At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Double-blind, Randomized, Placebo-controlled Parallel Groups Study Comparing the Efficacy and Safety of Vytorin Versus Placebo in Subjects With Primary Hypercholesterolemia
In Brief
A Phase 3 clinical trial evaluating ezetimibe with simvastatin, Ezetimibe with Simvastatin, and 1 other intervention for Hypercholesterolemia. Completed, enrolled 392 participants.
Detailed 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.
Study Details
Timeline
Interventions
Ezetimibe 10 mg with Simvastatin 10 mg once daily for a total of eight weeks
Ezetimibe 10 mg with Simvastatin 20 mg once daily for a total of eight weeks
Ezetimibe 10 mg with Simvastatin 40 mg once daily for a total of eight weeks
Placebo once daily for a total of eight weeks