Evaluation of the Rimonabant Impact on the Regression of Asymptomatic Damage Caused by Cardiovascular Risk Factors
Summary
Primary objective: * To assess the effect on microalbuminuria levels of treatment with rimonabant 20 mg versus a placebo during a 12 month period. Secondary objectives: * Percentage of patients in both arms of the study whose levels of microalbuminuria decrease, stabilise, increase towards macroalbuminuria or are unchanged after 12 months of treatment with rimonabant or placebo. * To assess the effect of treatment with rimonabant 20 mg versus placebo over a 12 month period on: * Weight and waist circumference. * Glycaemia profile: fasting glycaemia, fasting insulinaemia and HbA1c. * Lipid and lipoprotein profile: triglycerides, total cholesterol, HDL-C, LDL-C, apolipoproteins A1 and B. * Inflammatory markers * Adipocytokines. * Blood pressure. * Glomerular filtration rate. * To assess the quality of life by means of questionnaire filled in. * Safety parameters
Timeline
- Start
- 2007-03
- Primary completion
- 2009-01
- Completion
- 2009-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Rimonabant | Small molecule | 20 mg | — |