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Japanese Dose-Response Study of Rimonabant in Obese Patients

This study has been completed.
ClinicalTrials.gov Identifier:
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:

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:

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)

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

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

Tokyo, Japan
Sponsors and Collaborators
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:
Cannabinoid Receptor Antagonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs