TerminatedPhase 2

Study To Investigate Safety And Efficacy Of Sildenafil In The Newborns With Persistent Pulmonary Hypertension (PPHN)

Stopped: See termination reason in detailed description.

United Kingdom4 participantsStarted 2010-12

Plain-language summary

Sildenafil is efficacious in newborns with persistent pulmonary hypertension and its use will reduce the need for inhaled nitric oxide.

Age range1 Hour – 72 Hours

SexALL

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Percentage of Participants Requiring Inhaled Nitric Oxide (iNO) or Extracorporeal Membrane Oxygenation (ECMO)

Timeframe: From start of infusion (baseline) up to Day 14

Number of Participants With Adverse Events (AEs) Based on Severity

Timeframe: Baseline up to 28 days after last dose

Number of Participants With Abnormal Laboratory Data

Timeframe: Screening, once daily for 3 days, every 48 hours thereafter till the end of infusion (up to Day 14)

NCT IDNCT01069861

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

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2011-11

Results submitted2012-11-01