NCT02799758

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

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Kowa Research Institute, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Conditions

• Hyperlipidemia
• Dyslipidemia

Interventions

Type	Name	Description
DRUG	NK-104-CR	NK-104-CR 8 mg for 52 weeks
DRUG	Livalo® IR	Livalo® IR 4 mg daily for 52 weeks
DRUG	Placebo (for NK-104-CR)	NK-104-CR 8 mg placebo for 52 weeks
DRUG	Placebo (for Livalo® IR)	Livalo® IR 4 mg placebo for 52 weeks

Timeline

• Start date: 2016-02-01
• Primary completion: 2017-07-01
• Completion: 2017-11-01
• First posted: 2016-06-15
• Last updated: 2021-05-10

Locations

69 sites across 1 country: United States