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A multicenter, open-label, single-arm study to assess the pharmacokinetics and safety of macitentan in children aged 1 month to <2 years with pulmonary arterial hypertension

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Trial Profile

A multicenter, open-label, single-arm study to assess the pharmacokinetics and safety of macitentan in children aged 1 month to <2 years with pulmonary arterial hypertension

Status: Withdrawn prior to enrolment
Phase of Trial: Phase I

Latest Information Update: 12 Jan 2025

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At a glance

  • Drugs Macitentan (Primary)
  • Indications Pulmonary arterial hypertension
  • Focus Pharmacokinetics
  • Sponsors Actelion Pharmaceuticals

Most Recent Events

  • 27 May 2024 Planned End Date changed from 30 Sep 2025 to 1 Apr 2024.
  • 27 May 2024 Status changed from recruiting to withdrawn prior to enrolment.
  • 26 Apr 2024 This trial has been completed in Poland (Global end date: 2024-03-06) according to European Clinical Trials Database record.

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