Safety and Efficacy Comparison Study of NK-104-CR (Controled Release) in Patients With Primary Hyperlipidemia or Mixed Dyslipidemia

Inclusion Criteria:

- Male and female patients with primary hyperlipidemia or mixed dyslipidemia who are
≥18 and ≤80 years of age at the time of consent;

- Fasting plasma LDL-C ≥160 mg/dL and ≤250 mg/dL and TG values of ≤300 mg/dL

- Patients who are naïve to statin or who are able to safely discontinue the use of all
lipid-lowering agents for 6 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 >8%