CompletedPhase 3

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

United States59 participantsStarted 2013-08-05

Plain-language 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.

Who can participate

Age range0 Days – 4 Days

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Time on Inhaled Nitric Oxide (iNO) Treatment After Initiation of Intravenous (IV) Study Drug For Participants Without Treatment Failure

Timeframe: 14 days from the initiation of IV study drug or hospital discharge, whichever occurs first (maximum of 14 days)

Treatment Failure Rate

Timeframe: 14 days from the initiation of IV study drug or hospital discharge, whichever occurs first (maximum of 14 days)

Trial details

NCT IDNCT01720524

SponsorPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-10-17

Results submitted2019-10-16

View on ClinicalTrials.gov More Pulmonary Hypertension, Familial Persistent, of the Newborn trials