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: 16 Aug 2017

At a glance

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

    • 24 May 2017 Planned End Date changed from 20 Dec 2019 to 27 May 2020.
    • 24 May 2017 Planned primary completion date changed from 30 Oct 2017 to 30 Apr 2018.
    • 15 Jun 2015 Planned End Date changed from 1 Jan 2017 to 1 Dec 2019 as reported by ClinicalTrials.gov record.
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