Kusajili – Clinical trials directory

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.

• Country Australia, Austria, Belgium, Canada, Croatia, Czech Republic, France, Germany, Ireland, Israel, Italy, Japan, Korea, Republic of, Netherlands, Serbia, Spain, Switzerland, United Kingdom, United States,
• organs None
• Specialty None

Nilotinib in Newly Diagnosed Adult Philadelphia Chromosome & /or BCR-ABL Positive Chronic Myeloid Leukaemia in Chronic Phase This study will assess the efficacy and safety of nilotinib in adult patients with newly diagnosed Philadelphia chromosome positive/BCR-ABL positive chronic myeloid leukaemia in chronic phase. The aim of the study is to confirm the rates of complete molecular remission (CMR) of nilotinib in newly diagnosed CML chronic phase patients in a pan-European population using the EUTOS standardized laboratories.

• Country Austria, Belgium, Bulgaria, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Italy, Latvia, Lithuania, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Kingdom,
• organs None
• Specialty None

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.

• Country Austria, Croatia, Czech Republic, Denmark, France, Germany, Greece, Israel, Italy, Netherlands, Poland, Portugal, Romania, Serbia, Spain, Sweden, United Kingdom,
• organs None
• Specialty None

Efficacy and Safety of SR58611 Compared to Placebo and Paroxetine Primary objective : - To demonstrate the antidepressant efficacy on the Hamilton Depression Rating Scale of SR58611A 700mg/day compared with placebo in the treatment of patients with a recurrent major depressive episode. Secondary objectives: - To assess the safety profile of SR58611A 700 mg/d in comparison to placebo and to assess plasma concentrations of the active metabolite.

• Country Bulgaria, Croatia, Czech Republic, Estonia, France, Montenegro, Netherlands, Serbia,
• organs None
• Specialty None

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.

• Country Australia, Austria, Belgium, Canada, Croatia, Czech Republic, France, Germany, Hungary, Israel, Italy, Netherlands, Norway, Ukraine, United States,
• organs None
• Specialty None

Aripiprazole for Schizophrenia Outpatients Completing BMS Clinical Trials The purpose of this study is to provide aripiprazole to schizophrenic outpatients and Community Treated Patients who are currently receiving aripiprazole therapy on another BMS sponsored clinical trial.

• Country Canada, Croatia, Czech Republic, France, Hungary, Netherlands, Poland, Romania, Russian Federation, South Africa, United Kingdom,
• organs None
• Specialty None

Study Evaluating DVS-233 SR for Treatment of Vasomotor Symptoms Associated With Menopause Primary: To assess the efficacy and safety of DVS-233 SR compared with placebo for treatment of vasomotor symptoms (VMS) associated with menopause and to compare the bleeding incidence of DVS-233 SR and tibolone. Secondary: To assess the effects of DVS-233 SR and tibolone on changes from baseline in weight, breast pain, and health outcomes indicators.

• Country Belgium, Croatia, Czech Republic, Finland, France, Hungary, Mexico, Netherlands, Poland, Romania, South Africa, Spain, Sweden, Ukraine, United Kingdom,
• organs None
• Specialty None