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A Phase III, International, Multi-Center, Randomized, Double- Blind, Placebo-Controlled, Clinical Worsening Study of UT-15C in Subjects With Pulmonary Arterial Hypertension Receiving Background Oral Monotherapy

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Trial Profile

A Phase III, International, Multi-Center, Randomized, Double- Blind, Placebo-Controlled, Clinical Worsening Study of UT-15C in Subjects With Pulmonary Arterial Hypertension Receiving Background Oral Monotherapy

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 11 Dec 2023

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At a glance

  • Drugs Treprostinil (Primary)
  • Indications Pulmonary arterial hypertension
  • Focus Registrational; Therapeutic Use
  • Acronyms FREEDOM-Ev
  • Sponsors United Therapeutics Corporation

    • Most Recent Events

    • 06 Dec 2023 Results of three additional years of open-label observation after the close of the placebo-controlled, event-driven study, associated with improved survival in FREEDOM-EV and its Open-Label Extension published in the Advances in Therapy
    • 24 May 2023 Results performing time to first adjudicated clinical worsening (CW) event using Win Ratio Analysis , presented at the 119th International Conference of the American Thoracic Society
    • 19 Oct 2022 Results assessing efficacy of treprostinil in pulmonary arterial hypertension participants in Freedom-Ev (NCT01560624) and the Freedom-Ev Open-Label Extension (OLE, NCT01560637) studies, presented at the CHEST Annual Meeting 2022 by Annual Meeting of the American College of Chest Physicians.
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