Safety and Efficacy Comparison Study of NK-104-CR (Controled Release) in Patients With Primary Hyperlipidemia or Mixed Dyslipidemia

Dyslipidemia Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02670434
• Other study ID #: NK-104-CR-3.01US
• Status: Withdrawn
• Phase: Phase 3
• Start date: January 2016
• Est. completion date: October 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 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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 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 who are =18 and =80 years of age at the time of consent;

• Fasting plasma LDL-C =160 mg/dL and =250 mg/dL and TG values of =300 mg/dL

• Patients who are naïve to statin or who are able to safely discontinue the use of all lipid-lowering agents for 6 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 >8%

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias
• Hyperlipidemia
• Hyperlipidemias
• Hyperlipoproteinemias

Intervention

Drug:
• NK-104-CR
NK-104-CR 8 mg daily for 52 weeks
• Placebo
Placebo daily for 12 weeks
• Livalo
Livalo® IR daily from week 12 to week 52

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 LDL-C from baseline		12 Weeks
Secondary	The percent change from baseline in fasting serum total cholesterol (TC )		12 Weeks