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Japanese Dose-Response Study of Rimonabant in Obese Patients

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00459004
First received: April 10, 2007
Last updated: April 6, 2009
Last verified: April 2009
History of Changes
  Purpose

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
Obesity
 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:

U.S. FDA Resources

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)
  Eligibility

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

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

Locations
Japan
Sanofi-Aventis
Tokyo, Japan
Sponsors and Collaborators
Sanofi
Investigators
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:
Obesity
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013