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| Sponsor: | Sanofi-Aventis |
|---|---|
| Information provided by: | Sanofi-Aventis |
| ClinicalTrials.gov Identifier: | NCT00299325 |
Purpose
Primary objective:
To assess the effect of rimonabant on visceral fat area over a period of 12 months when prescribed with a mild hypocaloric diet in abdominally obese patients with metabolic syndrome
Secondary objectives:
To assess the effect of rimonabant over a period of 12 months on:
In four selected US sites the effect of rimonabant at 12 months will be also assessed on:
| Condition | Intervention | Phase |
|---|---|---|
|
Metabolic Syndrome |
Drug: Rimonabant Drug: Placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Randomized, Double Blind, Two-arm Placebo Controlled, 12-Month Study of the Effects of Rimonabant 20mg Once Daily on the Amount and the Activity of Visceral Fat in Abdominally Obese Patients With Metabolic Syndrome. |
| Enrollment: | 254 |
| Study Start Date: | March 2006 |
| Study Completion Date: | July 2008 |
| Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Once daily in the morning
|
Drug: Rimonabant
White-opaque tablets, for oral administration containing 20 mg of active rimonabant
|
|
Placebo Comparator: 2
Once daily in the morning
|
Drug: Placebo
Undistinguishable placebo tablets
|
Eligibility| Ages Eligible for Study: | 35 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion criteria :
Two other components of the metabolic syndrome (NCEP/ATPIII definition) among the following :
Exclusion criteria :
Administration of any of the following within 3 months prior to screening visit:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Contacts and Locations| United States, New Jersey | |
| Sanofi-Aventis Administrative Office | |
| Bridgewater, New Jersey, United States, 08807 | |
| Canada | |
| Sanofi-Aventis Administrative Office | |
| Laval, Canada | |
| Denmark | |
| Sanofi-Aventis Administrative Office | |
| Hoersholm, Denmark | |
| Finland | |
| Sanofi-Aventis Administrative Office | |
| Helsinki, Finland | |
| France | |
| Sanofi-Aventis Administrative Office | |
| Paris, France | |
| Italy | |
| Sanofi-Aventis Administrative Office | |
| Milan, Italy | |
| Spain | |
| Sanofi-Aventis Administrative Office | |
| Barcelona, Spain | |
| Sweden | |
| Sanofi-Aventis Administrative Office | |
| Stockholm, Sweden | |
| United Kingdom | |
| Sanofi-Aventis Administrative Office | |
| Guildford, United Kingdom | |
| Study Director: | Valérie Pilorget, MD | Sanofi-Aventis |
More Information
| Responsible Party: | Trial Transparency Team, sanofi-aventis |
| ClinicalTrials.gov Identifier: | NCT00299325 History of Changes |
| Other Study ID Numbers: | PM_C_0172, EUDRACT # : 2005-002568-27 |
| Study First Received: | March 3, 2006 |
| Last Updated: | December 9, 2010 |
| Health Authority: | United States: Food and Drug Administration |
|
Metabolic Syndrome X Insulin Resistance Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases |