## Protocol Section
### Identification Module
**NCT ID:** NCT06428383

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

**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)

#### Organization Study ID Info
**ID:** 1242-043
#### Organization
**Class:** INDUSTRY
**Full Name:** Merck Sharp & Dohme LLC
#### Secondary ID Infos
**Domain:** Merck
**ID:** MK-1242-043
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2032-04-15

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-20

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2032-04-15

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-03

**Type:** ESTIMATED

**Status Verified Date:** 2024-03

#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Merck Sharp & Dohme LLC

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** The primary objective of this study is to monitor the safety and tolerability of vericiguat.

### Conditions Module

**Conditions:**

- Systolic Dysfunction

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 342

**Type:** ESTIMATED

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Vericiguat administered orally in either tablet or suspension once daily until end of treatment

**Intervention Names:**

- Drug: Vericiguat tablet

- Drug: Vericiguat suspension

**Label:** Vericiguat

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Vericiguat

**Description:** Vericiguat tablet at doses 2.5 mg, 5 mg, or 10 mg taken orally once daily

**Name:** Vericiguat tablet

**Other Names:**

- MK-1242

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Vericiguat

**Description:** Vericiguat suspension at doses 0.2 mg/mL,

1 mg/mL taken orally once daily

**Name:** Vericiguat suspension

**Other Names:**

- MK-1242

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Percentage of participants with AEs

**Measure:** Participants with adverse events (AEs)

**Time Frame:** Up to approximately 8 years

**Description:** Percentage of participants who discontinued study drug due to an AE

**Measure:** Participants who discontinued study drug due to an AE

**Time Frame:** Up to approximately 8 years

#### Secondary Outcomes

**Description:** Change in NT-proBNP from baseline at Week 16.

**Measure:** Change from baseline in n-terminal pro-brain natriuretic peptide (NT-proBNP)

**Time Frame:** Baseline and Week 16

### Eligibility Module

**Eligibility Criteria:** 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

**Minimum Age:** 1 Year

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Overall Officials

**Official 1:**

**Affiliation:** Merck Sharp & Dohme LLC

**Name:** Clinical Director

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**Description:** http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

**IPD Sharing:** YES

**URL:** http://engagezone.msd.com/ds_documentation.php

### References Module

#### See Also Links

**Label:** Merck Clinical Trials Information

**URL:** http://www.merckclinicaltrials.com

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000006331

- Term: Heart Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000006337

- Term: Heart Murmurs

- ID: D000018754

- Term: Ventricular Dysfunction

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M9421

- Name: Heart Failure

- Relevance: HIGH

- As Found: Heart Failure

- ID: M27583

- Name: Systolic Murmurs

- Relevance: HIGH

- As Found: Systolic

- ID: M20591

- Name: Ventricular Dysfunction, Left

- Relevance: HIGH

- As Found: Left Ventricular Systolic Dysfunction

- ID: M20824

- Name: Ventricular Dysfunction

- Relevance: LOW

- As Found: Unknown

- ID: M9425

- Name: Heart Murmurs

- Relevance: LOW

- As Found: Unknown

- ID: M9419

- Name: Heart Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000006333

- Term: Heart Failure

- ID: D000018487

- Term: Ventricular Dysfunction, Left

- ID: D000054160

- Term: Systolic Murmurs

### Misc Info Module

- Version Holder: 2024-05-31
