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Efficacy, safety and pharmacokinetics of vericiguat in pediatric patients with heart failure due to left ventricular systolic dysfunction (MK-1242-036)-05714085

Study ID: 05714085

A phase 2/3, randomized, placebo-controlled, double-blind clinical trial to evaluate the efficacy, safety, and pharmacokinetics of vericiguat in pediatric participants with heart failure due to systemic left ventricular systolic dysfunction (VALOR)

About the study:

 

Inclusion criteria: * Has a history of symptomatic chronic heart failure (HF) resulting from systemic systolic dysfunction of the left ventricle (LV) * Has biventricular physiology with a morphological systemic left ventricle * Currently receiving stable medical therapy for HF * Has a left ventricular ejection fraction (LVEF) <45% assessed within 3 months prior to randomization * Women are eligible to participate if they are not pregnant or breastfeeding, and at least one of the following: is not a participant of childbearing potential (POCBP); or is a POCBP using a highly effective contraceptive method; has a negative highly sensitive pregnancy test; abstains from breastfeeding for at least 30 days after the study intervention; and their medical history; Their menstrual history has been reviewed, and recent sexual activity has been reviewed. Exclusion criteria: * Is clinically unstable, with at least one of the following: hypotension for age, recent use of an intravenous (IV) inotrope and/or IV vasodilator, or recent dose increase of an IV diuretic or oral diuretic * Has a known allergy or sensitivity to vericiguat, any of its components, or any other soluble guanylate cyclase (sGC) stimulator * Has a history of single ventricle heart disease or has a morphological systemic right ventricle * Has undergone a heart transplant, is awaiting a heart transplant from the United Network for Organ Exchange (UNOS) Class 1A or equivalent, is receiving a continuous IV infusion of an inotrope, or has an implanted ventricular assist device * Has sustained or symptomatic dysrhythmia not controlled with drug therapy or devices * Has recently undergone a cardiovascular (CV) surgical procedure or intervention Percutaneous to palliate or correct congenital cardiovascular malformations * Has hemodynamically significant, unoperated, or residual congenital heart disease * Has hypertrophic or restrictive cardiomyopathy * Has active myocarditis or has been recently diagnosed with suspected or definite myocarditis * Has severe pulmonary hypertension * Requires continuous home oxygen for significant lung disease and/or has known interstitial lung disease * Has severe chronic kidney disease * Has a liver disorder such as hepatic encephalopathy, liver laboratory abnormalities, or Child-Pugh Class C * Has a gastrointestinal or biliary disorder that could affect the absorption, metabolism, or excretion of medications * Is currently using, concurrently using, or anticipating using phosphodiesterase type 5 inhibitors or a sGC stimulator

Total length

Target audiences

Ages: 29 Days - 17 years
Sex: All

Location

Merck Sharp & Dohme LLC

Associated diseases

  • Pediatric Cardiology
  • Heart failure

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