Pemafibrate (K-877) to reduce cardiovascular outcomes by reducing triglycerides in patients with diabetes.

  • STATUS
    Recruiting
  • sponsor
    Kowa Research Institute
Updated on 25 March 2021

Summary

Pemafibrate (K-877) to reduce cardiovascular outcomes by reducing triglycerides in patients with diabetes.

Description

This study will compare pemafibrate (K-877) compared to placebo to discover if pemafibrate lowers cardiovascular complications such as heart attack, stroke, and death from these conditions in adults with Type II Diabetes mellitus who have elevated triglycerides and low high-density lipoprotein cholesterol (HDL-C "good cholesterol). The study will also test if the medication has other benefits for the patients and will test the safety of the study medication. Once tablet taken orally twice each day. The trial duration is expected to last up to 5 years. Subjects are reimburse for time and travel with a stipend of $100 at each office visit.

Details
Condition Elevated Triglycerides (Hypertriglyceridemia)
Clinical Study IdentifierTX148184
SponsorKowa Research Institute
Last Modified on25 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Current treatment with a stable dose of atorvastatin (Lipitor), rosuvastatin (Crestor), simvastatin (Zocor), or pitavastatin (Livalo)
Type II Diabetes Mellitus
Previous Cardiovascular Event (i.e., prior heart attack, stroke, carotid artery stenosis, stenting, bypass, etc.)
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