Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00228176
Status:
TERMINATED
Last Update Posted:
2016-05-20
First Post:
2005-09-26
Brief Title:
Atherosclerosis Underlying Development Assessed by Intima-Media Thickness in Patients on Rimonabant
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
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 Carotid Artery Intima-media Thickness CIMT in Overweight Patients With Additional Risk Factors
Status:
TERMINATED
Status Verified Date:
2016-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Company decision taken in light of demands by certain national health authorities
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AUDITOR
Brief Summary:
Objectives
Primary To evaluate the effect of rimonabant 20-mg once daily in comparison with placebo on the quantitative progression of atherosclerosis as assessed by carotid artery intima-media thickness CIMT
Secondary To evaluate the safety and tolerability of the above rimonabant regimen in the study population of atherosclerosis patients
Primary To evaluate the effect of rimonabant 20-mg once daily in comparison with placebo on the quantitative progression of atherosclerosis as assessed by carotid artery intima-media thickness CIMT
Secondary To evaluate the safety and tolerability of the above rimonabant regimen in the study population of atherosclerosis patients
Detailed Description:
This is a Phase III prospective multicentre multinational randomized double-blind placebo-controlled 2-arm parallel group trial rimonabant 20-mg od vs placebo There will be a three-stage screening process including successively a Screening visit a Screening CIMT and a validation of the Screening CIMT by the Imaging Core Laboratory Patients complying with all inclusion and exclusion criteria will be randomized in one of the 2 treatment groups less than two weeks after Screening visit Study drug rimonabant 20 mg od or matching placebo will be administered during 30 to 32 months At inclusion patients will be counseled to follow a mild hypocaloric diet to increase their exercise level and to stop smoking if smokers Glucoselipid parameters will be assessed at Baseline and every 6 months until the Month 30 visit CIMT will be performed at Baseline and every 6 months until final assessment at Month 30 primary endpointA post-treatment follow-up visit at Month 35 will allow the collection of all adverse events and cardiovascular outcomes occurring after last study drug administration
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2005-001612-49 | EUDRACT_NUMBER | None | None |