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

Phase 3

Withdrawn

• Conditions: Hyperlipidemia; Dyslipidemia
• Interventions: Drug: NK-104-CR; Drug: Livalo® IR; Drug: Placebo (for NK-104-CR); Drug: Placebo (for Livalo® IR)

• Registration Number: NCT02799758
• Lead Sponsor: Kowa Research Institute, Inc.

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-06-10
• Study First Submitted QC: 2016-06-10
• Study First Posted: 2016-06-15
• Primary Completion: 2017-07
• Study Completion: 2017-11
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-06
• Last Update Posted: 2021-05-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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%

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NK-104-CR	NK-104-CR	NK-104-CR 8 mg tablet and Placebo (for Livalo® IR 4 mg tablet) orally once daily for 52 weeks.
Livalo® IR	Placebo (for NK-104-CR)	Livalo® IR 4 mg tablet and Placebo (for NK-104-CR 8 mg tablet) orally once daily for 52 weeks.
Livalo® IR	Livalo® IR	Livalo® IR 4 mg tablet and Placebo (for NK-104-CR 8 mg tablet) orally once daily for 52 weeks.
NK-104-CR	Placebo (for Livalo® IR)	NK-104-CR 8 mg tablet and Placebo (for Livalo® IR 4 mg tablet) orally once daily for 52 weeks.

Primary Outcome Measures

Name	Time	Method
Percent change in Low-density lipoprotein cholesterol (LDL-C)	Baseline to Week 12 endpoint