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Safety and Efficacy Comparison Study of NK-104-CR (Controled Release) in Patients 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Withdrawn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
Placebo
Livalo
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 who are ≥18 and ≤80 years of age at the time of consent;
  • Fasting plasma LDL-C ≥160 mg/dL and ≤250 mg/dL and TG values of ≤300 mg/dL
  • Patients who are naïve to statin or who are able to safely discontinue the use of all lipid-lowering agents for 6 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 >8%

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Active Comparator

Arm Label

NK-104-CR

Placebo

Livalo® Immediate Release IR

Arm Description

Controlled release NK-104

Livalo Placebo

Immediate Release Livalo®

Outcomes

Primary Outcome Measures

Percent change in LDL-C from baseline

Secondary Outcome Measures

The percent change from baseline in fasting serum total cholesterol (TC )

Full Information

First Posted
January 28, 2016
Last Updated
May 6, 2021
Sponsor
Kowa Research Institute, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02670434
Brief Title
Safety and Efficacy Comparison Study of NK-104-CR (Controled Release) in Patients With Primary Hyperlipidemia or Mixed Dyslipidemia
Study Type
Interventional

2. Study Status

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Withdrawn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

3. Sponsor/Collaborators

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

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to compare the efficacy of NK-104-CR with Placebo and Livalo® on the reduction of LDL-C and to evaluate the safety of NK-104-CR in patients with primary hyperlipidemia or mixed dyslipidemia

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
Controlled release NK-104
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Livalo Placebo
Arm Title
Livalo® Immediate Release IR
Arm Type
Active Comparator
Arm Description
Immediate Release Livalo®
Intervention Type
Drug
Intervention Name(s)
NK-104-CR
Intervention Description
NK-104-CR 8 mg daily for 52 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Livalo
Intervention Description
Livalo® IR daily from week 12 to week 52
Primary Outcome Measure Information:
Title
Percent change in LDL-C from baseline
Time Frame
12 Weeks
Secondary Outcome Measure Information:
Title
The percent change from baseline in fasting serum total cholesterol (TC )
Time Frame
12 Weeks

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 who are ≥18 and ≤80 years of age at the time of consent; Fasting plasma LDL-C ≥160 mg/dL and ≤250 mg/dL and TG values of ≤300 mg/dL Patients who are naïve to statin or who are able to safely discontinue the use of all lipid-lowering agents for 6 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 >8%
Facility Information:
City
Beverly Hills
State/Province
California
Country
United States
City
Chino
State/Province
California
Country
United States
City
Lincoln
State/Province
California
Country
United States
City
Los Angeles
State/Province
California
Country
United States
City
Newport Beach
State/Province
California
Country
United States
City
North Hollywood
State/Province
California
Country
United States
City
Thousand Oaks
State/Province
California
Country
United States
City
Vista
State/Province
California
Country
United States
City
Brooksville
State/Province
Florida
Country
United States
City
Fort Lauderdale
State/Province
Florida
Country
United States
City
Jacksonville
State/Province
Florida
Country
United States
City
Jupiter
State/Province
Florida
Country
United States
City
Miami
State/Province
Florida
Country
United States
City
Pembroke Pines
State/Province
Florida
Country
United States
City
Port Orange
State/Province
Florida
Country
United States
City
Marietta
State/Province
Georgia
Country
United States
City
Meridian
State/Province
Idaho
Country
United States
City
Chicago
State/Province
Illinois
Country
United States
City
Evanston
State/Province
Illinois
Country
United States
City
Evansville
State/Province
Indiana
Country
United States
City
Indianapolis
State/Province
Indiana
Country
United States
City
Newton
State/Province
Kansas
Country
United States
City
Wichita
State/Province
Kansas
Country
United States
City
Auburn
State/Province
Maine
Country
United States
City
Elkridge
State/Province
Maryland
Country
United States
City
Edina
State/Province
Minnesota
Country
United States
City
Jackson
State/Province
Mississippi
Country
United States
City
Butte
State/Province
Montana
Country
United States
City
Las Vegas
State/Province
Nevada
Country
United States
City
Berlin
State/Province
New Jersey
Country
United States
City
Endwell
State/Province
New York
Country
United States
City
Rochester
State/Province
New York
Country
United States
City
Greensboro
State/Province
North Carolina
Country
United States
City
Cincinnati
State/Province
Ohio
Country
United States
City
Kettering
State/Province
Ohio
Country
United States
City
Lyndhurst
State/Province
Ohio
Country
United States
City
Marion
State/Province
Ohio
Country
United States
City
Willoughby Hills
State/Province
Ohio
Country
United States
City
Downingtown
State/Province
Pennsylvania
Country
United States
City
Charleston
State/Province
South Carolina
Country
United States
City
Mount Pleasant
State/Province
South Carolina
Country
United States
City
Kingsport
State/Province
Tennessee
Country
United States
City
Houston
State/Province
Texas
Country
United States
City
Hurst
State/Province
Texas
Country
United States
City
Madison
State/Province
Wisconsin
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Safety and Efficacy Comparison Study of NK-104-CR (Controled Release) in Patients With Primary Hyperlipidemia or Mixed Dyslipidemia

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