Evaluation of the Rimonabant Impact on the Regression of Asymptomatic Damage Caused by Cardiovascular Risk Factors (RIALTO)
|ClinicalTrials.gov Identifier: NCT00458081|
Recruitment Status : Terminated (Company decision has been taken in light of recent demands by certain national health authorities)
First Posted : April 9, 2007
Last Update Posted : December 10, 2010
- To assess the effect on microalbuminuria levels of treatment with rimonabant 20 mg versus a placebo during a 12 month period.
- 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
- Blood pressure.
- Glomerular filtration rate.
- To assess the quality of life by means of questionnaire filled in.
- Safety parameters
|Condition or disease||Intervention/treatment||Phase|
|Obesity Microalbuminuria Diabetes Mellitus, Type 2 Dyslipidemia||Drug: Rimonabant Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||174 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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.|
|Study Start Date :||March 2007|
|Actual Primary Completion Date :||January 2009|
|Actual Study Completion Date :||January 2009|
20 mg once per day + slightly reduced calorie diet
|Placebo Comparator: Placebo||
placebo once per day + slightly reduced calorie diet
- Relative change in the microalbuminuria level. [ Time Frame: between baseline visit and Month 12 ]
- Percentage of patients whose albuminuria levels decrease, stabilise, are progressing towards macroalbuminuria, are unaltered. [ Time Frame: between baseline visit and Month 12 ]
- Relative change and absolute change of Weight, Waist circumference, Body mass index (weight and height), Specific lipid parameters, Glycaemia control parameters, Proinflammatory markers, Adipocytokines, Glomerular filtration rate, Blood pressure [ Time Frame: between baseline visit and Month 12 ]
- Evaluation of the Quality of Life (questionnaire IWQOL). [ Time Frame: at baseline visit and at 3, 6 and 12 months visit ]
- Safety (including neuropsychiatric events) and Laboratory assessments. [ Time Frame: at each visit and at baseline, 3, 6 and 12 month visits ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00458081
|Sanofi-Aventis Administrative Office|
|Study Director:||José Mª Taboada||Sanofi|