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Therapeutic Areas: Cardiology/Vascular Diseases
Disease Category: Coronary Artery Disease
Trial Information
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).
Holy Cross Hospital Research Center
4875 N. Federal Hwy, Suite 700
Fort Lauderdale, FL 33308
Phone: 954-229-8400
Fax: 954-229-8597
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