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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Obesity

Intervention / Treatment
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* Drug: rimonabant (SR141716)
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: rimonabant (SR141716)<br>* oral administration once daily<br>|
| Placebo Comparator: 2<br> | Drug: placebo<br>* oral administration once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| body weight: relative change from baseline |  | Week 52 | 
| triglycerides: relative change from baseline |  | Week 52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HDL-cholesterol ;visceral fat area |  | Week 52 | 
| Safety: Adverse events |  | study period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity disease, cannabinoid-1 receptor