Pemafibrate to Reduce Cardiovascular OutcoMes by Reducing Triglycerides IN patiENts With diabeTes (PROMINENT)

  • STATUS
    Not Recruiting
  • participants needed
    10000
  • sponsor
    Kowa Research Institute, Inc.
Updated on 9 May 2021
carotid artery stenosis
atherosclerosis
diabetes
angiography
fasting
type 2 diabetes mellitus
myocardial infarction
primary prevention

Summary

The primary objective of the study is to determine whether pemafibrate administered twice daily will delay the time to first occurrence of any component of the clinical composite endpoint of:

  • nonfatal Myocardial Infarction (MI)
  • nonfatal ischemic stroke
  • hospitalization for unstable angina requiring unplanned coronary revascularization; or
  • Cardio Vascular (CV) death.

Description

A multi-regional clinical trial with participating sites planned in the following countries pending approval from the applicable oversight authorities:

  • Argentina
  • Brazil
  • Bulgaria
  • Canada
  • Colombia
  • Czech Republic
  • Denmark
  • France
  • Germany
  • Hungary
  • India
  • Israel
  • Japan
  • Mexico
  • Netherlands
  • Poland
  • Romania
  • Russian Federation
  • Slovakia
  • South Africa
  • Spain
  • Ukraine
  • United Kingdom
  • United States

Details
Condition Dyslipidemia, Type2 Diabetes
Treatment Placebo, K-877
Clinical Study IdentifierNCT03071692
SponsorKowa Research Institute, Inc.
Last Modified on9 May 2021

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