- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02799758
Efficacy & Long-term Safety Comparison Study of NK-104-CR & Livalo® IR With Primary Hyperlipidemia or Mixed Dyslipidemia
May 6, 2021 updated by: Kowa Research Institute, Inc.
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
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alabama
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Foley, Alabama, United States
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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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Arkansas
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Little Rock, Arkansas, United States
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California
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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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Connecticut
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Milford, Connecticut, United States
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Florida
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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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Georgia
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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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Illinois
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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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Indiana
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Evansville, Indiana, United States
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Kansas
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Topeka, Kansas, United States
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Kentucky
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Louisville, Kentucky, United States
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Owensboro, Kentucky, United States
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Maryland
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Oxon Hill, Maryland, United States
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Mississippi
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Biloxi, Mississippi, United States
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Olive Branch, Mississippi, United States
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Missouri
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Jefferson City, Missouri, United States
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Saint Louis, Missouri, United States
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Nebraska
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Omaha, Nebraska, United States
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New York
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Manlius, New York, United States
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North Carolina
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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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North Dakota
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Fargo, North Dakota, United States
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Ohio
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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
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Oklahoma City, Oklahoma, United States
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Oregon
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Medford, Oregon, United States
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Pennsylvania
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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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South Carolina
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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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Texas
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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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Utah
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Salt Lake City, Utah, United States
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Virginia
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Richmond, Virginia, United States
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Suffolk, Virginia, United States
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Washington
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Seattle, Washington, United States
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Wisconsin
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Kenosha, Wisconsin, United States
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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%
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: NK-104-CR
NK-104-CR 8 mg tablet and Placebo (for Livalo® IR 4 mg tablet) orally once daily for 52 weeks.
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NK-104-CR 8 mg for 52 weeks
Livalo® IR 4 mg placebo for 52 weeks
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ACTIVE_COMPARATOR: Livalo® IR
Livalo® IR 4 mg tablet and Placebo (for NK-104-CR 8 mg tablet) orally once daily for 52 weeks.
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Livalo® IR 4 mg daily for 52 weeks
NK-104-CR 8 mg placebo for 52 weeks
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Percent change in Low-density lipoprotein cholesterol (LDL-C)
Time Frame: Baseline to Week 12 endpoint
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Baseline to Week 12 endpoint
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2016
Primary Completion (ANTICIPATED)
July 1, 2017
Study Completion (ANTICIPATED)
November 1, 2017
Study Registration Dates
First Submitted
June 10, 2016
First Submitted That Met QC Criteria
June 10, 2016
First Posted (ESTIMATE)
June 15, 2016
Study Record Updates
Last Update Posted (ACTUAL)
May 10, 2021
Last Update Submitted That Met QC Criteria
May 6, 2021
Last Verified
May 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Metabolic Diseases
- Lipid Metabolism Disorders
- Dyslipidemias
- Hyperlipidemias
- Hyperlipoproteinemias
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Pitavastatin
Other Study ID Numbers
- NK-104-CR-3.02US
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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