Japanese Dose-Response Study of Rimonabant in Obese Patients

Obesity Clinical Trial

Official title:

A Dose-Response Relationship Study of SR141716 in Obese Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00459004
• Other study ID #: DRI5747
• Status: Completed
• Phase: Phase 2
• First received: April 10, 2007
• Last updated: April 6, 2009
• Start date: October 2004
• Est. completion date: April 2006

Study information

• Verified date: April 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 527
• Est. completion date: April 2006
• Est. primary completion date: April 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity

Intervention

Drug:
• rimonabant (SR141716)

Locations

Country	Name	City	State
Japan	Sanofi-Aventis	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	absolute change in body weight from baseline to Week 24
Secondary	Efficacy: body weight, visceral fat area, waist circumference, fasting plasma glucose, HbA1c, triglyceride, HDL-cholesterol, blood pressure
Secondary	Safety:adverse events, laboratory tests, ECGs
Secondary	Pharmacokinetics: SR141716 plasma trough concentrations