N/A
Completed 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
Source: ClinicalTrials.gov NCT01801982 ↗
Enrolled (actual)
1
Serious AEs
0.0%
Results posted
Dec 2014
Primary outcomePrimary: Number of Participants With Physical Examination Abnormalities at Month 12 — 0 participants
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.
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) |
— | — |
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.
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. Informational only — not medical advice.