Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
PlainTrials
RecruitingPhase 2 / Phase 3interventionalRules rewrite

Phase 2 / Phase 3: testing Vericiguat tablet for Heart Failure

This study aims to compare the how well it works of vericiguat versus dummy treatment (placebo) on change in n-terminal pro-brain natriuretic peptide (NTproBNP) from baseline to Week 16 of the Base Period. The primary hypothesis is that vericiguat is superior to dummy treatment (placebo) in reducing NT-proBNP at Week 16 of the Base Period.

Official registry: https://clinicaltrials.gov/study/NCT05714085 · Merck Sharp & Dohme LLC · enrollment listed as 342

What this phase means

Phase 2/3: earlier tests looked promising enough to expand. This stage asks, in a larger group, whether the treatment really works and is safe enough to seek approval.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Vericiguat tablet, Vericiguat suspension, or Placebo tablet. The registry lists allocation as randomized. This study aims to compare the how well it works of vericiguat versus dummy treatment (placebo) on change in n-terminal pro-brain natriuretic peptide (NTproBNP) from baseline to Week 16 of the Base Period.

They plan to enroll about 342 people at 112 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

A Phase 2/3 Randomized, Placebo-Controlled, Double-blind, Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Systemic Left Ventricular Systolic Dysfunction (VALOR)

Interventions: Vericiguat tablet, Vericiguat suspension, Placebo tablet, Placebo suspension

Primary outcome (registry wording): Base Period: Change from baseline to Week 16 in N-terminal pro-brain natriuretic peptide (NT-proBNP)

Who it is for (from inclusion criteria)

  • Ages 29 Days to 17 Years
  • Has symptomatic chronic heart failure (HF) resulting from systemic left ventricular (LV) systolic dysfunction
  • Has biventricular physiology with a morphologic systemic left ventricle
  • Is currently receiving stable medical therapy for HF
  • Has left ventricular ejection fraction (LVEF) \<45% assessed within 3 months before randomization
  • Is of any sex/gender, from \>28 days to \<18 years of age inclusive. Must weigh ≥3 kg to participate
  • Extension Period: Was randomly assigned, received at least 1 dose of study intervention (vericiguat or dummy treatment (placebo)), did not permanently discontinue study intervention, and completed the Week 52 visit and safety follow-up period of the Base Period

Public study contact (from the registry)

Toll Free Number

1-888-577-8839

Trialsites@msd.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

112 listed

+ 92 sites outside the US on the same record

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FAQ about this NCT record

Is NCT05714085 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT05714085?

Phase 2 / Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT05714085?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary