Conditions: Hypercholesterolemia
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 392
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Ezetimibe 10 mg with Simvastatin 10 mg arm 2: Ezetimibe 10 mg with Simvastatin 20 mg arm 3: Ezetimibe 10 mg with Simvastatin 40 mg arm 4: None

Interventions: intervention 1: ezetimibe with simvastatin intervention 2: Ezetimibe with Simvastatin intervention 3: Ezetimibe with Simvastatin intervention 4: Placebo
Intervention descriptions: intervention 1: Ezetimibe 10 mg with Simvastatin 10 mg once daily for a total of eight weeks intervention 2: Ezetimibe 10 mg with Simvastatin 20 mg once daily for a total of eight weeks intervention 3: Ezetimibe 10 mg with Simvastatin 40 mg once daily for a total of eight weeks intervention 4: Placebo once daily for a total of eight weeks

Protocol document: