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

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

Study Overview

• Status: Withdrawn
• Conditions: Dyslipidemia; Hyperlipidemia
• Intervention / Treatment: Drug: Placebo; Drug: NK-104-CR; Drug: Livalo

• Study Type: Interventional
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Beverly Hills, California, United States
    • Chino, California, United States
    • Lincoln, California, United States
    • Los Angeles, California, United States
    • Newport Beach, California, United States
    • North Hollywood, California, United States
    • Thousand Oaks, California, United States
    • Vista, California, United States
  • Florida
    • Brooksville, Florida, United States
    • Fort Lauderdale, Florida, United States
    • Jacksonville, Florida, United States
    • Jupiter, Florida, United States
    • Miami, Florida, United States
    • Pembroke Pines, Florida, United States
    • Port Orange, Florida, United States
  • Georgia
    • Marietta, Georgia, United States
  • Idaho
    • Meridian, Idaho, United States
  • Illinois
    • Chicago, Illinois, United States
    • Evanston, Illinois, United States
  • Indiana
    • Evansville, Indiana, United States
    • Indianapolis, Indiana, United States
  • Kansas
    • Newton, Kansas, United States
    • Wichita, Kansas, United States
  • Maine
    • Auburn, Maine, United States
  • Maryland
    • Elkridge, Maryland, United States
  • Minnesota
    • Edina, Minnesota, United States
  • Mississippi
    • Jackson, Mississippi, United States
  • Montana
    • Butte, Montana, United States
  • Nevada
    • Las Vegas, Nevada, United States
  • New Jersey
    • Berlin, New Jersey, United States
  • New York
    • Endwell, New York, United States
    • Rochester, New York, United States
  • North Carolina
    • Greensboro, North Carolina, United States
  • Ohio
    • Cincinnati, Ohio, United States
    • Kettering, Ohio, United States
    • Lyndhurst, Ohio, United States
    • Marion, Ohio, United States
    • Willoughby Hills, Ohio, United States
  • Pennsylvania
    • Downingtown, Pennsylvania, United States
  • South Carolina
    • Charleston, South Carolina, United States
    • Mount Pleasant, South Carolina, United States
  • Tennessee
    • Kingsport, Tennessee, United States
  • Texas
    • Houston, Texas, United States
    • Hurst, Texas, United States
  • Wisconsin
    • Madison, Wisconsin, United States

Participation Criteria

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 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%

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NK-104-CR; Controlled release NK-104	Drug: NK-104-CR; NK-104-CR 8 mg daily for 52 weeks
Placebo Comparator: Placebo; Livalo Placebo	Drug: Placebo; Placebo daily for 12 weeks
Active Comparator: Livalo® Immediate Release IR; Immediate Release Livalo®	Drug: Livalo; Livalo® IR daily from week 12 to week 52

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percent change in LDL-C from baseline	12 Weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
The percent change from baseline in fasting serum total cholesterol (TC )	12 Weeks

Collaborators and Investigators

• Sponsor: Kowa Research Institute, Inc.

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Anticipated): July 1, 2017
• Study Completion (Anticipated): October 1, 2017

Study Registration Dates

• First Submitted: January 28, 2016
• First Submitted That Met QC Criteria: January 28, 2016
• First Posted (Estimate): February 1, 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-3.01US