title: A Multicenter, Randomized, Double-Blind, Monotherapy-Controlled Study of Nifedipine Gastrointestinal Therapeutic System and Candesartan Cilexetil in Combination Taken Orally for 8 Weeks in Adult Subjects with Essential Hypertension Who Are Inadequately Controlled on 16 mg Candesartan Cilexetil Monotherapy


title: A Randomised Phase III Study of Elacytarabine vs. Investigator’s Choice in Patients with Late Stage Acute Myeloid Leukaemia

source: euctr

lead_sponsor: Clavis Pharma

study_type: Interventional

status: Ongoing

lead_sponsor_type: industriel

status_simplified: Ongoing


title: An open-label, multicentre, randomised phase II study of pazopanib in combination with pemetrexed in first-line treatment of subjects with predominantly non-squamous cell stage IIIBwet/IV non-small cell lung cancer

lead_sponsor: GlaxoSmithKline R&D Limited

status: Completed

status_simplified: Completed


title: A Phase IIb, Randomized, Placebo-Controlled, Dose-Range Finding Clinical Trial to Study the Safety and Efficacy of MK-3102 in Patients with Type 2 Diabetes Mellitus and Inadequate Glycemic Control

lead_sponsor: Merck & Co., Inc.


title: "A Two-Part, Adaptive, Randomized Trial of Ridaforolimus in Combination with Dalotuzumab Compared to Exemestane or Compared to Ridaforolimus or Dalotuzumab Monotherapy in Estrogen Receptor Positive Breast Cancer Patients"


title: A Randomized, Multicenter, Phase III Study Comparing the Combination of  Pazopanib and Lapatinib versus Lapatinib Monotherapy in Patients with ErbB2 over-expressing Inflammatory Breast Cancer

lead_sponsor: GlaxoSmithkline Research & Development Limited


title:
Assessment of Anatomical and Functional Outcomes in Patients Treated with Ocriplasmin for Vitreomacular Traction/Symptomatic Vitreomacular Adhesion
 (VMT/sVMA)

lead_sponsor: Alcon Research, Ltd.


title: Randomized, 16-Week, Multi-Phase, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Fulranumab as Monotherapy in Subjects with Signs and Symptoms of Osteoarthritis of the Hip or Knee

lead_sponsor: Janssen-Cilag International N.V.


title: A Parallel-Group, Double-Blind, Long Term Safety and Efficacy Trial of MK-8931 (SCH 900931) in Subjects with Amnestic Mild Cognitive Impairment Due to Alzheimer’s Disease (Prodromal AD).

acronym: A Long Term Safety and Efficacy Trial of MK-8931 (SCH 900931) in Subjects with Prodromal AD (APECS)

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


title: Phase III (Phase V Program), Open-Label, Randomized, Referred- Care-Controlled, Clinical Trial to Evaluate the Efficacy and Safety of MK-0217A/Alendronate Sodium 70 mg/Vitamin D3 5600 I.U. Combination Tablet on Vitamin D Inadequacy in the Treatment of Osteoporosis in Postmenopausal Women

lead_sponsor: Laboratoires Merck Sharp & Dohme - Chibret


title: Inhibitor Development in Previously Untreated Patients (PUPs) or Minimally Blood Component-Treated Patients (MBCTPs) when Exposed to plasma-derived von Willebrand Factor-Containing Factor VIII (VWF/FVIII) Concentrates and to Recombinant Factor VIII (rFVIII) Concentrates: An Independent, International, Multicentre, Prospective, Controlled, Randomised, Open Label, Clinical Trial.

acronym: SIPPET

lead_sponsor: FONDAZIONE CENTRO EMOFILIA E TROMBOSI ANGELO BIANCHI BONOMI


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


title: A Phase III Multicenter, Double-Blind, Randomized, Active Comparator-Controlled Clinical Trial to Study the Safety and Efficacy of Once Daily Raltegravir (MK-0518) Versus Twice Daily Raltegravir, Each in Combination With TRUVADA™, in Treatment-Naïve HIV Infected Patients

lead_sponsor: Laboratoires Merck Sharp & Dhome-Chibret


title: An open-label, multicenter, expanded access study of imatinib mesylate in adult patients with GIST in adjuvant setting after R0-resection

lead_sponsor: Novartis Pharma GmbH


title: A multicenter, randomized, double-blind study of dacarbazine with or without Genasense in chemotherapy naïve subjects with advanced melanoma and low LDH (The AGENDA Trial)

lead_sponsor: Genta Incorporated


title: Randomised controlled trial evaluating strategies to optimize disease activity control in RA patients treated with infliximab in clinical practice.

lead_sponsor: Integrated Therapeutics Group, Inc. - A subsidiary of Schering-Plough Corp.


title: A 12-month randomized, double-masked, controlled, multicenter, phase II study assessing safety and efficacy of verteporfin (Visudyne®) photodynamic therapy administered in conjunction with Lucentis™ versus Lucentis™ monotherapy in patients with subfoveal choroidal neovascularization secondary to age-related macular degeneration

acronym: MONT BLANC

lead_sponsor: Novartis Pharma Services AG

status: Prematurely Ended

status_simplified: Unknown


title: A Phase II Study of MK-0457 in Patients With BCR-ABL T315I Mutant Chronic Myelogenous Leukemia and Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia


title: A Multicenter, Randomized, Double-Blind, Parallel Group, 12-Week Study to Evaluate the Efficacy and Safety of Extended-Release (ER) Niacin/Laropiprant Added to Statin Versus Doubling the Dose of Statin in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia.

acronym: Extended Release Niacin/Laropiprant – Lipids


title: A 76-Week, Worldwide, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Assess the Tolerability and Efficacy of Anacetrapib When Added to Ongoing Therapy With a Statin in Patients With Coronary Heart Disease (CHD) or CHD Risk-Equivalent Disease


title: A Phase IIb/III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Dose- Range Finding Clinical Trial of MK-0941 in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Insulin

lead_sponsor: Laboratoires Merck Sharp & Dohme-Chibret


title: A Multicenter Study of the Efficacy and Safety of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects with Peripheral Spondyloarthritis

lead_sponsor: Abbott GmbH & Co. KG


title: A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency.

lead_sponsor: BioPartners GmbH


title: A Phase III, Multicenter, Randomized, Double-Blind Clinical Trial to Study  the Safety and Efficacy of the Addition of Sitagliptin (MK-0431) to Patients with Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Insulin Therapy (Alone or In Combination with Metformin)


title: A European Phase III, Multicentre, Double-blind, Randomised, Placebo-Controlled Monotherapy Study of Milnacipran for the Treatment of the Fibromyalgia Syndrome.

acronym: FMS Europe

lead_sponsor: Pierre Fabre Medicament


title: A Phase III, Randomized, Double-blinded, Parallel Group, Multi-centre Study to Assess the Efficacy and Safety of ZD6474 (ZACTIMA™) in Combination with Pemetrexed (Alimta®) versus Pemetrexed alone in Patients with Locally-Advanced or Metastatic (stage IIIB or IV) Non-Small Cell Lung Cancer (NSCLC) after Failure of 1st Line Anti-cancer Therapy

lead_sponsor: AstraZeneca AB


title: A Multicenter, Randomized, Controlled, Two-Arm, Phase III Study to Evaluate the Safety and Efficacy of MK-3475 Compared to Ipilimumab in Patients with Advanced Melanoma

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


title: A phase II, multicenter, randomized, double-masked, 4 parallel arms, controlled 6-month trial designed to evaluate the safety and efficacy of PAD ciclosporin (CsA 0.06% and 0.03%) ophthalmic dispersion administered once daily in combination with lubricant therapy and a 3-month post-treatment safety follow-up in moderate to severe dry eye patients

lead_sponsor: DRUG DELIVERY SOLUTIONS ApS (PART OF MC2 BIOTEK GROUP)


title: A randomized, multi center, parallel group, double-blind, placebo and formoterol controlled 14 day dose ranging trial 4 doses of indacaterol delivered via  Twisthaler®, in patients with COPD.


title: A Multicenter, Double-Blind, Placebo-Controlled, Parallel Group Multiple Attacks Study to Compare the Efficacy and Safety of Oral MK-0974 With Placebo for the Acute Treatment of Migraine With or Without Aura


title: Two-arm, randomized, open-label, phase IIIb study investigating the safety of a 3 hour i.p. infusion of catumaxomab with and without prednisolone premedication in patients with malignant ascites due to epithelial cancer

acronym: CASIMAS

lead_sponsor: Fresenius Biotech GmbH


title: A Phase III, Multicentre, Randomised, Placebo-Controlled, Double Blind Study of the Incidence of Recurring Pulmonary Exacerbations in Cystic Fibrosis Patients using Two Different Doses of Inhaled Nacystelyn®

lead_sponsor: Laboratoires SMB S.A.


title: A PROSPECTIVE, RANDOMIZED TRIAL COMPARING THE SAFETY, TOLERABILITY, AND EFFICACY OF VORICONAZOLE AND ANIDULAFUNGIN IN COMBINATION TO THAT OF VORICONAZOLE ALONE WHEN USED FOR PRIMARY THERAPY OF INVASIVE ASPERGILLOSIS IN PEDIATRIC SUBJECTS AGED 2 TO 17 YEARS

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


title: An open-label, multi-center, expanded access study of RAD001 in patients with subependymal giant cell astrocytomas (SEGA) associated with tuberous sclerosis complex (TSC). The EFFECTS STUDY: Everolimus For Fast Expanded aCcess in TSC SEGA

acronym: EFFECTS STUDY


title: A prospective, multicenter, randomized, double-blind, placebo-controlled, 2-parallel group, phase 3 study to compare efficacy and safety of masitinib 9 mg/kg/day in combination with bortezomib and dexamethazone to placebo in combination with bortezomib and dexamethazone in the treatment of patients with relapsing multiple myeloma who received one previous therapy

lead_sponsor: AB Science


title:
A prospective, multicenter, randomized, double blind, placebo-controlled, 2-parallel groups, phase 3 study to compare the efficacy and safety of masitinib in combination with FOLFIRI (irinotecan, 5-fluorouracil and folinic acid) to placebo in combination with FOLFIRI in second line treatment of patients with metastatic colorectal cancer

 Etude de phase 3, prospective, multicentrique, randomisée, en double aveugle, contrôlée, avec 2 groupes parallèles, visant à comparer l’efficacité et la tolérance de masitinib en association avec FOLFIRI (irinotecan, 5-fluorouracil et acide folinique) versus placebo en association avec FOLFIRI, chez des patients atteint d’un cancer colorectal métastatique en 2ème ligne de traitement


title: A Non-Randomized, Open-Label Study to Evaluate the Pharmacokinetics, Safety, and Efficacy of ReFacto AF in Previously Treated Pediatric Subjects Less Than Twelve Years of Age With Severe Hemophilia A (FVIII:C <1%)

lead_sponsor: Wyeth Pharmaceuticals Inc. Acting through its division Wyeth Research, a Pfizer Company


title:
Phase III Randomized Clinical Trial of Lurbinectedin (PM01183) versus Pegylated Liposomal Doxorubicin or Topotecan in Patients with Platinum-resistant Ovarian Cancer (CORAIL Trial)

 Étude clinique de phase III, randomisée, comparant la lurbinectédine (PM01183) à la doxorubicine liposomale pégylée ou au topotécan chez des patientes présentant un cancer de l’ovaire résistant au platine (Etude CORAIL)

acronym:
CORAIL Trial

 Etude CORAIL

lead_sponsor: Pharma Mar S.A., Sociedad Unipersonal


title:
Apixaban for the treatment of venous thromboembolism in patients with cancer: a prospective randomized open blinded end point (PROBE) study- the CARAVAGGIO study.

 APIXABAN POUR LE TRAITEMENT DE LA THROMBOEMBOLIE VEINEUSE CHEZ LES PATIENTS CANCÉREUX : UNE ÉTUDE PROSPECTIVE ALÉATOIRE AVEC CRITÈRE À L'INSU (PROBE) - ÉTUDE CARAVAGGIO

acronym:
CARAVAGGIO

 CARAVAGGIO

lead_sponsor: FONDAZIONE FADOI


title: A Long-term Follow-up of Study 64041575RSV2004 to Evaluate the Impact of Lumicitabine (JNJ-64041575) on the Incidence of Asthma and/or Wheezing in Infants and Children with a History of Respiratory Syncytial Virus Infection

acronym: PLUM Follow-up

lead_sponsor: Janssen-Cilag International NV


title:
A Phase 3, Randomized, Double-blind Study of Duvelisib Administered in Combination with Rituximab and Bendamustine vs Placebo Administered in Combination with Rituximab and Bendamustine in Subjects with Previously-Treated Indolent Non-Hodgkin Lymphoma

 Etude de phase 3, randomisée, en double aveugle comparant le duvelisib administré en association avec du rituximab et de la bendamustine contre placebo administré en association avec du rituximab et de la bendamustine chez des patients atteints de lymphome non hodgkinien indolent antérieurement traité

lead_sponsor: Infinity Pharmaceuticals, Inc.


title: Efficacy and tolerance of the emollient cream V0034 CR in the symptomatic treatment of ichthyosis in children. International, multicentric, randomised, controlled, double blind study, in parallel groups V0034 CR versus vehicle.

lead_sponsor: PIERRE FABRE MEDICAMENT


title: A double-blind, randomized, placebo-controlled, parallel group study of rimonabant 20 mg daily for the treatment of non-diabetic patients with nonalcoholic steatohepatitis (NASH)

lead_sponsor: sanofi-aventis Recherche & D2veloppement

status: Suspended by CA


title: A Phase 2 Study to Evaluate Dose and Duration of Treatment of Drotrecogin Alfa (Activated) Using Serial Measurements of Protein C in Patients with Severe Sepsis and Multiple Organ Dysfunction

acronym: RESPOND

lead_sponsor: Eli Lilly & Company Limited


title: A Prospective Randomized Open-label 6-Month Head-To-Head Trial to Compare Metabolic Effects of Paliperidone ER and Olanzapine in Subjects With Schizophrenia

lead_sponsor: Janssen-Cilag International NV,Turnhoutseweg 30, 2340 Beerse, Belgium


title: A 24-week, multicenter, multinational, randomized, double-blind, triple-dummy, 3-arm parallel group study comparing the efficacy and safety of CHF 1535 200/6 (beclomethasone dipropionate 200 μg plus formoterol 6 μg/actuation), 2 puffs b.i.d., versus beclomethasone diproprionate HFA (250 μg/actuation), 4 puffs b.i.d., versus Seretide® 500/50 (fluticasone 500 μg plus salmeterol 50 μg/actuation), 1 inhalation b.i.d., in patients with severe asthma

lead_sponsor: CHIESI FARMACEUTICI S.p.A.


title: ENABLE 1 (Eltrombopag to INitiate and Maintain Interferon Antiviral Treatment to Benefit Subjects with Hepatitis C related Liver DiseasE) Randomised, placebo-controlled, multi-centre study to assess the efficacy and safety of eltrombopag in thrombocytopenic subjects with hepatitis C virus (HCV) infection who are otherwise eligible to initiate antiviral therapy (peginterferon alfa-2a plus ribavirin)

acronym: ENABLE 1

lead_sponsor: GlaxoSmithKline Research & Development Ltd


title: A phase III study to compare SonoVue®  enhanced myocardial echocardiography (MCE) to single photon emission computerized tomography (ECG-GATED SPECT), at rest and at peak of low-dose Dipyridamole stress test, in the assessment of significant coronary artery disease (CAD) in patients with suspect or known CAD using Coronary Angiography as Gold Standard

acronym: SonoVue MCE vs SPECT

lead_sponsor: Bracco Imaging S.p.A.


title: A randomised, double-blind, placebo- and active comparator-controlled, five parallel groups study to investigate the efficacy and safety of BI 44370 TA (50 mg, 200 mg, and 400 mg) administered orally once during an acute migraine attack of moderate or severe intensity

lead_sponsor: Boehringer Ingelheim France


title: Safety and Efficacy of Exenatide Once Weekly Injection versus Metformin, Dipeptidyl  Peptidase-4 Inhibitor, or Thiazolidinedione as Monotherapy in Drug-Naive Patients with Type 2 Diabetes

acronym: GWCH

lead_sponsor: Eli Lilly and Company


title: A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension

lead_sponsor: United Therapeutics Corporation


title: Randomized Study of LAROTAXEL + Cisplatin (LC) vs. Gemcitabine + Cisplatin (GC) in the First Line Treatment of Locally Advanced/Metastatic Urothelial Tract or Bladder Cancer

acronym: CILAB

lead_sponsor: Sanofi-Aventis Recherche et Développement


title: A Phase III, Multicentre, Open Label, Flexible dose, Long term Safety Study of MCI-196 in Chronic Kidney Disease Stage V Subjects on Dialysis with Hyperphosphataemia (incorporating a Comparison with Sevelamer).

lead_sponsor: Mitsubishi Pharma Corporation


title: A phase IV, open-label, multi-centre trial evaluating the conversion from standard phosphate binder therapy to Fosrenol in chronic kidney disease stage 5 patients on haemodialysis

lead_sponsor: Shire Pharmaceutical Development Ltd


title: A double-blind, multicenter, international randomised study to assess the effects of 6 months or 12 months  administration of 2g per day of strontium ranelate versus alendronate 70mg per week on bone remodelling and bone safety assessed by histomorphometry in women with postmenopausal osteoporosis

lead_sponsor: Institut de Recherches Internationales Servier


title: A 16-Week International, Multicenter, Double-Blind,  Randomized, Placebo Controlled  Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Combination with an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 Inhibitor in Subjects with Pulmonary Arterial Hypertension

acronym: FREEDOM-C


title: A PHASE 2 RANDOMIZED, MULTICENTER, ACTIVE COMPARATOR-CONTROLLED TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF COADMINISTRATION OF CP-690,550 AND MYCOPHENOLATE MOFETIL / MYCOPHENOLATE SODIUM IN DE NOVO KIDNEY ALLOGRAFT RECIPIENTS

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


title: Open-Label Extension Study to Assess the Safety of a Fixed Dose of Subcutaneous Methylnaltrexone in Subjects With Advanced Illness and Opioid-Induced Constipation

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


title: A RANDOMISED, DOUBLE-BLIND, ADD-ON STUDY OF HYDROCHLOROTHIAZIDE IN SUBJECTS WITH MODERATE TO SEVERE HYPERTENSION NOT ACHIEVING TARGET BLOOD PRESSURE ON OLMESARTAN MEDOXOMIL/AMLODIPINE FIXED DOSE COMBINATION 40/10 MG ALONE

lead_sponsor: DAIICHI SANKYO EUROPE GmbH


title: An evaluation of the Ocular Surface Health in Subjects Using DuoTrav APS Eye Drops Solution Versus XALACOM® EYE Drops Solution

lead_sponsor: Alcon Research, Ltd.


title: An Open-Label, Flexible-Dose Study of Retigabine Immediate Release (IR) as Adjunctive Therapy to Specified Monotherapy Antiepileptic Treatments in Adults with Partial-Onset Seizures.

lead_sponsor: GlaxoSmithKline Research & Development Limited


title: A Randomized, Double-Blind, Parallel-Group, Comparative Study of Flexible Doses of Paliperidone Palmitate and Flexible Doses of Risperidone Long-Acting Intramuscular Injection in Subjects with Schizophrenia

lead_sponsor: Janssen-Cilag International N.V.


title: Multicenter, double-blind, randomized, placebo-controlled, parallel-group study to assess the efficacy, safety and tolerability of tezosentan in patients with pre-operative pulmonary hypertension, due to left heart disease, undergoing cardiac surgery

lead_sponsor: Actelion Pharmaceuticals Ltd


title: A 3 Month, Randomised, Open Label, Parallel Group, Descriptive Study to Explore and Compare Perceptions and Satisfaction for Two Different Delivery Mechanisms for Etanercept (Etanercept Autoinjector and the Etanercept Prefilled Syringe) in Patients with Psoriasis.

lead_sponsor: Wyeth Pharmaceuticals France


title: A Randomized Phase 3 Study of Pemetrexed in Combination with Cisplatin Versus Cisplatin Monotherapy in Patients with Recurrent or Metastatic Head and Neck Cancer

acronym: Spinnaker

lead_sponsor: Eli Lilly and Company limited


title: A four-arm randomised, double-blind, placebo-controlled, multicentre Phase II study to evaluate the safety, tolerability and efficacy as assessed by frequent MRI measures of three doses of atacicept monotherapy in subjects with relapsing multiple sclerosis (RMS) over a 36 weeks treatment course.

acronym: Atacicept frequent MRI study in RMS

lead_sponsor: Merck Serono International S.A.


title: A 12-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate the Efficacy and Safety of Adjunctive Aripiprazole Therapy in the Treatment of Mania in Bipolar I Disorder Patients Treated with Valproate or Lithium and in Need of Further Clinical Improvement.

lead_sponsor: Bristol Myers Squibb International Corporation


title: A Randomized, Double-Blind, Placebo-Controlled Study of a Fixed Dose of Subcutaneous Methylnaltrexone in Adults With Advanced Illness and Opioid-Induced Constipation: Efficacy, Safety, and Additional Health Outcomes


title: A multicenter, randomized, open label,  active-comparator  controlled study to assess the efficacy, safety and tolerability of taspoglutide (RO5073031) compared to exenatide in patients with type 2 diabetes mellitus inadequately controlled with metformin,  thiazolidinedione or a combination of both

lead_sponsor: F. Hoffmann-La Roche Ltd.


title: A Phase II Study of Lapatinib plus Topotecan or Lapatinib plus Capecitabine in the Treatment of Recurrent Brain Metastases from ErbB2-Positive Breast Cancer Following Cranial Radiotherapy

lead_sponsor: GlaxoSmithKline Research & Development Ltd.


title: A Randomized, Double-Blind, Placebo-Controlled, Dose-finding Study to Evaluate the Efficacy and Safety of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic Fibrosis

lead_sponsor: AOP Orphan Pharmaceuticals AG


title: Double-Blind, Parallel-Group Comparison of 23 mg Donepezil Sustained Release to 10 mg Donepezil Immediate Release in Patients with Moderate to Severe Alzheimer’s Disease

lead_sponsor: Eisai Ltd


title: A phase II, multicentre, randomised, assessor.blinded, active-comparator, parallel-group dose finding trial to evaluate AS900672-Enriched versus follitropin alfa (GONAL-f) in oligo-anovulatory infertile women undergoing ovulation induction (OI)

acronym: AS900672-Enriched Phase II in OI

lead_sponsor: Merck Serono SA International


title: Efficacy and Safety of Quadruple Therapy by Bismuth Subcitrate Potassium, Metronidazole, and Tetracycline Given x 10 days With Omeprazole in Eradication of Helicobacter pylori: A Comparison to Omeprazole, Amoxicillin and Clarithromycin Given x 7 days

lead_sponsor: Axcan Pharma Inc.


title: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF PROPHYLACTIC USE OF MARIBAVIR VERSUS ORAL GANCICLOVIR FOR THE PREVENTION OF CYTOMEGALOVIRUS DISEASE IN RECEIPIENTS OF ORTHOTOPIC LIVER TRANSPLANTS

lead_sponsor: ViroPharma Incorporated


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

lead_sponsor: Bristol-Myers Squibb International Corporation


title: An open-label, randomized, multicenter, parallel group study to demonstrate correction of anemia using once monthly subcutaneous injections of RO0503821 in patients with chronic kidney disease who are not on dialysis

lead_sponsor: F. Hoffmann-La Roche Ltd


title: A Phase 3, Randomized, Double-blind, Active-controlled, Parallel-group, Multi-center Study to Evaluate the Safety and Efficacy of Apixaban in Subjects Undergoing Elective Total Hip Replacement Surgery


title: D1532C00016: A Phase II, Double-Blind, Randomised, Placebo-Controlled Study to Assess the Efficacy of AZD6244 (Hyd-Sulfate) in Combination with Docetaxel, Compared with Docetaxel Alone, in 2nd Line Patients with KRAS Mutation Positive Locally Advanced or Metastatic Non Small Cell Lung Cancer (Stage IIIB - IV)

lead_sponsor: AstraZeneca AB


title: An open-label, multi-center, 24-month extension study to evaluate the safety of ranibizumab as symptomatic treatment for visual impairment due to diabetic macular edema in patients who have completed the RESTORE trial

acronym: RESTORE EXTENSION

lead_sponsor: Novartis Pharma Services AG


title: Safety and Efficacy of Exenatide Once Weekly versus Liraglutide in subjects with type 2 diabetes and inadequate glycemic control treated with lifestyle modification and oral antidiabetic medications

acronym: GWDE

lead_sponsor: Eli Lilly and Company


title: A Randomized, Double-blind, Parallel-group, Multicenter Study to Evaluate the Retention Rate, Efficacy, Safety, and Tolerability of Carisbamate, Topiramate and Levetiracetam as Adjunctive Therapy in Subjects with Partial Onset Seizures

acronym: CaReS (Carisbamate Retention Study)

lead_sponsor: Ortho-McNeil Janssen Scientific Affairs, LLC


title: A randomised, double-blind, parallel-group, placebo-controlled, duloxetine-referenced, fixed-dose study evaluating the efficacy and safety of three dosages of Lu AA21004, in acute treatment of Major Depressive Disorder.

acronym: Not applicable

lead_sponsor: H. Lundbeck A/S


title: EFFICACY AND SAFETY OF ESLICARBAZEPINE ACETATE (BIA 2 093) AS THERAPY FOR PATIENTS WITH POST-HERPETIC NEURALGIA: A DOUBLE-BLIND, DOUBLE-DUMMY, RANDOMISED, PLACEBO-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL TRIAL

lead_sponsor: BIAL - Portela & Ca, S.A.


title: A Phase IV multicentre, randomised, double-blind, placebo controlled, trial to evaluate the safety and efficacy of Raptiva ® in the treatment of subjects with moderate to severe plaque psoriasis involving hands and/or feet, with or without pustules.

acronym: TRUST study: Raptiva ® in hands & foot psoriasis

lead_sponsor: Merck Serono International SA


title: Calcipotriol Plus Hydrocortisone in Psoriasis Vulgaris on the Face and on the Intertriginous Areas.  A phase 3 study comparing an ointment containing calcipotriol 25 mcg/g plus hydrocortisone 10 mg/g (LEO 80190 ointment) with calcipotriol 25 mcg/g in the ointment vehicle, hydrocortisone 10 mg/g in the ointment vehicle and the ointment vehicle alone, all applied once daily in the treatment of psoriasis vulgaris on the face and on the intertriginous areas, followed by a 52-week safety study in patients with psoriasis vulgaris on the face and on the intertriginous areas.

lead_sponsor: LEO Pharma A/S


title: A Phase 2/3, Multicenter, Double-Blind, Randomized, Controlled Study of Recombinant Human Bone Morphogenetic Protein-2 (rhBMP 2)/Calcium Phosphate Matrix (CPM) in Closed Diaphyseal Tibial Fractures

lead_sponsor: Wyeth Pharmaceuticals Inc.


title: A Randomised, Double-Blind, Placebo-Controlled Trial Assessing the Efficacy and Safety of Dutasteride (AVODART™) 0.5 mg in Extending the Time to PSA Doubling in Men with Prostate Cancer and Biochemical Failure (PSA increase) after Radical Therapy with Curative Intent (ARTS – AVODART after Radical Therapy for prostate cancer Study)

acronym: ARTS

lead_sponsor: GlaxoSmithKline Research and Development Ltd


title: A Phase II study of Tarceva® in Combination with Avastin® versus chemotherapy plus Avastin® in 1st line advanced NSCLC patients

lead_sponsor: F. Hoffmann-La Roche


title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Dose-Response Study to Evaluate Efficacy and Safety of Prolonged Release (PR) OROS® methylphenidate (54 and 72 mg/day) in Adults with Attention Deficit/Hyperactivity Disorder.

acronym: Lamda 2

lead_sponsor: Janssen-Cilag International N.V., Turnhoutseweg 30, B-2340 Beerse, Belgium


title: A long-term, open-label, flexible-dose, extension study evaluating the safety and tolerability of Lu AA21004 in patients with Major Depressive Disorder


title: A double blind, randomized, placebo controlled, parallel group dose range exploration study of Sativex® in relieving pain in patients with advanced cancer, who experience inadequate analgesia during optimized chronic opioid therapy.

lead_sponsor: GW Pharma Ltd.


title: An Open-Label, Randomized, Phase 3 Study of Inotuzumab Ozogamicin (CMC-544) Administered in Combination With Rituximab Compared to a Defined Investigator’s Choice Therapy in Subjects With Relapsed or Refractory, CD22- Positive, Follicular B-Cell Non Hodgkin’s Lymphoma

lead_sponsor: Wyeth Research Division of Wyeth Pharmaceuticals Inc


title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study Evaluating the Efficacy and Safety of IPI-504 in Patients with Metastatic and/or Unresectable Gastrointestinal Stromal Tumors Following Failure of at Least Imatinib and Sunitinib

lead_sponsor: Infinity Pharmaceuticals, Inc.


title: PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF CP-690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATE WITH INADEQUATE RESPONSE TO TNF INHIBITORS

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


title: Randomised, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the MRI Efficacy and the Safety of Six Months' Administration of Firategrast (150 – 1200mg twice daily) in Subjects with Relapsing-Remitting Multiple Sclerosis

lead_sponsor: GlaxoSmithKline Research & Development Ltd


title: A multicenter, randomized, double blind, parallel-group placebo and pramipexole controlled study to assess efficacy and safety of SLV308 monotherapy in the treatment of patients with early stage Parkinson’s disease.

acronym: The Vermeer study

lead_sponsor: Solvay pharmaceuticals


title: A Randomized, Controlled, Open-Label Study of the Long-Term Impact on Functioning using Atomoxetine Hydrochloride Compared to Other Early Standard Care in the Treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in Treatment-Naïve Children and Adolescents. (ADHD-LIFE Study)

acronym: (ADHD-LIFE Study)


title: An open-label, randomized, multi-center, parallel group non-inferiority study of subcutaneous injections of RO0503821 given once monthly  vs. darbepoetin alfa given according to local label in patients with chronic kidney disease who are not on dialysis

lead_sponsor: F. Hoffmann-La Roche Ltd


title: Randomized, Double-Blind, Active- and Placebo-Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Multiple Doses of CG5503 Immediate Release Formulation in the Treatment of Acute Pain From Total Hip Replacement Surgery Followed by a Voluntary Open-Label Extension

lead_sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.


title: Open-label extension study in patients with Idiopathic Pulmonary Fibrosis who completed protocol AC-052-321 / BUILD 3

lead_sponsor: Actelion Pharmaceuticals Ltd


title: A randomized, double-masked, multicenter, laser-controlled Phase III study assessing the efficacy and safety of ranibizumab (intravitreal injections) as adjunctive and mono-therapy in patients with visual impairment due to diabetic macular edema

acronym: RESTORE

lead_sponsor: Novartis Pharma Services AG


title: A randomized, double-blind, placebo-controlled, Phase III trial of 2 regimens of telaprevir (with and without delayed start) combined with pegylated interferon alfa-2a (Pegasys®) and ribavirin (Copegus®) in subjects with chronic genotype 1 hepatitis C infection who failed prior pegylated interferon plus ribavirin treatment.

acronym: REALIZE

lead_sponsor: Tibotec BVBA


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

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


title: A Clinical Safety and Efficacy Comparison of NEVANAC® 0.1% to Vehicle  Following Cataract Surgery in Diabetic Retinopathy Patients

acronym: Macular Edema Incidence/Severity Reduction with NEVANAC®

lead_sponsor: ALCON RESEARCH, LTD.


title: A phase IV prospective, multicentre, randomized, open-label trial to assess the efficacy and safety of GONAL f® at a dose based on subject baseline characteristics determined according to the CONSORT calculator compared with a standard dose of GONAL f® 150 IU per day for ovarian stimulation in women undergoing assisted reproductive technology (ART)

acronym: CONSORT RCT in ART

lead_sponsor: Merck Serono International S.A.


title: A Phase 3b, Non-randomized, Open-label, Multi-Centre, Follow-on Safety Trial of Monthly Doses of Degarelix in Patients with Prostate Cancer

lead_sponsor: Ferring Pharmaceuticals A/S


title: Single agent phase II study of Forodesine (BCX1777) in the treatment of cutaneous T-Cell Lymphoma

acronym: forodesine in CTCL

lead_sponsor: BioCryst Pharmaceuticals, Inc.


title: A PHASE 2, RANDOMIZED, DOUBLE-MASKED, CONTROLLED TRIAL TO ESTABLISH THE SAFETY AND EFFICACY OF INTRAVITREOUS INJECTIONS OF E10030 (ANTI-PDGF PEGYLATED APTAMER) GIVEN IN COMBINATION WITH LUCENTIS® IN SUBJECTS WITH NEOVASCULAR AGE-RELATED MACULAR DEGENERATION

acronym: REGRESS

lead_sponsor: OPHTHOTECH CORPORATION


title: Efficacy and Safety of Drotrecogin Alfa (Activated) in Adult Patients with Septic Shock

acronym: PROWESS-SHOCK

lead_sponsor: Eli Lilly and Company


title: A Phase II, Dose-Escalation to rash Trial of Erlotinib (Tarceva®) plus Gemcitabine in Patients With Metastatic Pancreatic Cancer.

acronym: RACHEL

lead_sponsor: F. Hoffmann-La Roche


title: A Phase 3 Randomized Trial of Chemotherapy With or Without Panitumumab in Patients with Metastatic and/or Recurrent Squamous Cell Carcinoma of the Head and Neck

lead_sponsor: Amgen Inc


title: An open-label extension study following a double-blind, randomised, placebo-controlled, multi-centre study to assess the efficacy and safety of adjunctive zonisamide in paediatric partial onset seizures.

lead_sponsor: Eisai Ltd


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


title: A RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP MULTI-CENTER COMPARATIVE FLEXIBLE-DOSE STUDY OF PREGABALIN VERSUS LEVETIRACETAM AS ADJUNCTIVE THERAPY TO REDUCE SEIZURE FREQUENCY IN SUBJECTS WITH PARTIAL SEIZURES (A0081157).

lead_sponsor: Pfizer Inc,East 42nd street,New york, NY10017, USA


title: A RANDOMIZED PLACEBO-CONTROLLED TRIAL OF THE EFFICACY AND TOLERABILITY OF FLEXIBLY DOSED PREGABALIN IN THE TREATMENT OF CANCER-INDUCED BONE PAIN.

lead_sponsor: Pfizer


title: A Randomized, Double-Blind, Placebo-Controlled, 3-Arm, Parallel-Group, 26 Week Multicenter Study with a 26-Week Extension to Evaluate the Efficacy, Safety, and Tolerability of JNJ 28431754 (Canagliflozin) Compared with Placebo in the Treatment of Subjects With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin and Pioglitazone Therapy

acronym: The CANTATA-MP Trial

lead_sponsor: Janssen-Cilag International NV


title: Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Subjects with Relapsing-Remitting Multiple Sclerosis


title: Superiority of insulin glargine Lantus vs. NPH: “Treat to Normoglycemia concept”. Effect of Insulin Glargine in Comparison to Insulin NPH in Insulin-naïve People with Type 2 Diabetes Mellitus Treated with at Least One OAD and Not Adequately Controlled.

acronym: LANCELOT

lead_sponsor: SANOFI-AVENTIS GROUPE


title: A 12-week, randomised, double-blind, placebo-controlled trial to evaluate the efficacy and safety of prucalopride in subjects with chronic non-cancer pain suffering from opioid induced constipation

lead_sponsor: Movetis NV


title:
A 52-week, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Safety and Efficacy of Relamorelin in Patients with Diabetic Gastroparesis

 Etude de phase 3 randomisée d’une durée de 52 semaines, en double aveugle, contrôlée par placebo évaluant la sécurité d'emploi et l'efficacité de la relamoreline chez des patients atteints de gastroparésie diabétique

acronym:
Diabetic Gastroparesis Study 4

 Étude 4 évaluant la gastroparésie diabétique

lead_sponsor: Allergan Ltd.


title: Phase 3 Randomized, Double-Blind Clinical Study of Pembrolizumab + Epacadostat vs Pembrolizumab + Placebo as a Treatment for Recurrent or Progressive Metastatic Urothelial Carcinoma in Patients who have Failed a First-Line Platinum-containing Chemotherapy Regimen for Advanced/Metastatic Disease (KEYNOTE-698/ECHO-303)

acronym: Phase 3 Study of Pembrolizumab with/without Epacadostat in second line Urothelial Carcinoma

lead_sponsor: Incyte Corporation


title: A Randomized Open-Label Phase III Study of Single Agent Pembrolizumab versus Single Agent Chemotherapy per Physician’s Choice for Metastatic Triple Negative Breast Cancer (mTNBC) – (KEYNOTE-119)

acronym: A Study of Single Agent Pembrolizumab vs Single Agent Chemotherapy for mTNBC

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


title: A Phase 3, Randomized, Double-blind, Placebo-Controlled Study of Abiraterone Acetate (CB7630) Plus Prednisone in Patients with Metastatic Castration-Resistant Prostate Cancer Who Have Failed Docetaxel-Based Chemotherapy

lead_sponsor: Cougar Biotechnology, Inc


title:
A SAFETY AND EFFICACY TRIAL EVALUATING THE USE OF APIXABAN FOR THE EXTENDED TREATMENT OF DEEP VEIN THROMBOSIS AND PULMONARY EMBOLISM
 Revised Protocol 01 (version 4.0 dated 21-Apr-08), incorporating Amendment 02 (version 1.0 dated 21-Apr-08)

lead_sponsor: Bristol-Myers Squibb International Corporation


title: A randomized, multicenter phase II study to explore whether biomarkers correlate with treatment outcome in chemo-naive patients with advanced or recurrent non-squamous non-small cell lung cancer, who receive treatment with bevacizumab (at a dose of either 7.5 mg/kg or 15 mg/kg) in addition to carboplatin based chemotherapy (gemcitabine or paclitaxel)

lead_sponsor: F. Hoffmann La-Roche Ltd


title: A randomized, placebo controlled, multicenter clinical study investigating efficacy of rituximab (MabThera/Rituxan) in the inhibition of joint structural damage assessed by magnetic resonance imaging in patients with rheumatoid arthritis and inadequate response to methotrexate - the SCORE study.

acronym: SCORE

lead_sponsor: F. Hoffman-La Roche Ltd.


title: A Randomized, Open-Label, Parallel-Arm, Noninferiority Comparison of the Effects of Two Doses of LY2189265 and Insulin Glargine on Glycemic Control in Patients with Type 2 Diabetes on Stable Doses of Metformin and Glimepiride (AWARD-2: Assessment of Weekly AdministRation of LY2189265 in Diabetes-2)

acronym: GBDB

lead_sponsor: Eli Lilly & Company - Indianapolis


title:
A Safety and Efficacy Trial Evaluating the Use of Apixaban in the Treatment of Symptomatic Deep Vein Thrombosis and Pulmonary Embolism
 Revised Protocol Number: 01, Incorporates amendment(s) 02

lead_sponsor: Bristol-Meyers Squibb International Corporation


title: A Multicenter, Open-label Extension Trial to Assess the Long-term Use of Lacosamide Monotherapy and Safety of Lacosamide Monotherapy and Adjunctive Therapy in Subjects with Partial-onset Seizures

lead_sponsor: SCHWARZ BIOSCIENCES, Inc.


title: Randomized Trial to Evaluate the Efficacy and Safety of Cinacalcet Treatment in Combination with Low Dose Vitamin D for the Treatment of Subjects with Secondary Hyperparathyroidism (SHPT) Recently Initiating Hemodialysis

lead_sponsor: Amgen Inc


title: A Randomized, Open-Label, Multicenter, Phase 2 Study of the Combination of VELCADE, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone (VR-CAP) or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Subjects With Newly Diagnosed Non-Germinal Center B-Cell Subtype of Diffuse Large B-Cell Lymphoma

lead_sponsor: Janssen-Cilag International N.V.


title: GRACE (Genomics to combat Resistance against Antibiotics in Community-acquired LRTI in Europe). Workpackage 10: Antibiotic Trial One

acronym: GRACE AT ONE

lead_sponsor: University of Southampton

lead_sponsor_type: academique


title: Randomized Phase 3 Trial of Gemcitabine/Carboplatin With or Without BSI-201 (SAR240550) (a PARP1 Inhibitor) in Patients with Previously Untreated Stage IV Squamous Non Small Cell Lung Cancer (NSCLC)

lead_sponsor: BiPar Sciences, Inc.


title: A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to TNF-α antagonist therapy

acronym: Investigating efficacy of ofatumumab in RA patients with inadequate response to TNF-α antagonist

lead_sponsor: Genmab A/S


title: Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus A Multicentre, Randomised, Double-Blind, Placebo-Controlled Phase IV Trial to Evaluate the Effect of Saxagliptin on the Incidence of Cardiovascular Death, Myocardial Infarction or Ischaemic Stroke in Patients with Type 2 Diabetes

acronym: SAVOR

lead_sponsor: AstraZeneca AB


title: A Phase I/II Multi-centre Study of AZD8931 in Combination with Weekly Paclitaxel to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy in Patients with Advanced Solid Tumours and in a Selected Population with Low HER2-expressing Locally Recurrent and/or Metastatic Breast Cancer (THYME)

acronym: THYME


title:
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric
 Subjects with Moderate to Severe Ulcerative Colitis.

lead_sponsor: Abbvie Deutschland GmbH & Co. KG


title: A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Patients With Active Systemic Lupus Erythematosus

lead_sponsor: F. Hoffmann-La Roche Ltd


title: A Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Effect on Unassisted Erectile Function of the Early Use of Tadalafil 5 mg Once a Day and Tadalafil 20 mg On Demand Treatment for 9 Months in Subjects Undergoing Bilateral Nerve-Sparing Radical Prostatectomy

acronym: LVIK

lead_sponsor: Eli Lilly and Company Limited


title: A Phase II, randomized, parallel group safety, efficacy, and pharmacokinetics study of BI 10773 (1mg, 5mg, 10mg, 25mg, and 50mg) administered orally once daily over 12 weeks compared double blind to placebo with an additional open-label sitagliptin arm in type 2 diabetic patients with insufficient glycemic control despite metformin therapy

lead_sponsor: Boehringer Ingelheim France


title:
FondaparinUx Trial with UFH during Revascularization in Acute Coronary Syndromes (FUTURA)
 A prospective study evaluating the safety of two regimens of adjunctive intravenous UFH during PCI in high risk patients with UA/NSTEMI initially treated with subcutaneous fondaparinux and referred for early coronary angiography (OASIS 8)

acronym: OASIS 8 (FUTURA)

lead_sponsor: GlaxoSmithKline R & D


title: A randomized, double-blind, parallel group, placebo controlled, multi-center study of fixed dose combinations of solifenacin succinate (6 mg and 9 mg) with tamsulosin hydrochloride OCAS 0.4 mg and tamsulosin hydrochloride OCAS 0.4 mg monotherapy, in male subjects with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) with a substantial storage component

acronym: Neptune

lead_sponsor: Astellas Pharma Europe B.V.


title: Evaluation of the anti-arrhythmic effects of 3 oral dosages of S 44121 versus placebo in patients with chronic heart failure and left ventricular systolic dysfunction at risk for ventricular arrhythmia. A 12-week, randomized, double-blind, parallel-group, placebo controlled, international multicentre study.

lead_sponsor: Institut de Recherches Internationales Servier


title: An Open Label, Multicentre, Single Arm Study to Characterise the Efficacy, Safety and Tolerability of Gefitinib 250 mg (IRESSA™) as First line Treatment in Caucasian Patients, who have Epidermal Growth Factor Receptor (EGFR) Mutation Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)


title: A Randomized, Controlled, Open- label Study Evaluating the Efficacy and Tolerability of AMG 531 versus Medical Standard of Care as Chronic Therapy for Non-splenectomized Subjects with Immune (Idiopathic) Thrombocytopenic Purpura

lead_sponsor: Amgen Inc.


title: Double-Blind, Placebo-Controlled, Multicenter Acute Study of Clinical Effectiveness of Nesiritide in Subjects with Decompensated Heart Failure

acronym: ASCEND-HF

lead_sponsor: Janssen-Cilag International NV,Turnhoutseweg 30, 2340  Beerse, Belgium


title: An eight-week, multinational, multicenter, double-blind, active- and placebo-controlled clinical trial evaluating the efficacy and tolerability of three fixed doses of SSR125543 (20 mg daily, 50 mg daily and 100 mg daily) in outpatients with major depressive disorder.

acronym: AGATE

lead_sponsor: Sanofi-Aventis Recherche & Développement


title: Effect of γ-Secretase Inhibition on the Progression of Alzheimer’s Disease:  LY450139 versus Placebo

lead_sponsor: Eli Lilly and Company


title: TachoSil versus current practice in dura sealing techniques for the prevention of postoperative cerebrospinal fluid (CSF) leaks in patients undergoing skull base surgery: An open label, randomised, controlled, multicentre, parallel group efficacy and safety trial.

acronym: TASALL -TachoSil Against Liquor Leak

lead_sponsor: Nycomed Danmark ApS


title: A  Kaletra ONCE daily Randomised Trial of the pharmacokinetics, safety and efficacy of twice-daily versus once-daily lopinavir/ritonavir tablets dosed by weight as part of combination antiretroviral therapy in HIV-1 infected children (PENTA 18)

acronym: KONCERT

lead_sponsor: Paediatric European Network for Treatment of AIDS (PENTA) Foundation


title: A Randomised, Placebo Controlled, Double-Blinded Comparative Study Evaluating the Effect of Ramipril on Urinary Protein Excretion in Maintenance Renal Translplant Patients Converted to Sirolimus

lead_sponsor: Wyeth Pharmaceuticals


title: A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 302)

lead_sponsor: Shire Human Genetic Therapies, Inc.


title: A randomized, double blind, double dummy, placebo controlled study to evaluate the efficacy and safety of solifenacin succinate (5 and 10mg once daily) against placebo and oxybutynin hydrochloride (5 mg three times daily) in the treatment of subjects with neurogenic detrusor overactivity.

acronym: SONIC


title: A Randomised Open Label, Multicentre Phase 3 Study of the Combination of Rituximab, Cyclophosphamide, Doxorubicin, VELCADE and Prednisone (VcR-CAP) or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone (R-CHOP) in Patients with Newly Diagnosed Mantle Cell Lymphoma Who are Not Eligible for a Bone Marrow Transplant.

lead_sponsor: Janssen-Cilag International N.V.


title: An Open-Label, Phase IV, Multi-Centre Study to Investigate the Long-Term Safety and Efficacy of Subcutaneous Dynepo in Adult Patients with Anaemia Associated with Chronic Kidney Disease.

acronym: Dynepo long-term safety study

lead_sponsor: Shire


title: A twelve-month, multicenter, double-masked study of Travoprost / Brinzolamide fixed combination QD AM and Travoprost / Brinzolamide fixed combination QD PM versus COSOPT BID in patients with open-angle glaucoma or ocular hypertension

acronym: Travoprost / Brinzolamide Fixed Combination Once-Daily vs. COSOPT

lead_sponsor: Alcon Research, Ltd.


title: A Phase II, Double-Blind, Randomised Study to Assess the Efficacy of AZD6244 (Hyd-Sulfate) in Combination with Dacarbazine Compared with Dacarbazine Alone in First Line Patients with BRAF Mutation Positive Advanced Cutaneous or Unknown Primary Melanoma

lead_sponsor: AstraZeneca AB


title: Multicenter, Open-Label Study to Assess Early Response to Abatacept with Background Methotrexate Using Power Doppler Ultrasonography in Patients with Active Rheumatoid Arthritis and Inadequate Response to Methotrexate

lead_sponsor: Bristol Myers Squibb International Corporation


title: A phase II Randomized, Open-Label, Multicenter Study Comparing CO-1.01 With Gemcitabine as First-Line Therapy in Patients with Metastatic Pancreatic Adenocarcinoma

lead_sponsor: Clovis Oncology Inc


title:
A phase III, randomised, open label, active-controlled study of an
 interferon-free regimen of BI 207127 in combination with Faldaprevir
 and Ribavirin compared to Telaprevir in combination with pegylated
 interferon-a and ribavirin in treatment-naive patients with chronic
 genotype 1b Hepatitis C Virus infection.

lead_sponsor: Boehringer Ingelheim France


title: An Open-Label, Long-Term Extension, Multi-center, Sequential Dose Titration Study to Assess Safety and Efficacy of Solifenacin Succinate Suspension in Pediatric Subjects with Overactive Bladder (OAB)

lead_sponsor: Astellas Pharma Europe B.V.


title: An Open-Label Study to Evaluate the Efficacy and Safety of Alirocumab in Children and Adolescents with Homozygous Familial Hypercholesterolemia


title:
Safety and Efficacy of Low Molecular Weight Heparin for 72 Hours Followed by Dabigatran for the Treatment of Acute Intermediate-Risk Pulmonary Embolism.

 Safety and efficacy of low molecular weight heparin for at least 72 hours followed by Dabigatran for the treatment of acute intermediate-risk pulmonary embolism PEITHO-2

lead_sponsor: JOHANNES GUTENBERG UNIVERSITY


title: A confirmatory, placebo-controlled, randomised, double-blind, single-dummy, parallel group, ratio-finding study in constipated pain patients to establish an optimal hydromorphone – naloxone ratio with an improved bowel function and a comparable analgesic efficacy compared to hydromorphone alone

acronym: Optimisation of Hydromorphone - Naloxone Ratio for the treatment of pain

lead_sponsor: Mundipharma Research GmbH & Co. KG


title: A Multi-center, Randomized, Parallel Group, Double-blind, Placebo Controlled Estimation Study to Assess the Efficacy and Safety of Modified Release UK-369,003 in the Treatment of Men with Storage Lower Urinary Tract Symptoms (LUTS) With and Without Erectile Dysfunction (ED)

acronym: not applicable

lead_sponsor: Pfizer Ltd


title: A phase III multi-center, open-label, randomized study of nilotinib versus imatinib in adult patients with  Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia in chronic phase (CML - CP) who have suboptimal cytogenetic response (CyR) on imatinib.

lead_sponsor: Novartis Pharma Services


title: Use of Duloxetine or Pregabalin in Monotherapy versus Combination Therapy of Both Drugs in Patients with Painful Diabetic Neuropathy “The COMBO - DN (COmbination vs Monotherapy of pregaBalin and dulOxetine in Diabetic Neuropathy) Study”

acronym: HMGQ

lead_sponsor: Eli Lilly and Company


title: A 3-PHASE STUDY TO EVALUATE SUSTAINED REMISSION AND PRODUCTIVITY OUTCOMES IN SUBJECTS WITH EARLY RHEUMATOID ARTHRITIS INITIATED ON TREATMENT WITH ETANERCEPT PLUS METHOTREXATE

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


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


title: Comparison of Two Different Treatment Strategies in Patients with Major Depressive Disorder Not Exhibiting Improvement on Escitalopram Treatment: Early vs. Delayed Intervention Strategy

acronym: HMGD(a)

lead_sponsor: Eli Lilly and Company Limited


title: A 52-week randomised, controlled, open label, multicentre, multinational treat-to-target trial comparing the efficacy and safety of SIBA and insulin glargine, both injected once daily in combination with oral anti-diabetic drugs (OAD), in subjects with type 2 diabetes mellitus currently treated with OAD(s) and qualifying for more intensified treatment

lead_sponsor: Novo Nordisk A/S


title: GAP Grazax Asthma Prevention

acronym: GAP

lead_sponsor: ALK-Abelló A/S


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

acronym: PROGRESS

lead_sponsor: F. Hoffmann-La Roche Ltd


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

lead_sponsor: AVEO Pharmaceuticals, Inc.


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

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


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

lead_sponsor: PIERRE FABRE MEDICAMENT


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

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


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

acronym: ARTEMIS

lead_sponsor: Gilead Sciences Incorporated


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

acronym: GWBR(a)


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

acronym: PALETTE

lead_sponsor: GlaxoSmithKline Research & Development Limited


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


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

acronym: AMBITION


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

lead_sponsor: F.Hoffmann-La Roche Ltd


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

lead_sponsor: Pfizer Inc.


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

lead_sponsor: Genzyme Europe BV


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

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

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

lead_sponsor: Nutrinia


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

acronym: ARTISTS

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


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

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


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

lead_sponsor: Helsinn Healthcare SA


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

acronym: EXAMINER

lead_sponsor: Exelixis, Inc.


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

acronym: SIDEROS-E

lead_sponsor: Santhera Pharmaceuticals (Switzerland) Limited


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

lead_sponsor: Zogenix International Limited


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

lead_sponsor: Alexion Pharmaceuticals, Inc.


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

lead_sponsor: Kuros Biosurgery AG


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

lead_sponsor: MondoGEN AG


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

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

lead_sponsor: PregLem S.A.


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

acronym: Protégé Encore

lead_sponsor: MacroGenics, Inc.


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

acronym: MACSI

lead_sponsor: D-Pharm Ltd.


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

acronym: PEITHO

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


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

lead_sponsor: Genmab A/S


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

acronym: RELIEF

lead_sponsor: Nycomed Danmark Aps


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

acronym: Juvista in scar revision surgery of disfiguring scars

lead_sponsor: Renovo Ltd


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

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


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

acronym: The IMPROVE 2 Study

lead_sponsor: BioCryst Pharmaceuticals


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

acronym: ECHO Simplified Pill Regimen In Naive patients with TMC278

lead_sponsor: Tibotec Pharmaceuticals Limited


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

lead_sponsor: Bristol-Myers Squibb International Corporation


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

acronym: SUSTAIN

lead_sponsor: Novartis Pharma Services AG


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

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

acronym: ZEST Extension

lead_sponsor: Novartis Pharma AG


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

lead_sponsor: Boehringer Ingelheim France


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

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

lead_sponsor: Swedish Orphan Biovitrum AB (publ)


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

lead_sponsor: ChemoCentryx, Inc


title: A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of Orally Administered Lumicitabine (JNJ-64041575) Regimens in Hospitalized Infants and Children Aged 28 Days to 36 Months Infected with Respiratory Syncytial Virus

acronym: PLUM

lead_sponsor: Janssen-Cilag International NV


title: Efficacy and safety of oral budesonide-MMX™ (CB-01-02) 6 mg and 9 mg extended release tablets in patients with mild or moderate active ulcerative colitis.  A multicentre, randomised, double-blind, double-dummy, comparative study versus placebo with an additional reference arm evaluating entocort®EC

lead_sponsor: COSMO Technologies Ltd


title: A prospective, multicenter, randomized, open-label, active-controlled, 2-parallel group, phase III study to compare efficacy and safety of masitinib at 7.5 mg/kg/day to imatinib at 400 or 600 mg in treatment of patients with gastro-intestinal stromal tumour in first line medical treatment

lead_sponsor: AB SCIENCE


title: A multicentre, multinational, randomised, double-blind, parallel-group study comparing ACR16 45mg once-daily or twice-daily versus placebo for the symptomatic treatment of Huntington’s Disease

acronym: A Study of Treatment with ACR16 in Patients with Huntington's Disease (ACR16 C008)

lead_sponsor: NeuroSearch Sweden AB


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

acronym: HOLOCORE

lead_sponsor: Chiesi Farmaceutici S.p.A.


title: Multinational, multicenter, prospective, long-term safety and efficacy follow-up study after Autologous Cultivated Limbal Stem Cells Transplantation (ACLSCT) for restoration of corneal epithelium in patients with limbal stem cell deficiency due to ocular burns (HOLOCORE-FU)

acronym: HOLOCORE FU


title: A dose-finding phase Ib study followed by a randomized, double-blind phase II study of carboplatin and paclitaxel with or without buparlisib in patients with previously untreated metastatic non-small cell lung cancer (NSCLC) of squamous histology


title: A 16-Week, Multicenter, Randomized, Open-label Study to Assess the Effects of Aripiprazole versus other Atypical Antipsychotics in the Treatment of Schizophrenic Patients with Metabolic Syndrome

lead_sponsor: Bristol Myers Squibb International Corporation


title: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN PATIENTS WITH RELAPSING NEUROMYELITIS OPTICA (NMO)

lead_sponsor: Alexion Pharmaceuticals, Inc.


title: A randomised clinical trial of mycophenolate mofetil versus cyclophosphamide for remission induction in ANCA associated vasculitis.

acronym: MYCYC

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


study_start_date_type: Actual

intervention_type: Drug

lead_sponsor: Merck Sharp & Dohme LLC

summary: The primary objective of this study is to evaluate the pharmacokinetics (PK) of letermovir (LET) in pediatric participants. Participants will be enrolled in the following 3 age groups: Age Group 1: From 12 to <18 years of age (adolescents); Age Group 2: From 2 to <12 years of age (children); and Age Group 3: From birth to <2 years of age (neonates, infants and toddlers). All participants will receive open label LET for 14 weeks (~100 days) post-transplant, with doses based on body weight and age.

location_facility: Lady Cilento Children s Hospital ( Site 0182)

location_facility: National Center for Child Health and Development ( Site 0201)

location_facility: Pediatric Hemato Oncology Safra Children's Hospital, Sheba Medical Center ( Site 0123)

location_facility: Hospital Universitario "Dr. Jose Eleuterio Gonzalez" ( Site 0222)

location_facility: Universitaetsklinikum Muenster ( Site 0114)

location_facility: Universitatsklinikum Hamburg-Eppendorf ( Site 0111)

location_facility: H. de la Santa Creu I Sant Pau ( Site 0155)

location_facility: Children's Hospital of Pittsburgh of UPMC ( Site 0258)

location_facility: UCSF Benioff Children's Hospital San Francisco ( Site 0245)

location_facility: Children's Hospital of Orange County ( Site 0241)

location_facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckieg-Klinika Transplantacji Szpiku, Onkolog

location_facility: Nuevo Hospital Civil Dr Juan I Menchaca ( Site 0223)

location_facility: Akdeniz University Faculty of Medicine ( Site 0161)

location_facility: Schneider Children's Medical Center ( Site 0122)

location_facility: Hospital Universitari Vall d Hebron ( Site 0154)

location_facility: Instituto Nacional de Pediatria ( Site 0224)

location_facility: Hospital Universitario La Paz ( Site 0153)

location_facility: Universitaetsklinikum Frankfurt ( Site 0112)

location_facility: Charite Universitaetsmedizin Berlin - Campus-Virchow-Klinikum ( Site 0113)

location_facility: Hospital Infantil Universitario Nino Jesus ( Site 0151)

location_facility: Ege Univ.Tip Fakultesi Cocuk Has ( Site 0163)

location_facility: Hôpital Universitaire Necker Enfants Malades-, Unite d'Immunologie-Hematologie et Rhumatologie Pedi

location_facility: Royal Childrens Hospital Melbourne ( Site 0181)

location_facility: Memorial Sloan Kettering Cancer Center ( Site 0254)

location_facility: Duke University Health System ( Site 0252)

location_facility: Szpital Uniwersytecki nr 1 im. Dr. Antoniego Jurasza w Bydgoszczy ( Site 0141)

location_facility: Centro Medico Imbanaco de Cali S.A ( Site 0211)

location_facility: University Of Chicago School Of Medicine ( Site 0253)

location_facility: The Children s Hospital at Westmead ( Site 0185)

location_facility: Hospital Infantil de Mexico ( Site 0221)

location_facility: Instituto De Cancerologia S.A. ( Site 0213)

location_facility: Saitama Children's Medical Center ( Site 0202)

location_facility: City of Hope Comprehensive Cancer Center ( Site 0251)

location_facility: Cincinnati Children's Hospital Medical Center ( Site 0244)

title: A Phase 2b Open-label, Single-arm Study to Evaluate Pharmacokinetics, Efficacy, Safety and Tolerability of Letermovir in Pediatric Participants From Birth to Less Than 18 Years of Age at Risk of Developing CMV Infection and/or Disease Following Allogeneic Haematopoietic Stem Cell Transplantation (HSCT)

primary_purpose: Prevention

type: Other Identifier

type: Registry Identifier

type: EudraCT Number

enrollment_type: Actual

study_completion_date_type: Actual

location_country:
Germany
Poland
Colombia
Israel
Australia
Japan
Mexico
United States
Spain
Turkey
France

ipd_sharing: Yes


title: Evaluation of an eXtended and proacTive Dosing regimEn in Treatment-Naïve Patients With Wet Age-related Macular Degeneration (wAMD)

acronym: XTEND

summary: In this observational study researchers want to learn more about changes in visual acuity (clarity of vision) with proactive flexible treatments over time in patients suffering from wet age-related macular degeneration (wAMD) after decision to treat with Aflibercept (Eylea) was made. Wet AMD is an eye disease that progressively destroys the macula, the central portion of the retina, impairing central vision.

study_type: Observational

time_perspective: Prospective

ipd_sharing: No

ipd_sharing_description: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

lead_sponsor: Bayer

location_country:
Ireland
Italy
Colombia
Norway
Argentina
Denmark
Australia
Sweden
Switzerland
United Kingdom
Belgium
Korea, Republic of
China
Spain
Thailand
Canada
France


lead_sponsor: Pfizer

summary: Treatment with PF-06741086 is anticipated to demonstrate a clinically relevant advantage and/or a major contribution to patient care in comparison to current methods of treatment for hemophilia A or B because it works differently than factor replacement products and will work in the presence of inhibitors. The potential for once weekly (QW) subcutaneous (SC) administration provides for treatment options in the absence of reliable vascular access, increased convenience and may enable better compliance. Combined, these qualities should result in a reduction of bleeding episodes.

location_facility: Centro Multidisciplinario para el Desarrollo Especializado de la Inv. Clínica en Yucatán, S.C.P.

location_facility: Severance Hospital, Yonsei University Health System

location_facility: The Affiliated Hospital of Guizhou Medical University

location_facility: Kyung Hee University Hospital At Gangdong

location_facility: Beijing Children's Hospital, Capital Medical University

location_facility: Università degli Studi di Perugia, Azienda Ospedaliera di Perugia, Ospedale Santa Maria della

location_facility: Institute for Mother and Child healthcare "Dr Vukan Cupic"

location_facility: McMaster University Medical Centre - Hamilton Health Sciences

location_facility: FGBOU VO "Samara State Medical University" of MoH of Russia

location_facility: Sahyadri Clinical Research and Development Center

location_facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

location_facility: Hospital Universitario "Dr Jose Eleuterio Gonzalez"

location_facility: Dr. Behcet Uz Child Diseases Surgery Education and Research Hospital

location_facility: Nagoya University Hospital - Transfusion Medicine

location_facility: Ondokuz Mayıs University Medical Faculty

location_facility: King Faisal Specialist Hospital & Research Center

location_facility: USF Health Morsani Center For Advanced Healthcare

location_facility: National Specialized Hospital for the Active Treatment of Hematological Diseases - EAD, Sofia

location_facility: Gazi University Health Research and Practice Center Gazi Hospital

location_facility: Università degli Studi di Roma "Sapienza"-Policlinico Umberto I

location_facility: Charlotte Maxeke Johannesburg Academic Hospital

location_facility: Nanfang Hospital, Southern Medical University

location_facility: Tokyo Metropolitan Children's Medical Center

location_facility: Gaziantep University Sahinbey Research and Training Hospital

location_facility: Institute of Hematology, Chinese Academy of Medical Sciences

location_facility: Karadeniz Technical University Medical Faculty

status: Active, not recruiting

title: An Open-Label Study in Adolescent and Adult Severe (Coagulation Factor Activity <1%) Hemophilia A Participants With or Without Inhibitors or Moderately Severe to Severe Hemophilia B Participants (Coagulation Factor Activity ≤2%) With or Without Inhibitors Comparing Standard Treatment to PF-06741086 Prophylaxis

primary_purpose: Treatment

ipd_sharing_description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

study_completion_date_type: Anticipated

location_country:
Japan
Turkey
Croatia
Canada
Serbia
France
Hong Kong
United States
India
China
Oman
Italy
Mexico
Korea, Republic of
Saudi Arabia
Spain
South Africa
Taiwan
Bulgaria
Russian Federation


type: Other Grant/Funding Number

title: An Innovative Approach Towards Understanding and Arresting Type 1 Diabetes (INNODIA)

acronym: INNODIA

summary:
INNODIA is a global consortium linking 26 academic institutions, 4 industrial partners, a small to medium enterprise (SME), and 2 patient organisations, bringing their knowledge and experience together with one common goal: "To fight type 1 diabetes". (www.innodia.eu).

The project, approved in November 2015 and launched in January 2016, runs under the framework of the Innovative Medicines Initiative - Joint Undertaking (https://www.imi.europa.eu/projects-results/project-factsheets/innodia) with a dedicated governance structure ensuring close interaction, communication and adherence to the objectives and deliverables of the consortium.

The overall aim of INNODIA is to advance in a decisive way how to predict, stage, evaluate and prevent the onset and progression of type 1 diabetes (T1D). For this, INNODIA has established a comprehensive and interdisciplinary network of clinical and basic scientists, who are leading experts in the field of T1D research in Europe, with complementary expertise from the areas of immunology, Beta-cell biology, biomarker research and T1D therapy, joining forces in a coordinated fashion with industry partners and two foundations, as well as with all major stakeholders in the process, including regulatory bodies and patients with T1D and their families.

One of the objectives of INNODIA is to develop a new European clinical research network with standardized protocol based on repeated measures of C-peptide (including home measurements) and comprehensive collection of appropriate biological samples for 'omics', immune, viral and microbiome studies in new onset T1D patients and high-risk auto-antibody positive subjects. A protocol for the harmonization of sample collections in newly diagnosed type 1 diabetic patients and first degree relatives of patients with type 1 diabetes was developed following extensive preliminary work involving partners from across all specialities. Core laboratories with experience in their respective field were set up for analysis of auto-antibodies, fresh immune cells, handling of frozen immune cells, C-peptide measures. A series of standard operating procedures for sample collections and analysis were agreed. Sample tracking between clinical centres and central laboratories was included into a purposely designed electronic case report form (eCRF) into which all clinical and laboratory data collected are captured.

status: Unknown status

enrollment_type: Anticipated

ReferenceType: derived

ReferenceCitation: Wilhelm-Benartzi CS, Miller SE, Bruggraber S, Picton D, Wilson M, Gatley K, Chhabra A, Marcovecchio ML, Hendriks AEJ, Morobe H, Chmura PJ, Bond S, Aschemeier-Fuchs B, Knip M, Tree T, Overbergh L, Pall J, Arnaud O, Haller MJ, Nitsche A, Schulte AM, Mathieu C, Mander A, Dunger D. Study protocol: Minimum effective low dose: anti-human thymocyte globulin (MELD-ATG): phase II, dose ranging, efficacy study of antithymocyte globulin (ATG) within 6 weeks of diagnosis of type 1 diabetes. BMJ Open. 2021 Dec 7;11(12):e053669. doi: 10.1136/bmjopen-2021-053669.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

evidence: oa repository (via OAI-PMH doi match)

host_type: repository

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

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

repository_institution: University of Cambridge - Apollo

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_normalized: PubMed Central

repository_institution: Cardiff University - ORCA Online Research @Cardiff

version: acceptedVersion

repositories_concat: LIRIAS (KU Leuven);PubMed Central;orca.cardiff.ac.uk;www.repository.cam.ac.uk

unpaywall_oa_status: gold

publisher_dissemination: British Medical Journal

lead_sponsor: University of Cambridge

collaborators: The Leona M. and Harry B. Helmsley Charitable Trust

location_country:
Finland
Germany
Italy
Poland
Slovenia
Norway
United Kingdom
Denmark
Sweden
Austria
Belgium
Luxembourg
France

location_facility: Institut National de la Sante et de la Recherche Medicale (INSERM)

location_facility: Children's Hospital Auf der Bult, Hannover Medical School


title: Observational Study Evaluating Effectiveness and Safety of Real-World Treatment With Damoctocog Alfa Pegol in Previously Treated Patients With Hemophilia A

acronym: HEM-POWR

summary: The aim of the HEM-POWR study is to understand better how Damoctocog alfa pegol (Jivi) is used to treat people with Hemophilia A in day-to-day life, how well the treatment is tolerated and how satisfied patients and physicians are with the treatment.

status: Recruiting

ReferenceCitation: Sanabria M, Alvarez Roman MT, Castaman G, Janbain M, Matsushita T, Meijer K, Oldenburg J, Friedl S, Reding MT. Design of the HEM-POWR study: a prospective, observational study of real-world treatment with damoctocog alfa pegol in patients with haemophilia A. BMJ Open. 2021 Sep 2;11(9):e044997. doi: 10.1136/bmjopen-2020-044997.

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: PubMed Central - Europe PMC

repository_institution: University of Groningen / Centre for Information Technology - University of Groningen research database

repositories_concat: PubMed Central;pure.rug.nl

ipd_sharing: Undecided

ipd_sharing_description:
Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access.

As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

location_country:
Finland
Germany
Japan
Brazil
Kuwait
Luxembourg
Canada
France
Slovenia
Colombia
Portugal
Denmark
Switzerland
United States
Belgium
China
Italy
Norway
Netherlands
Austria
Mexico
United Arab Emirates
Saudi Arabia
Spain
Greece
Taiwan
Russian Federation
Sweden

location_facility: The Center for Comprehensive Care and Diagnosis of Inherited Blood Disorders

location_facility: South Alabama Medical Science Foundation

location_facility: East Carolina University - Brody School of Medicine

location_facility: Orthopaedic Hospital DBA Orthopaedic Institute for Children

location_facility: University of Colorado Hemophilia and Thrombosis Center


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

acronym: INVICTUS

lead_sponsor: Deciphera Pharmaceuticals, LLC


summary: This study will evaluate the efficacy, safety, and pharmacokinetics (PK) of sugammadex (MK-8616) for reversal of both moderate and deep neuromuscular blockade (NMB) in pediatric participants aged birth to <2 years. The primary hypothesis of this study is that sugammadex is superior to neostigmine in reversing moderate NMB as measured by time to neuromuscular recovery.

location_facility: Children City Clinical Hospital 13 n.a N.F.Filatov ( Site 4285)

location_facility: University of Vermont Medical Center ( Site 3013)

location_facility: St.Petersburg State Pediatric Medical University ( Site 4281)

location_facility: The Children's Hospital of Philadelphia ( Site 3021)

location_facility: McGovern Medical School at UT Health/ Memorial Hermann ( Site 3014)

location_facility: Centenario Hospital Miguel Hidalgo-Pediatrics Department ( Site 4152)

location_facility: Instituto Nacional Cardiovascular Incor ( Site 3928)

location_facility: Women and Children Hospital Kuala Lumpur (Hospital Tunku Azizah) ( Site 3875)

location_facility: Wilhelmina Kinderziekenhuis ( Site 4228)

location_facility: NMRC Obstetrics Gynecology and Perinatology n.a. V.I. Kulakov ( Site 4287)

location_facility: The Children s Hospital at Westmead ( Site 3805)

location_facility: Hospital General de Zona No. 1 ( Site 4153)

location_facility: University Medical Center Groningen ( Site 4227)

location_facility: Pediatric Hematology Oncology and Immunology Centre n.a. D.Rogachev. ( Site 4275)

location_facility: Lucille Packard Children's Hospital ( Site 3008)

location_facility: UZ Leuven - Campus Gasthuisberg ( Site 3202)

location_facility: Variety Children's Hospital D.B.A. Nicklaus Children's Hospital ( Site 3019)

location_facility: Instituto da Crianca do Hospital das Clinicas-FMUSP ( Site 3825)

location_facility: Erasmus University Medical Center ( Site 4225)

location_facility: Unidad de Cirugía Cardiovascular ( Site 4126)

location_facility: Universitaire Ziekenhuis Antwerpen - UZA ( Site 3200)

location_facility: Children's Hospital of Pittsburgh UPMC ( Site 3017)

location_facility: Scientific-Research Clinical Pediatric Institution n.a. Veltischev ( Site 4276)

location_facility: University Malaya Medical Centre. ( Site 3876)

location_facility: Children City Clinical Hospital #9 n.a. G.N.Speransky ( Site 4290)

location_facility: Scientific Research Institute Complex Problems Cardiovascular Disease ( Site 4288)

location_facility: C.H.R.U. de Lille. Hopital Jeanne de Flandres ( Site 3304)

location_facility: Royal Childrens Hospital Melbourne ( Site 3801)

location_facility: Debreceni Egyetem Klinikai Kozpont ( Site 4200)

location_facility: Radboud University Medical Center ( Site 4226)

location_facility: Queensland Children s Hospital ( Site 3806)

title: A Phase 4 Double-blinded, Randomized, Active Comparator-controlled Clinical Trial to Study the Efficacy, Safety, and Pharmacokinetics of Sugammadex (MK-8616) for Reversal of Neuromuscular Blockade in Pediatric Participants Aged Birth to <2 Years

design_allocation: Randomized

location_country:
Finland
Guatemala
Hungary
Denmark
Australia
Brazil
Netherlands
Mexico
Belgium
United States
Malaysia
Peru
Russian Federation
France


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

acronym: PATENT-CHILD

lead_sponsor: Bayer Healthcare AG


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

acronym: TIGER

lead_sponsor: European Organisation for Research and Treatment of Cancer


title: An Open-Label, Multi-Center Extension Study to Characterize the Long-Term Safety and Efficacy of BMS-986165 in Subjects with Moderate-to-Severe Plaque Psoriasis

lead_sponsor: Bristol-Myers Squibb International Corporation


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

lead_sponsor: GlaxoSmithKline Resaearch and Development Ltd


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

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

lead_sponsor: Seattle Genetics, Inc.


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

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

acronym: API-CAT

status: Temporarily Halted


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

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

lead_sponsor: UCB Biopharma SRL

status: Not Authorised


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

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

lead_sponsor: Zealand Pharma A/S


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

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

lead_sponsor: Albireo AB


title:
A Phase 2/3, Multicenter, Double-Blind, Randomized Study to
 Determine the Efficacy and Safety of DNL310 vs Idursulfase in
 Pediatric Participants With Neuronopathic or Non-Neuronopathic
 Mucopolysaccharidosis Type II

lead_sponsor: Denali Therapeutics Inc.


title:
A Phase 3 Global, Multicenter, Double-Blind Randomized Study of Carboplatin-Paclitaxel With INCMGA00012 or Placebo in Participants With Inoperable Locally Recurrent or Metastatic Squamous Cell Carcinoma of the Anal Canal Not Previously Treated With Systemic Chemotherapy (POD1UM-303/InterAACT 2)

 Étude de phase 3, internationale, multicentrique, randomisée en double aveugle, portant sur le carboplatine-paclitaxel en association avec l’INCMGA00012 ou un placebo chez des patients atteints d’un carcinome épidermoïde du canal anal métastatique ou en récidive locale non opérable, n’ayant pas été précédemment traité s par une chimiothérapie systémique (POD1UM-303/InterAACT 2)

lead_sponsor: Incyte Corporation


title:
A randomized, open label, multicenter phase II study evaluating the efficacy and safety of capmatinib (INC280) plus pembrolizumab versus pembrolizumab alone as first line treatment for locally advanced or metastatic non-small cell lung cancer with PD-L1≥ 50%

 Etude de phase II, randomisée, en ouvert, multicentrique, évaluant l’efficacité et l’innocuité du capmatinib (INC280) associé au pembrolizumab versus pembrolizumab en première ligne chez des patients ayant un cancer bronchique non à petites cellules localement avancé ou métastatique, avec surexpression de PD-L1 ≥ 50 %

lead_sponsor: Novartis Pharma AG


title: A Phase 1b, Multicenter Study to Determine the Dose, Safety, Efficacy and Pharmacokinetics of TRK-950 When Used in Combinations With Selected Anti-Cancer Treatment Regimens in Patients With Selected Advanced Solid Tumors

summary: The main purpose of this study is to establish the safety and the recommended dose of TRK-950 in combination with FOLFIRI, Gemcitabine / Cisplatin, Gemcitabine / Carboplatin, Ramucirumab / Paclitaxel, PD1 inhibitors (Nivolumab or Pembrolizumab), and Imiquimod Cream, Bevacizumab, Gemcitabine / Carboplatin / Bevacizumab, Topotecan, and Pegylated liposomal doxorubicin (PLD) for selected advanced solid tumors.

design_allocation: Non-Randomized

lead_sponsor: Toray Industries, Inc

location_country:
United States
France

location_facility: Texas Oncology, P.A. Baylor Charles A. Sammons Cancer Center

location_facility: Oncology Associates of Oregon, P.C.(Willamette Valley Cancer Institute and Research Center)

location_facility: Texas Oncology - Downtown Fort Worth Cancer Center


title: A Phase I/IIa Open-label, Multi-center Study to Evaluate the Safety, Tolerability, Whole-body Distribution, Radiation Dosimetry and Anti-tumor Activity of [177Lu]-NeoB Administered in Patients With Advanced Solid Tumors Known to Overexpress Gastrin-releasing Peptide Receptor (GRPR)

acronym: NeoRay

summary: The purpose of this first-in-human (FIH) study of [177Lu]-NeoB is to characterize the safety, tolerability, pharmacokinetics (PK) as well as the distribution and radiation dosimetry, and anti-tumor activity of [177Lu]-NeoB in patients with advanced solid tumors known to overexpress GRPR and with [68Ga]-NeoB lesion uptake.

ReferenceCitation: Sundlov A, Sjogreen-Gleisner K. Peptide Receptor Radionuclide Therapy - Prospects for Personalised Treatment. Clin Oncol (R Coll Radiol). 2021 Feb;33(2):92-97. doi: 10.1016/j.clon.2020.10.020. Epub 2020 Nov 12.

oa_host_type: publisher

evidence: open (via crossref license)

repositories_concat: closed

unpaywall_oa_status: hybrid

publisher_dissemination: Elsevier

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

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

lead_sponsor: Advanced Accelerator Applications

location_country:
Germany
United Kingdom
Netherlands
Austria
United States
Spain
France

location_facility:
Vall d'Hebron Institute of Oncology
Addenbroke's hospital
Pittsburgh University
University of Essen
Oregon Health & Science University
Stanford University
Lifespan Cancer Institute
Duke University
City of Hope
CHU de Grenoble
Erasmus MC
John Hopkins University
Medical University of Innsbruck