| ClinicalTrials Identifier: | NCT00202878 |
|---|---|
| Updated: | 2006_10_02 |
Descriptive Information |
|
| Brief title |
IMPROVE-IT: Examining Outcomes in Subjects With Acute Coronary Syndrome:Vytorin (Ezetimibe/Simvastatin) vs Simvastatin (Study P04103) |
| Official title |
Study to Establish the Clinical Benefit/Safety of Vytorin (Ezetimibe/Simvastatin Tablet) vs Simvastatin in Subjects With Acute Coronary Syndrome (IMProved Reduction of Outcomes: Vytorin Efficacy International Trial – IMPROVE IT) |
| 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 Ezetimibe/Simvastatin Combination 10/40 (single tablet, under the brand VYTORIN in the United States) compared with Simvastatin 40 mg. Clinical benefit will be defined as the reduction in the risk of the occurrence of the composite endpoint of CV death, major coronary events, and stroke. |
|
| Detailed description | |
| Phase | Phase 3 |
| Study type | Interventional |
| Condition | Hypercholesterolemia |
| Condition | Myocardial Infarction |
| Intervention |
Drug: ezetimibe/simvastatin combination 10 mg/40 mg (VYTORIN)
|
| Intervention |
Drug: simvastatin 40 mg (ZOCOR)
|
Recruitment Information |
|
| Status | Recruiting |
| Criteria | |
|
Inclusion Criteria: |
|
| Gender | Both |
| Minimum age | 18 Years |
| Maximum age | N/A |
| Healthy volunteers | No |
Administrative Data |
|
| Organization name | Schering-Plough |
| Organization study ID | P04103 |
| Lead sponsor | Schering-Plough |
| Sponsor | Merck |