Conditions: Hypercholesterolemia
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 328
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine whether ezetimibe/atorvastatin 10 mg/40 mg combination tablet is equivalent to the coadministration of ezetimibe 10 mg and atorvastatin 40 mg in lowering low-density-lipoprotein-cholesterol (LDL-C) after 6 weeks of treatment.

Detailed description:

Arms:
arm 1: Medication will be administered in a double dummy fashion as 3 tablets orally on a daily basis, including 10 mg ezetimibe, 40 mg atorvastatin, and placebo to ezetimibe/atorvastatin. arm 2: Medication will be administered in a double dummy fashion as 3 tablets orally on a daily basis, including ezetimibe/atorvastatin 10 mg/40 mg, placebo to ezetimibe, and placebo to atorvastatin.

Interventions: intervention 1: Atorvastatin intervention 2: Ezetimibe intervention 3: Ezetimibe/atorvastatin intervention 4: Placebo to atorvastatin intervention 5: Placebo to ezetimibe intervention 6: Placebo to ezetimibe/atorvastatin
Intervention descriptions: intervention 1: 40 mg tablet administered orally once daily intervention 2: 10 mg tablet administered orally once daily intervention 3: Ezetimibe/atorvastatin 10 mg/40 mg combination tablet administered orally once daily intervention 4: Administered orally once daily intervention 5: Administered orally once daily intervention 6: Administered orally once daily

Protocol document: