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)

• Status: Withdrawn
• Trial end date: 2014-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate and compare the effectiveness of MK-0653 (Vytorin) to current standard treatment with other statins for the treatment of dyslipidemia in moderate, moderately-high and high-risk participants.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Ezetimibe; Ezetimibe, Simvastatin Drug Combination; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Simvastatin

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