Japanese Dose-Response Study of Rimonabant in Obese Patients
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...
Brief Summary
Official Title: “A Dose-Response Relationship Study of SR141716 in Obese Patients”
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.
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
- Study Primary Completion Date: April 2006
Intervention(s) in this Clinical Trial
- Drug: rimonabant (SR141716)
Outcome Measures for this Clinical Trial
Primary Measures
- absolute change in body weight from baseline to Week 24
Secondary 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
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 20 Years
Maximum Age for this Clinical Trial: 70 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Sanofi-Aventis Industry
Overall Clinical Trial Officials and Contacts
Kohji SHIRAI, Professor Principal Investigator Toho University Sakura Medical Center, Japan
Additional Information
Information obtained from ClinicalTrials.gov on February 09, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00459004
Study ID Number: DRI5747
ClinicalTrials.gov Identifier: NCT00459004
Health Authority: Japan: Ministry of Health, Labor and Welfare
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00459004
