Japanese Dose-Response Study of Rimonabant in Obese Patients

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00459004

First Posted: April 11, 2007

Last Update Posted: April 7, 2009

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by:

Sanofi

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 Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment
Official Title:	A Dose-Response Relationship Study of SR141716 in Obese Patients

Resource links provided by NLM:

MedlinePlus related topics: Body Weight

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

Information from the National Library of Medicine

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Ages Eligible for Study:	20 Years to 70 Years (Adult, Senior)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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


Responsible Party:	ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier:	NCT00459004 History of Changes
Other Study ID Numbers:	DRI5747
First Submitted:	April 10, 2007
First Posted:	April 11, 2007
Last Update Posted:	April 7, 2009
Last Verified:	April 2009

Keywords provided by Sanofi:


weight loss

Additional relevant MeSH terms:


Rimonabant Cannabinoid Receptor Antagonists Cannabinoid Receptor Modulators Neurotransmitter Agents	Molecular Mechanisms of Pharmacological Action Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs

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