MedTrace Logo

A Study of Vericiguat in Participants With Heart Failure With Reduced Ejection Fraction (HFrEF) (MK-1242-001)

NCT02861534 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 5050

Last updated 2021-11-15

Study results available
· View outcomes & findings →

Summary

This is a randomized, placebo-controlled, parallel-group, multi-center, double-blind, event driven study of vericiguat (MK-1242) in participants with heart failure with reduced ejection fraction (HFrEF). The primary hypothesis is vericiguat (MK-1242) is superior to placebo in increasing the time to first occurrence of the composite of cardiovascular (CV) death or heart failure (HF) hospitalization in participants with HFrEF.

Conditions

  • Heart Failure
  • Chronic Heart Failure With Reduced Ejection Fraction

Interventions

DRUG

Vericiguat

2.5, 5.0, or 10.0 mg orally once daily

DRUG

Placebo for vericiguat

2.5, 5.0, or 10.0 mg orally once daily

Sponsors & Collaborators

  • Bayer

    collaborator INDUSTRY

  • Canadian VIGOUR Centre

    collaborator OTHER

  • Duke Clinical Research Institute

    collaborator OTHER

  • Merck Sharp & Dohme LLC

    lead INDUSTRY

Principal Investigators

  • Mahesh J. Patel, MD · Merck Sharp & Dohme LLC

  • Paul W. Armstrong, MD · Canadian VIGOUR Centre - University of Alberta

  • Christopher M. O'Connor, MD · Inova Heart and Vascular Institute

  • Burkert Pieske, MD · Charité University Medicine and German Heart Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-20
Primary Completion
2019-06-18
Completion
2019-09-02

More Related Trials

Entities

Diseases
Companies

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 NCT02861534 on ClinicalTrials.gov