Conditions: Hypercholesterolemia
Keywords: High Cholesterol
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1289
Healthy volunteers: no

Brief summary:
A multicenter study to evaluate the safety and efficacy of ezetimibe/simvastatin versus atorvastatin in elderly patients with high cholesterol at high or moderately high risk for coronary heart disease.

Detailed description:

Arms:
arm 1: Each patient will receive 1 active treatment dose \& 2 Placebo (Pbo) doses or 2 active treatment doses \& 1 Pbo dose at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 12 weeks. arm 2: Each patient will receive 1 active treatment dose \& 2 Pbo doses or 2 active treatment doses \& 1 Pbo dose at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 12 weeks. arm 3: Each patient will receive 1 active treatment dose \& 2 Pbo doses or 2 active treatment doses \& 1 Pbo dose at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 12 weeks. arm 4: Each patient will receive 1 active treatment dose \& 2 Pbo doses or 2 active treatment doses \& 1 Pbo dose at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 12 weeks. arm 5: Each patient will receive 1 active treatment dose \& 2 Pbo doses or 2 active treatment doses \& 1 Pbo dose at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 12 weeks.

Interventions: intervention 1: Atorvastatin 10 mg intervention 2: Ezetimibe 10 mg/simvastatin 20 mg intervention 3: Atorvastatin 20 mg intervention 4: Ezetimibe 10 mg/simvastatin 40 mg intervention 5: Atorvastatin 40 mg
Intervention descriptions: intervention 1: Atorvastatin 10 mg and Placebo for ezetimibe and placebo for simvastatin once daily for 12 weeks intervention 2: Ezetimibe 10 mg/simvastatin 20 mg and Placebo for atorvastatin once daily for 12 weeks intervention 3: Atorvastatin 20 mg and Placebo for ezetimibe and placebo for simvastatin once daily for 12 weeks intervention 4: Ezetimibe 10 mg/simvastatin 40 mg and Placebo for atorvastatin once daily for 12 weeks intervention 5: Atorvastatin 40 mg and Placebo for ezetimibe and placebo for simvastatin once daily for 12 weeks

Protocol document: