Efficacy & Long-term Safety Comparison Study of NK-104-CR & Livalo® IR With Primary Hyperlipidemia or Mixed Dyslipidemia
NCT ID: NCT02799758
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
WITHDRAWN
PHASE3
INTERVENTIONAL
2016-02-29
2017-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety and Efficacy Comparison Study of NK-104-CR (Controled Release) in Patients With Primary Hyperlipidemia or Mixed Dyslipidemia
NCT02670434
A Study of LY3015014 in Otherwise Healthy Participants With High Low-density Lipoprotein (LDL) Cholesterol
NCT01618916
A Study of LY3015014 in Healthy Participants With Elevated Low Density Lipoprotein Cholesterol
NCT01426412
Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of K-312 in Healthy Subjects
NCT02676596
Efficacy Study of Extended-Release Niacin/Lovastatin Versus Usual Care
NCT00345657
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
NK-104-CR
NK-104-CR 8 mg tablet and Placebo (for Livalo® IR 4 mg tablet) orally once daily for 52 weeks.
NK-104-CR
NK-104-CR 8 mg for 52 weeks
Placebo (for Livalo® IR)
Livalo® IR 4 mg placebo for 52 weeks
Livalo® IR
Livalo® IR 4 mg tablet and Placebo (for NK-104-CR 8 mg tablet) orally once daily for 52 weeks.
Livalo® IR
Livalo® IR 4 mg daily for 52 weeks
Placebo (for NK-104-CR)
NK-104-CR 8 mg placebo for 52 weeks
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
NK-104-CR
NK-104-CR 8 mg for 52 weeks
Livalo® IR
Livalo® IR 4 mg daily for 52 weeks
Placebo (for NK-104-CR)
NK-104-CR 8 mg placebo for 52 weeks
Placebo (for Livalo® IR)
Livalo® IR 4 mg placebo for 52 weeks
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* Any conditions which may cause secondary dyslipidemia.
* Newly diagnosed or poorly controlled diabetes mellitus as defined by HbA1c \>9%
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Kowa Research Institute, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Foley, Alabama, United States
Huntsville, Alabama, United States
Montgomery, Alabama, United States
Muscle Shoals, Alabama, United States
Little Rock, Arkansas, United States
Greenbrae, California, United States
Huntington Park, California, United States
Lomita, California, United States
Long Beach, California, United States
Los Angeles, California, United States
Santa Ana, California, United States
Spring Valley, California, United States
Tustin, California, United States
Walnut Creek, California, United States
Milford, Connecticut, United States
Atlantis, Florida, United States
Cooper City, Florida, United States
Coral Springs, Florida, United States
Fleming Island, Florida, United States
Jacksonville, Florida, United States
Miami, Florida, United States
Oviedo, Florida, United States
Dawsonville, Georgia, United States
Macon, Georgia, United States
Suwanee, Georgia, United States
Addison, Illinois, United States
Chicago, Illinois, United States
Gurnee, Illinois, United States
Morton, Illinois, United States
Evansville, Indiana, United States
Topeka, Kansas, United States
Louisville, Kentucky, United States
Owensboro, Kentucky, United States
Oxon Hill, Maryland, United States
Biloxi, Mississippi, United States
Olive Branch, Mississippi, United States
Jefferson City, Missouri, United States
St Louis, Missouri, United States
Omaha, Nebraska, United States
Manlius, New York, United States
High Point, North Carolina, United States
Salisbury, North Carolina, United States
Wilmington, North Carolina, United States
Winston-Salem, North Carolina, United States
Fargo, North Dakota, United States
Cincinnati, Ohio, United States
Columbus, Ohio, United States
Franklin, Ohio, United States
Oklahoma City, Oklahoma, United States
Medford, Oregon, United States
Beaver, Pennsylvania, United States
Harleysville, Pennsylvania, United States
Jersey Shore, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Moncks Corner, South Carolina, United States
Simpsonville, South Carolina, United States
Summerville, South Carolina, United States
Austin, Texas, United States
Houston, Texas, United States
Katy, Texas, United States
Plano, Texas, United States
Round Rock, Texas, United States
San Antonio, Texas, United States
Salt Lake City, Utah, United States
Richmond, Virginia, United States
Suffolk, Virginia, United States
Seattle, Washington, United States
Kenosha, Wisconsin, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NK-104-CR-3.02US
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.