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NCT05714085 · ClinicalTrials.gov registry record · Phase 2

Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036)

A Phase 2 study of Heart Failure and Left Ventricular Systolic Dysfunction, sponsored by Merck Sharp & Dohme.

Recruiting
Registry status
Phase 2
Development phase
342
Enrollment target
20
Study locations

NCT05714085 is a Phase 2 study of Heart Failure and Left Ventricular Systolic Dysfunction that is actively recruiting participants, run by Merck Sharp & Dohme. The registered enrollment target is 342 participants, below the 2,048-participant average among 397 other Heart Failure trials with a reported enrollment target (83% lower). The trial reports 20 study locations across 16 states.

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The verdict

NCT05714085, a Phase 2 study of Heart Failure and Left Ventricular Systolic Dysfunction, is actively recruiting participants, sponsored by Merck Sharp & Dohme.

RECRUITING
Registry status
Phase 2
Development phase
342 participants
Enrollment target
20
Study locations

Study Summary

This study aims to compare the efficacy of vericiguat versus 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 placebo in reducing NT-proBNP at Week 16 of the Base Period.

Interventions

  • DRUG Placebo tablet
  • DRUG Vericiguat tablet
  • DRUG Vericiguat suspension
  • DRUG Placebo suspension

Study Locations (20)

California

  • The Regents of the University of California - Los Angeles (UCLA Pediatrics) ( Site 0002) - Los Angeles
  • Loma Linda University Health System ( Site 0008) - San Bernardino

New York

  • Columbia University Medical Center-Pediatric Cardiology ( Site 0016) - New York
  • The Children's Hospital at Montefiore ( Site 0030) - The Bronx

Ohio

  • Cincinnati Children's Hospital Medical Center ( Site 0034) - Cincinnati
  • Cleveland Clinic-Cleveland Clinic Chidren's ( Site 0022) - Cleveland

Pennsylvania

  • Children's Hospital of Philadelphia (CHOP) ( Site 0004) - Philadelphia
  • Children's Hospital of Pittsburgh ( Site 0010) - Pittsburgh

Colorado

  • Children's Hospital Colorado ( Site 0012) - Aurora

District of Columbia

  • Children's National Medical Center ( Site 0020) - Washington D.C.

Florida

  • Johns Hopkins All Children's Hospital ( Site 0029) - St. Petersburg

Georgia

  • Children's Healthcare of Atlanta - Arthur M. Blank Hospital ( Site 0001) - Atlanta

Trial Details

FieldValue
Enrollment Target 342 participants
Start Date 2023-05-31
Est. Completion 2032-04-15
Phase Phase 2

Sponsor

Merck Sharp & Dohme

558 total trials

What the Registry Record Tells You About NCT05714085

The ClinicalTrials.gov registry entry for NCT05714085 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 342 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,048-participant average among 397 other Heart Failure trials with a reported enrollment target (83% lower). The listed sponsor is Merck Sharp & Dohme, which has 558 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Heart Failure appearing as the primary indexed condition, and to 4 interventions - of which Placebo tablet is the first listed.

NCT05714085 reports 20 study locations spanning 16 distinct geographic areas - top geographies include California, New York, Ohio.

Frequently Asked Questions

What is clinical trial NCT05714085 about?

NCT05714085 is a clinical study titled "Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036)". This study aims to compare the efficacy of vericiguat versus 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 placebo in reducing NT-proBNP at Week 16 of the Base Period.

What is the current status of trial NCT05714085?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 342 participants. The study started on 2023-05-31. Estimated completion is 2032-04-15.

What conditions does trial NCT05714085 study?

This clinical trial studies the following conditions: Heart Failure, Left Ventricular Systolic Dysfunction.

What interventions are being tested in trial NCT05714085?

The interventions under investigation include: Placebo tablet (DRUG), Vericiguat tablet (DRUG), Vericiguat suspension (DRUG), Placebo suspension (DRUG).

Who is sponsoring clinical trial NCT05714085?

This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05714085 being conducted?

This trial has 20 study locations across California, Colorado, District of Columbia, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.