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

NCT ID: NCT00434096

Last Updated: 2009-07-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 915 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-02-28
• Study Completion Date: 2009-02-28

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.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

Group Type: EXPERIMENTAL

rimonabant (SR141716)

Intervention Type: DRUG

oral administration once daily

2

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

oral administration once daily

Interventions

rimonabant (SR141716)

oral administration once daily

Intervention Type: DRUG

placebo

oral administration once daily

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

sanofi-aventis

Principal Investigators

ICD CSD

Role: STUDY_DIRECTOR

Sanofi

Locations

Sanofi-Aventis Administrative Office

Tokyo, , Japan

Countries

Japan

Other Identifiers

EFC5749

Identifier Type: -

Identifier Source: org_study_id