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A Study of Selexipag as Add-On Treatment to Standard of Care in Children With Pulmonary Arterial Hypertension

NCT04175600 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 138

Last updated 2026-05-08

No results posted yet for this study

Summary

The purpose of this study is to evaluate whether the addition of selexipag to standard of care treatment delays disease progression in children with Pulmonary Arterial Hypertension (PAH) in comparison to placebo.

Conditions

  • Hypertension, Pulmonary

Interventions

DRUG

Selexipag

Selexipag tablet will be administered orally.

DRUG

Placebo

Matching placebo tablets will be administered orally.

DRUG

Standard of Care (SOC): Endothelin receptor antagonist

ERAs will be administered as SOC therapy.

DRUG

SOC: Phosphodiesterase type 5 (PDE-5) inhibitor

PDE-5 inhibitor will be administered as SOC therapy.

DRUG

SOC: Soluble guanylate cyclase stimulator

Soluble guanylate cyclase stimulator will be administered as SOC therapy.

Sponsors & Collaborators

  • Actelion

    lead INDUSTRY

Principal Investigators

  • Actelion Clinical Trial · Actelion

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-16
Primary Completion
2024-10-11
Completion
2027-10-01
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belarus
  • Belgium
  • Brazil
  • Bulgaria
  • Canada
  • China
  • Colombia
  • Finland
  • France
  • Germany
  • Hungary
  • Ireland
  • Israel
  • Italy
  • Lithuania
  • Malaysia
  • Mexico
  • Poland
  • Portugal
  • Russia
  • Serbia
  • South Korea
  • Spain
  • Sweden
  • Switzerland
  • Taiwan
  • Thailand
  • Turkey (Türkiye)
  • Ukraine
  • Vietnam

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04175600 on ClinicalTrials.gov