Efficacy & Long-term Safety Comparison Study of NK-104-CR & Livalo® IR With Primary Hyperlipidemia or Mixed Dyslipidemia

• Status: Withdrawn
• Trial end date: 2017-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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

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

Details

• Lead Sponsor: Kowa Research Institute, Inc.
• Treatments: Pitavastatin

Criteria

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%