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NCT02670434 Clinical Trial

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Clinical Trial Details — Status: Withdrawn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
Secondary ID
Status Withdrawn
Phase Phase 3
First received
Last updated
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
Health authority
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Status Withdrawn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%

Study Design

Related Conditions & MeSH terms

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
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