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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00412698 |
Primary :
To determine the effect of Rimonabant 20 mg on changes in, HDL-Cholesterol (HDL-C), triglyceride levels over a period of 12 months when prescribed with a mild hypocaloric diet in abdominally obese patients with dyslipidemia with or without other associated comorbidities.
Main Secondary :
To determine the effect of 12 months Rimonabant treatment versus placebo on changes in waist circumference (WC), body weight, glycemic and lipid parameters. To assess the safety of 12 months Rimonabant treatment versus placebo in these patients.
In selected sites, a sub study will be conducted to determine the effect of 12 months of Rimonabant on additional lipoprotein and inflammatory parameters.
Condition | Intervention | Phase |
---|---|---|
Obesity Dyslipidemias |
Drug: rimonabant Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A European Randomized, Parallel Group, Two-Arm Placebo-Controlled, Double-Blind Multicenter Study of Rimonabant 20mg Once Daily in the Treatment of Abdominally Obese Patients With Dyslipidemia With or Without Other Comorbidities |
Enrollment: | 645 |
Study Start Date: | December 2006 |
Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: rimonabant
Administration of one tablet containing 20 mg of active rimonabantonce daily in the morning. White film-coated tablets, for oral administration containing 20 mg of active rimonabant |
2: Placebo Comparator |
Drug: Placebo
Administration of one rimonabant placebo tablet once daily in the morning. Undistinguishable placebo tablets.
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Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Concomitant medications:
Exclusion Criteria:
Presence of any condition (medical, including clinically significant abnormal laboratory tests, psychological, social or geographical) actual or anticipated that the investigator feels would compromise the patient's safety or limit his/her successful participation to the study. In particular :
Concomitant medications prior to study entry::
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.
Czech Republic | |
Sanofi-Aventis | |
Prague, Czech Republic | |
Finland | |
Sanofi-Aventis | |
Helsinki, Finland | |
Germany | |
Sanofi-Aventis | |
Berlin, Germany | |
Greece | |
Sanofi-Aventis | |
Athens, Greece | |
Hungary | |
Sanofi-Aventis | |
Budapest, Hungary | |
Ireland | |
Sanofi-Aventis | |
Dublin, Ireland | |
Italy | |
Sanofi-Aventis | |
Milan, Italy | |
Netherlands | |
Sanofi-Aventis | |
Gouda, Netherlands | |
Norway | |
Sanofi-Aventis | |
Lysaker, Norway | |
Portugal | |
Sanofi-Aventis | |
Porto-Salvo, Portugal | |
Slovakia | |
Sanofi-Aventis | |
Bratislava, Slovakia | |
Sweden | |
Sanofi-Aventis | |
Stockholm, Sweden | |
Turkey | |
Sanofi-Aventis | |
Istanbul, Turkey | |
United Kingdom | |
Sanofi-Aventis | |
Guildford, United Kingdom |
Study Director: | Valérie Pilorget, MD | Sanofi-Aventis |
Responsible Party: | sanofi-aventis ( Medical Affairs Study Director ) |
Study ID Numbers: | RIMON_R_00962, EUDRACT # : 2006-001715-30 |
Study First Received: | December 15, 2006 |
Last Updated: | March 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00412698 History of Changes |
Health Authority: | Portugal: National Pharmacy and Medicines Institute |
Body Weight Signs and Symptoms Obesity Metabolic Diseases Nutrition Disorders |
Overweight Overnutrition Metabolic Disorder Dyslipidemias Lipid Metabolism Disorders |
Body Weight Signs and Symptoms Obesity Metabolic Diseases Nutrition Disorders |
Overweight Overnutrition Dyslipidemias Lipid Metabolism Disorders |