Evaluation of the Rimonabant Impact on the Regression of Asymptomatic Damage Caused by Cardiovascular Risk Factors (RIALTO)
This study has been terminated.
(Company decision has been taken in light of recent demands by certain national health authorities)
Information provided by:
First received: April 6, 2007
Last updated: December 9, 2010
Last verified: December 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
Diabetes Mellitus, Type 2
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|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.|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Sanofi:
Primary Outcome Measures:
- Relative change in the microalbuminuria level. [ Time Frame: between baseline visit and Month 12 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Percentage of patients whose albuminuria levels decrease, stabilise, are progressing towards macroalbuminuria, are unaltered. [ Time Frame: between baseline visit and Month 12 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- Evaluation of the Quality of Life (questionnaire IWQOL). [ Time Frame: at baseline visit and at 3, 6 and 12 months visit ] [ Designated as safety issue: No ]
- Safety (including neuropsychiatric events) and Laboratory assessments. [ Time Frame: at each visit and at baseline, 3, 6 and 12 month visits ] [ Designated as safety issue: Yes ]
|Study Start Date:||March 2007|
|Study Completion Date:||January 2009|
|Primary Completion Date:||January 2009 (Final data collection date for primary outcome measure)|
20 mg once per day + slightly reduced calorie diet
|Placebo Comparator: Placebo||
placebo once per day + slightly reduced calorie diet
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