NCT00458081

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

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.

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 174 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 30 Years – 75 Years
• Healthy volunteers: Not accepted

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

Conditions

• Obesity
• Microalbuminuria
• Diabetes Mellitus, Type 2
• Dyslipidemia

Interventions

Type	Name	Description
DRUG	Rimonabant	20 mg once per day + slightly reduced calorie diet
DRUG	Placebo	placebo once per day + slightly reduced calorie diet

Timeline

• Start date: 2007-03-01
• Primary completion: 2009-01-01
• Completion: 2009-01-01
• First posted: 2007-04-09
• Last updated: 2010-12-10

Locations

1 site across 1 country: Spain