The purpose of this study is to demonstrate the superior efficacy of NK-104-CR 8 mg daily compared to Livalo® IR 4 mg daily on fasting serum low-density lipoprotein cholesterol (LDL-C) reduction and to evaluate the comparative safety of NK-104-CR 8 mg daily to Livalo® IR 4 mg daily after long-term treatment

Inclusion Criteria:

• Male and female patients with primary hyperlipidemia or mixed dyslipidemia
• Patients for whom lipid-lowering therapy is indicated according to NCEP ATPIII
• Patients who are naïve to statin or who are able to safely discontinue the use of all lipid-lowering agents for 4 weeks before randomization and throughout study participation

Exclusion Criteria:

• Homozygous familial hypercholesterolemia;
• Any conditions which may cause secondary dyslipidemia.
• Newly diagnosed or poorly controlled diabetes mellitus as defined by HbA1c >9%