Status:
TERMINATED
Japanese Study of Rimonabant in Obese Patients With Dyslipidemia (VENUS)
Lead Sponsor:
Sanofi
Conditions:
Obesity
Eligibility:
All Genders
20+ years
Phase:
PHASE3
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 evalu...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
915 Patients enrolled
Trial Details
Trial ID
NCT00434096
Start Date
February 1 2007
End Date
February 1 2009
Last Update
July 20 2009
Active Locations (1)
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1
Sanofi-Aventis Administrative Office
Tokyo, Japan