Japanese Study of Rimonabant in Obese Patients With Dyslipidemia (VENUS)

• Status: Terminated
• Trial end date: 2009-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study is to assess the efficacy of SR141716 compared to placebo on body weight and triglycerides changes over a period of 52 weeks.

Secondary objectives are:

• To evaluate the effect of SR141716 compared to placebo over a period of 52 weeks, on HDL-cholesterol and visceral fat area.

• To evaluate the safety of SR141716 compared to placebo over a period of 104 weeks.

• To evaluate the pharmacokinetics of SR141716.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Rimonabant

Criteria

Inclusion Criteria:

• Body Mass Index (BMI) > 25 kg/m²

• Visceral Fat Area (VFA) > 100 cm²

• Triglycerides (TG) > 150 mg/dL and < 700 mg/dL, and/or HDL-cholesterol < 40 mg/dL(Dyslipidemia)

• At least 1 criteria of the following 2 comorbidities:

• Impaired Glucose Tolerance or Type 2 diabetes

• Hypertension

Exclusion Criteria:

• Patient with a secondary obesity.

• Patients who have received the diet therapy for less than 8 weeks before start of the observation period.

• Patients whose body weight changed by more than the variation of ± 2kg for screening period.

• Low compliance to drug intake (< 80%) and dietary instruction during the observation period.

• Patients with type 1 diabetes.

• Patients with a primary hyperlipidemia (i.e., familial hypercholesterolemia, familial combined hyperlipidemia and familial type III hyperlipidemia).

• Patients with a LDL-cholesterol > 190 mg/dL at any of Weeks -8 or -4.

• Patients with a secondary hypertension.