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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

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 14 Nov 2019

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At a glance

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

    • 14 Nov 2019 This trial has been completed in France, according to European Clinical Trials Database record.
    • 15 Jul 2019 Planned End Date changed from 19 Oct 2020 to 15 Dec 2020.
    • 28 Jun 2019 According to an Pfizer Media release, Part B of the study is ongoing.
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