Viewing Study NCT03071692

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Ignite Creation Date: 2025-12-24 @ 3:36 PM
Ignite Modification Date: 2025-12-26 @ 10:49 PM
Study NCT ID: NCT03071692
Status: TERMINATED
Last Update Posted: 2025-09-25
First Post: 2017-02-23
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: Pemafibrate to Reduce Cardiovascular OutcoMes by Reducing Triglycerides IN patiENts With diabeTes (PROMINENT)
Sponsor: Kowa Research Institute, Inc.
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Study Overview

Official Title: Pemafibrate to Reduce Cardiovascular OutcoMes by Reducing Triglycerides IN patiENts With diabeTes (PROMINENT)
Status: TERMINATED
Status Verified Date: 2025-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: The study was stopped for futility based on efficacy results at the interim analysis; no unexpected safety findings were observed.
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: PROMINENT
Brief 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.
Detailed Description: A multi-regional clinical trial with participating sites in the following countries. India is being conducted under a previous protocol version due to regulatory requirements.

* 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

Study Oversight

Has Oversight DMC: True
Is a FDA Regulated Drug?: True
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: