et l'efficacité préliminaire d'APL-101 chez des patients atteints de cancer bronchique non à petites cellules avec mutations par saut de l'exon 14 de c-MET et des patients atteints de tumeurs solides avancées avec dérégulation de c-MET

acronym: SPARTA

lead_sponsor: Apollomics, Inc.


title:
Efficacy, Safety and Tolerability of 3 doses of Sulthiame in Patients with Obstructive Sleep Apnea. A Randomized, Double-Blind, Placebo Controlled, Dose-Ranging Study

 Efficacité, sécurité et tolérabilité de 3 doses de sultiame chez les patients souffrant d'apnée obstructive du sommeil. Étude de détermination de la dose, randomisée, en double insu, contrôlée par placebo

lead_sponsor: Desitin Arzneimittel GmbH


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

acronym: NASH-RX

lead_sponsor: Galectin Therapeutics Inc.


title:
A Phase 1b/3 double-blind, randomized, active-controlled, 3-stage, biomarker adaptive study of tazemetostat or placebo in combination with lenalidomide plus rituximab in subjects with relapsed/refractory follicular lymphoma

 Étude de phase 1b/3 randomisée, en double aveugle, en 3 étapes, avec design adaptatif selon biomarqueur, du tazémétostat ou placebo en association au lénalidomide et rituximab chez des patients atteints d’un lymphome folliculaire en rechute ou réfractaire

lead_sponsor: Epizyme, Inc.


title: A multicentre, open-label, three-arm randomised Phase II trial assessing the safety and efficacy of the HSP90 inhibitor Ganetespib in combination with Carboplatin followed by maintenance treatment with Niraparib versus Ganetespib plus Carboplatin followed by Ganetespib and Niraparib versus Carboplatin in combination with standard chemotherapy followed by Niraparib maintenance treatment in platinum-sensitive ovarian cancer patients

acronym: EUDARIO: European Trial on enhanced DNA Repair Inhibition in Ovarian Cancer

lead_sponsor: Katholieke Universiteit Leuven


title:
AN OPEN-LABEL, SAFETY STUDY FOR PREVIOUSLY TREATED VATIQUINONE (PTC743) SUBJECTS WITH INHERITED MITOCHONDRIAL DISEASE

 ÉTUDE EN OUVERT PORTANT SUR LA SÉCURITÉ DES PATIENTS PRÉCÉDEMMENT TRAITÉS PAR VATIQUINONE (PTC743) ET PRÉSENTANT UNE MALADIE MITOCHONDRIALE HÉRÉDITAIRE

lead_sponsor: PTC THERAPEUTICS, INC.


title: EXPLORE: A phase 2, outcomes assessor-masked, multicentre, randomised study to evaluate the safety and efficacy of two doses of GT005 administered as a single subretinal injection in subjects with geographic atrophy secondary to age-related macular degeneration

lead_sponsor: Gyroscope Therapeutics


title: MRX-800: A Long-Term Safety Study of Maralixibat, an Apical Sodium Dependent Bile Acid Transporter Inhibitor (ASBTi), in the Treatment of Cholestatic Liver Disease in Subjects Who Previously Participated in a Maralixibat Study.

lead_sponsor: Mirum Pharmaceuticals Inc.


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

lead_sponsor: Aridis Pharmaceuticals, Inc.


title:
Multi-Centre, Randomized, Double-Blind, Placebo-Controlled, Efficacy, and Safety Study of Etripamil Nasal Spray for the Termination of Spontaneous Episodes of Paroxysmal Supraventricular Tachycardia
 The RAPID Study (NODE-301 Part 2)

lead_sponsor: Milestone Pharmaceuticals Inc.


title:
A Phase 2 Study of Poziotinib in Patients with Non-Small Cell Lung Cancer, Locally Advanced or Metastatic, with EGFR or HER2 Exon 20 Insertion Mutation (POZITIVE20-1)

 Étude de phase II sur le poziotinib chez des patients atteints d'un cancer du poumon non à petites cellules, localement avancé ou métastatique, ayant une mutation par insertion au niveau de l’exon 20 de l’EGFR ou de l’HER2 (POZITIVE20-1)

lead_sponsor: Spectrum Pharmaceuticals, Inc.


title: A Phase 1b/2, Open-Label Study Evaluating the Safety and Efficacy of KRT-232 in Patients with p53 Wild Type (p53WT) Merkel Cell Carcinoma (MCC) Who Have Failed Anti-PD-1 or Anti-PD-L1 Immunotherapy, or in Combination with Avelumab in MCC Patients who are Anti-PD-1 or Anti-PD-L1 Treatment Naïve

lead_sponsor: Kartos Therapeutics, Inc.


title: A Phase 3, Double-blind, Randomized, Placebo-controlled Trial of Adjunctive Ganaxolone (GNX) Treatment in Children and Adults with Tuberous Sclerosis Complex (TSC)-related Epilepsy (TrustTSC)

acronym: Adjunctive GNX Treatment Compared with Placebo in Children and Adults with TSC-related Epilepsy

lead_sponsor: Marinus Pharmaceuticals Inc.


title: A PHASE 2 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF AL002 IN PARTICIPANTS WITH EARLY ALZHEIMER’S DISEASE

lead_sponsor: Alector Inc.


title:
Phase III randomized clinical trial for stage III epithelial ovarian cancer randomizing between primary cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy

 Etude de phase 3 randomisée multicentrique et internationale comparant la chirurgie de cytoréduction première avec ou sans chimiohyperthermie intrapéritonéale dans les cancers épithéliaux de l’ovaire de stade III

acronym:
OVHIPEC-2

 OVHIPEC-2

lead_sponsor: Institut du Cancer de Montpellier


title: A Multi-center, Double-Blind, Randomized, Two-Arm, Parallel-Group, Placebo Controlled Study to Assess the Efficacy and Safety of ELGN-2112 on Intestinal Malabsorption in Preterm Infants

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

lead_sponsor: Elgan Pharma Ltd


title: A Multi-center, Double-Blind, Randomized, Two-Arm, Parallel-Group, Placebo Controlled Basket Study to Assess the Safety of ELGN-2112 in Populations of Interest

acronym: A Study to Assess the Safety of ELGN-2112 in Populations of Interest


title:
A Phase 1/2 Study of the Oral RET Inhibitor LOXO-292 in Pediatric Patients with Advanced RET-Altered Solid or Primary Central Nervous System Tumors

 Étude de phase I/II portant sur l'inhibiteur du RET LOXO 292 administré par voie orale chez des enfants atteints de tumeurs solides avancées ou primitives du système nerveux central avec altération du gène RET.

lead_sponsor: Loxo Oncology, Inc., a wholly owned subsidiary of Eli Lilly and Company


title: A Phase III, adjudicator-blinded, randomised study to evaluate the efficacy and safety of treatment with olorofim versus treatment with AmBisome® followed by standard of care (SOC) in patients with invasive fungal disease (IFD) caused by Aspergillus species.

lead_sponsor: F2G Ltd.


title:
A Phase 3 Multinational, Randomized, Double-Blind, Placebo-Controlled Systemic Gene Delivery Study to Evaluate the Safety and Efficacy of SRP-9001 in Subjects With Duchenne Muscular Dystrophy (EMBARK)

 Étude de phase 3, multinationale, randomisée, en double aveugle, contrôlée par placebo, sur le transfert systémique de gènes, visant à évaluer la sécurité d’emploi et l’efficacité du SRP-9001 chez des sujets atteints de dystrophie musculaire de Duchenne (EMBARK)

lead_sponsor: Sarepta Therapeutics, Inc.


title: An Open-Label, Multicenter, Phase 2 Study of CLR 131 in Patients with Relapsed or Refractory (R/R) Select B-Cell Malignancies (CLOVER-1) and Expansion Cohort in Patients with Waldenstrom Macroglobulinemia (CLOVER-WaM)

lead_sponsor: Cellectar Biosciences, Inc.


title:
An Open-label, Phase 1b/2 Study of ACP-196 in Subjects
 with Waldenström Macroglobulinemia

 Etude ouverte de phase 1b/2 de l'ACP-196 chez des patients atteints d'une Macroglobulinémie de Waldenström

lead_sponsor: Acerta Pharma BV


title: A PHASE II, OPEN-LABEL, MULTICENTER, PLATFORM STUDY EVALUATING THE EFFICACY AND SAFETY OF BIOMARKER-DRIVEN THERAPIES IN PATIENTS WITH PERSISTENT OR RECURRENT RARE EPITHELIAL OVARIAN TUMORS

lead_sponsor: F. Hoffmann-La Roche Ltd


title:
Postauthorization Safety Study of the Long-Term Safety and Efficacy of Repeat Administration of Darvadstrocel in Patients With Crohn’s Disease and Complex Perianal Fistula (ASPIRE)

 Étude de sécurité post-AMM évaluant la tolérance et l’efficacité à long terme de l’administration répétée de darvadstrocel chez des patients présentant une maladie de Crohn et des fistules périanales complexes (ASPIRE)

acronym: ASPIRE

lead_sponsor: Millennium Pharmaceuticals, Inc (MPI)


title: Evaluation of Efficacy, Safety and Tolerability of NGM282 (Aldafermin) in a Phase 2b, Randomized, Double-blind, Placebo-controlled, Multi-center Study in Subjects with Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (ALPINE 4)

acronym: ALPINE 4

lead_sponsor: NGM Biopharmaceuticals, Inc.


title: A randomized, open-label, multi-center, comparative trial, to assess the efficacy and safety of pritelivir versus foscarnet for the treatment of acyclovir-resistant mucocutaneous HSV infections in immunocompromised subjects (PRIOH-1)

lead_sponsor: AiCuris Anti-infective Cures GmbH


title: A Phase 3, Double blind, Randomized, Placebo controlled, Parallel group, Multicenter Study to Evaluate the Safety, Tolerability, and Efficacy of 2000 mg/kg of Trappsol® Cyclo™ (Hydroxypropyl β cyclodextrin) and Standard of Care Compared to Placebo and Standard of Care in Patients with Niemann Pick Disease Type C1

lead_sponsor: Cyclo Therapeutics, Inc.


title: An Extended Access Program to Assess Long Term Safety of Bardoxolone Methyl in Patients with Chronic Kidney Disease

acronym: EAGLE

lead_sponsor: Reata Pharmaceuticals, Inc.


title:
A Phase 3, Multinational, Randomized, Double-Blind, Placebo-Controlled Systemic Gene Transfer Therapy Study to Evaluate the Safety and Efficacy of SRP-9001 in Non-Ambulatory and Ambulatory Subjects With Duchenne Muscular Dystrophy (ENVISION)

 Étude de phase 3, internationale, randomisée, en double aveugle, contrôlée contre placebo, de thérapie génique systémique, destinée à évaluer la sécurité d’emploi et l’efficacité du SRP9001 chez des patients non ambulatoires et ambulatoires atteints de dystrophie musculaire de Duchenne (ENVISION)

acronym: ENVISION


title: A Phase II, Multicenter Study of the EZH2 Inhibitor Tazemetostat in Adult Subjects with INI1-Negative Tumors or Relapsed/Refractory Synovial Sarcoma

lead_sponsor: Epizyme, Inc.


title:
A Phase 3, multi-center, randomized, double-blind, parallel-group, placebo-controlled clinical trial to evaluate the efficacy and safety of sodium oligomannate (GV-971) in treatment of mild to moderate Alzheimer’s disease (GREEN MEMORY: GREen Valley 971 EvaluatioN Memory)

 Étude clinique de phase 3, multicentrique, randomisée, en double aveugle, en groupes parallèles, contrôlée par placebo, visant à évaluer l’efficacité et la sécurité d’emploi de l’oligomannate de sodium (GV 971) dans le traitement de la maladie d’Alzheimer légère à modérée (GREEN MEMORY : GREen Valley 971 EvaluatioN Memory)

lead_sponsor: Shanghai Green Valley Pharmaceutical Co., Ltd.


title:
A phase 2 study of Belantamab Mafodotin in patients with relapsed or refractory AL amyloidosis

 Une étude de phase 2 de Belantamab Mafodotin chez des patients atteints d'Amylose de type AL, récidivante ou réfractaire

lead_sponsor: European Myeloma Network – EMN


title: A PHASE II STUDY EVALUATING THE SAFETY AND EFFICACY OF GLOFITAMAB IN COMBINATION WITH RITUXIMAB (R) PLUS CYCLOPHOSPHAMIDE, DOXORUBICIN, VINCRISTINE, AND PREDNISONE (CHOP) IN CIRCULATING TUMOR (ct)DNA HIGH-RISK PATIENTS WITH UNTREATED DIFFUSE LARGE B-CELL LYMPHOMA

lead_sponsor: F.Hoffmann-La Roche Ltd


title:
A randomised, double-blind, placebo-controlled, proof-of-concept, dose-ranging study of BI 655066 in patients with active psoriatic arthritis

 Etude randomisée en double aveugle, contrôlée versus placebo, de preuve de concept et de recherche de dose du BI 655066 chez des patients atteints de rhumatisme psoriasique actif

lead_sponsor: Boehringer Ingelheim France


title: A Multicenter, Randomized, Double-Blind, Double-Dummy, Parallel-Group Study Evaluating the Effects of 2 Different Regimens of Montelukast (Daily Dosing and Intermittent, Episode-Driven Dosing) Compared With Placebo in the Treatment of Episodic Asthma in Children Aged 6 Months to 5 Years

acronym: Intermittent and Daily Treatment for Episodic Asthma (IDEA)

lead_sponsor: Laboratoires Merck Sharp & Dohme - Chibret


title: A Dose-Ranging Study of the Effects of SCH 527123 in Subjects With Moderate to Severe COPD

lead_sponsor: Schering-Plough Research Institute


title: An observational, safety follow-up extension to studies 2203 and 2203E1 to assess the safety of AAE581 in postmenopausal women with osteopenia/osteoporosis

lead_sponsor: Novartis Pharma Services AG


title: A randomized phase II trial of ridaforolimus (AP23573; MK-8669) compared to progestin or chemotherapy in female adult patients with advanced endometrial carcinoma

lead_sponsor: ARIAD Pharmaceuticals, Inc.


title: Impact of the V0034CR 01B emollient on atopic dermatitis symptoms in children. A randomised, placebo-controlled, parallel-groups, double-blind study

lead_sponsor: Pierre Fabre Médicament


title: A Double-Blind, Randomised, Placebo-Controlled, Parallel-Group, 12-Week Study of Pitavastatin in High-Risk Hyperlipidaemia in Childhood P/266/2011, P267/2011, P268/2011

acronym: PASCAL 401

lead_sponsor: Kowa Research Europe, Ltd.


title: A Safety and Efficacy Study of SCH 503034 in Previously Untreated Subjects With Chronic Hepatitis C Infected With Genotype 1


title: An Open-Label Extension Study of the Long-Term Safety of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis (IPF) Who Complete the CAPACITY Studies

acronym: Open-Label Extension of Pirfenidone CAPACITY Studies

lead_sponsor: InterMune, Inc.


title: NON-INFERIORITY STUDY OF A METRONIDAZOLE 0.75% CREAM VERSUS REFERENCE THERAPY IN THE LOCAL TREATMENT OF PAPULOPUSTULAR ROSACEA.

lead_sponsor: Pierre Fabre Dermatologie represented by Institut de Recherche Pierre Fabre


title: Vicriviroc in Combination Treatment with an Optimized ART Regimen in HIV-Infected Treatment-Experienced Subjects (VICTOR-E4)


title: A Randomized, Double-Blind, Phase III Trial of STA-4783 in Combination with Paclitaxel versus Paclitaxel Alone for Treatment of Chemotherapy-Naïve Subjects with Stage IV Metastatic Melanoma

lead_sponsor: Synta Pharmaceuticals Corp.


title: An open-label, single-arm, multi-center phase 2 trial with ofatumumab in patients with relapsed Diffuse Large B-Cell Lymphoma (DLBCL) ineligible for transplant or relapsed after autologous transplant

acronym: Ofatumumab in patients with relapsed DLBCL ineligible for or relapsed after transplant

lead_sponsor: Genmab A/S


title: Phase II open label study to evaluate the safety of a second i.p. infusion cycle of catumaxomab in patients with malignant ascites due to carcinoma, requiring their first therapeutic puncture after treatment in the CASIMAS study (IP-CAT-AC-03)

acronym: SECIMAS

lead_sponsor: Fresenius Biotech GmbH


title: A Double-blind, Placebo-controlled, Multicenter Study of the Efficacy and Safety of Adalimumab in Pediatric Subjects with Enthesitis Related Arthritis

lead_sponsor: Abbott GmbH & Co. KG (Abbott)


title: A Worldwide, Multicenter, Double-Blind, Randomized, Parallel, Placebo-Controlled Study to Evaluate the Long-term Efficacy, Safety and Tolerability of Extended-Release (ER) Niacin and Laropiprant (ERN/LRPT) in Patients with Dyslipidemia

lead_sponsor: Merck & Co., Inc.


title: A multicenter, randomized, double-blind, 8 week study to evaluate the dose response, efficacy and safety of aliskiren in pediatric hypertensive patients 6-17 years of age.


title: A randomized, observer-blind, active-controlled phase III study to demonstrate the superior efficacy of GSK Biologicals’ adjuvanted influenza candidate vaccine [GSK2186877A], administered intramuscularly in elderly aged 65 years or above, as compared to Fluarix™.

acronym: FLU NG-006 PRI

lead_sponsor: GlaxoSmithKline Biologicals


title:
A Randomized, Open-Label Study to Evaluate the Safety and Efficacy of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 Coadministered
 with Ribavirin (RBV) in Adults with Genotype 1 Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis (TURQUOISE-II)

lead_sponsor: Abbott GmbH & Co. KG


title: A phase I pharmacokinetic and safety study of tocilizumab (TCZ) in patients less than 2 years old with active systemic juvenile idiopathic arthritis (sJIA)

lead_sponsor: F. Hoffmann-La Roche Ltd


title: A Ten-Week, Multicenter, Randomized, Double-Blind, Placebo and Active-Controlled, Parallel-Group, Flexible-Dose Study Evaluating the Efficacy, Safety, and Tolerability of GSK372475 (1.5 mg/day to 2.0 mg/day) or Extended Release Venlafaxine XR (150 mg/day to 225 mg/day) Compared to Placebo in Adult Subjects Diagnosed with Major Depressive Disorder.

lead_sponsor: GlaxoSmithKline Research & Development


title: A randomised, double-blind, placebo-controlled, multi-national, multi-centre, Phase III study to assess the long term efficacy, carry-over effect and safety of two dosing regimens of 300 IR sublingual immunotherapy (SLIT) administered as allergen-based tablets once daily to patients suffering from grass pollen rhinoconjunctivitis

lead_sponsor: Stallergenes S.A.


title: A Multi-center, Open-label, 5-Part Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Aprepitant and Fosaprepitant Dimeglumine in Pediatric Patients Receiving Emetogenic Chemotherapy

lead_sponsor: Laboratoires Merck Sharp & Dhome-Chibret


title: The H10 EORTC/GELA randomized intergroup trial on early FDG-PET scan guided treatment adaptation versus standard combined modality treatment in patients with supradiaphragmatic stage I/II Hodgkin's lymphoma

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


title: An eight-week double-blind, multi-center, randomized, placebo-controlled, parallel-group study to evaluate the efficacy and safety of aliskiren 75mg, 150mg and 300mg in elderly patients with essential hypertension when given with a light meal

lead_sponsor: Novartis Pharma Services AG


title: An open-label, randomized, multicenter, active-controlled, dose-ranging study to evaluate the safety and efficacy of albinterferon alfa 2b administered every 4 weeks plus ribavirin in interferon alfa-naïve patients with genotype 2/3 chronic hepatitis C


title: A Phase 3 Safety and Efficacy Study of Boceprevir in Subjects With Chronic Hepatitis C Genotype 1 Who Failed Prior Treatment With Peginterferon/Ribavirin

lead_sponsor: Schering Plough Research Institute, A Division of Schering Corporation


title: A Phase IIb/III Randomized, Placebo-controlled Clinical Trial to Study the Safety and Efficacy of MK-0364 in Obese Patients and in Overweight Patients with Obesity-related Co-morbidities.

lead_sponsor: Laboratoires Merck Sharp & Dohme-Chibret


title: A randomized, eight-week double-blind, parallel-group, multicenter study to evaluate the efficacy and safety of the combination of aliskiren / amlodipine (300/5 mg and 300/10 mg) in comparison with aliskiren 300 mg in patients with essential hypertension not adequately responsive to aliskiren 300 mg monotherapy.


title: A dose-finding study of efficacy and safety of F13640  in patients with moderate to severe painful peripheral diabetic polyneuropathy

acronym: BEST- Diabetes study (Befiradol Dose-Finding Study in diabetic patients)

lead_sponsor: Institut de Recherche Pierre Fabre


title: Multi-center, prospective trial to demonstrate Improved Metabolic control of PPEN vs DDDD in DIAbetic CAPD patients -The IMPENDIA Trial

acronym: IMPENDIA

lead_sponsor: Baxter Healthcare Corporation


title:
First international Inter-Group Study for nodular
 lymphocyte predominant Hodgkin`s Lymphoma in Children and Adolescents

lead_sponsor: Martin Luther University of Halle/Wittenberg


title: Compassionate Use Study of Adalimumab in Children 2 to < 4 Years Old or Age 4 and Above Weighing Less Than 15 kg with Active Juvenile Idiopathic Arthritis (JIA)


title: The Efficacy and Safety of Bimatoprost SR in Patients With Open-angle Glaucoma or Ocular Hypertension

lead_sponsor: Allergan Limited


title: A Long-Term, Open-Label Safety and Efficacy Study of Xyrem (sodium oxybate) in Subjects with Fibromyalgia

lead_sponsor: Jazz Pharmaceuticals, Inc.


title: A Multicenter, Randomized, Double-Blind, “Crossover” Design Study to Evaluate the Lipid-Altering Efficacy and Safety of MK-0524B Combination Tablet Compared to MK 0524A + Simvastatin Coadministration in Patients With Primary Hypercholesterolemia and Mixed Dyslipidemia.


title: An Observational Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steroid-Refractory Ulcerative Colitis

acronym: RESTORE™ S

lead_sponsor: PDL BioPharma, Inc.


title: A Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Sitagliptin Versus Glipizide in Patients With Type 2 Diabetes Mellitus and Chronic Renal Insufficiency Who Have Inadequate Glycemic Control


title: A Multicentre, Double-Blind, Double-Dummy, Two-Phase Crossover Study of Nasalfent (Fentanyl Citrate Nasal Spray) Compared to Immediate Release Morphine Sulphate Tablets in the Treatment of Breakthrough Cancer Pain (BTCP) in Subjects Taking Regular Opioid Therapy

lead_sponsor: Archimedes Development Ltd.


title: Randomized, Phase II Study of MK-3475 versus Chemotherapy in Patients with Advanced Melanoma

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


title:
Study NOG112264, a Phase II Study of Ozanezumab
 (GSK1223249) versus Placebo in the Treatment of Amyotrophic
 Lateral Sclerosis

acronym: Ozanezumab Phase II study in patients with ALS

lead_sponsor: GlaxoSmithKline Research and Development Limited


title: Long-Term Follow-Up of Subjects in a Phase 2 or 3 Clinical Trial in which SCH 503034 was Administered for the Treatment of Chronic Hepatitis C

lead_sponsor: Schering-Plough Research Institute


title: NEMO1 : An open label exploratory dose finding and pharmacokinetic clinical trial of bumetanide for the treatment of NEonatal seizure using Medication Off-patent.

lead_sponsor: Great Ormond Street Hospital for Children NHS Trust


title: Peanut Allergy Oral Immunotherapy Study of AR101 for Desensitization in Children and Adolescents: Real-World, Open-Label, Quality of Life Study

acronym: Quality of Life study of AR101 CODIT

lead_sponsor: Aimmune Therapeutics, Inc.


title: A Phase III Open-Label Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172/MK-8742 in Treatment-Naïve Subjects with Chronic HCV GT1, GT4, GT5, and GT6 Infection who are on Opiate Substitution Therapy.

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


title: Infliximab as First Line Therapy in Patients with Early Active Axial Spondyloarthritis Trial

acronym: INFAST

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


title: A PHASE 3, OPEN-LABEL STUDY OF THE SAFETY AND EFFECTIVENESS OF AA4500 ADMINISTERED TWICE PER TREATMENT CYCLE FOR UP TO FOUR TREATMENT CYCLES (2 x 4) IN MEN WITH PEYRONIE’S DISEASE

acronym: Open Label Study of AA4500 in Men With Peyronie's Disease

lead_sponsor: Auxilium UK Limited


title: Randomized phase II study assessing the combination of Vinflunine with Gemcitabine and Vinflunine with Carboplatin in patients ineligible to cisplatin with advanced or metastatic transitional cell carcinoma of the urothelium

lead_sponsor: PIERRE FABRE MEDICAMENT


title: A Phase 2b, Safety and Efficacy Study of Boceprevir in Patients Coinfected with HIV and Hepatitis C

lead_sponsor: Schering Plough Research Institute, A Division of Schering Corporation


title: "A Phase IIb, Randomized, Double-Blind, Placebo- and Active-Controlled, Dose-Range-Finding Study to Evaluate the Effects of MK-5442 on Bone Mineral Density (BMD) in the Treatment of Osteoporosis in Postmenopausal Women Previously Treated with an Oral Bisphosphonate"

lead_sponsor: Merck & Co., Inc.


title: A multicenter, double-blind, randomized, 52 week extension study to evaluate the long term safety, tolerability and efficacy of aliskiren compared to enalapril in pediatric hypertensive patients 6-17 years of age

lead_sponsor: Novartis Pharma Services AG


title: A Phase II Randomized Clinical Trial to Study the Efficacy and Safety of the combination regimen of MK-5172 and MK-8742 +/-Ribavirin (RBV) in Subjects with Chronic Hepatitis C Virus Infection

acronym: MK-5172 + MK-8742 +/- Ribavirin Pilot Study in GT1 TN Patients

lead_sponsor: Merck Sharp & Dohme Corp.


title: A phase 2b/3, randomized, double blind, dose confirming study of the safety, efficacy and tolerability of apricitabine versus lamivudine in treatment-experienced HIV-1 infected patients with the M184V/I mutation in reverse transcriptase

lead_sponsor: Avexa Limited


title: A double-blind, randomized, multicenter, parallel group study to evaluate the efficacy, tolerability, and safety of treatment with the combination of valsartan/amlodipine 160/5 mg compared to amlodipine 10 mg in patients with essential hypertension not adequately controlled with amlodipine 5 mg alone


title:
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active Comparator-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects with Moderate to Severe Chronic Plaque Psoriasis

 ÉTUDE DE PHASE 3, MULTICENTRIQUE, RANDOMISÉE, EN DOUBLE AVEUGLE, CONTRÔLÉE CONTRE PLACEBO ET COMPARATEUR ACTIF, À GROUPES PARALLÈLES, DESTINÉE À ÉVALUER L'EFFICACITÉ ET LA TOLÉRANCE DU BIMÉKIZUMAB CHEZ DES PATIENTS ADULTES PRÉSENTANT UN PSORIASIS EN PLAQUES CHRONIQUE MODÉRÉ À SÉVÈRE

lead_sponsor: UCB Biopharma SPRL


title: Randomized, double-blind, double-dummy, active controlled, multicentre, non-inferiority phase-III study to compare the pharmacokinetic, efficacy and safety of gabapentin liquid formulation to tramadol in children from 3 months to less than 18 years of age experiencing moderate to severe chronic neuropathic or mixed pain.

acronym: Efficacy and safety study to compare gabapentin versus tramadol in paediatric patients

lead_sponsor: PHARM – Pharmaceutical Research Management srl


title: A randomized Phase 3 trial of TRC105 and pazopanib versus pazopanib alone in patients with advanced angiosarcoma (TAPPAS)

lead_sponsor: TRACON Pharmaceuticals, Inc.


title: A Phase II Randomized, Placebo-Controlled Study to Evaluate the Safety and Efficacy of MK-7009 Administered Concomitantly With Pegylated-Interferon and Ribavirin for 28 Days in Treatment-Naïve Patients With Chronic Hepatitis C Infection.

lead_sponsor: Laboratoires Merck Sharp & Dohme - Chibret


title: A Phase IIa Randomized, Placebo-Controlled Clinical Trial to Study the Efficacy and Safety of MK-0773 in Patients with Sarcopenia

lead_sponsor: Laboratoires Merck Sharp & Dohme- Chibret


title: A randomised Phase III trial to evaluate the efficacy of chemoimmunotherapy with the monoclonal antibody Campath-1H (Alemtuzumab) given in combination with 2-weekly CHOP (Cyclophosphamide, Doxorubicin, Vincristine and Prednisone) versus 2-weekly CHOP alone in elderly patients with previously untreated systemic T- cell Lymphoma Short Title: A-CHOP-14 (elderly)

acronym: A-CHOP-14 (elderly)

lead_sponsor: University Medicine Goettingen


title: A single arm, multicenter phase II trial of RAD001 as monotherapy in the treatment of advanced papillary renal cell cancer

acronym: RAPTOR


title: MULTICENTRE, RANDOMIZED, DOUBLE BLIND WITHIN FREQUENCY OF ADMINISTRATION, PLACEBO CONTROLLED, DOSE-FINDING, PARALLEL-GROUP, EFFICACY AND SAFETY STUDY OF 3 DOSES OF P-3058 NAIL LACQUER (5% o.d., 10% o.d., AND 10% o.w.) GIVEN FOR 52 WEEKS IN PATIENTS WITH ONYCHOMYCOSIS

lead_sponsor: Polichem SA


title: A 28-week multicenter, randomized, double-masked, placebo controlled, dose-ranging phase III study to assess AIN457 versus placebo in inducing and maintaining uveitis suppression in adults with active, non-infectious, intermediate, posterior or panuveitis requiring immunosuppression (INSURE Study)

acronym: INSURE


title: A MULTI-NATIONAL, MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, PARALLEL GROUP STUDY TO COMPARE THE SAFETY AND EFFICACY OF 200 mg PAR-101 TAKEN q12h WITH 125 mg VANCOMYCIN TAKEN q6h FOR TEN DAYS IN SUBJECTS WITH CLOSTRIDIUM DIFFICILE-ASSOCIATED DIARRHEA

lead_sponsor: Optimer Pharmaceuticals, Inc.


title: A randomised, double-blind, placebo-controlled, parallel group, dose ranging study evaluating the efficacy and safety of GW642444M administered once daily compared with placebo for 28 days in adolescent and adult subjects with persistent asthma.

lead_sponsor: GlaxoSmithKline Research & Development


title: A RANDOMIZED, MULTICENTRE THERAPEUTIC CONFIRMATORY STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PROXINIUM™ PLUS BEST SUPPORTIVE CARE VERSUS BEST SUPPORTIVE CARE ALONE IN PATIENTS WITH ADVANCED SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK WHO HAVE RECEIVED AT LEAST ONE ANTI-CANCER TREATMENT REGIMEN FOR ADVANCED DISEASE

lead_sponsor: Viventia Biotech Inc.


title: A double-blind placebo controlled study of 1g, 2g and 4g V0251 efficacy and tolerance in vestibular neuritis.

lead_sponsor: PIERRE FABRE MEDICAMENT - IRPF


title: A randomized, open-label, controlled, mutli-center two-year study comparing efficacy and safety of telbivudine (LDT600) 600 mg PO in combination with peg alpha-2a sq 180 µg with peg alpha-2a montherapy, and with telbivudine monotherapy in treatment naïve patients with HBeAg-positive CHB


title: A randomized, open-label, active-controlled, multicenter, parallel group study to assess the efficacy, safety and tolerability of topical 10% terbinafine hydrogen chloride (HCl) formulation versus 5% amorolfine nail lacquer for 48 weeks of treatment in patients with mild to moderate toenail onychomycosis


title: Open Label Study of the Effect of Daily Treatment with MPC-7869 in Subjects with Dementia of the Alzheimer’s Type

lead_sponsor: Myriad Pharmaceuticals, Inc


title: An open-label study investigating long-term safety and tolearability of Nasalfent (Fentanyl Citrate Nasal Spray) in the treatment of breakthrough cancer pain (BTCP) in subjects taking regular opioid therapy

lead_sponsor: Archimedes Development Ltd


title: Study of Once-Daily Versus Twice-Daily Fosamprenavir plus Ritonavir, Administered with Abacavir/Lamivudine Once-Daily in Antiretroviral-Naïve HIV-1 Infected Adult Subjects.

lead_sponsor: GlaxoSmithKline Research & Development Ltd


title: A Randomized Double-Blind, Double Dummy, Placebo-Controlled, Parallel-Group, Multicenter Dose Ranging Study to Evaluate the Efficacy and Safety of GW685698X Inhalation Powder Once Daily and Fluticasone Propionate Inhalation Powder 500mcg Twice Daily compared with Placebo for 8 Weeks in Adolescent and Adult Subjects with Persistent Asthma Symptomatic on Moderate-Dose ICS Therapy.

lead_sponsor: GlaxoSmithKline Research and Development Ltd


title: A 26 week treatment, randomized, multi center, double blind, double dummy, parallel-group study to assess the safety of indacaterol (300 and 600 µg o.d.) in patients with moderate to severe persistent asthma, using salmeterol (50 µg b.i.d.) as an active control.

lead_sponsor: Novartis Pharma Services AG


title: A Randomized, Double-Blind, Placebo-Controlled, Safety and Efficacy Study of Xyrem® (sodium oxybate) in Subjects with Fibromyalgia

lead_sponsor: Jazz Pharmaceuticals, Inc.


title: Double-blind, randomised, placebo-controlled multicentre phase III clinical study followed by open-label phase on the efficacy and tolerability of budesonide 3 mg effervescent tablet in patients with resistant oral chronic GvHD

lead_sponsor: Dr. Falk Pharma GmbH


title: A Phase III, Multicenter, Randomized, Double-Blind, Placebo- Controlled, Parallel Group, Study to Evaluate the Safety and Efficacy of MK-4305 in Patients with Primary Insomnia- Study A

acronym: Phase III Safety and Efficacy Study in Primary Insomnia Patients - Study A

lead_sponsor: Merck & Co., Inc.


title: A 52-Week Open-Label Extension and Safety Study of Pitavastatin in High-Risk Hyperlipidaemia in Childhood, P/266/2011, P/267/2011, P/268/2011

lead_sponsor: Kowa Research Europe, Ltd.


title: Study 200622: A randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of mepolizumab in the treatment of adolescent and adult subjects with severe hypereosinophilic syndrome


title: A RANDOMIZED, OPEN, MULTINATIONAL, MULTICENTRE, 2-PART STUDY IN SPONTANEOUSLY BREATHING PRETERM NEONATES WITH MILD TO MODERATE RESPIRATORY DISTRESS SYNDROME TO INVESTIGATE THE SAFETY, TOLERABILITY AND EFFICACY OF INHALED NEBULIZED PORACTANT ALFA (PORCINE SURFACTANT, CUROSURF®) IN COMPARISON WITH nCPAP ALONE

lead_sponsor: Chiesi Farmaceutici S.p.A.


title: A Phase III, Multicenter, Double-Blind, Randmoized Study to Evaluate the Safety and Efficacy of the Addition of Sitagliptin Compared With the Addition of Glimepiride in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin

lead_sponsor: Laboratoires Merck Sharp & Dhome-Chibret


title: A twenty-six weeks, open-label extension trial to evaluate safety and efficacy of Org 50081 in outpatients with chronic primary insomnia who completed clinical trial protocol 21106.

acronym: Aquamarine

lead_sponsor: NV Organon


title: A 12-week multi-center, randomized, double-blind, placebo-controlled, parallel-group adaptive design study to evaluate the efficacy on blood glucose control and safety of five doses of LCQ908 (2, 5, 10, 15 and 20 mg) or sitagliptin 100 mg on a background therapy of metformin in obese patients with type 2 diabetes


title: A facilitated access open-label, non-randomized, multicenter, long-term safety and efficacy study in Chronic Kidney Disease patients treated with SBR759 who have completed previous SBR759 studies

lead_sponsor: Novartis Pharma


title: A Phase III randomized, double blind, placebo controlled, multicenter study of panobinostat for maintenance of response in patients with Hodgkin’s lymphoma who are at risk for relapse after high dose chemotherapy and autologous stem cell transplant


title: Open-label, single-arm, flexible dosing, Phase III trial, with oral tapentadol PR in subjects with chronic malignant tumor-related pain who have completed the Maintenance Period of the KF 5503/15 trial.

lead_sponsor: Grünenthal GmbH


title:
A Phase II Randomized Open Label Study of MM-121 in
 combination with Paclitaxel versus Paclitaxel alone in
 patient with Platinum Resistant/Refractory Advanced
 Ovarian Cancers.

lead_sponsor: MERRIMACK PHARMACEUTICALS


title: A Phase 3, Open-Label, Baseline-controlled, Multicenter, Sequential Dose Titration Study to Assess the Long-Term Efficacy and Safety, and the Pharmacokinetics of Solifenacin Succinate Suspension in Patients from 5 to Less than 18 years of Age with Neurogenic Detrusor Overactivity (NDO)

lead_sponsor: Astellas Pharma Europe B.V.


title: A PHASE III RANDOMIZED TRIAL OF GEMCITABINE (NSC# 613327) PLUS DOCETAXEL (NSC# 628503) FOLLOWED BY DOXORUBICIN (NSC# 123127) V. OBSERVATION FOR UTERUS-LIMITED, HIGH GRADE UTERINE LEIOMYOSARCOMA

lead_sponsor: EORTC


title: A Phase 3 Open-label Study to Assess the Efficacy, Safety, and Pharmacokinetics of Subcutaneously Administered Ustekinumab in the Treatment of Moderate to Severe Chronic Plaque Psoriasis in Pediatric Subjects greater than 6 to less than 12 Years of Age

lead_sponsor: Janssen-Cilag International N.V.


title: Open-label Phase 2 study evaluating efficacy and safety of SAR566658 treatment in patients with CA6 positive metastatic Triple Negative Breast Cancer

lead_sponsor: Sanofi-aventis recherche & développement


title: Follow-Up Study to Assess Long-Term Safety and Outcomes in Infants Born to Mothers Participating in Retosiban Treatment Studies

acronym: Follow-Up Study to Assess Long-Term Safety of Infants exposed to Retosiban

lead_sponsor: GlaxoSmithKline Research & Development Limited


title: An open label, randomised, parallel group clinical study to evaluate the effect of the Connected Inhaler System (CIS) on adherence to Relvar/Breo ELLIPTA therapy, in asthmatic subjects with poor control.

lead_sponsor: GlaxoSmithKline Research & Development Ltd


title: A Phase 3, Randomized, Multi-Center Study to Evaluate the Efficacy and Safety of Albumin Interferon Alfa-2b (alb-IFN) in Combination with Ribavirin Compared with Peginterferon Alfa-2a (PEGASYS or PEG-IFNα2a) in Combination with Ribavirin in Interferon Alfa Naïve Subjects with Chronic Hepatitis C Genotype 2 or 3. ACHIEVE-2/3

lead_sponsor: Human Genome Sciences, Inc.


title: Exploratory efficacy and safety, pharmacokinetics and dose-finding study of ATryn® (antithrombin alfa) in patients with disseminated intravascular coagulation associated with severe sepsis

lead_sponsor: LEO Pharma A/S


title: Study of the analgesic effects of repeated doses of F13640 in spinal cord injury patients with moderate to severe central neuropathic pain. A multinational, multicenter, randomized, double blind, parallel groups, placebo-controlled study.

lead_sponsor: PIERRE FABRE MEDICAMENT


title: Placebo-controlled trial on the efficacy of growth hormone replacement therapy in patients with growth hormone deficiency after traumatic brain injury

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


title: A Phase 3, Randomized, Multi-Center Study to Evaluate the Efficacy and Safety of Albumin Interferon Alfa-2b (alb-IFN) in Combination with Ribavirin Compared with Peginterferon Alfa-2a (PEGASYS or PEG-IFNα2a) in Combination with Ribavirin in Interferon Alfa Naïve Subjects with Chronic Hepatitis C Genotype 1.  ACHIEVE -1


title:
Safety and Efficacy with Twice Daily Brinzolamide 1% / Brimonidine 0.2% (SIMBRINZA) as an Adjunctive Therapy to Travoprost 0.004% / Timolol 0.5% (DUOTRAV)

 Efficacité et tolérance de l’association Brinzolamide 1% / Brimonidine 0.2% (SIMBRINZA) administrée 2 fois par jour en supplément d’un traitement par l’association Travoprost 0.004% / Timolol 0.5% (DUOTRAV).

acronym: Safety and Efficacy of Simbrinza as an Adjunctive to DuoTrav

lead_sponsor: Alcon Research Ltd


title: A MULTI-CENTRE,RANDOMISED,DOUBLE BLIND,PLACEBO CONTROLLED,PARALLEL GROUP STUDY TO INVESTIGATE EFFICACY AND SAFETY OF ONO-2506PO COMPARED TO PLACEBO,IN THE PRESENCE OF RILUZOLE,TO PATIENTS DIAGNOSED WITH AMYOTROPHIC LATERAL SCLEROSIS(ALS), WHO HAVE HAD ONSET OF MUSCLE WEAKNESS WITHIN 14 MONTHS OF RANDOMISATION

lead_sponsor: ONO Pharmaceutical Co.,Ltd


title: A 3 Month, Randomised, Open Label, Parallel Group, Descriptive Study To Explore And Compare Perceptions And Satisfaction For Two Different Delivery Mechanisms For Etanercept (Etanercept Autoinjector And The Etanercept Prefilled Syringe) In Patients With Rheumatoid Arthritis.

lead_sponsor: Wyeth Pharmaceuticals France


title:
DORADO-EX – A Dose-Blinded, Long-Term Safety Extension Study to the Phase 3 DORADO Study (Protocol DAR-311) of Darusentan in Resistant Hypertension
 A Dose-Blinded, Long-Term Safety Extension Study of Fixed Doses of Darusentan in Subjects with Resistant Systolic Hypertension Receiving Combination Therapy with Three or More Antihypertensive Drugs, Including a Diuretic

acronym: DORADO-EX

lead_sponsor: Gilead Sciences Inc.


title: A Randomised, Phase IIb Placebo-controlled Study of R-ICE Chemotherapy (Rituximab, Ifosfamide, Carboplatin, and Etoposide) with and without SGN-40 (anti-CD40 humanized monoclonal antibody) for Second-line Treatment of Patients with Diffuse Large B-Cell Lymphoma (DLBCL)

lead_sponsor: Seattle Genetics, Inc.


title:
DORADO-AC-EX – A Double-Blind, Active-Controlled, Long-Term Safety Extension Study to the Phase 3 DORADO-AC Study (Protocol DAR-312) of Darusentan in Resistant Hypertension
 A Double-Blind, Active-Controlled, Long-Term Safety Extension Study of Optimized Doses of Darusentan in Subjects with Resistant Hypertension Despite Receiving Combination Therapy with Three or More Antihypertensive Drugs, Including a Diuretic, as Compared to Guanfacine (Protocol DAR-312-E)

acronym: DORADO-AC-EX

lead_sponsor: Gilead Sciences, Inc.


title: PHASE 4, PROSPECTIVE, MULTI-NATIONAL, RANDOMIZED, DOUBLE-BLIND, PLACEBO- CONTROLLED STUDY TO EVALUATE SMOKING CESSATION WITH VARENICLINE TARTRATE COMPARED WITH PLACEBO IN THE SETTING OF PATIENT SELF-SELECTED (FLEXIBLE) QUIT DATE

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


title: A Multicenter, Double-Blind, Placebo-Controlled, Randomized Withdrawal, Parallel Group Study to Evaluate the Efficacy and Safety of 50 mg/day of DVS SR in Adult Outpatients With Major Depressive Disorder

lead_sponsor: Wyeth Research Division of Wyeth Pharmaceuticals Inc.


title: A Phase II, Open-Label, Randomized, Multicenter Trial of Pazopanib (GW786034) in Combination with Lapatinib (GW572016) Compared to Pazopanib Montherapy and Lapatinib Monotherapy in Subjects with FIGO Stage IVB or Recurrent or Persistent Cervical Cancer with Zero or One Prior Chemotherapy Regimen for Advanced/Recurrent Disease


title: Randomized phase II trial evaluating the feasibility and tolerance of the combination of FOLFOX with cetuximab and the combination of FOLFOX with cetuximab and bevacizumab as perioperative treatment in patients with resectable liver metastases from colorectal cancer.

acronym: BOS

lead_sponsor: European Organisation for Research and Treatment of Cancer


title: A multicenter, randomized, double blind, placebo controlled Phase III study to assess the efficacy of xaliproden in patients with oxaliplatin-induced peripheral sensory neuropathy (PSN) following adjuvant chemotherapy for colon cancer

acronym: XENON

lead_sponsor: sanofi-aventis groupe


title:
A Randomized Phase II Biomarker Neoadjuvant Study of Sequential AC Followed by Ixabepilone Compared to Sequential AC Followed by Paclitaxel in Women with Early Stage Breast Cancer Not Overexpressing HER-2 and Estrogen Receptors.
 And Pharmacogenetics Blood Sample Amendment 01 - Site Specific (Version 1.0, Date 21-Dec-2006).

lead_sponsor: Bristol-Myers Squibb International Corporation


title: Prospective, randomized, observer-blind, parallel-group, multi-center trial to assess efficacy and safety of two different dilutions of NT 201 in patients with upper limb spasticity

acronym: NT-SPIN

lead_sponsor: Merz Pharmaceuticals GmbH


title: Comparison of the safety and efficacy of eplivanserin and lormetazepam in the treatment of insomnia characterized by sleep maintenance difficulties. A 4 week, randomized, double-blind, comparative, parallel-group study.

lead_sponsor: sanofi-aventis recherche et développement


title: Post authorisation safety study to prospectively monitor the incidence of relevant drug-related adverse events and EPO-related lack of efficacy among CKD subjects receiving HX575 recombinant human erythropoietin alfa i.v.

acronym: not applicable

lead_sponsor: Hexal Biotech ForschungsGmbH


title: A 38-week, Multicenter, Randomized, Double-blind, Active-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of an Intramuscular Depot Formulation of Aripiprazole (OPC-14597) as Maintenance Treatment in Patients with Schizophrenia “ASPIRE EU” (Aripiprazole Intramuscular Depot Program in Schizophrenia)

acronym: ASPIRE EU

lead_sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.


title: Efficacy and safety of aclidinium bromide at two dose levels vs placebo when administered to patients with moderate to severe chronic obstructive pulmonary disease (COPD)

lead_sponsor: Laboratorios Almirall, S.A.


title: An Open-Label, Randomized, Phase 2 Dose-Finding Study of Pacritinib in Patients with Thrombocytopenia and Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis Previously Treated with Ruxolitinib

lead_sponsor: CTI BioPharma Corp.


title: Phase III Randomized, Multi Center Study of Sunitinib Malate (SU 011248) or Capecitabine in Subjects with Advanced Breast Cancer who failed both a taxane and an anthracycline chemotherapy regimen or failed with a taxane and for whom further anthracycline therapy is not indicated

lead_sponsor: PFIZER


title: A   Phase III,  Randomised,  Double-blind,  Multi-centre, Withdrawal Study comparing MCI-196 versus Placebo in Chronic Kidney Disease Stage V Subjects on Dialysis with Hyperphosphataemia (Incorporating a Randomised 12 Week Open-label Dose Titration Period with MCI-196 or Sevelamer)

lead_sponsor: Mitsubishi Pharma Corporation


title: A Phase III, Double-blind, Multi-centre, Randomised, Parallel Group Design, Placebo-controlled, Flexible Dose Study of MCI-196 in Combination with a Calcium-based Phosphate Binder in Chronic Kidney Disease Stage V Subjects on Dialysis with Hyperphosphataemia.


title: A Phase 3 Study of 2 Dose Regimens of Telaprevir in Combination With Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Treatment-Naive Subjects with Genotype 1 Chronic Hepatitis C

lead_sponsor: Vertex Pharmaceuticals Incorporated


title: A PHASE 2, DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED, INTERNATIONAL, MULTICENTER STUDY OF ORAL TAC 101 AS SECOND LINE TREATMENT IN PATIENTS WITH ADVANCED HEPATOCELLULAR CARCINOMA WHO RECEIVED SORAFENIB AS FIRST LINE THERAPY

lead_sponsor: Taiho Pharma USA, Inc.


title: A PHASE 2, OPEN-LABEL STUDY TO ASSESS THE EFFICACY AND SAFETY OF LENALIDOMIDE IN COMBINATION WITH CETUXIMAB IN PRETREATED SUBJECTS WITH KRAS MUTANT METASTATIC COLORECTAL CANCER

lead_sponsor: Celgene Corporation


title:
TPL108392:  An open-label, multi-centre rollover study to assess the safety and efficacy of eltrombopag in thrombocytopenic subjects with hepatitis C virus (HCV) infection who are otherwise eligible to initiate antiviral therapy (peginterferon alfa-2a or peginterferon alfa-2b plus ribavirin)
 ENABLE-ALL (Eltrombopag to INitiate and Maintain Interferon Antiviral Treatment to Benefit Subjects with Hepatitis C Related Liver DiseasE – All Subjects Withdrawing From ENABLE 1 and 2 through Lack of Response)

acronym: ENABLE ALL

lead_sponsor: GlaxoSmithKline Research and Development Ltd


title: SIOPEL 6: Essai thérapeutique international multicentrique randomisé de phase III: Effet du thiosulfate de sodium (STS) dans la réduction de la toxicité auditive chez des patients traités par cisplatine pour un hépatoblastome de risque standard

acronym: SIOPEL 6

lead_sponsor: Centre Hospitalier Universitaire de Besançon


title: An open label, comparative, randomised, balanced crossover trial comparing nasal fentanyl and oral transmucosal fentanyl (Actiq) in breakthrough pain in patients with cancer.

lead_sponsor: Nycomed Danmark ApS


title: A SIX MONTH, OPEN-LABEL OUTPATIENT, RANDOMIZED PARALLEL GROUP TRIAL ASSESSING THE IMPACT OF DRY POWDER INHALED INSULIN (EXUBERA®) ON GLYCEMIC CONTROL COMPARED TO INSULIN GLARGINE (LANTUS®) IN PATIENTS WITH TYPE 2 DIABETES MELLITUS WHO ARE POORLY CONTROLLED ON A COMBINATION OF TWO OR MORE ORAL AGENTS

lead_sponsor: Pfizer Inc


title: A Randomised, Double-Blind (with Open Comparator Etanercept Limb), Placebo-Controlled, Phase IIb, Multicentre Study to Evaluate the Efficacy of 4 Doses of AZD9056 Administered for 6 Months on the Signs and Symptoms of Rheumatoid Arthritis in Patients with Active Disease Receiving Background Methotrexate or Sulphasalazine

lead_sponsor: AstraZeneca AB


title:
A Phase IIB, Multi-Dose, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept Versus Placebo in the Treatment of Psoriatic Arthritis.
 And Pharmacogenetics Blood sample Amendment - Site Specific

lead_sponsor: Bristol Myers Squibb International Corporation


title: A Randomized, Parallel, Double-Blind, Placebo-Controlled Dose Regimen Finding Study to Evaluate the Safety and Efficacy of TRU-015 in Subjects With Active Seropositive Rheumatoid Arthritis on a Stable Background of Methotrexate

lead_sponsor: Wyeth Research Division of Wyeth Pharmaceuticals Inc.


title: A Multinational, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Tolerability and Safety of talampanel in Subjects with Amyotrophic Lateral Sclerosis (ALS)

lead_sponsor: Teva Pharmaceutical Industries, Ltd


title: A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Ustekinumab Therapy in Subjects with Moderately to Severely Active Crohn’s Disease Previously Treated with TNF Antagonist Therapy

acronym: CERTIFI

lead_sponsor: Centocor BV


title: A Multicenter, Randomized, Double-Masked, Parallel-Group Study Evaluating the Efficacy and Safety of Cyclosporine Ophthalmic Solution 0.010% Compared with its Vehicle Administered QID for 3 months Followed by a 9 Month Open-Label Phase in Patients with Atopic Keratoconjunctivitis.

lead_sponsor: Allergan Limited


title: A randomised, double-blind, active-controlled, double-dummy, parallel group study to determine the safety and efficacy of oxycodone / naloxone prolonged release tablets in subjects with moderate to severe, chronic cancer pain

lead_sponsor: Mundipharma Research GmbH & Co. KG


title: Randomized Phase II of Ixabepilone Alone and Ixabepilone Plus Cetuximab as First-Line Treatment for Female Subjects with Triple Negative (ER, PR, Her2 negative) Locally Advanced non-resectable and/or Metastatic Breast Cancer

lead_sponsor: Bristol-Myers Squibb International Corporation


title: A Phase 4, Multicenter, Open-Label, Assessor-blinded, Switch Study o fthe Efficacy and Safety of Infliximab (REMICADE) in Patients With Active Rheumatoid Arthritis Who Are Responding Inadequately to Etanercept (ENBREL) of Adalimumab (HUMIRA)

acronym: RESTART


title: A dose ranging,  randomized, double blind, parallel-group  placebo-controlled  multi-center study of  RO5313534 used as add-on to donepezil treatment in patients with mild to moderate symptoms of Alzheimer’s Disease

lead_sponsor: F. Hoffmann-La Roche Ltd


title: A 24-Week, Randomised, Double-Blind, Active-Controlled, Multi-Centre Phase IIIb/IV Study to Evaluate the Efficacy and Tolerability of Saxagliptin Add-on Compared to Uptitration of Metformin in Patients with Type 2 Diabetes Mellitus With Inadequate Glycaemic Control on Sub-Maximal Doses of Metformin

acronym: Prompt


title: A Phase 2, Multicenter, Single-Blind, Randomized, Stratified, Standard-of-Care Controlled, Feasibility and Safety Study of rhBMP-2/CPM as an Adjuvant Therapy for Fractures of the Proximal Femur

lead_sponsor: Wyeth Pharmaceuticals Inc.


title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Explore the Safety And Tolerability of Doses of E2007 up to a Maximum of 12 mg In Patients with Refractory Partial Seizures

lead_sponsor: Eisai Limited


title: A 12-week, double-blind, randomised, parallel group, multi-centre, study to evaluate efficacy and safety of budesonide/formoterol (Symbicort® Turbuhaler®) 320/9 µg one inhalation twice daily on top of tiotropium (Spiriva®) 18 µg one inhalation once daily compared with tiotropium 18 µg one inhalation once daily, in patients with severe chronic obstructive pulmonary disease (COPD)

acronym: CLIMB


title: A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study of the Safety and Efficacy of a Single Treatment with Two Dose Levels of BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex Followed by a Treatment with BOTOX® in Patients with Urinary Incontinence Due to Neurogenic Detrusor Overactivity

lead_sponsor: Allergan Ltd


title: A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ONCE-DAILY ORALLY ADMINISTERED PH-797804 (0.5, 3, 6 AND 10 MG) IN ADULTS WITH MODERATE TO SEVERE CHRONIC

lead_sponsor: Pfizer Ltd, Ramsgate Road, Sandwich, Kent


title: Study of Coronary Atheroma by InTravascular Ultrasound: Effect of Rosuvastatin Versus AtorvastatiN (SATURN): A 104-week, randomized, double-blind, parallel group, multi-center Phase IIIb study comparing the effects of treatment with rosuvastatin 40mg or atorvastatin 80mg on atherosclerotic disease burden as measured by intravascular ultrasound in patients with coronary artery disease

acronym: SATURN


title: A Phase IIIb/IV, Multi-centre, Double-blind, Randomised, Placebo-controlled Parallel Group Study to Compare the Efficacy and Safety of MOVICOL® with Placebo in Patients with Constipation Associated with Irritable Bowel Syndrome (IBS)

lead_sponsor: Norgine Pharmaceuticals Ltd


title: A 48-week, multicentre, multinational, randomized, double-blind, 2-arm parallel group study, comparing the efficacy of FOSTER™ for maintenance and reliever versus fixed-dose FOSTER™ for maintenance + salbutamol as reliever in asthmatics ≥12 years of age

lead_sponsor: Chiesi Farmaceutici S.p.A.


title: Impact of Tadalafil (LY450190) Once a Day or Tadalafil On Demand Compared to Sildenafil Citrate On Demand on Treatment Discontinuation in Patients with Erectile Dysfunction who are Naïve to PDE5 Inhibitors

lead_sponsor: Eli Lilly and Company Limited


title: A phase III study to compare SonoVue guided prostate biopsy with systematic biopsy in the detection of prostate malignant lesions in patients with suspected prostate cancer

acronym: SonoVue guided prostate biopsy

lead_sponsor: Bracco Imaging SPA


title: A MULTICENTER, OPEN, SINGLE SEQUENCE CROSSOVER STUDY TO ASSESS THE SAFETY AND EFFICACY OF A TACROLIMUS MODIFIED RELEASE, FK506E (MR4), BASED IMMUNOSUPPRESSIVE REGIMEN IN STABLE LIVER TRANSPLANT PATIENTS CONVERTED FROM A PROGRAF BASED IMMUNOSUPPRESSIVE REGIMEN

lead_sponsor: Astellas Pharma GmbH


title: A MULTICENTER, RANDOMIZED, OPEN-LABEL COMPARISON OF THE SAFETY AND EFFICACY OF TIGECYCLINE WITH THAT OF AMPICILLIN-SULBACTAM OR AMOXICILLIN-CLAVULANATE TO TREAT COMPLICATED SKIN AND SKIN STRUCTURE INFECTIONS.

lead_sponsor: Wyeth Pharmaceuticals, Inc.


title: PENTASA in active Crohn’s Disease: A 10-week, double-blind, multi-centre trial comparing PENTASA Sachet 6 g/day (mesalazine, mesalamine) with placebo

lead_sponsor: Ferring Pharmaceuticals A/S


title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial, with an Open-Label Extension, Investigating the Safety, Tolerability and Efficacy of TransCon PTH Administered Subcutaneously Daily in Adults with Hypoparathyroidism

lead_sponsor: Ascendis Pharma Bone Diseases A/S


title: KPL-716-C201: A Phase 2a/b, Randomized, Double-Blind, Placebo Controlled Study to Investigate the Efficacy, Safety, Tolerability and Pharmacokinetics of KPL-716 in Reducing Pruritus in Subjects with Prurigo Nodularis

lead_sponsor: Kiniksa Pharmaceuticals, Ltd.


title:
RINGSIDE: A Phase 2/3, Randomized, Multicenter Study to Evaluate AL102 in Patients with Progressing Desmoid Tumors

 RINGSIDE : Étude multicentrique randomisée de phase II/III visant à évaluer l’AL102 chez des patients atteints de tumeurs desmoïdes évolutives.

acronym: RINGSIDE

lead_sponsor: Ayala Pharmaceuticals, Inc.


title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Multicenter Study of Itolizumab in Combination with Corticosteroids for the Initial Treatment of Acute Graft Versus Host Disease

lead_sponsor: Equillium, Inc.

status: Not Authorised


title: A RANDOMIZED, OPEN-LABEL ECULIZUMAB AND RAVULIZUMAB CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF POZELIMAB AND CEMDISIRAN COMBINATION THERAPY IN PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA WHO ARE CURRENTLY TREATED WITH ECULIZUMAB OR RAVULIZUMAB

lead_sponsor: Regeneron Pharmaceuticals, Inc.


title:
A Single Group Treatment, Phase 2 study to investigate Pharmacokinetics, Safety and Tolerability of Cefepime-Enmetazobactam administered by intra-venous infusion over 2 hours in Male or Female Participants from birth to less than 18 years of age hospitalized with complicated urinary tract infections (cUTI) including Acute Pyelonephritis (AP).

 Étude de phase 2 à un seul groupe de traitement visant à évaluer la pharmacocinétique, la sécurité d’emploi et la tolérance de l’association céfépime-enmétazobactam administrée par perfusion intraveineuse sur 2 heures chez des participants de sexe masculin ou féminin de moins de 18 ans hospitalisés pour des infections des voies urinaires compliquées (IVUc), y compris une pyélonéphrite aiguë (PA).

lead_sponsor: Allecra Therapeutics SAS


title:
A randomized, subject and investigator blinded, placebo controlled and multi-center platform study, to assess efficacy and safety of different investigational drugs in patients with moderate to severe hidradenitis suppurativa

 Etude multicentrique, randomisée, en double aveugle, contrôlée par placebo, conçue en plateforme, évaluant l’efficacité et la sécurité d’emploi de l’iscalimab (CFZ533) et de LYS006 chez des patients atteints d’hidradénite suppurée modérée à sévère

acronym: Efficacy and safety of different investigational drugs for the treatment of hidradenitis suppurativa

lead_sponsor: Novartis Pharma AG


title:
A Randomized, Double-blind, Placebo-Controlled, Active Comparator, Multicenter, Phase 3 Study of Brentuximab Vedotin or Placebo in Combination With Lenalidomide and Rituximab in Subjects with Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)

 Étude randomisée, en double aveugle, contrôlée par placebo, avec comparateur actif, multicentrique, de phase 3 portant sur le brentuximab védotine ou un placebo en association avec du lénalidomide et du rituximab chez des patients atteints d’un lymphome diffus à grandes cellules B (LDGCB) en rechute ou réfractaire

lead_sponsor: Seattle Genetics, Inc.

status: Trial now transitioned


study_start_date_type: Actual

intervention_type: Drug

lead_sponsor: Eisai Co., Ltd.

summary: The name of this trial is MissionAD1. This phase 3 study consists of a Core and Open Label Extension (OLE) Phase in participants with Early Alzheimer's Disease (EAD), and will be conducted to evaluate the efficacy and safety of E2609. The Core is a 24-month treatment, multicenter, double blind, placebo controlled parallel group study. The OLE is a 24-month treatment, one group study. The data for the studies E2609-G000-301 (NCT02956486, MissionAD1) and E2609-G000-302 (NCT03036280, MissionAD2) will be pooled.

ReferenceType: derived

ReferenceCitation: Bullich S, Mueller A, De Santi S, Koglin N, Krause S, Kaplow J, Kanekiyo M, Roe-Vellve N, Perrotin A, Jovalekic A, Scott D, Gee M, Stephens A, Irizarry M. Evaluation of tau deposition using 18F-PI-2620 PET in MCI and early AD subjects-a MissionAD tau sub-study. Alzheimers Res Ther. 2022 Jul 27;14(1):105. doi: 10.1186/s13195-022-01048-x.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

repositories_concat: PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Springer-Nature

sponsor_collaborators:
Eisai Co., Ltd.
Biogen

location_facility:
Facility #8
Facility #9
Facility #1
Eisai Trial Site 1
Facility #5
Facility #11
Eisai Trial site 5
Facility #3
Facility #2
Eisai Trial Site 2
Facility #4
Eisai Trial Site 3
Facility #10
Eisai Trial site 2
Eisai Trial Site 4
Facility #7
Facility #6
Eisai Trail Site 1

status: Terminated

title: A Placebo-Controlled, Double-Blind, Parallel-Group, 24 Month Study With an Open-Label Extension Phase to Evaluate the Efficacy and Safety of Elenbecestat (E2609) in Subjects With Early Alzheimer's Disease

primary_purpose: Treatment

type: EudraCT Number

enrollment_type: Actual

design_allocation: Randomized

study_completion_date_type: Actual

location_country:
Germany
Poland
Portugal
Slovakia
United Kingdom
Argentina
Australia
Japan
Austria
United States
Korea, Republic of
Spain
Greece
Czechia
Bulgaria
Canada
Russian Federation
France

ipd_sharing: Undecided


title: A Phase II Study of Pembrolizumab (MK-3475) as Monotherapy in Subjects with Previously Systemically Treated Advanced Hepatocellular Carcinoma (KEYNOTE-224)

acronym: Phase II MK-3475 in subjects with  previously treated Hepatocellular Carcinoma

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


title: A Randomized, Open-Label Study of the Efficacy and Safety of Galinpepimut-S (GPS) Maintenance Monotherapy Compared to Investigator's Choice of Best Available Therapy in Subjects with Acute Myeloid Leukemia Who Have Achieved Complete Remission After Second-Line Salvage Therapy

lead_sponsor: Sellas Life Sciences


title: AN OPEN-LABEL, RANDOMIZED, CONTROLLED, PHASE 2 STUDY TO EVALUATE THE SAFETY AND EFFICACY OF PEGCETACOPLAN IN THE TREATMENT OF POST-TRANSPLANT RECURRENCE OF C3G OR IC‑MPGN

acronym: NOBLE

lead_sponsor: Apellis Pharmaceuticals, Inc.


title: Multicenter, Open-label, Efficacy, Safety, Tolerability, and Pharmacokinetic Study of Subcutaneous Ixekizumab with Adalimumab Reference Arm, in Children with Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related Arthritis (Including Juvenile-Onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis

lead_sponsor: Eli Lilly and Company


title: A Randomized, Placebo-controlled, Double-blind, Parallel-group, Multicenter, Phase 2a Study of the Efficacy and Safety of Oral AMT-101 in Subjects with Moderate to Severe Ulcerative Colitis

lead_sponsor: Applied Molecular Transport Inc.


title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 1b/2a Study of WVE-003 Administered Intrathecally in Patients With Huntington’s Disease

lead_sponsor: Wave Life Sciences UK Limited


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

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

lead_sponsor: InMed Pharmaceuticals Inc.


title: A RANDOMIZED, DOUBLE BLIND, MULTICENTER, MULTINATIONAL, PLACEBO CONTROLLED, PARALLEL GROUP, SINGLE DOSE, ADAPTIVE EFFICACY AND SAFETY STUDY OF GLENZOCIMAB USED AS AN ADD-ON THERAPY ON TOP OF STANDARD OF CARE IN THE 4.5 HOURS FOLLOWING AN ACUTE ISCHEMIC STROKE

acronym: ACTISAVE

lead_sponsor: ACTICOR BIOTECH


title: A Randomized, Double-Blind, Placebo-Controlled Study of the PI3Kδ Inhibitor Parsaclisib Plus Ruxolitinib in Participants With Myelofibrosis Who Have Suboptimal Response to Ruxolitinib

lead_sponsor: Incyte Corporation


title: Multicenter, open-label, extension study to characterize the long-term efficacy and safety of early versus delayed treatment with venglustat (GZ/SAR402671) in patients at risk of rapidly progressive autosomal dominant polycystic kidney disease (ADPKD)

acronym: STAGED-PKD-EXT

lead_sponsor: Sanofi-Aventis Recherche & Développement


title:
An Open-Label, Multicenter, Phase 1b/2 Study of the Safety and Efficacy of KRT-232 with TL-895 in Subjects with Relapsed/Refractory Myelofibrosis and of KRT-232 in Janus-associated Kinase Inhibitor-Intolerant Myelofibrosis

 Étude de phase 1b/2, multicentrique et en ouvert visant à évaluer l’innocuité et l’efficacité du KRT-232 avec le TL-895 chez des patients atteints de myélofibrose réfractaire ou en rechute et du KRT-232 dans le cas d’une myélofibrose intolérante aux inhibiteurs de Janus kinases

lead_sponsor: Kartos Therapeutics, Inc.


title:
A Randomized Multicenter Phase 3 Study of Milademetan Versus Trabectedin in Patients with Dedifferentiated Liposarcoma

 Étude de phase 3 multicentrique randomisée visant à évaluer le miladémétan par rapport à la trabectédine chez des patients atteints de liposarcome dédifférencié

lead_sponsor: Rain Therapeutics, Inc.


title:
BHV3000-406: A Phase 4, Randomized, Double-blind Placebo-Controlled, Efficacy and Tolerability Trial of Rimegepant for the Acute Treatment of Migraine in Adults Unsuitable for Triptan Use

 BHV3000-406: Essai de phase 4, randomisé, en double aveugle, contrôlé par placebo visant à évaluer l’efficacité et la tolérance du rimégépant dans le traitement aigu de la migraine chez des adultes pour lesquels l’utilisation de triptans est inappropriée

lead_sponsor: Biohaven Pharmaceuticals, Inc.


title:
A Phase 2, Open-Label, Single-Arm, Cohort Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Sparsentan Treatment in Pediatric Subjects with Selected Proteinuric Glomerular Diseases (EPPIK).
 P/024/2021

acronym: EPPIK

lead_sponsor: Travere Therapeutics, Inc.


title: A Phase 3, Randomized, Double-Blind Study of Pamrevlumab or Placebo in combination with Gemcitabine Plus Nab-paclitaxel as Neoadjuvant Treatment in Patients with Locally Advanced, Unresectable Pancreatic Cancer

acronym: Not available

lead_sponsor: FibroGen, Inc.


title: An Open-label, Randomized, Multi-center, Parallel Group, Two-arm Study to Assess the Safety, Overall Tolerability, and Antiviral Activity of Brincidofovir versus Standard of Care for Treatment of Adenovirus Infections in High-risk Pediatric Allogeneic Hematopoietic Cell Transplant Recipients

acronym: AdAPT: Adenovirus after Allogeneic Pediatric Transplantation

lead_sponsor: Chimerix, Inc


title: A Phase III, 3-Arm, Randomized, Double-Blind, Placebo-controlled, Multicenter Study to Investigate the Impact of Diamyd® on the Progression of Diabetes in Patients Newly Diagnosed with Type 1 Diabetes Mellitus

lead_sponsor: Diamyd Therapeutics AB


title: A 24-month randomized, multicenter study, evaluating efficacy, safety, tolerability and pharmacokinetics of sotrastaurin (STN) combined with tacrolimus (TAC) vs a tacrolimus / mycophenolate mofetil (MMF) - based control regimen in de novo liver transplant recipients

lead_sponsor: Novartis Pharma Services AG


title: An Open Label, Randomized Phase I/IIa Trial Evaluating MK-0646 in Combination With Erlotinib (TARCEVA™) for Patients With Recurrent Non-Small Cell Lung Cancer"

lead_sponsor: Laboratoires Merck Sharp & Dohme - Chibret


title: A Phase 3, randomized, double-blind, placebo-controlled study of oral talactoferrin in addition to best supportive care in patients with non-small cell lung cancer who have failed two or more prior treatment regimens.

acronym: FORTIS-M

lead_sponsor: Agennix Incorporated


title: A multicenter, double-blind, randomized, parallel-group study to evaluate the safety, tolerability, and efficacy of once daily amlodipine/valsartan 5/80mg as compared to amlodipine/valsartan 5/40mg or to amlodipine 5mg once daily in elderly patients with essential hypertension not adequately controlled after four weeks on amlodipine 5mg once daily


title: A Phase 3, Safety and Efficacy Study of Boceprevir in Previously Untreated Subjects With Chronic Hepatitis C Genotype 1

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


title: A controlled, randomised, double-blind, double-dummy, parallel-group, phase III, multicenter study to evaluate efficacy and safety of the oral direct thrombin inhibitor AZD0837 compared to warfarin for the prevention of stroke and systemic embolic events (SEE) in patients with atrial fibrillation (ASSURE-AF)

acronym: ASSURE-AF

lead_sponsor: AstraZeneca AB


title:
30-day, open-label, active-controlled, randomized study of the safety, efficacy and the
 pharmacokinetic and pharmacodynamic properties of oral rivaroxaban in young
 children with various manifestations of venous thrombosis

acronym: EINSTEIN Junior Phase II-part B: oral rivaroxaban in young children with venous thrombosis

lead_sponsor: Bayer HealthCare AG


title: ENABLE 2 (Eltrombopag to INitiate and Maintain Interferon Antiviral Treatment to Benefit Subjects with Hepatitis C related Liver DiseasE) Randomised, placebo-controlled, multi-centre study to assess the efficacy and safety of eltrombopag in thrombocytopenic subjects with hepatitis C virus (HCV) infection who are otherwise eligible to initiate antiviral therapy (peginterferon alfa-2b plus ribavirin)

acronym: ENABLE 2

lead_sponsor: GlaxoSmithKline Research & Development Ltd


title: A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency.

lead_sponsor: BioPartners GmbH


title: A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Long Term Safety Study of MK-4305 in Patients with Primary Insomnia

lead_sponsor: Merck & Co., Inc.


title: A 24-week randomized placebo-controlled, double-blind multi-center clinical trial evaluating the efficacy and safety of oral QTI571 as an add-on therapy in the treatment of severe pulmonary arterial hypertension: Imatinib in Pulmonary arterial hypertension, a Randomized, Efficacy Study

acronym: IMPRES

lead_sponsor: Novartis Pharma AG


title: A 26-week treatment, multi center, randomized, double blind, double dummy, placebo controlled, parallel group study to assess the efficacy and safety of indacaterol (150 μg o.d.) in patients with chronic obstructive pulmonary disease, using salmeterol (50 μg b.i.d.) as an active control.


title: A prospective, multicenter, randomized, open-label, active-controlled, two-parallel groups, phase 3 study to compare the efficacy and safety of masitinib at 7.5 mg/kg/day to dacarbazine in the treatment of patients with non-resectable or metastatic stage 3 or stage 4 melanoma carrying a mutation in the juxta membrane domain of c-kit

acronym: Not applicable

lead_sponsor: AB Science


title:
Randomized Phase II study comparing single agent oral vinorelbine administered with two different schedules in patients with Advanced Non Small Cell Lung Cancer unfit for a platinum-based chemotherapy

 Étude randomisée de phase II comparant la vinorelbine orale en monothérapie administrée selon deux schémas différents, chez des patients atteints de cancer bronchique non à petites cellules avancé pour lesquels la chimiothérapie à base de platine n'est pas indiquée.

acronym: TEMPO LUNG 01

lead_sponsor: PIERRE FABRE MEDICAMENT


title: A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06438179 AND INFLIXIMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE

lead_sponsor: Pfizer Inc.


title: A Randomized Acceptability and Safety Study of the Transfer From Subutex to Suboxone in Opioid-Dependent Subjects.

lead_sponsor: Schering-Plough Research Institute


title: A Randomized, Double-Blind, Active-Controlled, Multicenter Study to Assess the LDL-C Lowering of Switching to a Combination tablet Ezetimibe/Simvastatin (10mg/20mg) compared to Rosuvastatin 10mg in patients with primary hypercholesterolemia and high cardiovascular risk and not adequately controlled with a  prior statin treatment. (IN-CROSS).


title: A 12-month open-label, randomized, multicenter, sequential cohort, dose finding study to evaluate the efficacy, safety and tolerability of oral AEB071 versus Neoral® in combination with Certican®, Simulect® and corticosteroids in de novo adult renal transplant recipients


title: A Study of Dose Optimization of Infliximab in the Treatment of Moderate to Severe Plaque Psoriasis.

acronym: DOSE

lead_sponsor: Schering Plough Research Institute, a Division of Schering Corporation


title: A 6-month, double-blind, randomized, placebo-controlled, parallel group outpatient trial, investigating the efficacy and safety of Org 50081 in adult patients with chronic primary insomnia.

acronym: AQUAMARINE

lead_sponsor: NV Organon


title: A Multicenter, Randomized, Open-Label Phase 3 Study to Investigate the Efficacy and Safety of Aldoxorubicin Compared to Investigator’s Choice in Subjects with Metastatic, Locally Advanced, or Unresectable Soft Tissue Sarcomas Who Either Relapsed or Were Refractory to Prior Non-Adjuvant Chemotherapy

lead_sponsor: CytRx Corporation


title:
A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06410293 AND ADALIMUMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELY
 TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN
 INADEQUATE RESPONSE TO METHOTREXATE


title:
Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1).
 Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission:   A Follow-up of Efficacy and Safety (Part 2)

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