Kusajili – Centralise les essais cliniques mondiaux

BUILD 3: Bosentan Use in Interstitial Lung Disease BUILD 3 is a prospective, multicenter, randomized, double-blind, parallel group, placebo-controlled, event-driven, group sequential, phase III superiority study. The primary objective is to demonstrate that bosentan delays disease worsening or death in patients with Idiopathic Pulmonary Fibrosis.

• Pays Australia, Austria, Belgium, Canada, Croatia, Czech Republic, France, Germany, Ireland, Israel, Italy, Japan, Korea, Republic of, Netherlands, Serbia, Spain, Switzerland, United Kingdom, United States,
• Organes Aucun
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Clinical Trial to Assess Efficacy, Safety, and Tolerability of Rasagiline Mesylate 1 mg in Patients With Multiple System Atrophy of the Parkinsonian Subtype (MSA-P) To test the clinical effect of rasagiline on subjects with MSA of the parkinsonian subtype.

• Pays Austria, Canada, France, Germany, Hungary, Israel, Italy, Netherlands, Portugal, Spain, United Kingdom, United States,
• Organes Aucun
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A Study of PS-341 Given to Patients With Multiple Myeloma Who Experienced Progressive Disease After Receiving Dexamethasone in M34101-039 The purpose of this study is to allow patients to receive VELCADE™ (bortezomib) for Injection who experienced progressive disease(PD) while receiving high-dose dexamethasone from the M34101-039 study.

• Pays Austria, Belgium, Canada, France, Germany, Ireland, Israel, Italy, Netherlands, Spain, Sweden, United Kingdom, United States,
• Organes Aucun
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Optimal Timing of Dronedarone Initiation After Conversion in Patients With Persistent Atrial Fibrillation Primary Objective: - Evaluate the rate of Atrial Fibrillation (AF) recurrences one month after randomization according to different timings of initiation of dronedarone. Secondary Objective: - Evaluate the rate of AF recurrences two months after randomization. - Assess the safety of the change from amiodarone to dronedarone - Assess dronedarone safety - Explore dronedarone and its active metabolite plasma level (in a subset of countries) - Explore potential Pharmacokinetic (PK) interaction between dronedarone and amiodarone (in a subset of countries)

• Pays Australia, Austria, Estonia, Finland, France, Germany, Israel, Italy, Korea, Republic of, Mexico, Netherlands, Portugal, Spain, Switzerland, Taiwan, Province of China, United Kingdom,
• Organes Aucun
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Clinical Study to Investigate the Long-term Safety, Tolerability, and Efficacy of Ponesimod in Patients With Relapsing-remitting Multiple Sclerosis This study is an extension to the study AC-058B201 and will investigate the long-term safety, tolerability and efficacy of ponesimod in patients with relapsing-remitting multiple sclerosis.

• Pays Austria, Bulgaria, Canada, Czech Republic, Finland, France, Germany, Hungary, Israel, Italy, Netherlands, Poland, Romania, Russian Federation, Serbia, Spain, Sweden, Switzerland, Ukraine, United Kingdom, United States,
• Organes Aucun
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A Prospective, Multicentre European Registry for Newly Diagnosed Patients With Myelodysplastic Syndromes Study Objectives: To collect and describe demographics, disease-management, and treatment outcomes of Myelodysplastic Syndromes (MDS) patients who are newly diagnosed and classified according to the WHO criteria. To perform observational studies concerning relevant scientific research questions in MDS using clinical data and biological samples, and to present relevant research outcomes in the fields of diagnosis and prognostication, health related quality of life issues, health economics, and risk stratification for newly developed classes of drugs. To disseminate results of the studies to all stakeholders involved.

• Pays Austria, Croatia, Czech Republic, Denmark, France, Germany, Greece, Israel, Italy, Netherlands, Poland, Portugal, Romania, Serbia, Spain, Sweden, United Kingdom,
• Organes Aucun
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PS-341 (VELCADE™) Versus High-Dose Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma This study will compare the efficacy of PS-341 versus high dose dexamethasone.

• Pays Austria, Belgium, Canada, France, Germany, Ireland, Israel, Italy, Netherlands, Spain, Sweden, United Kingdom, United States,
• Organes Aucun
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Comparison of Methotrexate vs Placebo in Corticosteroid-dependent Ulcerative Colitis - PHASE: II - TYPE OF STUDY : With direct benefit - DESCRIPTIVE: Multicenter, randomized, double-blind study - INCLUSION CRITERIA: Steroid-dependent ulcerative colitis - OBJECTIVES: To show superiority of methotrexate vs placebo in inducing steroid-free remission in steroid-dependent ulcerative colitis - STUDY TREATMENTS: Methotrexate 1 intramuscular injection (25 mg) per week Placebo 1 intramuscular injection per week - NUMBERS OF PATIENTS: 55 patients in each group, i.e. a total of 110 patients - INCLUSION PERIOD: 24 months - STUDY DURATION: 36 months - EVALUATION CRITERIA: Remission without steroids, immunosuppressives and without colectomy at 16 weeks of treatment.

• Pays Austria, Belgium, France, Israel, Italy, Netherlands,
• Organes Aucun
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Study of Visilizumab Versus Placebo in Subjects With Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study The purpose of this study is to compare the efficacy, safety, pharmacokinetics, and immunogenicity in subjects retreated with visilizumab or placebo after a response in a prior visilizumab study.

• Pays Australia, Austria, Belgium, Canada, Croatia, Czech Republic, France, Germany, Hungary, Israel, Italy, Netherlands, Norway, Ukraine, United States,
• Organes Aucun
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Oral Topotecan Versus Intravenous Docetaxel In Pretreated, Advanced Non-Small Cell Lung Cancer The purpose of this study is to collect information on how effective and how well tolerated an oral investigational drug is compared to a standard intravenous drug in patients with pretreated, advanced non-small lung cancer (NSCLC).

• Pays Australia, Austria, Belgium, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Israel, Italy, Latvia, Lithuania, Netherlands, New Zealand, Philippines, Poland, Portugal, Russian Federation, Singapore, South Africa, Spain, Switzerland, Taiwan, Province of China, Thailand, Turkey, Ukraine, United Kingdom,
• Organes Aucun
• Spécialités Aucun