A Study To Evaluate Safety And Efficacy Of IV Sildenafil In The Treatment Of Neonates With Persistent Pulmonary Hypertension Of The Newborn

• Status: Completed
• Trial end date: 2020-09-28
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate whether IV sildenafil can reduce the time on inhaled nitric oxide treatment and reduce the failure rate of available treatments for persistent pulmonary hypertension of the newborn.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer; Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• Treatments: Sildenafil Citrate

Criteria

Inclusion Criteria:

• Neonates with persistent pulmonary hypertension of the newborn

• Age <=96 hours and >=34 weeks gestational age

• Oxygenation Index >15 and <60

• Concurrent treatment with inhaled nitric oxide and >=50% oxygen

Exclusion Criteria:

• Prior or immediate need for extracorporeal membrane oxygenation or cardiopulmonary resuscitation

• Expected duration of mechanical ventilation <48 hours

• Profound hypoxemia

• Life-threatening or lethal congenital anomaly