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

Kowa

Status and phase

Completed

Phase 3

Conditions

Hypercholesterolemia

Dyslipidemia

Treatments

Drug: Pitavastatin

Study type

Interventional

Funder types

Industry

Identifiers

2005-001112-41

NK-104-307

Details and patient eligibility

About

This study is a long-term follow-up protocol for patients who participated in study NK-104-3.01EU or study NK-104-3.02EU.

Full description

Patients from the NK-104-3.01EU and NK-104-3.02EU studies will continue to receive either pitavastatin or the comparator statin for 1 year.

Enrollment

1,355 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients have completed 12 weeks of treatment in Study NK-104-301 (NCT00249249) or NK-104-302 (NCT00309777)
Patients who have not developed any treatment emergent and, in the opinion of the investigator, related adverse event (AE) of clinical significance where the investigator is uncomfortable with continuing the patient on therapy with pitavastatin.
Patients who have been following a fat and cholesterol restrictive diet.

Exclusion criteria

Any conditions which may cause secondary dyslipidemia should be reassessed at the beginning of the follow-up study.
Uncontrolled diabetes mellitus should be reassessed at the beginning of the follow-up study.
Abnormal pancreatic, liver, or renal function
Abnormal serum ALAT/SGPT/ALT, ASAT/SGOT/AST, or creatine kinase (CK) above the pre-specified level
Significant heart disease