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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02670434
Recruitment Status : Terminated
First Posted : February 1, 2016
Last Update Posted : June 9, 2016
Sponsor:
Information provided by (Responsible Party):
Kowa Research Institute, Inc.

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

Condition or disease Intervention/treatment Phase
Hyperlipidemia Dyslipidemia Drug: NK-104-CR Drug: Placebo Drug: Livalo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 216 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : January 2016
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : October 2017

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Percent change in LDL-C from baseline [ Time Frame: 12 Weeks ]

Secondary Outcome Measures :
  1. The percent change from baseline in fasting serum total cholesterol (TC ) [ Time Frame: 12 Weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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%

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02670434


Locations
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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
United States, Florida
Brooksville, Florida, United States
Ft. 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
United States, Georgia
Marietta, Georgia, United States
United States, Idaho
Meridian, Idaho, United States
United States, Illinois
Chicago, Illinois, United States
Evanston, Illinois, United States
United States, Indiana
Evansville, Indiana, United States
Indianapolis, Indiana, United States
United States, Kansas
Newton, Kansas, United States
Wichita, Kansas, United States
United States, Maine
Auburn, Maine, United States
United States, Maryland
Elkridge, Maryland, United States
United States, Minnesota
Edina, Minnesota, United States
United States, Mississippi
Jackson, Mississippi, United States
United States, Montana
Butte, Montana, United States
United States, Nevada
Las Vegas, Nevada, United States
United States, New Jersey
Berlin, New Jersey, United States
United States, New York
Endwell, New York, United States
Rochester, New York, United States
United States, North Carolina
Greensboro, North Carolina, United States
United States, Ohio
Cincinnati, Ohio, United States
Kettering, Ohio, United States
Lyndhurst, Ohio, United States
Marion, Ohio, United States
Willoughby Hills, Ohio, United States
United States, Pennsylvania
Dowingtown, Pennsylvania, United States
United States, South Carolina
Charleston, South Carolina, United States
Mount Pleasant, South Carolina, United States
United States, Tennessee
Kingsport, Tennessee, United States
United States, Texas
Houston, Texas, United States
Hurst, Texas, United States
United States, Wisconsin
Madison, Wisconsin, United States
Sponsors and Collaborators
Kowa Research Institute, Inc.
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Responsible Party: Kowa Research Institute, Inc.
ClinicalTrials.gov Identifier: NCT02670434    
Other Study ID Numbers: NK-104-CR-3.01US
First Posted: February 1, 2016    Key Record Dates
Last Update Posted: June 9, 2016
Last Verified: June 2016
Additional relevant MeSH terms:
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Dyslipidemias
Hyperlipidemias
Hyperlipoproteinemias
Lipid Metabolism Disorders
Metabolic Diseases
Pitavastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents