Effects of Vytorin Versus Placebo in Subjects With Primary Hypercholesterolemia (Study P04420)
Status:
Completed
Trial end date:
2006-11-01
Target enrollment:
Participant gender:
Summary
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group Phase 3
study of Vytorin 10/10 (ezetimibe 10 mg with simvastatin 10 mg), Vytorin 10/20 (ezetimibe 10
mg with simvastatin 20 mg), and Vytorin 10/40 (ezetimibe 10 mg with simvastatin 40 mg)
compared to placebo administered daily for 8 consecutive weeks in subjects with primary
hypercholesterolemia (LDL-C >3.64 mmol/L [140 mg/dL]). The efficacy of daily Vytorin versus
placebo in reducing the concentration of LDL-C will be evaluated, and the efficacy of daily
Vytorin versus placebo with respect to change in the concentrations of total cholesterol,
triglycerides, and HDL-C will be compared. The safety of Vytorin versus placebo will also be
assessed.
Phase:
Phase 3
Details
Lead Sponsor:
Merck Sharp & Dohme Corp.
Collaborator:
Schering-Plough
Treatments:
Ezetimibe Ezetimibe, Simvastatin Drug Combination Simvastatin