A Multi-centre, Randomized, Placebo-controlled, Double-blind, Two-armed, Parallel Group Study To Evaluate Efficacy And Safety Of Iv Sildenafil In The Treatment Of Neonates With Persistent Pulmonary Hypertension Of The Newborn (Pphn) Or Hypoxic Respiratory Failure And At Risk For Pphn, With A Long Term Follow-up Investigation Of Developmental Progress 12 And 24 Months After Completion Of Study Treatment

Trial Profile

A Multi-centre, Randomized, Placebo-controlled, Double-blind, Two-armed, Parallel Group Study To Evaluate Efficacy And Safety Of Iv Sildenafil In The Treatment Of Neonates With Persistent Pulmonary Hypertension Of The Newborn (Pphn) Or Hypoxic Respiratory Failure And At Risk For Pphn, With A Long Term Follow-up Investigation Of Developmental Progress 12 And 24 Months After Completion Of Study Treatment

Recruiting
Phase of Trial: Phase III

Latest Information Update: 01 Dec 2017

At a glance

  • Drugs Sildenafil (Primary)
  • Indications Pulmonary hypertension
  • Focus Registrational; Therapeutic Use
  • Sponsors Pfizer
  • Most Recent Events

    • 30 Oct 2017 Planned End Date changed from 27 May 2020 to 1 Aug 2020.
    • 30 Oct 2017 Planned primary completion date changed from 30 Apr 2018 to 1 Jul 2018.
    • 24 May 2017 Planned End Date changed from 20 Dec 2019 to 27 May 2020.
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