Clinical Trial Details
| Trial ID: | L3965 |
| Source ID: | NCT00458081 |
| Associated Drug: | Rimonabant |
| Title: | Evaluation of the Rimonabant Impact on the Regression of Asymptomatic Damage Caused by Cardiovascular Risk Factors |
| Acronym: | RIALTO |
| Status: | TERMINATED |
| Study Results: | NO |
| Results: | |
| Conditions: | Obesity|Microalbuminuria|Diabetes Mellitus, Type 2|Dyslipidemia |
| Interventions: | DRUG: Rimonabant|DRUG: Placebo |
| Outcome Measures: | Primary: Relative change in the microalbuminuria level., between baseline visit and Month 12 | Secondary: Percentage of patients whose albuminuria levels decrease, stabilise, are progressing towards macroalbuminuria, are unaltered., 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, between baseline visit and Month 12|Evaluation of the Quality of Life (questionnaire IWQOL)., at baseline visit and at 3, 6 and 12 months visit|Safety (including neuropsychiatric events) and Laboratory assessments., at each visit and at baseline, 3, 6 and 12 month visits |
| Sponsor/Collaborators: | Sponsor: Sanofi |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE3 |
| Enrollment: | 174 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT |
| Start Date: | 2007-03 |
| Completion Date: | 2009-01 |
| Results First Posted: | |
| Last Update Posted: | 2010-12-10 |
| Locations: | Sanofi-Aventis Administrative Office, Barcelona, Spain |
| URL: | https://clinicaltrials.gov/show/NCT00458081 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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