Status:
COMPLETED
IMPROVE-IT: Examining Outcomes in Subjects With Acute Coronary Syndrome: Vytorin (Ezetimibe/Simvastatin) vs Simvastatin (P04103)
Lead Sponsor:
Organon and Co
Conditions:
Hypercholesterolemia
Myocardial Infarction
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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/Sim...
Eligibility Criteria
Inclusion
- Clinically stable participants may be eligible to enroll within 10 days following hospital admission with high-risk acute coronary syndrome (either ST-elevation myocardial infarction \[STEMI\] or Non-STEMI or unstable angina)
- Participants not taking a statin must have an LDL-C of 125 mg/dl or less. Participants taking a statin must have an LDL-C of 100 mg/dl or less.
Exclusion
- Pregnant or lactating woman, or intending to become pregnant
- Participant with active liver disease or persistent unexplained serum transaminase elevation
- History of alcohol or drug abuse
- History of sensitivity to statin or ezetimibe
- A participant for whom discontinuation of existing lipid lowering regimen poses an unacceptable risk.
Key Trial Info
Start Date :
October 17 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 18 2014
Estimated Enrollment :
18144 Patients enrolled
Trial Details
Trial ID
NCT00202878
Start Date
October 17 2005
End Date
September 18 2014
Last Update
June 18 2024
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