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View of NCT00202878 on 2005_12_08

ClinicalTrials Identifier:NCT00202878
Updated:2005_12_08

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

PhasePhase 4
Study typeInterventional
Study designTreatment
Study designRandomized
Study designDouble Blind
Study designActive Control
Study designParallel Assignment
Study designSafety/Efficacy Study
Condition Hypercholesterolemia
Condition Myocardial Infarction
Intervention
Drug: ezetimibe/simvastatin combination 10 mg/40 mg (VYTORIN)
Intervention
Drug: simvastatin 40 mg (ZOCOR)

Recruitment Information
Status Not yet recruiting
Criteria

Inclusion Criteria:
 - Clinically stable subjects may be eligible to enroll within 10 days following hospital admission with high-risk acute coronary syndrome (either STEMI or Non-STEMI or unstable angina) .

 - Subjects not taking a statin must have an LDL-C of 125 mg/dl or less.  Subjects taking s statin must have an LDL-C of 100 mg/dl or less.


Exclusion Criteria:
 - Pregnant or lactating woman, or intending to become pregnant
 - Subject with active liver disease or persistent unexplained serum transaminase elevation
 - Subject with a history of alcohol or drug abuse,
 - Subject with a history of sensitivity to statin or ezetimibe
 - A subject for whom discontinuation of existing lipid lowering regimen poses an unacceptable risk.
Gender Both
Minimum age18 Years
Maximum ageN/A
Healthy volunteersNo

Administrative Data
Organization nameSchering-Plough
Organization study IDP04103
Lead sponsor Schering-Plough
Sponsor Merck
Health Authority United States: Food and Drug Administration