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A Study of Macitentan in Children Below 2 Years of Age

NCT05731492 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2025-03-30

No results posted yet for this study

Summary

The purpose of this study is to learn what happens to macitentan and its active metabolite (aprocitentan) in the body of children aged between 1 month and 2 years.

Conditions

  • Arterial Hypertension, Pulmonary

Interventions

DRUG

Macitentan

Macitentan will be administered orally.

Sponsors & Collaborators

  • Actelion

    lead INDUSTRY

Principal Investigators

  • Actelion Pharmaceuticals Ltd Clinical Trial · Actelion

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2024-03-14
Primary Completion
2024-04-01
Completion
2024-04-01
FDA Drug
Yes

Countries

  • Germany
  • Poland

Study Locations

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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 NCT05731492 on ClinicalTrials.gov