Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00263042
Status:
TERMINATED
Last Update Posted:
2016-05-20
First Post:
2005-12-06
Brief Title:
Comprehensive Rimonabant Evaluation Study of Cardiovascular ENDpoints and Outcomes
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
Randomized Multinational Multicenter Double-blind Placebo-controlled Two-arm Parallel Group Trial of Rimonabant 20 mg OD for Reducing the Risk of Major Cardiovascular Events in Abdominally Obese Patients With Clustering 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:
CRESCENDO
Brief Summary:
The primary objective is to show whether rimonabant reduces the risk of a heart attack MI stroke or death from an MI or stroke in patients with abdominal obesity with other cardiovascular CV risk factors
The secondary objective is to show whether rimonabant reduces the risk of MI stroke CV death or CV hospitalization in these patients
The secondary objective is to show whether rimonabant reduces the risk of MI stroke CV death or CV hospitalization in these patients
Detailed Description:
The estimated study duration per patient is 36 to 53 months All patients will be followed from randomization until a common study end date which will occur when the last patient has been followed for 33 months
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 |
|---|---|---|---|
| 2005-002942-20 | EUDRACT_NUMBER | None | None |