Study to Compare the Efficacy and Safety of Pitavastatin and Simvastatin

Study of Pitavastatin Vs. Simvastatin (Following Up-Titration) in Patients With Primary Hypercholesterolemia or Combined Dyslipidemia and 2 or More Risk Factors for Coronary Heart Disease

The purpose of this study is to compare the efficacy and safety of pitavastatin with that of simvastatin in patients with risk factors for heart disease.

Inclusion Criteria:

• Males and females (18-75 years of age)
• At least two cardiovascular disease risk factors
• Must have been following a restrictive diet
• Diagnosis of primary hypercholesterolemia or combined dyslipidemia

Exclusion Criteria:

• Homozygous familial hypercholesterolemia
• Conditions which may cause secondary dyslipidemia
• Uncontrolled diabetes mellitus
• Abnormal pancreatic, liver or renal function
• Abnormal serum creatine kinase (CK) above the pre-specified level