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

Withdrawn before enrolling · Phase 3 · Has a placebo group

Conditions studied: Hyperlipidemia, Dyslipidemia

In brief

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

Key facts

Study ID

NCT02799758

Run by

Kowa Research Institute, Inc.

People needed

0

Starts

2016-02-01

Expected to finish

2017-11-01

Last updated by the study team

2021-05-10

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Homozygous familial hypercholesterolemia;
• Any conditions which may cause secondary dyslipidemia.
• Newly diagnosed or poorly controlled diabetes mellitus as defined by HbA1c >9%

Where it is running

• Study site — Huntsville, Alabama, United States
• Study site — Montgomery, Alabama, United States
• Study site — Muscle Shoals, Alabama, United States
• Study site — Little Rock, Arkansas, United States
• Study site — Greenbrae, California, United States
• Study site — Huntington Park, California, United States
• Study site — Lomita, California, United States
• Study site — Long Beach, California, United States
• Study site — Los Angeles, California, United States
• Study site — Santa Ana, California, United States
• Study site — Spring Valley, California, United States
• Study site — Tustin, California, United States
• Study site — Walnut Creek, California, United States
• Study site — Milford, Connecticut, United States
• Study site — Atlantis, Florida, United States
• Study site — Cooper City, Florida, United States
• Study site — Coral Springs, Florida, United States
• Study site — Fleming Island, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Oviedo, Florida, United States
• Study site — Dawsonville, Georgia, United States
• Study site — Macon, Georgia, United States
• Study site — Suwanee, Georgia, United States
• Study site — Foley, Alabama, United States

Full record on ClinicalTrials.gov

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