Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-043)

Description

The primary objective of this study is to monitor the safety and tolerability of vericiguat.

Conditions

Systolic Dysfunction

Study Overview

Study Details

Study overview

The primary objective of this study is to monitor the safety and tolerability of vericiguat.

A Phase 3, Single-arm, Open-label Extension of the Vericiguat VALOR Study in Pediatric Participants With Heart Failure Due to Systemic Left Ventricular Systolic Dysfunction (VALOR EXT)

Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-043)

Condition
Systolic Dysfunction
Intervention / Treatment

-

Contacts and Locations

Memphis

Le Bonheur Children's Hospital ( Site 0007), Memphis, Tennessee, United States, 38103

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Was randomized, received at least 1 dose of study intervention (vericiguat or placebo), and completed the Week 52 visit and safety follow-up period for the VALOR base study.
  • * A participant assigned female sex at birth is not pregnant or breastfeeding, and is not a participant/participants of childbearing potential (POCBP) or is a POCBP who Uses a contraceptive method that is highly effective, has a negative highly sensitive pregnancy test, abstains from breastfeeding during the study intervention period and for at least 30 days after study intervention., and whose medical history, menstrual history, and recent sexual activity has been reviewed by the investigator to decrease the risk for inclusion of a POCBP with an early undetected pregnancy.
  • * Is able to receive medication via the oral or gastric route .
  • * Is hypotensive for age at Visit 1
  • * Has a known allergy or sensitivity to vericiguat, any of its constituents, or any other soluble guanylate cyclase (sGC )stimulator.
  • * Has undergone heart transplantation or has an implanted ventricular assist device.
  • * Has severe chronic kidney disease
  • * Has hepatic disorder
  • * Has concurrent or anticipated concomitant use of phosphodiesterase type 5 inhibitors during the study.
  • * Has concurrent or anticipated use of an sGC stimulator.
  • * Is both ≥18 years of age and vericiguat is commercially available to the participant

Ages Eligible for Study

1 Year to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Merck Sharp & Dohme LLC,

Clinical Director, STUDY_DIRECTOR, Merck Sharp & Dohme LLC

Study Record Dates

2032-04-15