Kusajili – Centralise les essais cliniques mondiaux

Comparison of Voriconazole and Amphotericin B in Treating Patients With Aspergillosis RATIONALE: Antifungal therapy with voriconazole or amphotericin B may be an effective treatment for aspergillosis. It is not yet known whether voriconazole is more effective than amphotericin B in treating patients with aspergillosis. PURPOSE: Randomized phase III trial to compare the effectiveness of voriconazole with amphotericin B in treating patients with aspergillosis.

• Pays Australia, Belgium, France, Germany, Hungary, Ireland, Israel, Italy, Luxembourg, Netherlands, Spain, Sweden, Switzerland, United Kingdom, United States,
• Organes Aucun
• Spécialités Aucun

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
• Spécialités Aucun

A Study of Visilizumab in Subjects With Intravenous Steroid-Refractory Ulcerative Colitis The purpose of this study is to compare the efficacy of visilizumab to placebo in subjects with intravenous steroid-refractory ulcerative colitis.

• Pays Australia, Austria, Belgium, Canada, Czech Republic, France, Germany, Hungary, Israel, Netherlands, Norway, Slovakia, Ukraine, United States,
• Organes Aucun
• Spécialités Aucun

Evaluation of Safety and Efficacy of AVE5530 as add-on to Ongoing High Doses of Statins in Patients With Primary Severe Hypercholesterolemia The present study is assessing the efficacy and safety of AVE5530 (25 mg and 50 mg) in add-on to ongoing treatment with high doses of statin in a double-blind manner in comparison with placebo, in the management of patients with severe primary hypercholesterolemia considered as inadequately controlled despite their ongoing statin treatment. The main objective is to evaluate the effects of the association AVE5530+statin on LDL-C level reduction after 12 weeks of treatment. The effects of AVE5530 on other lipid parameters will be assessed as secondary objectives.

• Pays Australia, Belgium, Bulgaria, Canada, Czech Republic, France, Israel, Netherlands, Russian Federation, Slovakia, South Africa, Ukraine, United States,
• Organes Aucun
• Spécialités Aucun

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
• Spécialités Aucun

The Efficacy and Safety of Sildenafil Citrate Used in Combination With Intravenous Epoprostenol in PAH Determination of the effects of sildenafil citrate and epoprostenol when used in combination in patients with pulmonary arterial hypertension

• Pays Belgium, Canada, Czech Republic, Denmark, France, Israel, Italy, Netherlands, Spain, United Kingdom, United States,
• Organes Aucun
• Spécialités Aucun

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
• Spécialités Aucun

Talampanel for Amyotrophic Lateral Sclerosis (ALS) The purpose of this study is to assess the efficacy, tolerability and safety of oral administration of talampanel compared to a placebo in subjects with ALS.

• Pays Belgium, Canada, France, Germany, Hungary, Israel, Italy, Netherlands, Spain, United States,
• Organes Aucun
• Spécialités Aucun

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
• Spécialités Aucun

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
• Spécialités Aucun