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

July 17, 2009 updated by: Sanofi

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.

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

915

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Tokyo, Japan
        • Sanofi-Aventis Administrative Office

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: rimonabant (SR141716)
oral administration once daily
Placebo Comparator: 2
Drug: placebo
oral administration once daily

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (Actual)

November 1, 2008

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

February 9, 2007

First Submitted That Met QC Criteria

February 9, 2007

First Posted (Estimate)

February 12, 2007

Study Record Updates

Last Update Posted (Estimate)

July 20, 2009

Last Update Submitted That Met QC Criteria

July 17, 2009

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EFC5749

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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