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

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

    • Alabama
      • Foley, Alabama, United States
      • Huntsville, Alabama, United States
      • Montgomery, Alabama, United States
      • Muscle Shoals, Alabama, United States
    • Arkansas
      • Little Rock, Arkansas, United States
    • California
      • 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
    • Connecticut
      • Milford, Connecticut, United States
    • Florida
      • 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
    • Georgia
      • Dawsonville, Georgia, United States
      • Macon, Georgia, United States
      • Suwanee, Georgia, United States
    • Illinois
      • Addison, Illinois, United States
      • Chicago, Illinois, United States
      • Gurnee, Illinois, United States
      • Morton, Illinois, United States
    • Indiana
      • Evansville, Indiana, United States
    • Kansas
      • Topeka, Kansas, United States
    • Kentucky
      • Louisville, Kentucky, United States
      • Owensboro, Kentucky, United States
    • Maryland
      • Oxon Hill, Maryland, United States
    • Mississippi
      • Biloxi, Mississippi, United States
      • Olive Branch, Mississippi, United States
    • Missouri
      • Jefferson City, Missouri, United States
      • Saint Louis, Missouri, United States
    • Nebraska
      • Omaha, Nebraska, United States
    • New York
      • Manlius, New York, United States
    • North Carolina
      • High Point, North Carolina, United States
      • Salisbury, North Carolina, United States
      • Wilmington, North Carolina, United States
      • Winston-Salem, North Carolina, United States
    • North Dakota
      • Fargo, North Dakota, United States
    • Ohio
      • Cincinnati, Ohio, United States
      • Columbus, Ohio, United States
      • Franklin, Ohio, United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
    • Oregon
      • Medford, Oregon, United States
    • Pennsylvania
      • Beaver, Pennsylvania, United States
      • Harleysville, Pennsylvania, United States
      • Jersey Shore, Pennsylvania, United States
      • Philadelphia, Pennsylvania, United States
      • Pittsburgh, Pennsylvania, United States
    • South Carolina
      • Moncks Corner, South Carolina, United States
      • Simpsonville, South Carolina, United States
      • Summerville, South Carolina, United States
    • Texas
      • 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
    • Utah
      • Salt Lake City, Utah, United States
    • Virginia
      • Richmond, Virginia, United States
      • Suffolk, Virginia, United States
    • Washington
      • Seattle, Washington, United States
    • Wisconsin
      • Kenosha, Wisconsin, United States

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
EXPERIMENTAL: 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 8 mg for 52 weeks
Livalo® IR 4 mg placebo for 52 weeks
ACTIVE_COMPARATOR: Livalo® IR
Livalo® IR 4 mg tablet and Placebo (for NK-104-CR 8 mg tablet) orally once daily for 52 weeks.
Livalo® IR 4 mg daily for 52 weeks
NK-104-CR 8 mg placebo for 52 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent change in Low-density lipoprotein cholesterol (LDL-C)
Time Frame: Baseline to Week 12 endpoint
Baseline to Week 12 endpoint

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

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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