Evaluation of the Rimonabant Impact on the Regression of Asymptomatic Damage Caused by Cardiovascular Risk Factors
Status:
Terminated
Trial end date:
2009-01-01
Target enrollment:
Participant gender:
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