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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Bosentan Effects in Inoperable Forms of Chronic Thromboembolic Pulmonary Hypertension The present trial investigates a possible use of oral bosentan, which is currently approved for the treatment of symptoms of pulmonary arterial hypertension (PAH), to patients suffering from inoperable chronic thromboembolic pulmonary hypertension (CTEPH) because of (i) peripheral localization of thrombotic material or (ii) persistent or recurrent pulmonary hypertension after pulmonary endarterectomy.

• Pays Australia, Austria, Belgium, Canada, Czech Republic, France, Germany, Italy, Netherlands, Poland, Spain, United Kingdom, United States,
• Organes Aucun
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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,
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Efficacy & Safety of Dronedarone Versus Amiodarone for the Maintenance of Sinus Rhythm in Patients With Atrial Fibrillation The objective of this study is to compare the efficacy and safety of dronedarone to that of amiodarone for the treatment of patients with atrial fibrillation.

• Pays Argentina, Australia, Austria, Belgium, Canada, Chile, China, Czech Republic, Estonia, Finland, France, Germany, Italy, Korea, Republic of, Mexico, Morocco, Netherlands, Poland, Russian Federation, Sweden, Tunisia, Turkey, United States,
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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
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Bosentan in Patients With Inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH) The present trial investigates the long-term safety, tolerability and efficacy of bosentan in patients with inoperable CTEPH.

• Pays Australia, Austria, Belgium, Canada, Czech Republic, France, Germany, Italy, Netherlands, Poland, Spain, United Kingdom, United States,
• Organes Aucun
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Study Evaluating of Calcineurin Inhibitor and Sirolimus (Rapamune) Treatment in Liver Transplant Recipients The purpose of this study is to evaluate the sirolimus conversion regimen as compared with the calcineurin inhibitor continuation regimen with regards to renal function in stable liver transplant subjects.

• Pays Belgium, Canada, Czech Republic, France, Germany, Italy, Netherlands, Portugal, Spain, Switzerland, United Kingdom, United States,
• Organes Aucun
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Efficacy and Safety Study of Apremilast to Treat Active Ulcerative Colitis The purpose of the study is to evaluate the clinical efficacy, safety and tolerability of apremilast (30 mg twice daily [BID] and 40 mg BID), compared with placebo, in subjects with active Ulcerative Colitis (UC).

• Pays Australia, Bulgaria, Canada, Czech Republic, France, Germany, Hungary, Italy, Netherlands, New Zealand, Poland, Russian Federation, Ukraine, United States,
• 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,
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Open Label Extension Study in Patients With Idiopathic Pulmonary Fibrosis Who Completed Protocol AC-052-321/ BUILD 3 / NCT00391443 This Open-label extension study in patients with Idiopathic Pulmonary Fibrosis who completed protocol AC-052-321 / BUILD 3 (NCT00391443) will asses the long term safety and tolerability of bosentan in patients with idiopathic pulmonary fibrosis (IPF).

• Pays Australia, Belgium, Canada, Czech Republic, France, Germany, Ireland, Israel, Italy, Japan, Korea, Republic of, Spain, Switzerland, United Kingdom, United States,
• Organes Aucun
• Spécialités Aucun