Conditions: Hypercholesterolemia
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 83
Healthy volunteers: no

Brief summary:
This is a randomized, open label, parallel group comparison study. Following a 1-week screening period, patients will be randomized to 1 of 2 treatment groups: ezetimibe added to ongoing statin treatment (ezetimibe plus simvastatin, atorvastatin or pravastatin at doses of 10/20, 10/10 or 10/20 mg), or doubling the dose of ongoing statin (simvastatin 40 mg, atorvastatin 20 mg, or pravastatin 40 mg). Study drug will be administered once daily in the evening for 8 weeks. Patients will be instructed to follow a National Cholesterol Education Program (NCEP) or similar cholesterol-lowering dietary regimen throughout the study.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Ezetimibe + Statin (simvastatin, atorvastatin, or pravastatin) intervention 2: Double Statin (simvastatin, atorvastatin, or pravastatin)
Intervention descriptions: intervention 1: ezetimibe 10 mg plus ongoing statin (simvastatin 20 mg or atorvastatin 10 mg or pravastatin 20 mg) once daily for 8 weeks intervention 2: simvastatin 40 mg or atorvastatin 20 mg or pravastatin 40 mg once daily for 8 weeks

Protocol document: