Conditions: Hypercholesterolemia Coronary Disease
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 120
Healthy volunteers: no

Brief summary:
This study is being conducted to compare the efficacy, safety, and tolerability of ezetimibe/simvastatin 10/20 mg when administered daily versus doubling the dose of simvastatin to 40 mg in patients with hypercholesterolemia and coronary heart disease.

Detailed description:

Arms:
arm 1: Subjects will receive 2 tablets. The first tablet is Ezetimibe/Simvastatin 10/20 mg. The second tablet is simvastatin placebo. Subjects will receive a maximum of 6 weeks of treatment arm 2: Subjects will receive 2 tablets. The first tablet is Ezetimibe/Simvastatin placebo. The second tablet is simvastatin 40 mg. Subjects will receive a maximum of 6 weeks of treatment.

Interventions: intervention 1: Ezetimibe/Simvastatin 10/20 mg intervention 2: simvastatin 40 mg
Intervention descriptions: intervention 1: 1 tablet containing 10 mg of ezetimibe and 20 mg of simvastatin per day for 6 weeks intervention 2: 1 tablet containing 40 mg of simvastatin per day for 6 weeks

Protocol document: