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

Primary Purpose

Obesity

Status

Terminated

Phase

Phase 3

Locations

Japan

Study Type

Interventional

Intervention

rimonabant (SR141716)

placebo

About this trial

This is an interventional treatment trial for Obesity focused on measuring Obesity disease, cannabinoid-1 receptor

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Sanofi-Aventis Administrative Office

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

body weight: relative change from baseline

triglycerides: relative change from baseline

Secondary Outcome Measures

HDL-cholesterol ;visceral fat area

Safety: Adverse events

Full Information

NCT ID

NCT00434096

First Posted

February 9, 2007

Last Updated

July 17, 2009

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT00434096

Brief Title

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.

Study Type

Interventional

2. Study Status

Record Verification Date

July 2009

Overall Recruitment Status

Terminated

Why Stopped

Company decision taken in light of demands by certain national health authorities

Study Start Date

February 2007 (undefined)

Primary Completion Date

November 2008 (Actual)

Study Completion Date

February 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Sanofi

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity

Keywords

Obesity disease, cannabinoid-1 receptor

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

915 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

rimonabant (SR141716)

Intervention Description

oral administration once daily

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

oral administration once daily

Primary Outcome Measure Information:

Title

body weight: relative change from baseline

Time Frame

Week 52

Title

triglycerides: relative change from baseline

Time Frame

Week 52

Secondary Outcome Measure Information:

Title

HDL-cholesterol ;visceral fat area

Time Frame

Week 52

Title

Safety: Adverse events

Time Frame

study period

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

ICD CSD

Organizational Affiliation

Sanofi

Official's Role

Study Director

Facility Information:

Facility Name

Sanofi-Aventis Administrative Office

City

Tokyo

Country

Japan

12. IPD Sharing Statement

Learn more about this trial

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

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