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A Study of Macitentan in Japanese Pediatric Participants With Pulmonary Arterial Hypertension

NCT05167825 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2026-05-07

Study results available
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Summary

The purpose of this study is to evaluate the effect of macitentan on hemodynamic measures at Week 24 in pediatric populations.

Conditions

Interventions

DRUG

Macitentan

Macitentan will be administered orally as a tablet.

Sponsors & Collaborators

  • Janssen Pharmaceutical K.K.

    lead INDUSTRY

Principal Investigators

  • Janssen Pharmaceutical K.K. Clinical Trial · Janssen Pharmaceutical K.K.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Months
Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-14
Primary Completion
2024-08-23
Completion
2025-03-05
FDA Drug
Yes

Countries

  • Japan

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 NCT05167825 on ClinicalTrials.gov