Safety and Efficacy Comparison Study of NK-104-CR (Controled Release) in Patients With Primary Hyperlipidemia or Mixed Dyslipidemia
NCT ID: NCT02670434
Last Updated: 2021-05-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE3
INTERVENTIONAL
2016-01-31
2017-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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NK-104-CR
Controlled release NK-104
NK-104-CR
NK-104-CR 8 mg daily for 52 weeks
Placebo
Livalo Placebo
Placebo
Placebo daily for 12 weeks
Livalo® Immediate Release IR
Immediate Release Livalo®
Livalo
Livalo® IR daily from week 12 to week 52
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* Any conditions which may cause secondary dyslipidemia.
* Newly diagnosed or poorly controlled diabetes mellitus as defined by HbA1c \>8%
18 Years
80 Years
ALL
No
Sponsors
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Kowa Research Institute, Inc.
INDUSTRY
Responsible Party
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Locations
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Beverly Hills, California, United States
Chino, California, United States
Lincoln, California, United States
Los Angeles, California, United States
Newport Beach, California, United States
North Hollywood, California, United States
Thousand Oaks, California, United States
Vista, California, United States
Brooksville, Florida, United States
Fort Lauderdale, Florida, United States
Jacksonville, Florida, United States
Jupiter, Florida, United States
Miami, Florida, United States
Pembroke Pines, Florida, United States
Port Orange, Florida, United States
Marietta, Georgia, United States
Meridian, Idaho, United States
Chicago, Illinois, United States
Evanston, Illinois, United States
Evansville, Indiana, United States
Indianapolis, Indiana, United States
Newton, Kansas, United States
Wichita, Kansas, United States
Auburn, Maine, United States
Elkridge, Maryland, United States
Edina, Minnesota, United States
Jackson, Mississippi, United States
Butte, Montana, United States
Las Vegas, Nevada, United States
Berlin, New Jersey, United States
Endwell, New York, United States
Rochester, New York, United States
Greensboro, North Carolina, United States
Cincinnati, Ohio, United States
Kettering, Ohio, United States
Lyndhurst, Ohio, United States
Marion, Ohio, United States
Willoughby Hills, Ohio, United States
Downingtown, Pennsylvania, United States
Charleston, South Carolina, United States
Mt. Pleasant, South Carolina, United States
Kingsport, Tennessee, United States
Houston, Texas, United States
Hurst, Texas, United States
Madison, Wisconsin, United States
Countries
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Other Identifiers
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NK-104-CR-3.01US
Identifier Type: -
Identifier Source: org_study_id
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