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PHIRST-1: Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment in Patients With Pulmonary Arterial Hypertension

Trial Profile

PHIRST-1: Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment in Patients With Pulmonary Arterial Hypertension

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 07 Nov 2021

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At a glance

  • Drugs Tadalafil (Primary)
  • Indications Pulmonary arterial hypertension
  • Focus Registrational; Therapeutic Use
  • Acronyms PHIRST-1
  • Sponsors Eli Lilly and Company
  • Most Recent Events

    • 11 Aug 2021 Results of pooled adult/pediatric population analysis assessing pharmacokinetics of tadalafil to explored in a pediatric phase Ib/II (NCT01484431; n=19) study and pooled with prior phase III (pulmonary arterial hypertension and response to tadalafil [PHIRST-1; NCT00125918; n=305]) adult data to develop the first population PK model for tadalafil in pediatric patients with pulmonary arterial hypertension, published in the Clinical Pharmacokinetics.
    • 14 Oct 2013 New trial record
    • 04 Sep 2013 Results for long-term safety and survival outcomes from open-label extension PHIRST2-Part 2 presented at the ESC Congress 2013: Annual Congress of the European Society of Cardiology.
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