Trial Information

Summary: Study to Establish the Clinical Benefit and Safety of Vytorin (Ezetimibe/Simvastatin Tablet) vs Simvastatin Monotherapy in High-Risk Subjects Presenting with Acute Coronary Syndrome.

The intent of this clinical study is to demonstrate the benefit of Ezetimibe/Simvastatin combination over at least 2.5 years of follow-up in high-risk coronary artery disease subjects beyond the known benefits of simvastatin monotherapy.

Several Study Inclusion Criteria Include:

• A statin-naïve subject will be eligible to enroll if his/her LDL-C concentration is = 50 mg/dL and =125 mg/dL;
• A subject receiving chronic statin therapy will be eligible to enroll, if his/her LDL-C concentration is = 50 mg/dL and = 100 mg/dL.

Several Study Exclusion Criteria Include:

• Subject who is clinically unstable.
• Subject is receiving statin therapy with LDL-C lowering potency greater than simvastatin 40 mg (eg, atorvastatin 40 - 80 mg, all doses of rosuvastatin, and all doses of Ezetimibe/Simvastatin Combination).

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Trial listings updated: February 25, 2008 at 2:32:24 PM