Japanese Dose-Response Study of Rimonabant in Obese Patients
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ClinicalTrials.gov Identifier: NCT00459004 |
Recruitment Status
:
Completed
First Posted
: April 11, 2007
Last Update Posted
: April 7, 2009
|
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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 or disease | Intervention/treatment | Phase |
---|---|---|
Obesity | Drug: rimonabant (SR141716) | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 527 participants |
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 |
Study Start Date : | October 2004 |
Actual Primary Completion Date : | April 2006 |
Actual Study Completion Date : | April 2006 |

- absolute change in body weight from baseline to Week 24
- 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

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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

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
Japan | |
Sanofi-Aventis | |
Tokyo, Japan |
Principal Investigator: | Kohji SHIRAI, Professor | Toho University Sakura Medical Center, Japan |
Responsible Party: | ICD Study Director, sanofi-aventis |
ClinicalTrials.gov Identifier: | NCT00459004 History of Changes |
Other Study ID Numbers: |
DRI5747 |
First Posted: | April 11, 2007 Key Record Dates |
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 |