N/A N=1

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

Pulmonary Hypertension, Persistent, of the Newborn

Bottom Line

View on ClinicalTrials.gov: NCT01801982 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2014

Primary outcome: Primary: Number of Participants With Physical Examination Abnormalities at Month 12 — 0 participants

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: non-interventional (Other)
Age: Pediatric · 0+ yrs
Sex: All
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Primary completion: Dec 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Physical Examination Abnormalities at Month 12	—	—
PRIMARY Number of Participants With Physical Examination Abnormalities at Month 24	—	—
PRIMARY Number of Participants With Clinically Significant Medical History at Month 12	—	—
PRIMARY Number of Participants With Clinically Significant Medical History at Month 24	—	—
SECONDARY Overall Survival at Month 12	1	—
SECONDARY Overall Survival at Month 24	—	—
SECONDARY Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)	—	—

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01801982). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.