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| Sponsor: | Sanofi-Aventis |
|---|---|
| Information provided by: | Sanofi-Aventis |
| ClinicalTrials.gov Identifier: | NCT00408148 |
Purpose
The objective of the study is to evaluate the effect of Rimonabant 20mg in comparison to placebo, on HDL and VLDL lipoprotein kinetics, over a 12 months period.
Primary objectives:
Secondary objectives:
| Condition | Intervention | Phase |
|---|---|---|
|
Obesity |
Drug: Placebo Drug: Rimonabant |
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, Parallel, Placebo Controlled Study of Rimonabant 20 mg Effect on High Density Lipoprotein Kinetics in Patients With Abdominal Obesity and Additional Cardiometabolic Risk Factors |
| Enrollment: | 64 |
| Study Start Date: | October 2006 |
| Study Completion Date: | December 2008 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: 2
Administration of one rimonabant placebo tablet once daily in the morning
|
Drug: Placebo
Undistinguishable placebo tablets
|
|
Experimental: 1
Administration of one tablet containing 20 mg of active rimonabant once daily in the morning
|
Drug: Rimonabant
White film-coated, for oral administration containing 20 mg of active rimonabant
|
Eligibility| Ages Eligible for Study: | 35 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Contacts and Locations| Australia | |
| Sanofi-Aventis Administrative Office | |
| North Ryde, Australia | |
| Finland | |
| Sanofi-Aventis Administrative Office | |
| Helsinki, Finland | |
| France | |
| Sanofi-Aventis Administrative Office | |
| Paris, France | |
| United Kingdom | |
| Sanofi-Aventis Administrative Office | |
| Guildford, United Kingdom | |
| Study Director: | Valérie Pilorget | Sanofi-Aventis |
More Information
| Responsible Party: | Trial Transparency Team, sanofi-aventis |
| ClinicalTrials.gov Identifier: | NCT00408148 History of Changes |
| Other Study ID Numbers: | RIMON_C_01346, EUDRACT # : 2006-001716-71 |
| Study First Received: | December 5, 2006 |
| Last Updated: | December 9, 2010 |
| Health Authority: | Finland: Ethics Committee |
|
Obesity Overnutrition Nutrition Disorders |
Overweight Body Weight Signs and Symptoms |