CompletedNot Applicable

A Non-Interventional Follow Up Study For Subjects Who Received Sildenafil for Persistent Pulmonary Hypertension of the Newborn (PPHN)

United Kingdom1 participantsStarted 2012-11

Plain-language summary

This single center study will monitor the developmental progress of PPHN patients who received iv sildenafil in study A1481276. Two visits will be conducted, at 12 and 24 months following the end of study drug infusion.

Who can participate

Age range0 Years – 1 Year

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: * Any subject who received sildenafil treatment in study A1481276. * Signed and dated informed consent document by legal guardian. Exclusion Criteria: * Any subject who did not receive sildenafil treatment during study A1481276.

What they're measuring

Number of Participants With Physical Examination Abnormalities at Month 12

Timeframe: Month 12

Number of Participants With Physical Examination Abnormalities at Month 24

Timeframe: Month 24

Number of Participants With Clinically Significant Medical History at Month 12

Timeframe: Month 12

Number of Participants With Clinically Significant Medical History at Month 24

Timeframe: Month 24

Trial details

NCT IDNCT01801982

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

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2013-12

Results submitted2014-12-02

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