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

Systolic Dysfunction Clinical Trial

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06428383
• Other study ID #: 1242-043
• Secondary ID: MK-1242-043
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: June 3, 2024
• Est. completion date: April 15, 2032

Study information

• Verified date: March 2024
• Source: Merck Sharp & Dohme LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 342
• Est. completion date: April 15, 2032
• Est. primary completion date: April 15, 2032
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Systolic Dysfunction
• Systolic Murmurs
• Ventricular Dysfunction, Left

Intervention

Drug:
• Vericiguat tablet
Vericiguat tablet at doses 2.5 mg, 5 mg, or 10 mg taken orally once daily
• Vericiguat suspension
Vericiguat suspension at doses 0.2 mg/mL, 1 mg/mL taken orally once daily

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme LLC

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participants with adverse events (AEs)	Percentage of participants with AEs	Up to approximately 8 years
Primary	Participants who discontinued study drug due to an AE	Percentage of participants who discontinued study drug due to an AE	Up to approximately 8 years
Secondary	Change from baseline in n-terminal pro-brain natriuretic peptide (NT-proBNP)	Change in NT-proBNP from baseline at Week 16.	Baseline and Week 16

External Links

•   Merck Clinical Trials Information