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 range

0 Years – 1 Year

Sex

ALL

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

Who can participate

Age range

0 Years – 1 Year

Sex

ALL

See this in plain English?

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

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