COMPLETED

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

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Conditions

Systolic Dysfunction

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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)

Quick Facts

Study Start:2024-07-03
Study Completion:2025-08-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06428383

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.

Ages Eligible for Study:1 Year
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * 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.
  3. * Is able to receive medication via the oral or gastric route .
  1. * Is hypotensive for age at Visit 1
  2. * Has a known allergy or sensitivity to vericiguat, any of its constituents, or any other soluble guanylate cyclase (sGC )stimulator.
  3. * Has undergone heart transplantation or has an implanted ventricular assist device.
  4. * Has severe chronic kidney disease
  5. * Has hepatic disorder
  6. * Has concurrent or anticipated concomitant use of phosphodiesterase type 5 inhibitors during the study.
  7. * Has concurrent or anticipated use of an sGC stimulator.
  8. * Is both ≥18 years of age and vericiguat is commercially available to the participant

Contacts and Locations

Principal Investigator

Clinical Director
STUDY_DIRECTOR
Merck Sharp & Dohme LLC

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Merck Sharp & Dohme LLC

  • Clinical Director, STUDY_DIRECTOR, Merck Sharp & Dohme LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-03
Study Completion Date2025-08-15

Study Record Updates

Study Start Date2024-07-03
Study Completion Date2025-08-15

Terms related to this study

Additional Relevant MeSH Terms

  • Systolic Dysfunction