NCT01801982

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

A Follow Up Investigation For Patients Completing Study A1481276 To Investigate Developmental Progress 12 And 24 Months Following Completion Of Sildenafil Treatment

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1 (actual)
• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Industry
• Sex: All
• Age: 0 Years – 1 Year
• Healthy volunteers: Not accepted

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.

Detailed description

This study will monitor developmental progress of PPHN patients for 2 years following study treatment, using Bayley III and Hammersmith tools. Data will be explored with descriptive statistics.

Conditions

• Pulmonary Hypertension, Persistent, of the Newborn

Interventions

Type	Name	Description
OTHER	non-interventional	non-interventional

Timeline

• Start date: 2012-11-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2013-03-01
• Last updated: 2021-02-01
• Results posted: 2014-12-10

Locations

1 site across 1 country: United Kingdom