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Efficacy & Long-term Safety Comparison Study of NK-104-CR & Livalo® IR With Primary Hyperlipidemia or Mixed Dyslipidemia

Primary Purpose

Hyperlipidemia, Dyslipidemia

Status
Withdrawn
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
NK-104-CR
Livalo® IR
Placebo (for NK-104-CR)
Placebo (for Livalo® IR)
Sponsored by
Kowa Research Institute, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperlipidemia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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%

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

NK-104-CR

Livalo® IR

Arm Description

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

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

Outcomes

Primary Outcome Measures

Percent change in Low-density lipoprotein cholesterol (LDL-C)

Secondary Outcome Measures

Full Information

First Posted
June 10, 2016
Last Updated
May 6, 2021
Sponsor
Kowa Research Institute, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02799758
Brief Title
Efficacy & Long-term Safety Comparison Study of NK-104-CR & Livalo® IR With Primary Hyperlipidemia or Mixed Dyslipidemia
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Withdrawn
Study Start Date
February 2016 (undefined)
Primary Completion Date
July 2017 (Anticipated)
Study Completion Date
November 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kowa Research Institute, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperlipidemia, Dyslipidemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NK-104-CR
Arm Type
Experimental
Arm Description
NK-104-CR 8 mg tablet and Placebo (for Livalo® IR 4 mg tablet) orally once daily for 52 weeks.
Arm Title
Livalo® IR
Arm Type
Active Comparator
Arm Description
Livalo® IR 4 mg tablet and Placebo (for NK-104-CR 8 mg tablet) orally once daily for 52 weeks.
Intervention Type
Drug
Intervention Name(s)
NK-104-CR
Intervention Description
NK-104-CR 8 mg for 52 weeks
Intervention Type
Drug
Intervention Name(s)
Livalo® IR
Intervention Description
Livalo® IR 4 mg daily for 52 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo (for NK-104-CR)
Intervention Description
NK-104-CR 8 mg placebo for 52 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo (for Livalo® IR)
Intervention Description
Livalo® IR 4 mg placebo for 52 weeks
Primary Outcome Measure Information:
Title
Percent change in Low-density lipoprotein cholesterol (LDL-C)
Time Frame
Baseline to Week 12 endpoint

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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%
Facility Information:
City
Foley
State/Province
Alabama
Country
United States
City
Huntsville
State/Province
Alabama
Country
United States
City
Montgomery
State/Province
Alabama
Country
United States
City
Muscle Shoals
State/Province
Alabama
Country
United States
City
Little Rock
State/Province
Arkansas
Country
United States
City
Greenbrae
State/Province
California
Country
United States
City
Huntington Park
State/Province
California
Country
United States
City
Lomita
State/Province
California
Country
United States
City
Long Beach
State/Province
California
Country
United States
City
Los Angeles
State/Province
California
Country
United States
City
Santa Ana
State/Province
California
Country
United States
City
Spring Valley
State/Province
California
Country
United States
City
Tustin
State/Province
California
Country
United States
City
Walnut Creek
State/Province
California
Country
United States
City
Milford
State/Province
Connecticut
Country
United States
City
Atlantis
State/Province
Florida
Country
United States
City
Cooper City
State/Province
Florida
Country
United States
City
Coral Springs
State/Province
Florida
Country
United States
City
Fleming Island
State/Province
Florida
Country
United States
City
Jacksonville
State/Province
Florida
Country
United States
City
Miami
State/Province
Florida
Country
United States
City
Oviedo
State/Province
Florida
Country
United States
City
Dawsonville
State/Province
Georgia
Country
United States
City
Macon
State/Province
Georgia
Country
United States
City
Suwanee
State/Province
Georgia
Country
United States
City
Addison
State/Province
Illinois
Country
United States
City
Chicago
State/Province
Illinois
Country
United States
City
Gurnee
State/Province
Illinois
Country
United States
City
Morton
State/Province
Illinois
Country
United States
City
Evansville
State/Province
Indiana
Country
United States
City
Topeka
State/Province
Kansas
Country
United States
City
Louisville
State/Province
Kentucky
Country
United States
City
Owensboro
State/Province
Kentucky
Country
United States
City
Oxon Hill
State/Province
Maryland
Country
United States
City
Biloxi
State/Province
Mississippi
Country
United States
City
Olive Branch
State/Province
Mississippi
Country
United States
City
Jefferson City
State/Province
Missouri
Country
United States
City
Saint Louis
State/Province
Missouri
Country
United States
City
Omaha
State/Province
Nebraska
Country
United States
City
Manlius
State/Province
New York
Country
United States
City
High Point
State/Province
North Carolina
Country
United States
City
Salisbury
State/Province
North Carolina
Country
United States
City
Wilmington
State/Province
North Carolina
Country
United States
City
Winston-Salem
State/Province
North Carolina
Country
United States
City
Fargo
State/Province
North Dakota
Country
United States
City
Cincinnati
State/Province
Ohio
Country
United States
City
Columbus
State/Province
Ohio
Country
United States
City
Franklin
State/Province
Ohio
Country
United States
City
Oklahoma City
State/Province
Oklahoma
Country
United States
City
Medford
State/Province
Oregon
Country
United States
City
Beaver
State/Province
Pennsylvania
Country
United States
City
Harleysville
State/Province
Pennsylvania
Country
United States
City
Jersey Shore
State/Province
Pennsylvania
Country
United States
City
Philadelphia
State/Province
Pennsylvania
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
City
Moncks Corner
State/Province
South Carolina
Country
United States
City
Simpsonville
State/Province
South Carolina
Country
United States
City
Summerville
State/Province
South Carolina
Country
United States
City
Austin
State/Province
Texas
Country
United States
City
Houston
State/Province
Texas
Country
United States
City
Katy
State/Province
Texas
Country
United States
City
Plano
State/Province
Texas
Country
United States
City
Round Rock
State/Province
Texas
Country
United States
City
San Antonio
State/Province
Texas
Country
United States
City
Salt Lake City
State/Province
Utah
Country
United States
City
Richmond
State/Province
Virginia
Country
United States
City
Suffolk
State/Province
Virginia
Country
United States
City
Seattle
State/Province
Washington
Country
United States
City
Kenosha
State/Province
Wisconsin
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Efficacy & Long-term Safety Comparison Study of NK-104-CR & Livalo® IR With Primary Hyperlipidemia or Mixed Dyslipidemia

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