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Sponsored by: |
Sanofi-Aventis |
Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00408148 |
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 IV |
MedlinePlus related topics: | Obesity |
Drug Information available for: | Rimonabant SR 141716A |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 80 |
Study Start Date: | October 2006 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
2: Placebo Comparator
Administration of one rimonabant placebo tablet once daily in the morning
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Drug: Placebo
Undistinguishable placebo tablets
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1: Experimental
Administration of one tablet containing 20 mg of active rimonabant once daily in the morning
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Drug: Rimonabant
White film-coated, for oral administration containing 20 mg of active rimonabant
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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.
Contact: Public Registry GMA | publicregistryGMA@sanofi-aventis.com |
Australia | |||||
Sanofi-Aventis | Recruiting | ||||
North Ryde, Australia | |||||
Finland | |||||
Sanofi-Aventis | Recruiting | ||||
Helsinki, Finland | |||||
France | |||||
Sanofi-Aventis | Recruiting | ||||
Paris, France | |||||
United Kingdom | |||||
Sanofi-Aventis | Terminated | ||||
Guildford, United Kingdom |
Sanofi-Aventis |
Study Director: | Valérie Pilorget | Sanofi-Aventis |
Responsible Party: | sanofi-aventis ( Medical Affairs Study Director ) |
Study ID Numbers: | RIMON_C_01346, EUDRACT # : 2006-001716-71 |
First Received: | December 5, 2006 |
Last Updated: | October 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00408148 |
Health Authority: | Finland: Ethics Committee |
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