A Study to Evaluate the Efficacy and Safety of Vytorin Versus Standard Treatment of Other Statins in Moderate, Moderately High and High Risk Participants (MK-0653A-406)

Launched by ORGANON AND CO · Apr 27, 2012

Keywords

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Gender

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Eligibility criteria

• Inclusion Criteria:
• • Low-density lipoprotein cholesterol (LDL-C) ≥100 mg/dL
• • Either treatment naïve (no previous treatment with lipid-lowering medication) or if previously treated with lipid-lowering medication, must complete a wash-out 6 weeks prior to enrollment
• Exclusion Criteria:
• • LDL-C level ≥ 190 mg/dL
• • Hypersensitivity or intolerance to Vytorin, ezetimibe or simvastatin
• • Taking other lipid lowering agent except statins. (i.e. fenofibrate, niacin, ezetimibe, etc)
• • Pregnant or breastfeeding, or expecting to conceive within the projected duration of the study
• • Currently participating in or has previously participated in a study within 30 days
• • Congestive heart failure defined by New York Heart Association (NYHA) Class III or IV within previous 6 months
• • Uncontrolled cardiac arrhythmias or recent significant electrocardiogram (ECG) changes
• • Unstable angina pectoris
• • Myocardial infarction, coronary artery bypass surgery, or angioplasty within previous 3 months
• • Unstable or severe peripheral artery disease within previous 3 months
• • Uncontrolled hypertension (treated or untreated)
• • Type 1 or Type 2 diabetes mellitus that is poorly controlled or recently diagnosed (within previous 3 months)
• • Uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins
• • Serious cerebrovascular disorder (ischemic stroke or cerebral hemorrhage) within the previous 6 months
• • Received treatment with systemic corticosteroids, any cyclical hormones
• • within previous 8 weeks