NCT02670434

Safety and Efficacy Comparison Study of NK-104-CR (Controled Release) in Patients 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• Status: Withdrawn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 compare the efficacy of NK-104-CR with Placebo and Livalo® on the reduction of LDL-C and to evaluate the safety of NK-104-CR in patients with primary hyperlipidemia or mixed dyslipidemia

Conditions

• Hyperlipidemia
• Dyslipidemia

Interventions

Type	Name	Description
DRUG	NK-104-CR	NK-104-CR 8 mg daily for 52 weeks
DRUG	Placebo	Placebo daily for 12 weeks
DRUG	Livalo	Livalo® IR daily from week 12 to week 52

Timeline

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

Locations

45 sites across 1 country: United States