Safety and Efficacy Comparison Study of NK-104-CR (Controled Release) in Patients 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Withdrawn before enrolling · Phase 3 · Has a placebo group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 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

Key facts

Study ID

NCT02670434

Run by

Kowa Research Institute, Inc.

People needed

0

Starts

2016-01-01

Expected to finish

2017-10-01

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 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

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 >8%

Where it is running

• Study site — Beverly Hills, California, United States
• Study site — Chino, California, United States
• Study site — Lincoln, California, United States
• Study site — Los Angeles, California, United States
• Study site — Newport Beach, California, United States
• Study site — North Hollywood, California, United States
• Study site — Thousand Oaks, California, United States
• Study site — Vista, California, United States
• Study site — Brooksville, Florida, United States
• Study site — Fort Lauderdale, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Jupiter, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Pembroke Pines, Florida, United States
• Study site — Port Orange, Florida, United States
• Study site — Marietta, Georgia, United States
• Study site — Meridian, Idaho, United States
• Study site — Chicago, Illinois, United States
• Study site — Evanston, Illinois, United States
• Study site — Evansville, Indiana, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Newton, Kansas, United States
• Study site — Wichita, Kansas, United States
• Study site — Auburn, Maine, United States
• Study site — Elkridge, Maryland, United States

Full record on ClinicalTrials.gov

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