Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00202878
Status:
COMPLETED
Last Update Posted:
2024-06-18
First Post:
2005-09-13
Brief Title:
IMPROVE-IT Examining Outcomes in Subjects With Acute Coronary Syndrome Vytorin EzetimibeSimvastatin vs Simvastatin P04103
Sponsor:
Organon and Co
Organization:
Organon and Co
Study Overview
Official Title:
A Multicenter Double-Blind Randomized Study to Establish the Clinical Benefit and Safety of Vytorin EzetimibeSimvastatin Tablet vs Simvastatin Monotherapy in High-Risk Subjects Presenting With Acute Coronary Syndrome IMProved Reduction of Outcomes Vytorin Efficacy International Trial - IMPROVE IT
Status:
COMPLETED
Status Verified Date:
2022-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a randomized active-control double-blind study of subjects with stabilized high-risk acute coronary syndrome ACS The primary objective is to evaluate the clinical benefit of EzetimibeSimvastatin Combination 1040 single tablet under the brand VYTORIN in the United States compared with Simvastatin 40 mg As per the original protocol if low-density lipoprotein cholesterol LDL-C response was inadequate the dose of simvastatin in the VYTORIN arm or simvastatin arm could be increased to 80 mg Note per June 2011 protocol amendment criteria for continued use of 80 mg simvastatin were modified and new increases of simvastatin dose to 80 mg were stopped Clinical benefit will be defined as the reduction in the risk of the occurrence of the composite endpoint of cardiovascular CV death major coronary events and stroke
Detailed Description:
None
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 |
|---|---|---|---|
| MK-0653A-080 | OTHER | Merck Study Number | None |