NCT01360671

IV Sildenafil Persistent Pulmonary Hypertension Of The Newborn

An Open Label Single Arm, Single Centre Study to Investigate the Safety and Efficacy of IV Sildenafil in Neonates With Persistent Pulmonary Hypertension of the Newborn (PPHN)

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Industry
• Sex: All
• Age: 72 Hours
• Healthy volunteers: Not accepted

Summary

To determine the efficacy of iv sildenafil in term and near term infants with PPHN (persistent pulmonary hypertension of the newborn), by measuring the need for inhaled nitric oxide (iNO) or extracorporeal membrane oxygenation (ECMO) compared to a historical control group not treated with sildenafil.

Conditions

• Persistent Pulmonary Hypertension of the Newborn

Interventions

Type	Name	Description
DRUG	Sildenafil	Loading dose of 0.1 mg/kg for 30 minutes followed by maintenance treatment of 0.03 mg/kg.h for up to 14 days

Timeline

• Start date: 2012-03-01
• Primary completion: 2013-04-01
• Completion: 2013-04-01
• First posted: 2011-05-26
• Last updated: 2021-02-02