Trials Today

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

Purpose

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

Condition

Systolic Dysfunction

Eligibility

Eligible Ages: Over 1 Year
Eligible Sex: All
Accepts Healthy Volunteers: No

Inclusion 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 .

Exclusion Criteria

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

Study Design

Phase: Phase 3
Study Type: Interventional
Allocation: N/A
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Vericiguat	Vericiguat administered orally in either tablet or suspension once daily until end of treatment	Drug: Vericiguat tablet Vericiguat tablet at doses 2.5 mg, 5 mg, or 10 mg taken orally once daily Other names: MK-1242 Drug: Vericiguat suspension Vericiguat suspension at doses 0.2 mg/mL, 1 mg/mL taken orally once daily Other names: MK-1242

Recruiting Locations

More Details

NCT ID: NCT06428383
Status: Active, not recruiting
Sponsor: Merck Sharp & Dohme LLC

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.