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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00458081 |
Primary objective:
Secondary objectives:
To assess the effect of treatment with rimonabant 20 mg versus placebo over a 12 month period on:
Condition | Intervention | Phase |
---|---|---|
Obesity Microalbuminuria Diabetes Mellitus, Type 2 Dyslipidemia |
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 12-Month Multicentre, Randomised, Double-Blind, Placebo-Controlled Study With Two Parallel Groups to Assess the Effects of Rimonabant 20 mg in Patients With Abdominal Obesity and Microalbuminuria, With Type 2 Diabetes Mellitus or Dyslipidaemia With or Without Other Cardiometabolic Risk Factors. |
Enrollment: | 174 |
Study Start Date: | March 2007 |
Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Rimonabant: Experimental |
Drug: Rimonabant
20 mg once per day + slightly reduced calorie diet
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Placebo: Placebo Comparator |
Drug: Placebo
placebo once per day + slightly reduced calorie diet
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Ages Eligible for Study: | 30 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Concomitant medication prior to the screening visit
Administration of any of the following products in the 3 months prior to the screening visit
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Responsible Party: | sanofi-aventis ( Medical Affairs Study Director ) |
Study ID Numbers: | RIMON_L_01031, EudraCT # : 2006-002951-33 |
Study First Received: | April 6, 2007 |
Last Updated: | February 27, 2009 |
ClinicalTrials.gov Identifier: | NCT00458081 History of Changes |
Health Authority: | Spain: Spanish Agency of Medicines |
Obesity Albuminuria Metabolic Diseases Urination Disorders Diabetes Mellitus Endocrine System Diseases Overweight Body Weight Signs and Symptoms Proteinuria |
Urologic Diseases Diabetes Mellitus, Type 2 Nutrition Disorders Overnutrition Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder Dyslipidemias Lipid Metabolism Disorders |
Obesity Albuminuria Metabolic Diseases Urination Disorders Diabetes Mellitus Endocrine System Diseases Overweight Body Weight Urological Manifestations |
Signs and Symptoms Proteinuria Urologic Diseases Diabetes Mellitus, Type 2 Nutrition Disorders Overnutrition Glucose Metabolism Disorders Dyslipidemias Lipid Metabolism Disorders |