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| Descriptive Information Fields | |||||
| Brief Title † | STRADIVARIUS (Strategy To Reduce Atherosclerosis Development InVolving Administration of Rimonabant - the Intravascular Ultrasound Study) | ||||
| Official Title † | Randomized, Multicenter, Double-Blind, Placebo-Controlled, Two-Arm Parallel Group Trial of Rimonabant 20-mg od, for Inhibition of Atherosclerosis Progression Assessed by IVUS (IntraVascular UltraSounds), in Overweight Patients With Clustering Risk Factors | ||||
| Brief Summary | The purpose of this study is to determine if rimonabant 20 mg once daily (od) administered during 18-20 months will reduce progression of coronary atherosclerosis as assessed by intravascular ultrasound (IVUS) when administered on top of standard behavioral and pharmacological therapy given as needed, in patients with abdominal obesity associated with current smoking and/or metabolic syndrome. |
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| Detailed Description | |||||
| Study Phase | Phase III | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study | ||||
| Primary Outcome Measure † | change from baseline in percent atheroma volume (PAV) [ Time Frame: Month 18 visit ] | ||||
| Secondary Outcome Measure † | change from baseline in normalized total atheroma volume (TAV) [ Time Frame: Month 18 visit ] | ||||
| Condition † | Coronary Atherosclerosis | ||||
| Intervention † | Drug: Rimonabant (SR141716) Drug: Placebo |
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| MEDLINE PMIDs | 18387931 | ||||
| Links | |||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Completed | ||||
| Enrollment † | 839 | ||||
| Start Date † | January 2005 | ||||
| Completion Date | October 2007 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United States, Australia, Belgium, Canada, France, Italy, Netherlands, Poland, Spain | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00124332 | ||||
| Organization ID | EFC5827 | ||||
| Secondary IDs †† | SR141716 | ||||
| Study Sponsor † | Sanofi-Aventis | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | Sanofi-Aventis | ||||
| Verification Date | July 2008 | ||||
| First Received Date † | July 26, 2005 | ||||
| Last Updated Date | July 7, 2008 | ||||