Conditions: Hypercholesterolemia
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 250
Healthy volunteers: no

Brief summary:
Participants currently taking atorvastatin 20 mg will be switched to either atorvastatin 40 mg or ezetimibe/simvastatin 10 mg/40 mg (10/40). After 6 weeks of treatment, the percent reduction in low-density lipoprotein cholesterol (LDL-C) will be assessed and compared between the two treatment groups.

Detailed description:

Arms:
arm 1: Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, ezetimibe/simvastatin 10/40 was administered once daily in tablet form during the 6-week double-blind treatment period arm 2: Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, 40 mg atorvastatin was administered once daily in tablet form during the 6-week double-blind treatment period

Interventions: intervention 1: ezetimibe/simvastatin 10/40 intervention 2: atorvastatin 40 mg intervention 3: atorvastatin 20 mg
Intervention descriptions: intervention 1: ezetimibe/simvastatin 10/40 tablet once daily for 6 weeks. intervention 2: atorvastatin 40 mg tablet once daily for 6 weeks intervention 3: All participants will take atorvastatin 20 mg tablet once daily for the 5 week run-in period before randomization

Protocol document: