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

Dyslipidemia Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02799758
• Other study ID #: NK-104-CR-3.02US
• Status: Withdrawn
• Phase: Phase 3
• Start date: February 2016
• Est. completion date: November 2017

Study information

• Verified date: May 2021
• Source: Kowa Research Institute, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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%

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias
• Hyperlipidemia
• Hyperlipidemias
• Hyperlipoproteinemias

Intervention

Drug:
• NK-104-CR
NK-104-CR 8 mg for 52 weeks
• Livalo® IR
Livalo® IR 4 mg daily for 52 weeks
• Placebo (for NK-104-CR)
NK-104-CR 8 mg placebo for 52 weeks
• Placebo (for Livalo® IR)
Livalo® IR 4 mg placebo for 52 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kowa Research Institute, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent change in Low-density lipoprotein cholesterol (LDL-C)		Baseline to Week 12 endpoint