Ezetimibe Plus Atorvastatin Versus Atorvastatin Alone in Subjects With Primary Hypercholesterolemia (Study P03406)

Inclusion criteria

• >=18 years and <= 75 years of age with LDL-C concentration >= 2.6 mmol/L (100 mg/dL) to <= 4.1 mmol/L (160 mg/dL) using the Friedewald calculation available at the time of randomization Visit 3 (Baseline Visit) and triglyceride concentrations of < 3.99 mmol/L (350 mg/dL) at Baseline Visit
• documented coronary heart disease
• currently taking atorvastatin 10 mg daily and history has taken 80 % of daily doses for the preceding 6 weeks prior to Visit 3
• liver transaminases (ALT, AST) < 50 % above the upper limit of normal, with no active liver disease, and CK < 50 % above the upper limit of normal at Baseline Visit.
• cholesterol lowering diet and exercise program for at least 4 weeks prior to and during the study, and stable weight history.
• women receiving hormonal therapy, including hormone replacement, any estrogen antagonist/agonist, or oral contraceptives, must have been maintained on a stable dose and regimen for at least 8 weeks and continue same regimen during the study.
• women of non-childbearing potential or using acceptable method of birth control.
• subjects must be free of any clinically significant diseases other than hyperlipidemia or coronary heart disease that would interfere with study evaluations.

Exclusion criteria

• Subjects whose body mass index is >=30 kg/sqm at baseline.
• Subjects who consume >14 alcoholic drinks per week.
• Any condition or situation that, in the opinion of the investigator, might pose a risk to the subject or interfere with participation in the study.
• Women who are pregnant or nursing.
• Subjects who have not observed designated washout periods for prohibited medications (eg, potent inhibitors of CYP3A4, prescription or over-the-counter agents know to lower lipid levels, corticosteroids), or have been on a stable regimen of any cardiovascular agent for <6 weeks.