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



Status:Recruiting
Conditions:High Cholesterol
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 80
Updated:4/21/2016
Start Date:January 2016
End Date:October 2017
Contact:Richard Oh, M.D.
Email:Clinical@KowaUS.com
Phone:919-433-1600

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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


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%
We found this trial at
45
sites
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Lyndhurst, OH
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Beverly Hills, California 90211
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Charleston, South Carolina 29412
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Ft. Lauderdale, FL
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Greensboro, North Carolina 27401
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Houston, TX
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Jacksonville, FL
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Kettering, OH
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Miami, FL
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Mount Pleasant, South Carolina 29464
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Newport Beach, California 92660
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Newton, KS
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North Hollywood, California 91606
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Rochester, NY
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Thousand Oaks, California 91360
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Vista, CA
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Wichita, KS
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Willoughby Hills, OH
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