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

Phase 3

Terminated

• Conditions: Obesity
• Interventions: Drug: rimonabant (SR141716); Drug: placebo

• Registration Number: NCT00434096
• Lead Sponsor: Sanofi

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-02
• Study First Submitted: 2007-02-09
• Study First Submitted QC: 2007-02-09
• Study First Posted: 2007-02-12
• Primary Completion: 2008-11
• Study Completion: 2009-02
• Status Verified: 2009-07
• Last Update Submitted: 2009-07-17
• Last Update Posted: 2009-07-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 915

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	rimonabant (SR141716)	-
2	placebo	-

Primary Outcome Measures

Name	Time	Method
body weight: relative change from baseline	Week 52
triglycerides: relative change from baseline	Week 52

Secondary Outcome Measures

Name	Time	Method
HDL-cholesterol ;visceral fat area	Week 52
Safety: Adverse events	study period

Trial Locations

Locations (1)

Sanofi-Aventis Administrative Office; 🇯🇵 Tokyo, Japan