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A Study to Assess Whether Macitentan Delays Disease Progression in Children With Pulmonary Arterial Hypertension (PAH)

NCT02932410 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 165

Last updated 2026-03-13

Study results available
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Summary

This is a prospective, multicenter, open-label, randomized, controlled, parallel Phase 3 study with an open-label single-arm extension period to evaluate pharmacokinetics (PK), safety and efficacy of macitentan in children with pulmonary arterial hypertension (PAH).

Conditions

Interventions

DRUG

Macitentan

Dispersible tablet; Oral use

OTHER

Standard-of-care

Standard-of-care as per site's clinical practice which may comprise treatment with PAH non-specific treatment and/or up to two PAH-specific medications excluding macitentan and IV/SC prostanoids.

Sponsors & Collaborators

  • Actelion

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Month
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-24
Primary Completion
2024-08-28
Completion
2025-11-27
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Austria
  • Brazil
  • Canada
  • China
  • Colombia
  • Finland
  • France
  • Hungary
  • Israel
  • Malaysia
  • Mexico
  • Philippines
  • Poland
  • Portugal
  • Russia
  • South Africa
  • South Korea
  • Spain
  • Thailand
  • Ukraine
  • Vietnam

Study Locations

More Related Trials

Entities

Diseases

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 NCT02932410 on ClinicalTrials.gov