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

NCT03071692 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 10544

Last updated 2025-09-25

Study results available
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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
* coronary revascularization; or
* Cardio Vascular (CV) death.

Conditions

Interventions

DRUG

K-877

0.2mg tablet

DRUG

Placebo

K-877 matching placebo tablet

Sponsors & Collaborators

  • Brigham and Women's Hospital

    collaborator OTHER

  • Kowa Research Institute, Inc.

    lead INDUSTRY

Principal Investigators

  • Paul Ridker, MD · CCVDP & The Brigham and Women's Hospital

  • Aruna Pradhan, MD · CCVDP & The Brigham and Women's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-23
Primary Completion
2022-07-27
Completion
2022-07-27
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Brazil
  • Bulgaria
  • Canada
  • Colombia
  • Czechia
  • Denmark
  • France
  • Germany
  • Hungary
  • India
  • Israel
  • Japan
  • Mexico
  • Netherlands
  • Poland
  • Puerto Rico
  • Romania
  • Russia
  • Slovakia
  • South Africa
  • Spain
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03071692 on ClinicalTrials.gov