Long-Term Extension Study of Pitavastatin in Patients With Primary Hypercholesterolemia or Combined Dyslipidemia

Inclusion Criteria:

• Patients have completed 12 weeks of treatment in Study NK-104-301 (NCT00249249) orNK-104-302 (NCT00309777)

• Patients who have not developed any treatment emergent and, in the opinion of theinvestigator, related adverse event (AE) of clinical significance where theinvestigator is uncomfortable with continuing the patient on therapy withpitavastatin.

• Patients who have been following a fat and cholesterol restrictive diet.

Exclusion Criteria:

• Any conditions which may cause secondary dyslipidemia should be reassessed at thebeginning of the follow-up study.

• Uncontrolled diabetes mellitus should be reassessed at the beginning of the follow-upstudy.

• Abnormal pancreatic, liver, or renal function

• Abnormal serum ALAT/SGPT/ALT, ASAT/SGOT/AST, or creatine kinase (CK) above thepre-specified level

• Significant heart disease