Efficacy & Long-term Safety Comparison Study of NK-104-CR & Livalo® IR With Primary Hyperlipidemia or Mixed Dyslipidemia
1 other identifier
interventional
N/A
1 country
69
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Feb 2016
69 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2016
CompletedFirst Submitted
Initial submission to the registry
June 10, 2016
CompletedFirst Posted
Study publicly available on registry
June 15, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2017
CompletedMay 10, 2021
May 1, 2021
1.4 years
June 10, 2016
May 6, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Percent change in Low-density lipoprotein cholesterol (LDL-C)
Baseline to Week 12 endpoint
Study Arms (2)
NK-104-CR
EXPERIMENTALNK-104-CR 8 mg tablet and Placebo (for Livalo® IR 4 mg tablet) orally once daily for 52 weeks.
Livalo® IR
ACTIVE COMPARATORLivalo® IR 4 mg tablet and Placebo (for NK-104-CR 8 mg tablet) orally once daily for 52 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Homozygous familial hypercholesterolemia;
- Any conditions which may cause secondary dyslipidemia.
- Newly diagnosed or poorly controlled diabetes mellitus as defined by HbA1c \>9%
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (69)
Unknown Facility
Foley, Alabama, United States
Unknown Facility
Huntsville, Alabama, United States
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Montgomery, Alabama, United States
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Muscle Shoals, Alabama, United States
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Little Rock, Arkansas, United States
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Greenbrae, California, United States
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Huntington Park, California, United States
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Lomita, California, United States
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Long Beach, California, United States
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Los Angeles, California, United States
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Santa Ana, California, United States
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Spring Valley, California, United States
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Tustin, California, United States
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Walnut Creek, California, United States
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Milford, Connecticut, United States
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Atlantis, Florida, United States
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Cooper City, Florida, United States
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Coral Springs, Florida, United States
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Fleming Island, Florida, United States
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Jacksonville, Florida, United States
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Miami, Florida, United States
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Oviedo, Florida, United States
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Dawsonville, Georgia, United States
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Macon, Georgia, United States
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Suwanee, Georgia, United States
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Addison, Illinois, United States
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Chicago, Illinois, United States
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Gurnee, Illinois, United States
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Morton, Illinois, United States
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Evansville, Indiana, United States
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Topeka, Kansas, United States
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Louisville, Kentucky, United States
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Owensboro, Kentucky, United States
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Oxon Hill, Maryland, United States
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Biloxi, Mississippi, United States
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Olive Branch, Mississippi, United States
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Jefferson City, Missouri, United States
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St Louis, Missouri, United States
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Omaha, Nebraska, United States
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Manlius, New York, United States
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High Point, North Carolina, United States
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Salisbury, North Carolina, United States
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Wilmington, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Fargo, North Dakota, United States
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Cincinnati, Ohio, United States
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Columbus, Ohio, United States
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Franklin, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Medford, Oregon, United States
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Beaver, Pennsylvania, United States
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Harleysville, Pennsylvania, United States
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Jersey Shore, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Moncks Corner, South Carolina, United States
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Simpsonville, South Carolina, United States
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Summerville, South Carolina, United States
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Austin, Texas, United States
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Houston, Texas, United States
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Katy, Texas, United States
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Plano, Texas, United States
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Round Rock, Texas, United States
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San Antonio, Texas, United States
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Salt Lake City, Utah, United States
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Richmond, Virginia, United States
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Suffolk, Virginia, United States
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Seattle, Washington, United States
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Kenosha, Wisconsin, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 10, 2016
First Posted
June 15, 2016
Study Start
February 1, 2016
Primary Completion
July 1, 2017
Study Completion
November 1, 2017
Last Updated
May 10, 2021
Record last verified: 2021-05