drugset / Trial / NCT00458081

Evaluation of the Rimonabant Impact on the Regression of Asymptomatic Damage Caused by Cardiovascular Risk Factors

NCT00458081

Phase 3 Terminated 174 enrolled Sanofi
RandomizedParallel-groupDouble-blindTreatment

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

EvaluationDrugModalityDoseRoute
Subject Rimonabant Small molecule 20 mg