WithdrawnPhase 3

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

United States0Started 2016-02

Plain-language 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

Who can participate

Age range18 Years – 80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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%

What they're measuring

Percent change in Low-density lipoprotein cholesterol (LDL-C)

Timeframe: Baseline to Week 12 endpoint

Trial details

NCT IDNCT02799758

SponsorKowa Research Institute, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-07

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