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Clinical Trial 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


Clinical Trial Description

n/a


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00458081
Study type Interventional
Source Sanofi
Contact
Status Terminated
Phase Phase 3
Start date March 2007
Completion date January 2009

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