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An Open-label, International, Multicenter, Single-arm, Uncontrolled, Phase IIIb Study of Riociguat in Patients With Pulmonary Arterial Hypertension (PAH) Who Demonstrate an Insufficient Response to Treatment With Approved Dosages of Phosphodiesterase-5 Inhibitors (PDE-5i)

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Trial Profile

An Open-label, International, Multicenter, Single-arm, Uncontrolled, Phase IIIb Study of Riociguat in Patients With Pulmonary Arterial Hypertension (PAH) Who Demonstrate an Insufficient Response to Treatment With Approved Dosages of Phosphodiesterase-5 Inhibitors (PDE-5i)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 22 Dec 2023

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At a glance

  • Drugs Riociguat (Primary)
  • Indications Pulmonary hypertension
  • Focus Registrational; Therapeutic Use
  • Acronyms RESPITE
  • Sponsors Bayer

    • Most Recent Events

    • 13 Nov 2023 Results of pooled post hoc analysis (n=741 from studies PATENT-1, PATENT PLUS, RESPITE, MOTION, REPLACE) assessing the impact of riociguat in patients with PAH and comorbidities presented at the American Heart Association Scientific Sessions 2023
    • 14 Apr 2018 Results of post-hoc analysis of switching from PDE5i to Riociguat in the RESPITE study, presented at the 38th Annual Meeting and Scientific Sessions of the International Society for Heart and Lung Transplantation
    • 01 Sep 2017 Primary endpoint (Change from baseline in 6 minute walking distance) has been met, according to the results published in the European Respiratory Journal.

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