Japanese Dose-Response Study of Rimonabant in Obese Patients

This study has been completed.
Information provided by:
ClinicalTrials.gov Identifier:
First received: April 10, 2007
Last updated: April 6, 2009
Last verified: April 2009

The primary objective is to verify the dose-response relationship of rimonabant on body weight change.

The secondary objectives are to compare the effect of 3 doses of SR141716 to placebo, on body weight loss and on secondary criteria associated with comorbidities, and to evaluate the safety and the pharmacokinetics of SR141716.

Condition Intervention Phase
Drug: rimonabant (SR141716)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Dose-Response Relationship Study of SR141716 in Obese Patients

Resource links provided by NLM:

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • absolute change in body weight from baseline to Week 24

Secondary Outcome Measures:
  • Efficacy: body weight, visceral fat area, waist circumference, fasting plasma glucose, HbA1c, triglyceride, HDL-cholesterol, blood pressure
  • Safety:adverse events, laboratory tests, ECGs
  • Pharmacokinetics: SR141716 plasma trough concentrations

Enrollment: 527
Study Start Date: October 2004
Study Completion Date: April 2006
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Body Mass Index ≥25 kg/m²
  • Viceral Fat Area ≥ 100 cm²
  • Diet therapy for more than 8 weeks before start of the placebo observation period
  • Stable weight (variation < ±3kg within 8 weeks before start of observation period)
  • At least 2 criteria of the following 3 comorbidities: Impaired Glucose Tolerance or Type 2 diabetes, Dyslipidemia (hypertriglyceridemia and/or low HDL-choresterol), Hypertension
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00459004

Tokyo, Japan
Sponsors and Collaborators
Principal Investigator: Kohji SHIRAI, Professor Toho University Sakura Medical Center, Japan
  More Information

No publications provided

Responsible Party: ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00459004     History of Changes
Other Study ID Numbers: DRI5747
Study First Received: April 10, 2007
Last Updated: April 6, 2009
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Sanofi:
weight loss

Additional relevant MeSH terms:
Nutrition Disorders
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014