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

• Status: Completed
• Trial end date: 2007-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kowa Research Europe
• Treatments: Pitavastatin

Criteria

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