NCT02861534

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

A Randomized Parallel-Group, Placebo-Controlled, Double-Blind, Event-Driven, Multi-Center Pivotal Phase III Clinical Outcome Trial of Efficacy and Safety of the Oral sGC Stimulator Vericiguat in Subjects With Heart Failure With Reduced Ejection Fraction (HFrEF) - VerICiguaT GlObal Study in Subjects With Heart Failure With Reduced EjectIon FrAction (VICTORIA)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 5,050 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2016-09-20
• Primary completion: 2019-06-18
• Completion: 2019-09-02
• First posted: 2016-08-10
• Last updated: 2021-11-15
• Results posted: 2020-06-29