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

Obesity Clinical Trial

Official title: 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

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

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

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