Japanese Dose-Response Study of Rimonabant in Obese Patients

Phase 2

Completed

• Conditions: Obesity

• Registration Number: NCT00459004
• Lead Sponsor: Sanofi

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-10
• Primary Completion: 2006-04
• Study Completion: 2006-04
• Study First Submitted: 2007-04-10
• Study First Submitted QC: 2007-04-10
• Study First Posted: 2007-04-11
• Status Verified: 2009-04
• Last Update Submitted: 2009-04-06
• Last Update Posted: 2009-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 527

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
absolute change in body weight from baseline to Week 24

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Sanofi-Aventis; 🇯🇵 Tokyo, Japan