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

Official Title: “A Randomized Double-blind, Placebo-controlled, Parallel-group, Fixed Single-dose Regimen (SR141716 20 mg), Multicenter Study to Assess the Efficacy and Safety of SR141716 in Obese Patients With Dyslipidemia.”

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.

Intervention(s) in this Clinical Trial

• Drug: rimonabant (SR141716)
  • oral administration once daily
• Drug: placebo
  • oral administration once daily

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Placebo Comparator: 2

Primary Measures

• body weight: relative change from baseline
  • Time Frame: Week 52
    Safety Issue?: No
• triglycerides: relative change from baseline
  • Time Frame: Week 52
    Safety Issue?: No

Secondary Measures

• HDL-cholesterol ;visceral fat area
  • Time Frame: Week 52
    Safety Issue?: No
• Safety: Adverse events
  • Time Frame: study period
    Safety Issue?: Yes

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 20 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Sanofi-Aventis Industry

Overall Clinical Trial Officials and Contacts

ICD CSD Study Director Sanofi-Aventis  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00434096

Study ID Number: EFC5749

ClinicalTrials.gov Identifier: NCT00434096

Health Authority: Japan: Ministry of Health, Labor and Welfare