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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

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: 21 Oct 2019

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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

    • 21 Oct 2019 According to a United Therapeutics Corporation media release, the U.S. FDA has approved a supplemental NDA to update the label for Orenitram. The updated label will reflect data from the FREEDOM-EV study to indicate that Orenitram delays disease progression when used in conjunction with an approved oral background PAH therapy.
    • 06 Apr 2019 Results assessing the effect of Oral Treprostinil on Time to Clinical Worsening in Patients with Pulmonary Arterial Hypertension, presented at the 39th Annual Meeting and Scientific Sessions of the International Society for Heart and Lung Transplantation
    • 31 Jan 2019 According to an United Therapeutics Corporation media release, additional detailed data from this study will be made available through oral presentations at the upcoming International Society for Heart and Lung Transplantation (Apr. 3-6, 2019; Orlando, FL) and American Thoracic Society (May 17-22, 2019; Dallas, TX) conferences and through scientific publications.
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