Kusajili – Centralise les essais cliniques mondiaux

Macitentan Use in an Idiopathic Pulmonary Fibrosis Clinical Study The AC-055B201/MUSIC study is a Phase II study, comparing one dose of ACT-064922 (macitentan) 10 mg with placebo in patients with idiopathic pulmonary fibrosis (IPF). The main study objective is to demonstrate that macitentan positively affects the forced vital capacity (FVC) in comparison with placebo in patients with idiopathic pulmonary fibrosis (IPF). The secondary objectives are to evaluate the effect of macitentan on the time to disease worsening or death in patients with IPF, and to evaluate the benefit/risk profile of macitentan in the treatment of patients with IPF.

• Pays Australia, Canada, France, Germany, Israel, Italy, Slovenia, South Africa, Spain, Sweden, Turkey, United States,
• Organes Aucun
• Spécialités Aucun

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

Open-label Study With Bosentan in Interstitial Lung Disease This study will asses the long term safety and efficacy of oral bosentan to patients suffering from Interstitial Lung Disease.

• Pays Canada, France, Germany, Israel, Italy, Korea, Republic of, Netherlands, Sweden, Switzerland, United Kingdom, United States,
• Organes Aucun
• Spécialités Aucun

Satavaptan in the Prevention of Ascites Recurrence in Patients With Ascites Due to Cirrhosis of the Liver Primary To evaluate the efficacy of satavaptan on top of diuretic drugs in reducing the recurrence of ascites. Secondary To evaluate the tolerability and safety of satavaptan on top of diuretic drugs over a 52-week treatment period in participants with cirrhosis of the liver and recurrent ascites. The one-year double blind placebo controlled period is extended up to 2 years in a long term safety study (PASCCAL-2).

• Pays Argentina, Australia, Belgium, Bosnia and Herzegovina, Bulgaria, Canada, Croatia, Czech Republic, France, Germany, Hungary, Israel, Italy, Korea, Republic of, Malaysia, Portugal, Romania, Serbia, Singapore, South Africa, Spain, Taiwan, Province of China, United Kingdom, United States,
• Organes Aucun
• Spécialités Aucun

Rivaroxaban Pharmacokinetics/Pharmacodynamics (PK/PD) Study in Pediatric Subjects The first study with rivaroxaban in pediatric subjects is a Phase I study, where the pharmacokinetic/pharmacodynamic (PK/PD) profile of rivaroxaban will be investigated to confirm that the exposure is comparable to adults. This study is a single dose study with multiple PK/PD measurements in pediatric subjects at the end of their Venous Thromboembolism (VTE) treatment.

• Pays Australia, Austria, Canada, France, Germany, Ireland, Israel, Italy, Switzerland, United States,
• Organes Aucun
• Spécialités Aucun

A Study of Lenalidomide Versus Placebo in Subjects With Transfusion Dependent Anemia in Lower Risk Myelodysplastic Syndrome (MDS) Without Del 5q The purpose of this study is to investigate whether lenalidomide would reduce the number of red blood cell transfusions (RBC) needed in anemic (RBC transfusion-dependent) participants with low or intermediate-1 risk MDS without a deletion 5q chromosome abnormality. The study also investigated the safety of lenalidomide use in these participants. Two-thirds of the participants received oral lenalidomide and one-third of the participants received oral placebo.

• Pays Australia, Austria, Belgium, Canada, Czech Republic, France, Germany, Israel, Italy, Japan, Poland, Portugal, Spain, Turkey, United Kingdom, 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

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
• Spécialités Aucun

A Study of Lenalidomide Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Patients With Multiple Myeloma The study compared the efficacy of oral lenalidomide in combination with oral pulse high-dose dexamethasone to that of placebo and oral high-dose pulse dexamethasone as treatment for participants with relapsed or refractory multiple myeloma.

• Pays Australia, Austria, Belgium, France, Germany, Greece, Ireland, Israel, Italy, Poland, Spain, Sweden, Switzerland, Ukraine, United Kingdom,
• Organes Aucun
• Spécialités Aucun