title: A phase 3, open-label 96-week extension study of the safety of apricitabine in treatment-experienced HIV-1 infected patients who have completed protocol AVX-301 or AVX-302 or who have met the criteria for open-label access to ATC because of virologic failure/lack of response.

lead_sponsor: Avexa Limited


title: A Phase III, Randomized, Active Comparator-Controlled Clinical Trial to Study the Safety and Efficacy of MK-0826/Ertapenem and Meropenem in Patients with Complicated Urinary Tract Infections

source: euctr

lead_sponsor: Merck & Co., Inc.

study_type: Interventional

status: Prematurely Ended

lead_sponsor_type: industriel

status_simplified: Unknown


title: A Worldwide, Double-Blind, Randomized, Placebo-Controlled Study of MK-0524A 2g Coadministered with Intensive LDL-C Lowering Therapy Compared to Intensive LDL-C Lowering Therapy Alone on Carotid Artery Intima Medial Thickness (cIMT) in Patients With Heterozygous Familial Hypercholesterolemia (HeFH).

acronym: Carotid IMT Study

lead_sponsor: Laboratoires Merck Sharp & Dohme - Chibret


title: An Open-Label Evaluation of Safety of the IONSYS™ System [Fentanyl Iontophoretic Transdermal System (40 µg)] for Management of Acute Post- Operative Pain in Pediatric Patients

lead_sponsor: Janssen Cilag International N.V.,

status: Ongoing

status_simplified: Ongoing


title: Study of peripheral enthesitis with ultrasonography doppler in spondyloarthropathies treated with infliximab

acronym: EUSpA

lead_sponsor: Schering-Plough France


title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, 12-Week Study to Evaluate the Efficacy and Safety of Extended Release (ER) Niacin/Laropiprant When Added to Ongoing Lipid-Modifying Therapy in Dyslipidemic Patients.


title: ASSESSMENT OF GLOBAL AND REGIONAL LEFT VENTRICULAR FUNCTION AT REST AND DURING DOBUTAMINE STRESS WITH SONOVUE®-ENHANCED REALTIME 3D-ECHOCARDIOGRAPHY

lead_sponsor: Bracco ALTANA Pharma GmbH


title: A Phase IIa, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial of MK-0941 in Patients with Type 2 Diabetes Mellitus with Inadequate Glycemic Control on Insulin

lead_sponsor: Laboratoires MSD-Chibret

status: Completed

status_simplified: Completed


title: A randomised, double blind study to evaluate the safety and efficacy of the p38 kinase inhibitor, GW856553, in subjects with neuropathic pain from lumbosacral radiculopathy

lead_sponsor: GlaxoSmithKline Research & Development Limited


title: A phase III, Multicenter, Randomized, Placebo-Controlled Clinical Trial to Study the Safety and Efficacy of Oral MK-0974 in the Acute Treatment of Migraine with or Without Aura.


title: A randomised, double-blind, double-dummy, active-controlled, parallel-group study to assess and compare efficacy and safety of an 8-week treatment with BI 54903 at doses of 90.9 181.8 and 363.6 μg b.i.d. administered via Respimat® inhaler and fluticasone propionate HFA MDI 440 μg b.i.d. in patients with asthma inadequately controlled on medium dose ICS therapy

lead_sponsor: Boehringer Ingelheim Pharma GmbH & Co. KG


title:
A Phase II Open-Label Trial of Pazopanib Administered as a Single Agent in Patients with Unresectable or Metastatic Solitary Fibrous Tumor (SFT) and Extraskeletal Myxoid Chondrosarcoma (EMC)

 Essai de phase II, en ouvert, de pazopanib en monothérapie chez des patients porteurs de tumeurs fibreuses solitaires (SFT) et chondrosarcomes myxoïdes extra squelettiques (EMC), non résécables ou métastatiques.

acronym:
GEIS-32

 GEIS-32

lead_sponsor: Grupo Español de Investigación en Sarcomas


title: A prospective, multicenter, non-comparative, open label extension of the FUTURE 5 study to assess safety and tolerability of the pediatric formulation of bosentan in children with pulmonary arterial hypertension

acronym: FUTURE 6

lead_sponsor: Actelion pharmaceuticals Ltd


title: L'Erythropoïetine dans les traumatismes crâniens (EPO-TBI)

acronym: EPO-TBI

lead_sponsor: Monash University

lead_sponsor_type: academique


title: A Phase II Multicenter, Randomized, Double-Blind, Two-Stage Clinical Trial to Evaluate the Efficacy and Safety of MK-0594 in Patients with Alcohol Dependence

lead_sponsor: Laboratoires Merck Sharp & Dhome-Chibret


title: A phase Ib/II study of the ALK inhibitor ceritinib in combination with the CDK4/6 inhibitor LEE011 in patients with ALK-positive Non-small Cell Lung Cancer

lead_sponsor: Novartis Pharma Services AG


title: A Pivotal, Open-Label, Randomized, Crossover, Four Sequences Study in Male and Female Patients with Advanced Parkinson’s Disease to Assess the Relative Bioavailability of Levodopa Administered as ND0612 Subcutaneous Infusion via a Pump System plus Additional Oral Administered Levodopa/Carbidopa versus Levodopa Administered as Carbidopa-Levodopa Enteral Suspension

lead_sponsor: NeuroDerm Ltd.


title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Emricasan, an Oral Caspase Inhibitor, in Subjects with Non-alcoholic Steatohepatitis (NASH) Cirrhosis and Severe Portal Hypertension

lead_sponsor: Conatus Pharmaceuticals Inc.


title:
A randomised trial of dolutegravir (DTG)-based antiretroviral therapy vs. standard of care (SOC) in children with HIV infection starting first-line or switching to second-line ART.

 Essai randomisé évaluant une thérapie antirétrovirale basée sur le dolutegravir (DTG) en comparaison avec une thérapie antirétrovirale standard chez les enfants infectés par le VIH-1 commençant une première ligne ou  changeant pour une seconde ligne de traitement.

acronym: ODYSSEY (Once daily DTG-based ART in young people vs standard therapy)

lead_sponsor: Fondazione PENTA ONLUS


title: A Multi-Center, Open label, Repeated Dose Range Finding Study to Evaluate the Safety, Tolerability, Immunogenicity, Pharmacokinetics and Efficacy of an Anti-IL-1β Monoclonal Antibody (ACZ885) Given Subcutaneously in Pediatric Subjects with Active Systemic Juvenile Idiopathic Arthritis (SJIA)


title: A phase I/II open label, dose escalation trial to explore the safety and efficacy of ICL670 in patients with iron overload resulting from hereditary hemochromatosis


title: An Open-Label Extension of the Phase III Study CL-758010 with Alzhemed™ in Patients with Alzheimer’s Disease.

lead_sponsor: Neurochem Inc


title: Follow-up protocol to collect the outcome of frozen-thawed embryo transfer cycles after cryopreservation of embryos in clinical trial 107012

lead_sponsor: NV Organon


title: A multi-center, parallel-group, comparative trial evaluating the efficacy, pharmacokinetics and safety of 4.0 mg.kg-1 sugammadex administered at 1-2 PTC in subjects with normal or severely impaired renal function


title: A randomized, 32 week double-blind, parallel-group, multicenter study to compare the efficacy and safety of initiating treatment with combination (aliskiren/amlodipine) therapy in comparison with the sequential add-on treatment strategies in patients with essential hypertension.

acronym: ACCELERATE: Aliskiren and the Calcium Channel BlockEr amLodipine combination as an initial trEatment


title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Crossover Trial to Evaluate the Efficacy and Tolerability of Rizatriptan 10 mg ODT for the Treatment of Acute Migraine in Patients on Topiramate for Migraine Prophylaxis

lead_sponsor: Merck & Co., Inc.


title: A Phase III Randomized, Placebo-Controlled Study to Evaluate the Effect of Odanacatib (MK-0822) on Bone Mineral Density (BMD) and Overall Safety, and to Estimate the Effect of Odanacatib (MK-0822) on Bone Micro-architecture in Postmenopausal Women Treated with Vitamin D


title: A Phase I/II Open-Label Dose Escalation Study to Investigate the Safety and Tolerability of Acadesine in Patients with B-Cell Chronic Lymphocytic Leukaemia

lead_sponsor: Protherics Medicines Development Ltd


title: A Phase 3, Multicenter, Double-Blind, Randomized, Parallel-Arm, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Adalimumab for Treatment of Nail Psoriasis in Subjects with Chronic Plaque Psoriasis

lead_sponsor: AbbVie Deutschland GmbH & Co. KG


title: "A randomized, single-blind, placebo-controlled, parallel-group study evaluating the anti-inflammatory activity of GSK315234 in synovial biopsy tissue obtained from subjects with rheumatoid arthritis"


title: A phase II, randomized, partially double blind, controlled study to evaluate the immunogenicity, safety, and clinical efficacy of three doses of Neovacs’ TNF-Kinoid in adult patients with rheumatoid arthritis (RA) who have relapsed despite use of an anti-TNFα biological drug, due to anti-drug antibodies

lead_sponsor: Neovacs SA


title: A multi-center, double-blind, flexible-dose efficacy trial with Org 25935 versus placebo as add-on therapy in subjects with predominant, persistent negative symptoms of schizophrenia treated with a stable dose of a second generation antipsychotic.

acronym: Glycine uptake Inhibitor Add-on in Negative symptoms Trial (GIANT).


title: OFA110867 : Clinical phase I/IIA study of subcutaneous administration of Ofatumumab in Rheumatoid Arthritis patients on stable dose Methotrexate

lead_sponsor: GlaxoSmithKline Research & Development Ltd


title: A multicenter, double-blind, randomized study to compare the efficacy of 24 weeks treatment with fixed combination therapy of vildagliptin and metformin (25/1000 mg bid) versus metformin monotherapy (1000 mg bid) in patients with type 2 diabetes inadequately controlled with metformin monotherapy


title: An open-label, non-controlled multicentre trial to evaluate the insertion characteristics of the radiopaque etonogestrel implant using a next generation applicator


title: Phase II study evaluating oral vinorelbine as a single agent in patients with hormone receptor breast cancer with bone metastases previously treated by a hormone therapy

lead_sponsor: PIERRE FABRE MEDICAMENT


title: Randomised Phase III Trial of Paclitaxel plus Carboplatin (TC) Therapy versus Irinotecan plus Cisplatin (CPT-P) Therapy as a First Line Chemotherapy for Clear Cell Carcinoma of the Ovary

lead_sponsor: Kitasato institute clinical trial coordinating center


title: Pharmacodynamic and clinical assessment of DC 982 GE (2,4 or 6 capsules per day) in patients with chronic venous disorders :  randomised, placebo-controlled, dose effect, double blind, parallel group study

lead_sponsor: PIERRE FABRE MEDICAMENT-IRPF-IDPF


title:
A randomised Phase II trial of Imatinib (IM) versus Hydroxychloroquine (HCQ) and Imatinib (IM) for patients with Chronic Myeloid Leukaemia (CML) in Cytogenetic Response (CyR) with residual disease detectable by quantitative polymerase chain reaction (Q-PCR)

 Essai randomisé de phase II comparant l'Imatinib versus Imatinib + hydroxychloroquine chez les patients atteints d’une leucémie myéloïde chronique en phase chronique, en réponse cytogénétique majeure, mais avec une maladie résiduelle détectable par PCR (polymerase chain reaction)

acronym: CHOICES-CHlOroquine and Imatinib Combination to Eliminate Stem cells

lead_sponsor: NHS Greater Glasgow and Clyde


title: A Dose-Ranging Study of the Efficacy, Safety, and Pharmacokinetics of Deferiprone Delayed Release Tablets in Patients with Parkinson’s Disease

lead_sponsor: ApoPharma Inc.


title: A Double-Blind, Randomised, Placebo-Controlled, Parallel Group, Phase II, Dose Ranging Trial to Evaluate the Efficacy, Safety and Tolerability of oral Litoxetine 10mg, 20mg and 40mg Twice Daily (BID) versus placebo in women with Mixed Urinary Incontinence

lead_sponsor: IXALTIS


title:
A Randomized, Double-Blind, Placebo-Controlled Phase II Trial of Neoadjuvant Carboplatin and Paclitaxel, With or Without Debio 1143 in Patients With Newly Diagnosed Advanced Epithelial Ovarian Cancer.

 Étude de phase II, randomisée, en double aveugle, contrôlée par placebo, portant sur le traitement néoadjuvant par carboplatine et paclitaxel, avec ou sans Debio 1143, chez des patientes atteintes d'un cancer épithélial nouvellement diagnostiqué et avancé de l'ovaire

lead_sponsor: Debiopharm International SA


title: A Phase IB Dose Exploration Trial with MK-8628, a Small Molecule Inhibitor of the Bromodomain and Extra-Terminal (BET) Proteins, in Subjects with Selected Advanced Solid Tumors

acronym: MK-8628 Solid Tumor Trial

lead_sponsor: Oncoethix GmbH, a wholly owned subsidiary of Merck Sharp & Dohme Corp.


title: A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Efficacy and Safety Study of Ezetimibe Monotherapy in Children (Ages 6 to 10 Years) With Primary Hypercholesterolemia (Heterozygous Familial and Nonfamilial)

lead_sponsor: Schering-Plough Research Institute


title: Safety and Efficacy Evaluation of Topical Moxidex Otic Solution in the Treatment of Acute Otitis Media with Otorrhea in Tympanostomy Tubes

acronym: Safety and Efficacy of Moxidex Otic Solution in AOMT

lead_sponsor: Alcon Research Ltd.


title: Pilot Study of Nivolumab in Pediatric Patients with Hypermutant Cancers

lead_sponsor: Hospital for Sick Children


title: Multi-center non-drug-interventional extension study to assess long-term safety and effects on growth in patients who received bosentan or placebo as adjunctive therapy to inhaled nitric oxide for persistent pulmonary hypertension of the newborn in FUTURE 4 (AC-052-391)

lead_sponsor: Actelion Pharmaceuticals Ltd.


title:
Vitamin D3 – Omega3 – Home Exercise – HeALTHy Ageing and Longevity
 Trial Randomized, double-blind, placebo-controlled, multi-centre clinical
 trial

 Vitamine D3 – Omega3 – Programme d’entraînement à la maison – longévité et vieillissement en bonne santé (DO-HEALTH)

acronym: DO – HEALTH

lead_sponsor: University Hospital of Zurich and City Hospital Waid


title: Phase 2 single-arm studies of Temozolomide in combination with Topotecan in refractory or relapsing Neuroblastoma and Other pediatric solid tumours.

acronym: ITCC 013 - TOTEM2

lead_sponsor: Institut Gustave Roussy


title: Study PMA112509, a Phase I/II Study of Eltrombopag in Thrombocytopenic Subjects with Advanced Myelodysplastic Syndrome (MDS) or secondary Acute Myeloid Leukemia after MDS (sAML/MDS)

lead_sponsor: GlaxoSmithKline Research & Development Limited


title: Pregnancy and neonatal follow-up of ongoing pregnancies established after controlled ovarian stimulation in clinical trial 38825 for Org 36286 (corifollitropin alfa)

lead_sponsor: NV Organon


title: A Phase 2, Randomized, Open-Label Study of Single Agent Azacitidine (Vidaza®) vs. Single Agent MGCD0103 vs. Azacitidine in Combination With MGCD0103 for the Treatment of Elderly Subjects With Newly Diagnosed Acute Myeloid Leukemia or Intermediate-2 or High-Risk Myelodysplastic Syndrome

lead_sponsor: Pharmion Corporation


title: A randomized, double-blind, placebo controlled, parallel group, multi-center study, to assess the safety and tolerability of 28 days treatment with NVA237 (100 or 200µg once a day) in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD)

lead_sponsor: Novartis Pharma Services AG


title: An Open-Label, Multi-Center, Single Arm Study to Evaluate the Safety and Tolerability of Intravenous Zanamivir in the Treatment of Hospitalized Adult, Adolescent and Pediatric Subjects with Confirmed Influenza Infection

lead_sponsor: GlaxoSmithKline Research & Development Ltd


title:
A Phase 1/2 Study of the Safety, Pharmacokinetics, and Anti-Tumor Activity of the Oral EGFR/HER2 Inhibitor TAK-788 (AP32788) in Non-Small Cell Lung Cancer

 Étude de phase 1/2 évaluant la tolérance, la pharmacocinétique et l’activité antitumorale de l’inhibiteur oral de EGFR/HER2 TAK-788 (AP32788) dans les cancers du poumon non à petites cellules

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


title:
CareCN: A phase I/II, open label, escalating dose study to evaluate safety and efficacy of an intravenous injection of GNT0003 (Adeno-associated Viral Vector expressing the UGT1A1 transgene) in patients with severe Crigler-Najjar syndrome requiring phototherapy

 « CareCN : Etude de phase I/II,  en ouvert, avec escalade de dose, visant à évaluer la tolérance et l’efficacité d’un traitement par GNT0003 administré par voie intraveineuse chez des patients atteints d’un syndrome de Crigler-Najjar sévère nécessitant un traitement par photothérapie

acronym: CareCN

lead_sponsor: Genethon


title: A phase 3 safety and efficacy study of boceprevir in combination with peginterferon alfa-2a and ribavirin 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 Multicenter, Double-Blind, Randomized, Active-Controlled Study to Evaluate the Safety and Antiretroviral Activity of MK- 0518 Versus Efavirenz in Treatment Naïve HIV-Infected Patients, Each in Combination With TRUVADA™

lead_sponsor: Laboratoires Merck Sharp & Dohme-Chibret


title: Prospective, open-label, multicenter, international study of mifepristone for symptomatic treatment of Cushing's syndrome caused by ectopic Adrenal Corticotrophin Hormone (ACTH) secretion.

acronym: HRA052015 in EAS

lead_sponsor: Laboratoire HRA Pharma


title: A randomised open-label study comparing the safety and efficacy of three different combination antiretroviral regimens as initial therapy for HIV infection.

acronym: Altair

lead_sponsor: University of New South Wales


title: A Phase I/II, Open-Label, Multicenter, Two-Arm, Feasibility Study of Pazopanib, Carboplatin, and Paclitaxel in Women with Newly Diagnosed, Previously Untreated, Gynaecological Tumors

lead_sponsor: GlaxoSmithkline Research & Development Limited


title:
AN OPEN LABEL PHASE II STUDY  TO EVALUATE THE EFFICACY AND SAFETY OF INDUCTION AND CONSOLIDATION THERAPY WITH DASATINIB IN COMBINATION WITH CHEMOTHERAPY IN PATIENTS AGED 55 YEARS AND OVER WITH PHILADELPHIA CHROMOSOME POSITIVE (PH+ OR BCR-ABL+) ACUTE LYMPHOBLASTIC LEUKEMIA (ALL).
 EWALL-PH-01

acronym: EWALL

lead_sponsor: CH-Versailles


title: A phase III randomized, double-blind, double dummy, placebo controlled, multicenter, 4 treatments, 3 period incomplete block crossover study to assess the effect on FEV1 of indacaterol 300 µg o.d. dosed in the evening in patients with moderate to severe chronic obstructive pulmonary disease (COPD) with salmeterol as active control


title: An open-label, one arm, multi-centre Phase II trial evaluating the efficacy and safety of DTS-201 as a second-line chemotherapy in patients with hormone refractory prostate cancer

lead_sponsor: Diatos S.A.


title: Efficacy and safety assessment of intracameral T2380  (Fixed combination of lidocaïne, phenylephrine and tropicamide)  for anaesthesia and mydriasis in phacoemulsification cataract surgery

lead_sponsor: Laboratoires Théa


title: A multi-center, randomized, double-blind, placebo and active controlled, parallel group, dose finding study to evaluate the efficacy and safety of LCI699 compared to placebo after 8 weeks treatment in patients with essential hypertension


title: An open-label, single treatment, safety and efficacy, long-term study of deferiprone in subjects with Friedreich's ataxia.

acronym: Not applicable

lead_sponsor: ApoPharma Incorporated


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

lead_sponsor: STEBA BIOTECH SA


title: International, multicenter, randomized, non-comparative controlled study of therapeutic intensification plus immunomodulation in HIV patients with long-term viral suppression

lead_sponsor: ORVACS


title:
Efficacy and safety of a Double Icodextrin Dose in elderly incident CAPD patients on incremental Peritoneal Dialysis therapy: the DIDo study

 Efficacité et sécurité d’une double dose d’icodextrine chez des patients âgés, incidents en dialyse péritonéale continue ambulatoire (DPCA), débutant une dialyse péritonéale incrémentale: l’étude DIDo

acronym: DIDo

lead_sponsor: Université catholique de Louvain


title: A phase Ib/II, open-label study of LJM716 in combination with BYL719 compared to taxane or irinotecan in patients with previously treated esophageal squamous cell carcinoma


title:
A Phase 3, Multicenter, Randomized, Double-blind, Placebo- and Active Comparatorcontrolled
 Trial of Flexible-dose Brexpiprazole (OPC-34712) as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder, the Delphinus Trial

acronym: Delphinus

lead_sponsor: Otsuka Pharmaceutical Development & Commercialization,Inc


title: Phase I-II study of F14512 in combination with cytarabine in patients 60 years old and older with acute myeloid leukemia.

lead_sponsor: Pierre Fabre Medicament


title:
TIGER-1:  A Randomized, Open-label, Phase 2/3 Study of CO-1686 or Erlotinib as First-Line Treatment of Patients with EGFR-Mutant Advanced/Metastatic  Non-Small Cell Lung Cancer (NSCLC)

 TIGER-1 : Étude randomisée, ouverte, de phase 2/3 visant à évaluer le CO-1686 ou l’Erlotinib comme traitement de première ligne chez des patients atteints d’un cancer du poumon non à petites cellules (CPNPC) muté EGFR à un stade avancé/métastatique

lead_sponsor: Clovis Oncology, Inc.


title: A Long Term Follow-up Study of AMG0001 in Subjects with Critical Limb Ischemia

lead_sponsor: AnGes Inc.


title: A multicenter, open-label, sponsor-blinded, randomized, active-controlled, parallel group, pivotal study to evaluate the efficacy, safety, and tolerability of murepavadin given with ertapenem versus an anti-pseudomonal-β lactam-based antibiotic in adult subjects with nosocomial pneumonia suspected or confirmed to be due to Pseudomonas aeruginosa.

lead_sponsor: Polyphor Ltd.


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

lead_sponsor: NV Organon


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

lead_sponsor: Novartis Pharma Services AG


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


title: An Observational Follow-Up Study of Pediatric Patients Who Participated in a Previous Respiratory Syncytial Virus (RSV)-Induced Bronchiolitis Study of Montelukast

lead_sponsor: Laboratoires Merck Sharp & Dohme - Chibret


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

lead_sponsor: STEBA BIOTECH NV


title: A twenty-four week, open-label, non-comparative, multicenter study to assess the efficacy and tolerability of an aliskiren-based treatment algorithm in patients with mild to moderate hypertension.


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

lead_sponsor: GlaxoSmithKline Research and Development Ltd


title: A Randomized, Double-blind, Multicenter Phase III Study of Brivanib versus Placebo as Adjuvant Therapy to Trans-Arterial Chemo-Embolization (TACE) in Patients with Unresectable Hepatocellular Carcinoma: The BRISK TA Study

acronym: The BRISK TA Study

lead_sponsor: Bristol Myers Squibb International Corporation


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

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


title: A multicentre, randomised, double-blind, placebo-controlled, parallel group, dose ranging study to determine the effect of mepolizumab on exacerbation rates in subjects with severe uncontrolled refractory asthma.

lead_sponsor: GlaxoSmithKline Research & Development Ltd


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

acronym: FEIBA NF Prophylaxis Study

lead_sponsor: Baxter Innovations GmbH


title: A phase II multicentric study in adults with acute myelogenous leukaemia (AML) in first complete remission (CR1) using IV BuCy2 in a once daily Bu regimen targeting a narrow therapeutic window prior to hematopoietic stem cell transplantation.

lead_sponsor: PIERRE FABRE MEDICAMENT


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

lead_sponsor: Boehringer Ingelheim Pharma GmbH & Co. KG,


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

lead_sponsor: Astellas Pharma Global Development, Inc.


title:
Exploratory phase II study in patients after treatment of high grade brain tumors to assess the technical performance of Tc-99m tetrofosmin for differentiation of recurrence versus radiation necrosis

 Étude préliminaire phase II auprès de patients après traitement de tumeurs cérébrales de haut grade pour déterminer la performance technique du Tc-99m tétrofosmine pour différencier la tumeur récidivante de la nécrose de rayonnement

lead_sponsor: pro-ACTINA S.A.


title:
A Randomized, Phase 3, Double-blind, Placebo-controlled Study of Pazopanib With or Without Abexinostat in Patients With Locally Advanced or Metastatic Renal Cell Carcinoma

 Étude randomisée de phase 3, en double aveugle, contrôlée versus placebo, évaluant le traitement par pazopanib avec ou sans abexinostat chez des patients présentant un cancer du rein localement avancé ou métastatique

lead_sponsor: Xynomic Pharmaceuticals, Inc.


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

lead_sponsor: INNOVIVE Pharmaceuticals


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

acronym: IGNITE Trial

lead_sponsor: Debiopharm S.A.


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

acronym: VIKING


title: The Effect of Acadesine on Clinically Significant Adverse Cardiovascular and Cerebrovascular Events in High-Risk Subjects Undergoing Coronary Artery Bypass Graft (CABG) Surgery Using Cardiopulmonary Bypass (Protocol No. P05633): RED-CABG Trial (Reduction in Cardiovascular Events by Acadesine in Subjects Undergoing CABG)

acronym: RED-CABG Trial

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


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

lead_sponsor: SmithKline Beecham Corporation (doing business as GlaxoSmithKline)


title: Phase I/II/III Pharmacokinetic and Outcome Study of Inspiration's Recombinant Factor IX Product, IB1001, in Subjects with Hemophilia B

lead_sponsor: Inspiration Biopharmaceuticals


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

lead_sponsor: Merck & Co., Inc.


title: An open-label, randomised crossover pharmacokinetic, palatability and safety study to assess the bioavailability of a new 6MP oral liquid formulation by comparison to a currently registered 6MP 50 mg adult tablet (part A) followed by an open, non-randomised multiple-doses study with adjusted doses of 6MP oral liquid formulation (part B)  in children with acute lymphoblastic leukaemia.

lead_sponsor: Only For Children Pharmaceuticals


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

acronym: SECOND-LINE

lead_sponsor: National Centre in HIV Epidemiology and Clinical Research


title: Randomised phase II study evaluating, as first-line chemotherapy, weekly oral vinorelbine as a single-agent versus weekly paclitaxel as a single-agent in estrogen receptor positive, HER2 negative patients with advanced breast cancer.


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

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

acronym:
RE-ARRANGE

 RE-ARRANGE

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


title:
A Prospective, Open-Label, Active-Controlled Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Efficacy of Rivaroxaban for Thromboprophylaxis in Pediatric Subjects 2 to 8 Years of Age after the Fontan Procedure

 Etude prospective, en ouvert, contrôlée versus traitement actif, pour évaluer la pharmacocinétique, la pharmacodynamie, la sécurité d’emploi et l’efficacité du rivaroxaban dans la thromboprophylaxie chez des patients âgés de 2 à 8 ans, ayant subi une procédure de Fontan

acronym: UNIVERSE

lead_sponsor: Janssen-Cilag International N.V


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

acronym: REAKT

lead_sponsor: Atox Bio


title: COLCHICINE CORONAVIRUS SARS-CoV2 TRIAL

acronym: COLCORONA

lead_sponsor: Montreal Heart Institute Coordinating Centre


title: PHASE III, MULTI-CENTER, RANDOMIZED, 48 WEEKS, DOUBLE-BLIND, PARALLEL-GROUP, PLACEBO-CONTROLLED STUDY TO EVALUATE EFFICACY AND SAFETY OF CER-001 ON VESSEL WALL AREA IN PATIENTS WITH GENETICALLY DEFINED FAMILIAL PRIMARY HYPOALPHALIPOPROTEINEMIA AND RECEIVING BACKGROUND OPTIMIZED LIPID THERAPY

acronym: TANGO

lead_sponsor: CERENIS THERAPEUTICS SA


title: An Open-label, Single-dose, Safety and Pharmacokinetic Study of Regadenoson in Paediatric Patients

lead_sponsor: GE Healthcare Ltd.


title: BT8009-100:  Phase I/II Study of the Safety, Pharmacokinetics, and Preliminary Clinical Activity of BT8009 in Patients with Nectin-4 Expressing Advanced Malignancies

lead_sponsor: BicycleTx Ltd.


title:
A Phase 2, Multicenter, Randomized, Parallel-Group, Double-Blind, Controlled Study of Aducanumab (BIIB037) in Subjects With Mild Cognitive Impairment due to Alzheimer’s Disease or With Mild Alzheimer’s Disease Dementia to Evaluate the Safety of Continued Dosing in Subjects with Asymptomatic Amyloid-Related Imaging Abnormalities

 Étude de phase 2 contrôlée, multicentrique, randomisée, en groupes parallèles et en double aveugle portant sur de l’aducanumab (BIIB037) chez des patients atteints de troubles cognitifs légers dus à la maladie d’Alzheimer ou de la maladie d’Alzheimer au stade léger, dont le but est d’évaluer la sécurité d’emploi lorsque l’on poursuit l’administration chez des patients présentant des anomalies d’imagerie  liées à l’amyloïde (ARIA) asymptomatiques

lead_sponsor: Biogen Idec Research Limited


title: A Phase 2, Open-label Study to Evaluate the Safety and Efficacy of Switching to Tenofovir Alafenamide (TAF) from Tenofovir Disoproxil Fumarate (TDF) and/or Other Oral Antiviral Treatment (OAV) in Virologically Suppressed Chronic Hepatitis B Subjects with Renal and/or Hepatic Impairment

lead_sponsor: Gilead Sciences, Inc.


title: A 3-part study to evaluate the efficacy and safety of venglustat in combination with Cerezyme in adult and pediatric patients with Gaucher disease Type 3 (GD3) with open-label long-term treatment

lead_sponsor: Genzyme Corporation


title: A Randomised, Double-Blind, Single dose, One-Day Early Administration, Multicentre Study comparing the Efficacy and Safety of Acyclovir Lauriad 50 mg muco-adhesive buccal tablet to matching Placebo, in the Treatment of Herpes Labialis in Immunocompetent Patients

acronym: LIP

lead_sponsor: Bioalliance Pharma


title: Effect of Duloxetine 60 mg to 120 mg Once Daily in Patients with Chronic Low Back Pain

acronym: HMEN

lead_sponsor: Eli Lilly and Company Ltd.


title: An Eight-Week, Multinational, Multicenter, Randomized, Double-blind, Placebo-controlled Study, with Escitalopram as an Active Control, to Evaluate the Efficacy, Safety and Tolerability of a Saredutant 100 mg Dose Once Daily, in Elderly Patients with Major Depressive Disorder

acronym: INDIGO

lead_sponsor: sanofi-aventis recherche & développement


title: A Phase 2, Multicenter, Double-Blind, Randomized, Stratified, Controlled, Efficacy, Safety and Feasibility Study of rhBMP-2/CPM as an Adjuvant Therapy in Closed Fractures of the Humerus

lead_sponsor: Wyeth Pharmaceuticals Inc.


title: An Open Label Multi-center Study to Assess the Efficacy and Safety of B-Domain Deleted Recombinant Factor VIII (BDDrFVIII, ReFacto AF) in Patients With Hemophilia A Undergoing Elective Major Surgery

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


title: A Phase II Study Of Oral LBH589 In Adult Patients With Multiple Myeloma Who Have Received At Least Two Prior Lines Of Therapy And Whose Disease Is Refractory To The Most Recent Line Of Therapy

lead_sponsor: Novartis Pharma Services AG


title: Efficacy and Safety of Hydrochlorothiazide Used as Add-on Therapy in Moderately to Severely Hypertensive Patients not Adequately Controlled by Olmesartan Medoxomil 40 mg Monotherapy

lead_sponsor: DAIICHI SANKYO EUROPE GmbH


title: A Phase I/II Clinical Trial of PXD101 in Combination with Idarubicin in Patients with AML Not Suitable for Standard Intensive Therapy

lead_sponsor: TopoTarget A/S


title: A Phase II multi-centre, extension study to investigate the long term safety of ONO-2506PO in patients diagnosed with Amyotrophic Lateral Sclerosis (ALS).

lead_sponsor: ONO Pharmaceutical Co., Ltd.


title: A randomized, observer blind, multinational phase III study to evaluate the safety and efficacy of a nanoemulsion gel formulation BF-200 ALA, in comparison with Metvix® and placebo, for the treatment of actinic keratosis with photodynamic therapy

lead_sponsor: Biofrontera Bioscience GmbH


title: A Randomized, Parallel Group, Double-Blind, Placebo Controlled Study to Evaluate the Clinical Efficacy and Safety of BMS-582949 Given Orally to Subjects with Rheumatoid Arthritis Having an Inadequate Response to Methotrexate. Pharmacogenetics Blood Sample Amendment 01 (version 1.0, dated 19-Dec-2007); Revised Protocol 01, incorporating administrative letter 01 and amendment 03 (version 1.0, dated 12-Mar-2008)

lead_sponsor: Bristol Myers Squibb International Corporation


title: A Randomized, Double-Blind, Placebo-Controlled, Clinical Evaluation of the Efficacy, Safety and Tolerability of Neramexane in Patients with Subjective Tinnitus

lead_sponsor: Merz Pharmaceuticals GmbH


title: A PHASE 2, 12 WEEK, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, PROOF OF CONCEPT STUDY EVALUATING THE EFFICACY AND SAFETY OF PD 0299685 FOR THE TREATMENT OF SYMPTOMS ASSOCIATED WITH INTERSTITIAL CYSTITIS/PAINFUL BLADDER SYNDROME.

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


title:
A Multicenter, Randomized, Double-Blind, Phase 3b Trial to Evaluate the Efficacy and Safety of Saxagliptin Added to Insulin Monotherapy or to Insulin in Combination with Metformin in Subjects with Type 2 Diabetes Who Have Inadequate Glycemic Control on Insulin Alone or on Insulin in Combination with Metformin
 + Pharmacogenetics Blood Sample Protocol Amendment 1 (v1.0, Date 13-Aug-2008)

lead_sponsor: Bristol-Myers Squibb International Corporation


title: A Phase 2, Randomized, Open-Label Study to Evaluate ECG 	Results and Pharmacokinetic Parameters for Fludarabine, Cyclophosphamide, and Rituximab (FCR) in Combination with Lumiliximab Versus FCR Alone in Subjects with Previously Untreated Chronic Lymphocytic Leukemia.

lead_sponsor: Biogen Idec Ltd


title: A Phase II Open Label, Randomized, 3 Arm Trial of 2 Schedules of Ixabepilone Plus Bevacizumab and Paclitaxel Plus Bevacizumab as first Line Therapy for Locally Recurrent or Metastatic Breast Cancer.


title: A MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, PARALLEL-GROUP STUDY OF THE EFFICACY AND SAFETY OF TWO LENALIDOMIDE DOSE REGIMENS IN SUBJECTS WITH RELAPSED OR REFRACTORY B-CELL CHRONIC LYMPHOCYTIC LEUKEMIA

lead_sponsor: Celgene Corporation


title:
Study of the Antiviral Activity of Entecavir in Patients Receiving Liver Transplant Due to Chronic Hepatitis B Virus Infection.
 Revised Protocol 01, incorporating Amendment 02 (Version 1.0 Date 20-Nov-2006).


title:
A Comparative Study of Chronic Hepatitis B Subjects Treated with Entecavir Plus Tenofovir Combination Therapy vs Entecavir Monotherapy in Adults who are Treatment-Naïve to Nucleosides and Nucleotides: The BE-LOW Study.
 Revised Protocol 01, incorporating protocol amendment 02 (Version 2.0, Date 22-Jan-07).

acronym: The BE-LOW Study


title: A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, TREATMENT-WITHDRAWAL STUDY OF THE EFFICACY AND SAFETY OF PANTOPRAZOLE SODIUM ENTERIC-COATED GRANULES IN INFANTS (1 THROUGH 11 MONTHS) WITH SYMPTOMATIC GERD.

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


title: Phase II, multicenter, open-label, clinical trial of Trabectedin (Yondelis®) in Metastatic Breast Cancer Patients with triple negative profile (ER-, PR-, HER2-), HER2 overexpressing tumors and BRCA1 or BRCA2 mutation carriers

lead_sponsor: Pharma Mar, S.A.


title: Efficacy and safety of 2 mg/day M100907 on Sleep Maintenance Insomnia: a 6-week, multicenter, randomized, double-blind, placebo-controlled Polysomnographic study

acronym: Nocturne 907 (NPSG study of M100907)


title: Tolerability, Safety and Treatment Response of Flexible Doses of Paliperidone ER in Acutely Exacerbated Subjects With Schizophrenia

acronym: PERTAIN

lead_sponsor: Janssen-Cilag International NV, Turnhoutsweg 30, 2340 BEERSE, Belgium


title: The Effects of Fx-1006A on Transthyretin Stabilization and Clinical Outcome Measures in Patients with Non-V30M Transthyretin Amyloidosis

acronym: Not applicable

lead_sponsor: FoldRx Pharmaceuticals, Inc.


title: An Open-label (OL) Extension Study evaluating the Long-Term Safety of OxabactTM in Subjects with Primary Hyperoxaluria (PH) who participated in the Double-Blind (DB) Efficacy Study

acronym: Open label extension study to verify long term safety of OxabactTM , the Phoenix II study

lead_sponsor: OxThera, Inc.


title: A Phase III open-label titration trial to evaluate the effectiveness and safety of different doses of a dermal application of Testosterone MD-Lotion® (cutaneous solution) in hypogonadal men

lead_sponsor: Acrux Pharma Pty Ltd


title: A randomized, double-blind, placebo controlled, multi-centre phase IIb dose finding study to assess the effect on GERD symptoms, safety and tolerability during four weeks treatment with AZD3355 in doses 60 mg, 120 mg, 180 mg and 240 mg bid as add-on treatment to a PPI in patients with GERD that are partial responders to PPI treatment

lead_sponsor: AstraZeneca AB


title: A Multicentre, Double-Blind, Placebo-Controlled, Randomized Study of Etanercept in the Treatment of Adults Patients with Refractory Heel Enthesitis in Spondylarthropathy

lead_sponsor: Wyeth Pharmaceuticals France


title: A double-blind, randomised study comparing the safety and tolerance of SMOFlipid 20% and Intralipid 20% in long-term treatment with parenteral nutrition

lead_sponsor: Fresenius Kabi Deutschland GmbH


title: A Phase II Multicenter, Open-Label Study of YM155 in Refractory Diffuse Large B-Cell Lymphoma (DLBCL) Subjects

lead_sponsor: Astellas Pharma US, Inc.


title: An Open-Label Extension of Study Fx-005 Evaluating Long-Term Safety and Clinical Outcomes of Fx-1006A in Patients with Transthyretin Amyloid Polyneuropathy


title: A Phase IIa randomized, partially blinded trial of telaprevir (VX-950) in treatment-naïve subjects with chronic genotype 2 or 3 hepatitis C infection

lead_sponsor: Tibotec BVBA


title:
A Randomized, Double-Blind, Parallel, Three Arm, Multicenter, Phase II Trial Evaluating the Efficacy and Safety of Ipilimumab (BMS-734016) in Combination with Taxol®/Paraplatin® (Paclitaxel/Carboplatin) Compared to Taxol®/Paraplatin® Alone in Previously Untreated Subjects with Lung Cancer
 + Pharmacogenetics Blood Sample Amendment Number 01 - Site Specific, version 2.0 dated 20-Jul-07


title:
A Randomized, Multi-Dose, Open-Label, Phase II Study of BMS-663513 as a Second-Line Monotherapy in Subjects with Previously Treated Unresectable Stage III or Stage IV Melanoma.
 And Pharmacogenetics Blood Sample Amendment Number 01 - Site Specific (Version 1.0, Date 26-Nov-2007).


title: A Phase IIa, Double-blind, Randomised, Placebo-Controlled Dose Escalation Study to Evalulate the Safety, Tolerability, Pharmacokinetics and Activity of GS-9450, a Caspase Inhibitor, in Subjects with Chronic Hepatitis C

lead_sponsor: Gilead Sciences Incorporated


title: A Double-Blind, Randomized, Placebo-Controlled Multicenter Study Evaluating the Efficacy and Safety of two doses of Satavaptan (SR121463B) Versus Placebo in Patients with Dilutional Hyponatremia due to the Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH)

acronym: AQUARIST I

lead_sponsor: sanofi-aventis recherche et développement


title: Plasma Pharmacokinetics study of CD5024 1% cream in subjects with papulopustular rosacea

lead_sponsor: GALDERMA R&D SNC


title: A Phase 4, 8-Week, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy of Duloxetine 60 mg Once Daily in Outpatients with Major Depressive Disorder and Associated Painful Physical Symptoms

acronym: Etude HMGR

lead_sponsor: Eli Lilly and Company


title: Phase II Study of Dasatinib (BMS-354825) for Advanced ‘Triple-negative’ Breast Cancer + Pharmacogenetics Blood Sample Amendment Number 01 - Site Specific (version 2.0 dated 16-Aug-06) + Pharmacogenomics Tissue Sample Amendment Number 02 - Site Specific - (version 1.0 dated 16-Aug-06)

lead_sponsor: Bristol-Myers Squibb International Corporation


title:
A Sequential Adaptive Phase II/III Multi-Center, Randomized, Double-Blind, Placebo- Controlled Study to Evaluate the Efficacy and Safety of Abatacept Versus Placebo on a Background of Mycophenolate Mofetil and Glucocorticosteroids in Subjects with Active Proliferative Glomerulonephritis Due to Systemic Lupus Erythematosus (SLE).
 And Pharmacogenetics Blood Sample Amendment Number 1 - Site Specific (Version 2.0, Date 19-Jan-07).


title: A  Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Multi-center, International Study to Evaluate the Efficacy and Safety of Oxabact(TM) to Reduce Urinary Oxalate in Subjects with Primary Hyperoxaluria.

acronym: Study to see if Oxabact reduces urinary oxalate, the Phoenix study

lead_sponsor: OxThera Inc.


title: A 54 week, randomized, double-blind, parallel-group, multicenter study evaluating the long-term gastrointestinal (GI) safety and tolerability of aliskiren (300 mg) compared to ramipril (10 mg) in patients with essential hypertension

lead_sponsor: Novartis Pharma Services AG


title: An Open-label, Randomized Study of Subcutaneous and Intravenous VELCADE® in Subjects With Previously Treated Multiple Myeloma

lead_sponsor: Janssen-Cilag International NV (JCI)


title: A Randomized Phase 2 Study of Ixabepilone Plus Carboplatin and Paclitaxel Plus Carboplatin in Subjects With Advanced Non-Small Cell Lung Cancer


title: “A randomised, double-blind, placebo-controlled, parallel-group study of the efficacy and safety of two doses of ketoprofen (as lysinate) lozenges (6.25mg and 12.5mg ) in patients with sore throat”

acronym: KRYSTAL

lead_sponsor: SANOFI-AVENTIS GROUPE


title: A multi-center, double-masked study of the safety and efficacy of Travoprost APS compared to TRAVATAN in patients with open-angle glaucoma or ocular hypertension.

acronym: Efficacy study of Travoprost APS versus TRAVATAN

lead_sponsor: Alcon Research, Ltd.


title: A Study To Evaluate The Safety And Efficacy Of IPX066 In Advanced Parkinson’s Disease

lead_sponsor: Impax Laboratories, Inc.


title: A phase II, multinational, multicentre, double blind, double dummy, randomised, 5-way cross-over, placebo and active controlled clinical study to test the non-inferiority of a single dose of CHF 1535 (fixed combination of beclomethasone dipropionate 100 µg plus formoterol fumarate 6 µg dry powder) via NEXT™ DPI 1 or 4 inhalations versus CHF 1535 (beclomethasone dipropionate 100 µg plus formoterol fumarate 6 µg) pMDI with HFA-134a propellant 1 or 4 puffs on FEV1 AUC0-12h in partly controlled adult asthmatic patients

lead_sponsor: Chiesi Farmaceutici S.p.A.


title:
Phase II Study of Dasatinib (BMS-354825) for Advanced Estrogen/Progesterone Receptor-Positive or Her2/neu-Positive Breast Cancer
 + Pharmacogenetics Blood Sample Amendment Number 01 - Site Specific (version 1.0 dated 16-Aug-06) + Pharmacogenomics Tissue Sample Amendment Number 02 - Site Specific - (version 1.0 dated 16-Aug-06)


title: Clinical study to investigate the efficacy, the safety and immunogenicity of Wilate in children <6 years of age with inherited von Willebrand disease (VWD)

lead_sponsor: OCTAPHARMA AG


title: A Multicentre, Double-Blind, Placebo-Controlled, Randomized Study of Etanercept in the Treatment of Adults Patients with Active, Severe and Advanced Axial Ankylosing Spondylitis

lead_sponsor: Wyeth Pharmaceuticals France


title: Clinical study to evaluate the efficacity and safety of octagam®10% in idiopathic thrombocytopenic purpura in adults

lead_sponsor: Octapharma AG


title: A RANDOMIZED, DOUBLE BLIND, TWO ARM, PARALLEL, PLACEBO CONTROLLED STUDY OF RIMONABANT 20MG EFFECT ON HIGH DENSITY LIPOPROTEIN KINETICS IN PATIENTS WITH ABDOMINAL OBESITY AND ADDITIONAL CARDIOMETABOLIC RISK FACTORS

acronym: HDL TURNOVER

lead_sponsor: sanofi aventis Groupe


title: A 26-week, multinational, multi-centre, open-labelled, two-arm, parallel, randomised, treat-to-target trial comparing efficacy and safety of soluble insulin analogue combination (SIAC) once daily plus meal-time insulin aspart for the remaining meals vs. basal-bolus treatment with insulin detemir plus meal-time insulin aspart in subjects with type 1 diabetes

lead_sponsor: Novo Nordisk A/S


title: An open, randomised, parallel group, multicentre study to compare the efficacy and safety of FlutiForm pMDI vs Seretide pMDI in paediatric subjects with mild to moderate persistent, reversible asthma.

lead_sponsor: Mundipharma Research Ltd.


title: A MULTICENTER, OPEN LABEL SAFETY STUDY OF 2 DOSES OF PANTOPRAZOLE SODIUM ENTERIC-COATED SPHEROID SUSPENSION IN INFANTS AGED LESS THAN 12 MONTHS WITH PRESUMED GERD

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


title: A Phase II Study of PHA-739358 in Patients with Metastatic Hormone Refractory Prostate Cancer.

acronym: not available

lead_sponsor: Nerviano Medical Sciences S.r.l.


title: Randomized, double-blind, placebo-controlled add-on trial of the safety and efficacy of RO4917838 in outpatients on olanzapine, quetiapine, risperidone or paliperidone with prominent negative or disorganized thought symptoms

lead_sponsor: F.Hoffmann-La Roche Ltd


title: A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, COMPARATIVE STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF TIGECYCLINE VERSUS IMIPENEM/CILASTATIN FOR THE TREATMENT OF SUBJECTS WITH HOSPITAL-ACQUIRED PNEUMONIA

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


title: A PHASE 2 MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF MULTIPLE DOSES OF PF-04360365 IN PATIENTS WITH MILD TO MODERATE ALZHEIMER’S DISEASE.

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


title: A double blind, randomised, placebo controlled, parallel group study of Sativex® when added to the existing treatment regimen, in the relief of central neuropathic pain in subjects with multiple sclerosis.

lead_sponsor: GW Pharma Ltd


title: A 2-YEAR, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE 3 STUDY TO EVALUATE THE LONG-TERM EFFICACY AND SAFETY OF CP-945,598 IN THE TREATMENT OF OBESE SUBJECTS

lead_sponsor: Pfizer Inc.


title: A randomized, open-label, multi-center study of larotaxel at 90mg/m² or docetaxel every 3 weeks, alone or in combination with trastuzumab according to Her2neu status, administered after a combination regimen of anthracycline and cyclophosphamide as pre-operative therapy in patients with high risk localized breast cancer

acronym: SATIN

lead_sponsor: sanofi-aventis recherche & developpement


title: A multicenter, double-blind, parallel-group, placebo-controlled study of the effect on cognitive performance and safety/tolerability of SSR180711C, at the doses of 2, 8 and 20 mg/d for 4 weeks, using donepezil as calibrator, in patients with mild Alzheimer's Disease.

lead_sponsor: sanofi-aventis recherche & développement


title: A MULTICENTER, RANDOMIZED, OPEN LABEL, SINGLE AND MULTIPLE DOSE STUDY OF THE PHARMACOKINETICS AND PHARMACODYNAMICS OF 2 DOSE LEVELS OF  PANTOPRAZOLE SODIUM ENTERIC-COATED SPHEROID SUSPENSION IN INFANTS AGED 1 THROUGH 11 MONTHS WITH PRESUMED GERD.


title: A double-blind, randomized, placebo-controlled, study of the safety and activity of four escalating single doses of AVE0657 in patients suffering from Obstructive Sleep Apnea Hypopnea Syndrome


title: A 76-week prospective, open-label, multicenter study to evaluate the long-term effect of Exelon® capsule and transdermal patch on worsening of the underlying motor symptoms of PD in patients with mild to moderately severe dementia associated with Parkinson’s disease (PDD).

lead_sponsor: Novartis Pharma AG


title: A multicenter, Investigator-Masked, Parallel Group, Randomized, Study of the Efficacy and Safety of Indomethacin 0.1% Eyedrops Compared with Ketorolac 0.5% Eyedrops in the Ocular Inflammation After Cataract Surgery.

lead_sponsor: Bausch&Lomb Dr Gerhard Mann chem.-Fabrik GmbH


title: Multicenter, randomized, double-blind, placebo-controlled, Phase IIa study to evaluate the efficacy, safety, and tolerability of ACT-128800, an S1P1 receptor agonist, administered for 6 weeks to subjects with moderate to severe chronic plaque psoriasis

lead_sponsor: Actelion Pharmaceuticals Ltd


title: A randomised controlled parallel group open-label study to evaluate the efficacy and safety of intravenous ferric carboxymaltose versus no treatment in anaemic subjects with multiple myeloma and iron-restricted erythropoiesis receiving chemotherapy

lead_sponsor: Vifor Pharma Inc.


title: A 52 week randomised, controlled, open label, multicentre, multinational, parallel, treat-to-target trial comparing efficacy and safety of SIBA and insulin glargine both administered once daily in a basal-bolus regimen with insulin aspart as mealtime insulin in subjects with type 1 diabetes


title: A 6-Month, Single-Masked, Multicenter, Randomized, Controlled Study to Assess the Safety and Efficacy of 700 μg Dexamethasone Posterior Segment Drug Delivery System Applicator System as Adjunctive Therapy to Lucentis® Compared with Lucentis® Alone in the Treatment of Patients with Choroidal Neovascularization Secondary to Age-Related Macular Degeneration

lead_sponsor: Allergan Limited


title: Xenetix 350 : comparative assessment of image quality for coronary CT angiography

acronym: X-ACT study

lead_sponsor: GUERBET


title: A Double-Blind, Placebo-Controlled Study on the Effects of MIN-102 on Biochemical, Imaging, Neurophysiological, and Clinical Markers in Patients with Friedreich’s Ataxia

lead_sponsor: Minoryx Therapeutics BE, SA


title: An eight-week, double-blind, placebo-controlled study to evaluate the efficacy, safety, and tolerability of saredutant 100 mg once daily in combination with escitalopram 10 mg once daily in patients with major depressive disorder


title: Randomized parallel-group, multicentre study to evaluate the after-use sensation and safety of carteolol LA 2% versus timolol LA 0.5% in simple intra-ocular hypertension and glaucoma.


title: A PHASE 2 EFFICACY AND SAFETY STUDY OF SU011248 IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND BRAIN METASTASES

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


title:
A Multicenter, Double-Blind, Placebo-Controlled, Parallel Group, Randomized, Phase 2 Trial to Evaluate the Glycemic Efficacy, Renal Safety, Pharmacokinetics, and Pharmacodynamics of Dapagliflozin in Subjects with Type 2 Diabetes Mellitus and Moderate Renal Impairment Who Have Inadequate Glycemic Control.
 Revised Protocol 01, incorporating Protocol Amendment 02 (Version 1.0, Date 10-Apr-2008). And Pharmacogenetics Blood Sample Amendment 01 - Site specific (Version 2.0, Date 10-Mar-2008).

lead_sponsor: Bristol-Myers Squibb International Corporation


title: A randomized, double-blind, placebo-controlled, 2-arm parallel-group, multicenter study with a 24-week main treatment period and an extension assessing the efficacy and safety of AVE0010 on top of pioglitazone in patients with type 2 diabetes not adequately controlled with pioglitazone.

acronym: GETGOAL-P

lead_sponsor: Sanofi-Aventis Recherche & Développement


title: A Phase 1/2, Multiple-dose, Dose-escalation Study to Assess the Safety, Efficacy, and Pharmacokinetics of Intravenous CNTO 328, an Anti-interleukin 6 (IL-6) Monoclonal Antibody, in Subjects with Solid Tumors

lead_sponsor: Centocor B.V.


title: Effects of three oral dosages of S 44121 on cardiac arrhythmia during exercise testing in patients with catecholaminergic polymorphic ventricular tachycardia type 1. A 3-day, single-blind, international multicentre study.

lead_sponsor: Institut de Recherches Internationales Servier


title: A Multicenter Phase II Clinical Trial of Neoadjuvant Trabectedin (Yondelis®) in Patients with Localized Myxoid / Round Cell Liposarcoma

lead_sponsor: Pharma Mar, S.A.


title: Tadalafil 5 mg Once a Day Compared to Placebo in Improving Erectile Dysfunction  and Sexual Quality of Life

acronym: LVGH

lead_sponsor: Lilly ICOS LLC


title: A Phase 2 Double-Blind Randomized Study of Oral Enzastaurin HCl versus Placebo Concurrently with Pemetrexed (Alimta®) as Second Line Therapy in Patients with Advanced or Metastatic Non Small Cell Lung Cancer

lead_sponsor: Eli Lilly and Company limited


title: A Phase 4 Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Centre Study of Colesevelam as Add-on Therapy in Patients with Familial Hypercholesterolaemia

lead_sponsor: Genzyme Europe BV


title: A Phase Ib/II, open-label study of the safety, tolerability, and efficacy of trastuzumab-MCC-DM1 in combination with pertuzumab administered intravenously to patients with HER2-positive locally advanced or metastatic breast cancer who have progressed while receiving prior therapy

lead_sponsor: F. Hoffmann-la Roche Ltd


title: A Multicentre, Double-blind, Placebo-Controlled, Parallel Group Study of the Effect of Oral Etamsylate (Dicynone®) in Patients with Menorrhagia

acronym: Effects of Oral Etamsylate in Patients with Menorrhagia

lead_sponsor: OM PHARMA


title: Safety and Immunogenicity of an Intramuscular H5N1 Inactivated, Split Virion Influenza Vaccine Adjuvanted with AF03 in Adults and Elderly subjects

lead_sponsor: Sanofi Pasteur SA


title: A Phase 2 Study of Pembrolizumab (MK 3475) in Subjects with Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL)

acronym: A phase II study of pembrolizumab in subjects with relapsed or refractory PMBCL

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


title: A Phase 2 Clinical Study to Evaluate Daily Oral Doses of LY500307 for 24 weeks in Men with Lower Urinary Tract Symptoms (LUTS) and Prostatic Enlargement Secondary to Benign Prostatic Hyperplasia (BPH).

acronym: BPAE

lead_sponsor: Eli Lilly and Company Limited


title: A Randomized Open-Label Study to Evaluate the Safety and Efficacy of Denosumab and Ibandronate in Postmenopausal Women Sub-Optimally Treated with Daily or Weekly Bisphosphonates.

lead_sponsor: Amgen Inc


title: A double-blind, randomized, placebo-controlled, parallel-group, dose escalation trial to explore the potential antidyskinetic properties of safinamide in patients with Parkinson's disease suffering from levodopa induced dyskinesias.

lead_sponsor: Merck Serono S.A. - Geneva


title: Randomized Phase II study of Ixabepilone Plus Trastuzumab vs. Docetaxel Plus Trastuzumab in Female Subjects with Her2+ Locally Advanced and/or Metastatic Breast Cancer.


title: A Double-Blind, Randomized, Crossover Trial of CSII Reservoir In-use Comparing Insulin Lispro Formulation to Insulin Aspart in Patients with Type 1 Diabetes Mellitus

lead_sponsor: Eli Lilly and Company


title: A Randomized, Partially-blind Study to Evaluate the Safety, Tolerability and Effect on Virological Response of Treatment with the HCV Protease Inhibitor RO5190591 in combination with Pegasys and Copegus for 12 or 24 weeks, versus treatment with Pegasys and Copegus alone, in Treatment-Naïve Patients with Chronic Hepatitis C Genotype 1 Virus Infection

lead_sponsor: F.Hoffmann-La Roche


title: A Phase 2, Randomized, Open-Label trial of GS-9256 plus GS-9190 alone and in combination with Ribavirin for 28 days in Treatment Naive Subjects with Chronic Genotype 1 Hepatitis C Virus Infection.

lead_sponsor: Gilead Sciences Inc


title: A Randomized, 6-Week, Double-Blind, Placebo-controlled, Fixed-Flexible-Dose, Parallel-Group Study of Lurasidone in the Treatment of Bipolar I Depression

lead_sponsor: Dainippon Sumitomo Pharma America Inc.


title: A Phase 2a, 2-Part, Randomized, Double Blind, Placebo Controlled, Parallel Group, Multicenter Study of Telaprevir in Combination with Peginterferon Alfa 2a (Pegasys®) and Ribavirin (Copegus®) in Subjects who Have  Chronic HCV-1/HIV-1 Co-Infection and are Treatment-Naïve for Hepatitis C

lead_sponsor: Vertex Pharmaceuticals Incorporated


title: A Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dosage Study to Evaluate the Efficacy and Safety of Armodafinil Treatment (150 and 200 mg/day) as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder

lead_sponsor: Cephalon, Inc.


title: A Multicenter, Multinational, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Aerosolized ALN-RSV01 Plus Standard of Care in Lung Transplant Patients Infected with Respiratory Syncytial Virus (RSV)

lead_sponsor: Alnylam Pharmaceuticals, Inc.


title: Nemorubicin hydrochloride (PNU-152243A) administered via intrahepatic artery in combination with cisplatin in adult patients with unresectable hepatocellular carcinoma: Phase II study preceded by dose-escalation.

lead_sponsor: Nerviano Medical Sciences S.r.l.


title: A Multicenter, Randomized, Double-Blind, Placebo Controlled Study to Compare the Efficacy and Safety of Denosumab versus Placebo in Males with Low Bone Mineral Density


title: A Phase 2, Randomized, Double-blind, Placebo-controlled Study Evaluating the Safety and Efficacy of FOLFIRI in Combination With AMG 479 or AMG 655 Versus FOLFIRI for the Second-line Treatment of KRAS-mutant Metastatic Colorectal Carcinoma


title: A Phase 2/3, Placebo-Controlled, Efficacy and Safety Study of Once-Weekly, Subcutaneous LY2189265 Compared to Sitagliptin in Patients with Type 2 Diabetes Mellitus on Metformin

acronym: GBCF

lead_sponsor: Eli Lilly and Company - Indianapolis


title: A Randomized, Double Blind Study Evaluating Tenofovir Disoproxil Fumarate (DF) Monotherapy Versus the Combination of Emtricitabine and Tenofovir DF for the Treatment of Chronic Hepatitis B

lead_sponsor: Gilead Sciences Incorporated


title: A prospective multicentre phase II trial of zoledronic acid in patients with myelofibrosis with myeloid metaplasia (MMM)

lead_sponsor: University Hospital Leuven - Department of Haematology


title: Effectiveness of Somatostatin Analogues in Patients with hereditary hemorrhagic telangiectasia and symptomatic gastrointestinal bleeding, the SAIPAN-trial: a multicenter, randomized, open-label, parallelgroup, superiority trial.

acronym: SAIPAN-trial

lead_sponsor: Radboudumc


title: Phase 3 open-label study to evaluate efficacy, safety, and tolerability of FIX gene transfer with fidanacogene elaparvovec (PF-06838435) in pediatric male participants <18 years of age with moderately severe to severe hemophilia B (FIX:C≤2%) (BeneGene 3)

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


title: A Randomized, Double Blinded, Multi-Center Study 2 Study to Estimate the Efficacy and Evaluate the Safety and Tolerability of Sorafenib in Combination with AMG 386 or Placebo in Subjects with Metastatic Clear Cell Carcinoma of the Kidney

lead_sponsor: Amgen Inc.


title:
A Phase 1b Study Followed by an Open label, Parallel, Randomized Phase 2 Study Evaluating the Safety, Tolerability and Efficacy of GS-5829 in Combination with Exemestane or Fulvestrant Comparing
 with Exemestane or Fulvestrant Alone in Subjects with Advanced Estrogen Receptor Positive HER2- Breast Cancer

lead_sponsor: Gilead Sciences, Inc.


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

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

acronym: Glasdegib (PF-04449913)

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


title: Belatacept Conversion Trial in Renal Transplantation

lead_sponsor: Bristol-Myers Squibb International Corporation


title: A Phase 3, Multicenter, randomized, double-blind study evaluating the efficacy and safety of ABP 501 compared with Adalimumab in subjects with moderate to severe plaque psoriasis

lead_sponsor: Amgen Inc


title: Randomzied Phase 2 Trial of AG-013736 or Bevacizumab in Combination with Paclitaxel and Carboplatin as First Line Treatment For Patients with Advanced Non-small Cell Lung Cancer

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


title: A MULTICENTER OPEN LABEL PHASE II STUDY OF THE EFFICACY AND SAFETY OF AMG 479, A FULLY HUMAN MONOCLONAL ANTIBODY AGAINST INSULIN-LIKE GROWTH FACTOR TYPE 1 RECEPTOR (IGF-1R) AS SECOND LINE THERAPY IN PATIENTS WITH RECURRENT PLATINUMSENSITIVE OVARIAN CANCER

lead_sponsor: Cancer International research Group


title: A phase II, open label multicenter trial of panobinostat (LBH589) monotherapy in women with HER2 negative locally recurrent or metastatic breast cancer

lead_sponsor: Cancer International Research Group


title: An open-label randomized phase II trial of belinostat (PXD101) in combination with carboplatin and paclitaxel (BelCaP) compared to carboplatin and paclitaxel in patients with previously untreated carcinoma of unknown primary

acronym: BelCaP in CUP

lead_sponsor: TopoTarget A/S


title:
A PHASE II, MULTICENTER, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND STUDY OF MOXR0916 IN COMBINATION WITH
 ATEZOLIZUMAB VERSUS ATEZOLIZUMAB ALONE IN PATIENTS WITH UNTREATED LOCALLY ADVANCED OR METASTATIC UROTHELIAL CARCINOMA WHO ARE INELIGIBLE FOR CISPLATIN-BASED THERAPY

lead_sponsor: Genentech, Inc


title: Two Approaches to Escalate Lispro Therapy in Patients with Type 2 Diabetes Mellitus Not Achieving Adequate Glycemic Control on Basal Insulin Therapy and Oral Agents Alone

acronym: AUTONOMY

lead_sponsor: Eli Lilly and Company


title: A Phase 2, Open-Label, Single-Arm, Multidose Study to Investigate the Effects of Orteronel on the QT/QTc Interval in Patients With Metastatic Castration-Resistant Prostate Cancer

lead_sponsor: Millennium Pharmaceuticals, Inc.


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

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

lead_sponsor: GlaxoSmithKline Research & Development Ltd


title:
A Randomized-Controlled Three-arm Phase II Study of Lurbinectedin (PM01183) Alone or In Combination with Gemcitabine and a control arm with Docetaxel as Second-Line Treatment in Unresectable Non-Small Cell Lung Cancer (NSCLC) Patients.

 Étude de phase II, randomisée, contrôlée, à trois bras, comparant la lurbinectedine (PM01183) seule ou en association avec la gemcitabine  versus  docétaxel comme traitement de deuxième intention chez des patients atteints de cancer bronchique non à petites cellules (CBNPC) non résécable

acronym: Not applicable

lead_sponsor: Pharma Mar S.A. Sociedad Unipersonal


title: Safety and pharmacokinetics of ODM-207 in patients with selected advanced solid tumours: an open-label, non-randomised, uncontrolled, multicentre, first-in-human study  with cohort expansion

acronym: BETIDES

lead_sponsor: Orion Corporation Orion Pharma


title: A randomized, multicenter, open-label, Phase 2 study with a safety run-in part to evaluate safety, pharmacodynamics and efficacy of azacitidine compared to no anticancer treatment in children and young adults with acute myeloid leukemia in molecular relapse after first complete remission.

lead_sponsor: Celgene Corporation


title: A Phase II (BRF113710) single-arm, open-label study of GSK2118436 in previously treated BRAF mutant metastatic melanoma

lead_sponsor: GlaxoSmithKline Research & Development Limited


title: A European, randomised, double-blind, active comparator-controlled, cross-over, efficacy and safety study of a new 10% ready-to-use liquid human intravenous immunoglobulin (I10E) versus Kiovig® in patients with Multifocal Motor Neuropathy

lead_sponsor: LFB BIOTECHNOLOGIES


title:
AN OPEN-LABEL, EXPLORATORY, MULTICENTER, EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY, TOLERABILITY, PHARMACOKINETICS AND EFFICACY OF UCB5857 IN SUBJECTS WITH ACTIVATED PHOSPHOINOSITIDE 3 KINASE (PI3K) DELTA SYNDROME (APDS)

 ÉTUDE D’EXTENSION MULTICENTRIQUE, EXPLORATOIRE, OUVERTE, ÉVALUANT LA TOLÉRANCE À LONG TERME, LA SÉCURITÉ D’EMPLOI, LA PHARMACOCINÉTIQUE ET L’EFFICACITÉ DE L’UCB5857 CHEZ DES PATIENTS PRÉSENTANT UN SYNDROME DE PHOSPHO-INOSITIDE-3-KINASE (PI3K) DELTA ACTIVÉE (SYNDROME APDS)

lead_sponsor: UCB BioPharma SPRL


title: Efficacy and safety of the fixed oral low-dose perindopril arginine 3.5 mg/amlodipine 2.5 mg combination compared with each component (perindopril arginine 3.5 mg and amlodipine 2.5 mg) and with perindopril arginine 5 mg and amlodipine 5 mg. Randomized, double-blind, placebo-controlled study over 8 weeks in hypertensive patients.

lead_sponsor: Institut de Recherches Internationales Servier


title: A Phase II, multicentre, double-blind, randomized, dose range finding placebo controlled study of Rifaximin- EIR tablet: clinical effectiveness and tolerability in the treatment of moderate, active Crohn’s disease

lead_sponsor: Alfa Wassermann S.p.A.


title: PHASE II OPEN-LABEL SAFETY EXTENSION STUDY OF TANEZUMAB IN CANCER PATIENTS WITH PAIN DUE TO BONE METASTASES

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


title: Multicentre, controlled, randomized, investigator-blinded, comparative study of oral  Mesalazine 4g per day Once daily versus 4g per day in Two divided doses  in patients with active Ulcerative colitiS

acronym: MOTUS

lead_sponsor: Ferring SAS


title: RENAL SAFETY EVALUATION AFTER DOTAREM-ENHANCED  MRA COMPARED WITH NON-ENHANCED MRI IN PATIENTS AT HIGH RISK OF DEVELOPING CONTRAST MEDIUM INDUCED NEPHROPATHY.

lead_sponsor: GUERBET


title: Randomised, double-blind, placebo-controlled dose-effect study of V0114 (2.5, 5, 7.5 and 10 mg) versus mequitazine 10 mg and placebo in the treatment of seasonal allergic rhinitis.

lead_sponsor: PIERRE FABRE MEDICAMENT


title: A Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) in Advanced Parkinson’s Disease

lead_sponsor: Impax Laboratories, Inc., acting through its Impax Pharmaceuticals Division (Impax)


title: MULTICENTER PHASE 2 TRIAL OF ARQ 197 FOR SUBJECTS WITH RELAPSED OR REFRACTORY GERM CELL TUMORS

lead_sponsor: Daiichi Sankyo Pharma Development


title:
Intralesional steroids injections to prevent refractory  strictures in patients with esophageal atresia - a randomized controlled tiral

 Injections intralésionnelles de stéroides pour prévenir les sténoses réfractiares chez les patients atteints d'atrésie de l'oesophage - essai controlé randomisé

acronym: STEPS-EA

lead_sponsor: Erasmus Universitu Medical Center - Sophia Children's Hospital


title: Preoperative chemoradiotherapy and postoperative chemotherapy with capecitabine and oxaliplatin vs. capecitabine alone in locally advanced rectal cancer (PETACC-6)

lead_sponsor: EORTC


title: A comparison of ipratropium bromide/salbutamol delivered by the Respimat inhaler to COMBIVENT Inhalation Aerosol and ipratropium bromide delivered by the Respimat in a 12-week, double-blind, safety and efficacy study in adults with chronic obstructive pulmonary disease

acronym: Safety&Efficacy of Comb. Respimat  COPD

lead_sponsor: Boehringer Ingelheim France


title: A multicenter, double-blind, randomized, placebo-controlled study to evaluate the efficacy, safety and tolerability of AVE5530 when added to ongoing stable statin therapy at high doses in patients with severe primary hypercholesterolemia

lead_sponsor: Sanofi-Aventis Recherche & Développement


title: RANDOMIZED MULTICENTER PHASE III STUDY IN PATIENTS WITH LOCALLY ADVANCED ADENOCARCINOMA OF THE PANCREAS: GEMCITABINE WITH OR WITHOUT CHEMORADIOTHERAPY AND WITH OR WITHOUT ERLOTINIB

acronym: LAP 07

lead_sponsor: GERCOR


title:
A Phase 3b, Open-Label, Single Arm, Multi-Centre Study to Assess the Safety and Efficacy of Pegvaliase (BMN 165) Treatment in adults With Phenylketonuria Not Controlled With Current Management

 Étude de phase 3b, en ouvert, à un seul bras, multicentrique visant à évaluer l’innocuité et l’efficacité du traitement par Pegvaliase (BMN 165) chez des adultes atteints de phénylcétonurie non contrôlée par la prise en charge actuelle

acronym: OPTIC Study

lead_sponsor: BioMarin Pharmaceutical Inc.

status: Not Authorised


title: PHASE I-II STUDY OF VINBLASTINE IN COMBINATION WITH NILOTINIB IN CHILDREN, ADOLESCENTS, AND YOUNG ADULTS WITH REFRACTORY OR RECURRENT LOW-GRADE GLIOMA

acronym: Vinilo

lead_sponsor: Institut de cancérologie Gustave Roussy


title:
A Non-Interventional Study to Monitor the Survival Status of
 Patients that Discontinued from ISIS 420915-CS2 or
 ISIS 420915-CS3

 Étude non interventionnelle visant à surveiller le statut de survie des patients ayant quitté l'étude ISIS 420915-CS2 ou ISIS 420915-CS3

lead_sponsor: Ionis Pharmaceuticals, Inc.


title: A Phase 3 Study Evaluating Gene Therapy by Transplantation of Autologous CD34+ Stem Cells Transduced Ex Vivo with the LentiGlobin BB305 Lentiviral Vector in Subjects with Sickle Cell Disease.

lead_sponsor: bluebird bio, Inc.


title: A 24-WEEK MULTICENTRE, RANDOMISED, DOUBLE BLIND, CONTROLLED, PARALLEL GROUP NON-INFERIORITY STUDY TO ASSESS THE EFFICACY AND SAFETY OF OLMESARTAN MEDOXOMIL VERSUS CANDESARTAN CILEXETIL IN PATIENTS WITH SYMPTOMATIC HEART FAILURE (NYHA II-IV)

acronym: OLMEBNP

lead_sponsor: DAIICHI SANKYO EUROPE GmbH


title: A randomized phase II, open-label multicenter trial of panobinostat monotherapy in women with HER2 positive locally recurrent or metastatic breast cancer

lead_sponsor: Cancer International Research Group


title: A PHASE Ib/II, OPEN-LABEL, MULTICENTER STUDY OF THE SAFETY, PHARMACOKINETICS, AND EFFICACY OF Apo2L/TRAIL ADMINISTERED INTRAVENOUSLY IN COMBINATION WITH RITUXIMAB TO SUBJECTS WITH FOLLICULAR AND OTHER LOW-GRADE, CD20+, B-CELL NON-HODGKIN’S LYMPHOMAS THAT HAVE PROGRESSED FOLLOWING PREVIOUS RITUXIMAB THERAPY

lead_sponsor: Genentech Inc.


title: Essai multicentrique prospectif randomisé en double aveugle et en groupes parallèles, destiné à évaluer les effets de doses ascendantes de BF2.649 et de BF2.649 combiné à du modafinil dans le traitement de la cataplexie chez des patients narcoleptiques

acronym: Harmony II

lead_sponsor: Bioprojet


title: Essai multicentrique prospectif randomisé en double aveugle contre placebo et en groupes parallèles, destiné à évaluer les effets du BF2.649 dans le traitement de la somnolence diurne excessive associée à une narcolepsie

acronym: Harmony I


title: A Randomized, Double blind, Placebo-Controlled Dose Escalation Study to Investigate the Safety and Pharmacokinetics after Single and Multiple Doses of SLV334 in Sequential Cohorts of Patients with Moderate and Severe Traumatic Brain Injury

lead_sponsor: Solvay Pharmaceuticals B.V.


title: Clinical study to evaluate the efficacy, safety and kinetics of Octagam® 10% for replacement therapy in Primary Immunodeficiency Diseases (PID)

lead_sponsor: Octapharma AG


title: A 12-week, randomized, double-blind, placebo-controlled, parallel-group. fixed-dosage study to evaluate the efficacy and safety of armodafinil (50, 150, and 250 mg/day) as treatment for patients with excessive sleepiness associated with mild or moderate closed traumatic brain injury

lead_sponsor: Cephalon Inc.


title: A Double-Blind, Randomized, Placebo-Controlled, Phase 2 Study of Enzastaurin with 5 FU/LV plus Bevacizumab as Maintenance Regimen Following First Line Therapy for Metastatic Colorectal Cancer

lead_sponsor: Eli Lilly and Company limited


title: AN EXPLORATIVE PHASE IIa STUDY TO ASSESS SAFETY, TOLERABILITY, PHARMACODYNAMICS AND PHARMACOKINETICS OF VAS203 IN PATIENTS WITH MODERATE AND SEVERE TRAUMATIC BRAIN INJURY

lead_sponsor: vasopharm GmbH


title: Prospective, Open-label, Non-controlled, Multicenter, Phase III Clinical Study to Evaluate the Efficacy and Safety of Immunoglobulin Intravenous (Human) 10% (NEWGAM) in Primary Immune Thrombocytopenia


title:
Phase 1/2 Study Of Intratumoral G100 With Or Without Pembrolizumab In Patients With Follicular Non-Hodgkin’s Lymphoma

 Étude de Phase I/II sur le G100 en injection intratumorale avec ou sans le pembrolizumab chez des patients porteurs de lymphome non hodgkinien folliculaire

lead_sponsor: Immune Design Ltd


title: A randomised, double-blind, double-dummy, placebo-controlled, parallel-group study to assess and compare efficacy and safety of an 8-week treatment with BI 54903 at doses of 45.5, 90.9 and 181.8 μg b.i.d. administered via Respimat® inhaler and fluticasone propionate HFA MDI 220 μg b.i.d. in patients with asthma inadequately controlled on low dose ICS therapy.

lead_sponsor: Boehringer Ingelheim Pharma GmbH & Co. KG,


title: An open label, prospective, multicenter trial, on the effect of anti-TNF alpha Chimeric monoclonal antibody (Infliximab, Remicade) on the inflammatory and fibrous lesions in patients with intestinal Crohn's Disease.

lead_sponsor: CHRU de Lille


title: A Phase I/II randomised therapeutic HIV vaccine trial in individuals who started antiretrovirals during primary or chronic infection.

lead_sponsor: Inserm-ANRS


title: A MULTICENTER, OPEN-LABEL PHARMACOKINETIC, PHARMACODYNAMIC, CLINICAL SYMPTOMS, AND SAFETY STUDY OF PANTOPRAZOLE DELAYED-RELEASED GRANULES ADMINISTERED AS A SUSPENSION IN NEONATES AND PRETERM INFANTS WITH A CLINICAL DIAGNOSIS OF GASTROESOPHAGEAL REFLUX DISEASE

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


title: A double-blind, double-dummy, randomized, parallel groups study to assess the Efficacy, Safety and Tolerability of switching patients with early Parkinson’s disease (PD) from Pramipexole IR to Pramipexole ER or Pramipexole IR.

lead_sponsor: BOEHRINGER INGELHEIM


title: An Exploratory, Multi-center, Open-Label, Single-Arm study to evaluate the Discontinuation Effect of Clopidogrel After Drug Eluting Stent (DECADES) on Inflammatory and Platelet Activation Markers in Subjects Who Are Receiving Low Dose Acetylsalicylic Acid (ASA).

acronym: DECADES

lead_sponsor: Bristol Myers Squibb International Corporation


title: A Multi-Centre, Randomized, Double-Blind, Placebo-Controlled, Repeat-Dose study to evaluate the Efficacy and Safety of Intravenous GSK679586 in Patients with Severe Asthma

lead_sponsor: GlaxoSmithKline Research and Development Ltd


title: A RANDOMIZED, PARTIALLY-BLINDED, MULTI-CENTER, ACTIVE-CONTROLLED, DOSE RANGING STUDY ASSESSING THE SAFETY, EFFICACY, AND PHARMACODYNAMICS OF THE REG1 ANTICOAGULATION SYSTEM COMPARED TO UNFRACTIONATED HEPARIN OR LOW MOLECULAR HEPARIN IN SUBJECTS WITH ACUTE CORONARY SYNDROME

acronym: RADAR

lead_sponsor: Regado Biosciences, Inc


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

lead_sponsor: Novartis Pharma AG


title: A Placebo-Controlled, Single-Blind, Single-Center Phase 1 Study in Normal Healthy Volunteers and Open-Label Multi Center Study in Patients with Primary Hyperoxaluria to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Doses of DCR PHXC Solution for Injection (subcutaneous use)

acronym: 2-part study of DCR-PHXC in NHV and PH patients

lead_sponsor: Dicerna Pharmaceuticals Inc


title: Rituximab as second line treatment for ITP: A Multicentre, Randomized, Double blind, Placebo-controlled, Phase III study. “The RITP study”

acronym: RITP study

lead_sponsor: Rikshospitalet


title: A double-blind, randomized phase II study of once daily versus twice daily PTK787/ZK 222584 treatment in patients with advanced, previously treated metastatic adenocarcinoma of the colon or rectum

acronym: Comparison of once daily versus twice daily administration of PTK787/ZK 222584 in mCRC

lead_sponsor: Schering AG


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

lead_sponsor: Boehringer Ingelheim France SAS


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

acronym: REST

lead_sponsor: sanofi-aventis recherche & développement


title: A double-blind, randomized, placebo-controlled, study evaluating the safety and activity of four escalating single doses of AVE0657 in congestive heart failure patients presenting as Cheyne-Stokes Breathing Syndrome


title: Phase 1b/2, Multicenter, Open-label Study of Carfilzomib, Carboplatin, and Etoposide in Subjects with Previously Untreated Extensive-stage Small-cell Lung Cancer

lead_sponsor: Onyx Therapeutics, Inc.


title: Multicenter, randomized, open label study evaluating an anti Insulin-like Growth Factor-1 Receptor (IGF-1R/CD221) monoclonal antibody, AVE1642, administered every 4 weeks in combination with fulvestrant (Faslodex®) in postmenopausal patients with advanced hormono-dependent breast cancer

lead_sponsor: sanofi-aventis recherche et développement


title: A multicentre, multinational, randomised, double-blind, placebo-controlled, 3-arm, 24-week parallel-group study to evaluate the safety, tolerability and preliminary efficacy of ORY-2001 in patients with mild-moderate Alzheimer's Disease. ETHERAL Study

acronym: ETHERAL

lead_sponsor: Oryzon Genomics S.A.


title: Phase I/II gene transfer clinical trial of rAAV9.CMV.hNAGLU for Mucopolysaccharidosis (MPS) IIIB

lead_sponsor: Abeona Therapeutics Europe SL.


title: A multi-center open label extension study of HGT-1111 (Recombinant Human Arylsulfatase A or rhASA) treatment in patients with Late Infantile Metachromatic Leukodystrophy (MLD)

lead_sponsor: Shire Human Genetic Therapies Inc


title:
A RANDOMISED, SINGLE-BLIND, ACTIVE CONTROLLED, MULTI-CENTRE TRIAL TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY, ACCEPTABILITY AND PALATABILITY OF PMF104 COMPARED TO A CONVENTIONAL PEG-ELECTROLYTE SOLUTION IN CHILDREN  AGED FROM 2 TO LESS THAN 6, FROM 6 TO LESS THAN 12 AND ADOLESCENTS FROM 12 TO LESS THAN 18 YEARS OF AGE REQUIRING A DIAGNOSTIC PROCEDURE CONCERNING THE COLON (EMA Decision P/019/2017 on the acceptance of modification of Paediatric Investigation Plan)

 Essai multicentrique, randomisé, en simple aveugle, contrôlé par substance active, visant à évaluer l’efficacité, la sécurité d’emploi, la tolérance, l’acceptabilité et la palatabilité du PMF104 par comparaison à une solution électrolytique conventionnelle contenant du PEG, chez des enfants âgés de 2 ans à moins de 6 ans, de 6 ans à moins de 12 ans et chez des adolescents âgés de 12 ans à moins de 18 ans, devant subir une procédure à visée diagnostique concernant le côlon  (Décision de l’EMA P/019/2017 relative à l’approbation de modification du Plan d’Investigation Pédiatrique)

lead_sponsor: Alfa Wassermann S.p.A.


title:
A Phase 3, Randomized, Double-Blind, Vehicle-Controlled Study to Evaluate the Efficacy and Safety of Maintenance Treatment and Flare Reduction with Crisaborole Ointment, 2%, Once Daily Over 52 Weeks in Pediatric and Adult Participants (Ages 2 Years and Older) with Mild-to-Moderate Atopic Dermatitis, who Responded to Twice Daily Crisaborole Ointment, 2%, Treatment

 Étude de phase 3, randomisée, en double aveugle, contrôlée par placébo, évaluant l’efficacité et la tolérance du traitement d’entretien et de la réduction des poussées par crisaborole, pommade à 2 %, une fois par jour pendant 52 semaines chez l’adulte et l’enfant (à partir de 2 ans) présentant une dermatite atopique légère à modérée, ayant répondu au traitement deux fois par jour par crisaborole, pommade à 2 %

acronym: CrisADe Control

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


title: Effect of an octenidine-based topical antimicrobial agent (Octenisept) on wound healing of chronic venous leg ulcers: a prospective, twelve week comparison versus local treatment with Ringer solution. A randomised, double-blind, controlled, parallel-group, multicentre, multinational Phase IIIb study

lead_sponsor: Schülke & Mayr GmbH


title: A Human Clinical Trial to Evaluate the Safety and Clinical Utility of GEM OS1 as a Bone Regeneration System in Foot and Ankle Arthrodesis Procedures

lead_sponsor: BioMimetic Therapeutics, Inc


title: Open-label, Dose escalation, followed by Double-blind, Randomized, Two-dose, Parallel Group, Multi-center Clinical Trial of HuMax-CD4, a Fully Human Monoclonal Anti-CD4 Antibody, in Patients with Mycosis Fungoides type CTCL (stage IB-IVB) who are Refractory or Intolerant to Targretin® (bexarotene) and one other Standard Therapy

acronym: HuMax-CD4 in Refractory Mycosis Fungoides

lead_sponsor: Genmab A/S


title: A Double-Masked, Placebo-Controlled, Multi-Centre, Parallel Group, Dose-Ranging Study to Assess the Efficacy and Safety of LX211 as Therapy in Subjects with Clinically Quiescent Sight Threatening, Non-Infectious Intermediate-, Anterior and Intermediate-, Posterior-, or Pan-Uveitis.

lead_sponsor: Lux Biosciences GmbH


title: A Double-Masked, Placebo-Controlled, Parallel Group, Multi-Centre, Dose-Ranging Study to Assess the Efficacy and Safety of LX211 as Therapy in Subjects with Active Sight Threatening, Non-Infectious Anterior Uveitis.


title: A Double-Masked, Placebo-Controlled, Parallel-Group, Multi-Center, Dose-Ranging Study to Assess the Efficacy and Safety of LX211 as Therapy in Subjects with Active Sight Threatening, Non-Infectious Intermediate-, Anterior and Intermediate-, Posterior-, or Pan-Uveitis.


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

lead_sponsor: Kenta Biotech Ltd


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

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


title: A Randomized, Open-Label Study Comparing the Effectiveness of Olanzapine Pamoate Depot with Haloperidol Decanoate in the Treatment of Schizophrenia

acronym: HGMT

lead_sponsor: Eli Lilly and Company Limited


title: A Multi-Center, Placebo-Controlled, Double-Blind Trial To Examine the Safety and Efficacy of ACP-103 in the Treatment of Psychosis in Parkinson's Disease

lead_sponsor: Acadia Pharmaceuticals Inc


title: A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Dose Study of R935788 in Patients with Rheumatoid Arthritis Who Have Failed at Least One Biologic

lead_sponsor: Rigel Pharmaceuticals, Inc.


title: A Phase 3, Open-label, Multicenter, Prospective, Randomized Study of the Efficacy and Safety of Conversion from Prograf® Capsules Twice Daily to LCP-Tacro™ Tablets Once Daily for the Prevention of Acute Allograft Rejection in Stable Kidney Transplant Patients

lead_sponsor: LifeCycle Pharma A/S


title: A phase 2B, randomised, double-blind, placebo-controlled, parallel group, multi-centre study to investigate the efficacy, mechanism of action, pharmacokinetics, safety and tolerability of the mGluR5 negative allosteric modulator ADX10059 as monotherapy in patients with Gastroesophageal Reflux Disease (GERD)

lead_sponsor: Addex Pharma SA


title: A phase 2B, randomised, double-blind, placebo-controlled, parallel group, dose-ranging, multi-centre study to investigate the efficacy, safety and tolerability of the mGluR5 negative allosteric modulator ADX10059 in patients with Gastroesophageal Reflux Disease (GERD) who are partial responders to proton pump inhibitor (PPI) treatment.


title: A Multi-Centre, Randomized, Placebo-controlled, Parallel-Group, double-Blinded Study to Compare the Therapeutic Efficacy, Safety and Tolerability of 3 Single Vaginal Doses of Arasertaconazole Nitrate pessaries in the Treatment of Vulvovaginal Candidiasis

lead_sponsor: Ferrer Internacional, S.A


title: SELECT-2: Phase 2B, Partially Blinded, Randomized Study In Treatment Naïve Subjects With HCV Genotype 1 To Compare The Efficacy, Safety, And Tolerability Of Three Doses of Locteron™ Plus Ribavirin Given Bi-weekly In Comparison With PEG-Intron™ Plus Ribavirin Given Weekly

lead_sponsor: Biolex Therapeutics Inc.


title: A multi-center, randomized, double-blind, controlled dose-finding study to evaluate the safety and efficacy of MP4OX treatment plus standard of care in severely injured trauma patients with lactic acidosis due to hemorrhagic shock

lead_sponsor: Sangart, Inc.


title: A Phase IIa randomised, double-blind, placebo controlled, parallel group,  multicentre study evaluating the efficacy, safety, tolerability and pharmacokinetics of AZD1386 after 3 weeks of treatment in patients with Posttraumatic Neuralgia (PTN) and Postherpetic Neuralgia (PHN)

lead_sponsor: AstraZeneca AB


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

acronym: General anaesthesia with xenon

lead_sponsor: AIR LIQUIDE


title: A phase III randomized study evaluating surgery of residual disease in patients with metastatic gastro-intestinal stromal tumor responding to Imatinib mesylate.

lead_sponsor: European Organization for Research and Treatment of Cancer


title:
A phase I/II multi-center study of HDM201 added to chemotherapy in adult subjects with relapsed/refractory (R/R) or newly diagnosed acute myeloid leukemia (AML)

 Etude de phase I/II, multicentrique, évaluant HDM201 associé à un traitement par chimiothérapie chez des patients adultes atteints de leucémie aiguë myéloïde (LAM) en rechute ou réfractaire (R/R) ou nouvellement diagnostiquée

lead_sponsor: Novartis Pharma AG


title: A Phase IIa, open-label, dose-titration, multicentre study to assess the safety and preliminary efficacy of NI-0401 in patients with acute cellular renal allograftt rejection

lead_sponsor: NovImmune S.A.


title: A randomized, prospective, double-blind, placebo-controlled, group sequential multicenter study to assess efficacy, safety, and tolerability of the pediatric formulation of bosentan in children with pulmonary arterial hypertension

acronym: FUTURE 5

lead_sponsor: Actelion pharmaceuticals Ltd


title: An Open-label, International, Multi-Center, Phase I/II, Dose-escalation Trial Investigating the Safety of Zalutumumab, a Human Monoclonal Epidermal Growth Factor Receptor Antibody in Combination with Radiotherapy, in Patients with Stage III, IVa or IVb Locally Advanced Squamous Cell Carcinoma of the Head and Neck Ineligible for Platinum based Chemotherapy

acronym: Zalutumumab in combination with radiotherapy in SCCHN patients ineligible for platinum based chemoth

lead_sponsor: Genmab A/S


title: A Randomized, Rater-Blinded Study to Explore the Effect of  Mefloquine in Subjects with Progressive Multifocal Leukoencephalopathy (PML)

lead_sponsor: Biogen Idec Ltd


title:
A Phase 2, Open-Label, Single-Arm, Multi-Center Study of AL101 in Patients With Adenoid Cystic Carcinoma (ACC) Bearing Activating Notch Mutations

 Étude de phase 2 multicentrique ouverte à un seul bras visant à évaluer l’AL101 chez des patients atteints de carcinome adénoïde kystique (CAK) présentant des mutations activant la voie Notch

acronym: ACCURACY Study

lead_sponsor: Ayala Pharmaceuticals, Inc.


title:
Treatment of High Grade Non-Muscle Invasive Urothelial Carcinoma of the Bladder by Standard Number and Dose of  Intravesical BCG Instillations Versus Reduced Number of Intravesical Instillations with Standard Dose of BCG.  A European Association of Urology Research Foundation Randomised Phase III Clinical Trial.

 Etude randomisée comparant le traitement standard de 15 instillations par BCG thérapie à un traitement allégé de 9 instillations chez les patients porteurs d’une tumeur de vessie n'infiltrant pas le muscle. Etude NIMBUS

acronym: NIMBUS

lead_sponsor: EAU Foundation for Urological Research


title: A phase I-II, randomized, observer-blind, placebo-controlled, dose escalation study to evaluate the safety and immune responses of various doses of Neovacs’ IFNα-Kinoid in adult patients with Systemic Lupus Erythematosus.

acronym: IFN-Kinoid in Systemic Lupus Erythematosus

lead_sponsor: Neovacs SA


title: Phase I/II dose-escalation study of oral administration of the Pan-Histone Deacetylase (HDAC) Inhibitor S 78454 in Hodgkin’s Disease, non-Hodgkin Lymphoma and Chronic Lymphocytic Leukaemia

lead_sponsor: Institut de Recherches Internationales Servier


title:
A Randomized, Double-Blinded, Placebo-Controlled, Multicenter, Phase II Study to Evaluate Senaparib Maintenance in mCRPC Patients with Homologous Recombination Repair Gene Alterations after Docetaxel Treatment

 Étude multicentrique de phase II, randomisée, en double aveugle, contrôlée contre placebo évaluant un traitement d’entretien par senaparib après un traitement par docétaxel chez des patients atteints de CPRCm avec altérations des gènes impliqués dans la réparation par recombinaison homologue

lead_sponsor: IMPACT Therapeutics, Inc.


title: A Phase II Study of Pembrolizumab Monotherapy in Third-line Previously Treated Subjects with Advanced/Metastatic Adenocarcinoma or Squamous Cell Carcinoma of the Esophagus or Advanced/Metastatic Siewert Type I Adenocarcinoma of the Esophagogastric Junction (KEYNOTE -180)

acronym: Study of Pembrolizumab in Previously Treated Subjects with Advanced/Metastatic Adenocarcinoma

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


title: INTERVENTIONAL, NON-BLINDED, RANDOMIZED CONTROLLED MULTICENTER STUDY OF POSACONAZOLE PROPHYLAXIS FOR THE PREVENTION OF INFLUENZA-ASSOCIATED ASPERGILLOSIS (IAA) IN CRITICALLY ILL PATIENTS

acronym: POSA-FLU

lead_sponsor: UZ Leuven


title:
Randomized, Double-Blind, Placebo Controlled, Phase 3 Trial of Beloranib in Obese Subjects with Prader-Willi Syndrome to Evaluate Food-related Behavior, Total Body Weight, and Safety Over 52 Weeks

 Essai de phase III randomisé, en double aveugle et contrôlé contre placebo, du béloranib chez les patients obèses présentant le syndrome de Prader-Willi, visant à évaluer le comportement alimentaire, le poids corporel total et l’innocuité pendant 52 semaines

acronym: bestPWS|EU

lead_sponsor: Zafgen Inc.


title: A MULTICENTER, OPEN-LABEL STUDY TO EVALUATE THE SAFETY AND EFFICACY OF ONCE DAILY ORAL VADADUSTAT FOR THE TREATMENT OF PEDIATRIC SUBJECTS WITH ANEMIA OF CHRONIC KIDNEY DISEASE NAÏVE TO ERYTHROPOIESIS-STIMULATING AGENTS

lead_sponsor: Akebia Therapeutics, Inc.


title: A Phase 3 Randomized, Double-Blind, Placebo- and Oxycodone-Controlled, Multicenter Study of the Efficacy and Safety of Tanezumab in Patients with Osteoarthritis of the Knee or Hip

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


title: A Randomised, Placebo-controlled, Double-blind, Multicentre Efficacy and Safety Study of LJPC-501 in Paediatric Patients > 2 to 17 Years of Age with Catecholamine-Resistant Hypotension Associated with Distributive Shock

lead_sponsor: La Jolla Pharmaceutical Company


title: A Phase 1b/2 study of AMG 655 Combination with Paclitaxel and Carboplatin for the First-Line Treatment of Advanced Non-Small Cell Lung Cancer

lead_sponsor: Amgen Inc


title: A 10-week randomised, double-blind, parallel-group, placebo-controlled phase 2 study to investigate the extent of symptom relief and the safety and tolerability of SMP-986 (20 mg, 40 mg, 80 mg and 120 mg) administered once daily for 8 weeks to patients with overactive bladder syndrome

acronym: SMP-986 phase 2 proof of concept in patients with OABS

lead_sponsor: Dainippon Sumitomo Pharma Europe Ltd.


title: A single-blind, placebo-controlled, multicentre study evaluating continued long-term treatment with satavaptan (SR121463B) in patients with ascites due to liver cirrhosis who have previously been treated in studies LTS5634 or LTS5635.

lead_sponsor: sanofi-aventis recherche et développement


title: A Phase III, Multicenter, Randomized, Controlled, Double-Masked Trial of NOVA22007 (Ciclosporin 0.1%) Ophthalmic Cationic Emulsion versus Vehicle in Patients with Moderate to Severe Dry Eye Syndrome

acronym: SICCANOVE

lead_sponsor: Novagali Pharma S.A.


title: A multi-centre, multinational, open-label single-dose acute hemodynamic study followed by a multi-centre, multinational, randomized, double-blind, parallel-group, placebo controlled study to assess the safety, tolerability, pharmacokinetics and preliminary efficacy (proof-of-concept) of NS-304 in the treatment of pulmonary arterial hypertension in subjects aged 18 years and over

lead_sponsor: Nippon Shinyaku Co., LTD


title: A Phase III, Multicentre, Randomised, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Subcutaneous Bioresorbable CUV1647 Implants in Patients with Erythropoietic Protoporphyria (EPP)

acronym: Multicentre Phase III EPP Study

lead_sponsor: Clinuvel Pharmaceuticals Limited


title: A Study of INT-747 (6-ECDCA) in Combination with Ursodeoxycholic Acid (URSO®, UDCA) in Patients with Primary Biliary Cirrhosis

lead_sponsor: Intercept Pharmaceuticals


title: A Randomized, Double-blind, Multi-center Phase III Study of Brivanib plus Best Supportive Care (BSC) versus Placebo plus BSC in Subjects with Advanced Hepatocellular Carcinoma (HCC) who have Failed or are Intolerant to Sorafenib: The BRISK Study

acronym: BRISK study

lead_sponsor: Bristol Myers Squibb International Corporation


title: A Phase IIa, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Sequential Cohorts, Dose Range Finding Study to Evaluate the Safety, Tolerability and Clinical Effect of Escalating Doses of Laquinimod in Active Moderate to Severe Crohn’s Disease

lead_sponsor: Teva Pharmaceutical Industries Ltd.


title: CONCERT: A Phase 3 Multicenter, Randomized, Placebo-Controlled, Double-Blind Twelve-Month Safety and Efficacy Study Evaluating Dimebon in Patients with Mild-to-Moderate Alzheimer’s Disease on Donepezil

acronym: CONCERT

lead_sponsor: Medivation, Inc.


title: Initiation of agomelatine after antidepressant treatment by SSRI or SNRI in outpatients suffering Major Depressive Disorder. A 3-week, randomised, double then single-blind, controlled, parallel groups, international, multicentre safety study with a 5-week open extension period.

lead_sponsor: Institut de Recherches Internationales Servier


title: A Multicenter, Randomized, Double-Blind, Parallel Group, Placebo- Controlled, Phase III, Efficacy and Safety Study of 3 Fixed Dose Groups of TC-5214 (S-mecamylamine) as an Adjunct to an Antidepressant in Patients with Major Depressive Disorder Who Exhibit an Inadequate Response to Antidepressant Therapy

lead_sponsor: AstraZeneca AB


title: An Open-Label Extension Study of Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Rheumatoid Arthritis

lead_sponsor: Eli Lilly and Company


title: A Phase II, Open-label, 1:1 Randomized, Controlled Trial Exploring the Efficacy of EMD 1201081 in Combination with Cetuximab in Second-Line Cetuximab-Naïve Subjects with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (R/M SCCHN)

acronym: EMD 1201081 in Cetuximab-Naïve Subjects with R/M SCCHN

lead_sponsor: Merck KGaA