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Prospective, Multi-center, Single-arm, Open-label Long-term Study Assessing the Safety, Tolerability, and Effectiveness of Macitentan in Fontan-palliated Adult and Adolescent Subjects

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Trial Profile

Prospective, Multi-center, Single-arm, Open-label Long-term Study Assessing the Safety, Tolerability, and Effectiveness of Macitentan in Fontan-palliated Adult and Adolescent Subjects

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 09 Mar 2023

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At a glance

  • Drugs Macitentan (Primary)
  • Indications Congenital heart defects
  • Focus Adverse reactions
  • Acronyms RUBATO OL
  • Sponsors Actelion Pharmaceuticals

    • Most Recent Events

    • 06 Mar 2023 Status has been changed to discontinued.
    • 26 Oct 2021 Planned End Date changed from 8 Sep 2023 to 17 Jan 2022.
    • 26 Oct 2021 Planned primary completion date changed from 30 Jul 2023 to 17 Jan 2022.

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