Kusajili – Clinical trials directory

A Study of SR58611A in the Prevention of Depression Relapse in Patients With Major Depressive Disorder The purpose of the study is to assess whether treatment with SR58611A can prevent relapse of depressive symptoms in patients with major depressive disorder. Relapse will be assessed using the MADRS scale.Patients who demonstrate improvement in depressive symptoms at the end of the initial 12-week open-label treatment period with SR58611A are randomized to continue SR58611A or switch to placebo under double blind conditions for up to 52 weeks of additional treatment. The secondary objective is to evaluate the safety of SR58611A in patients with MDD.

• Country Argentina, Bulgaria, Croatia, Czech Republic, Finland, France, Mexico, Poland, Romania, Russian Federation, Serbia, Slovakia, South Africa,
• organs None
• Specialty None

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.

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

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.

• Country Australia, Belgium, Bulgaria, Canada, Czech Republic, France, Israel, Netherlands, Russian Federation, Slovakia, South Africa, Ukraine, United States,
• organs None
• Specialty None

Efficacy of Pioglitazone on Macrovascular Outcome in Patients With Type 2 Diabetes The purpose of this study is to determine whether pioglitazone, once daily (QD), can delay the time to death, heart attack, acute coronary syndrome, heart bypass surgery, stroke, leg bypass surgery or amputation in patients with type 2 diabetes.

• Country Austria, Belgium, Czech Republic, Denmark, Estonia, Finland, France, Germany, Hungary, Italy, Latvia, Lithuania, Netherlands, Norway, Poland, Slovakia, Sweden, Switzerland, United Kingdom,
• organs None
• Specialty None

The SEPIA-PCI Trial: Otamixaban in Comparison to Heparin in Subjects Undergoing Non-Urgent Percutaneous Coronary Intervention The objective of this dose-ranging study is to determine the effects of several intravenous (IV) regimens of otamixaban on pharmacodynamic markers (including markers of thrombosis and coagulation markers), safety/tolerability, clinical efficacy and pharmacokinetics.

• Country Belgium, Canada, Czech Republic, France, Germany, Netherlands, Slovakia, South Africa, Spain, United States,
• organs None
• Specialty None

A Randomized Double Blind Study Evaluating Duloxetine in Outpatients With MDD and Pain To determine the efficacy of Duloxetine vs. placebo on pain as determined by change in the Brief Pain Inventory (BPI) from baseline over 8 weeks of treatment

• Country Belgium, Czech Republic, Finland, France, Germany, Slovakia,
• 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

SOLMANIA - Comparison of Valproate-Amisulpride and Valproate-Haloperidol in Bipolar I Patients The primary objective is: - To compare the efficacy of the association valproate-amisulpride (400 to 800 mg/day) to the association valproate-haloperidol (5 to 15 mg/day) in bipolar I patients suffering from a manic episode according to DSM IV TR (American Psychiatric Association [APA] 2000) and treated for a 3-month period. The secondary objectives are: - To evaluate the clinical and biological safety of the association valproate-amisulpride to the association valproate-haloperidol; - To assess the patient status 3 weeks and 3 months after inclusion; and - To assess patient satisfaction at 3 months.

• Country Czech Republic, France, Poland, Slovakia, Spain,
• organs None
• Specialty None

Bipolar Maintenance Study of Lurasidone Adjunctive to Lithium or Divalproex This is a multi-center, randomized, placebo-controlled, flexible-dose, parallel-group study designed to evaluate the efficacy and safety of lurasidone (in combination with lithium or divalproex) for the maintenance treatment of bipolar I disorder in subjects with or without rapid cycling and /or psychotic features.

• Country Argentina, Australia, Bulgaria, Chile, Croatia, Czech Republic, France, Hungary, Japan, Poland, Russian Federation, Serbia, Slovakia, United States,
• organs None
• Specialty None

Almorexant (ACT 078573) in Adult Subjects With Chronic Primary Insomnia A polysomnography study to evaluate the effect, safety and tolerability of oral administration of almorexant (ACT 078573) in adult subjects with primary insomnia.

• Country Australia, Austria, Belgium, Bulgaria, Czech Republic, Denmark, Finland, France, Germany, Hungary, Israel, Italy, Poland, Slovakia, South Africa, Spain, Sweden, Switzerland, Ukraine, United Kingdom,
• organs None
• Specialty None