NCT01069861

Study To Investigate Safety And Efficacy Of Sildenafil In The Newborns With Persistent Pulmonary Hypertension (PPHN)

A Single Arm Single Centre Study To Investigate Safety And Efficacy Of Sildenafil In Near Term And Term Newborns With Persistent Pulmonary Hypertension Of The Newborn (PPHN)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Industry
• Sex: All
• Age: 1 Hour – 72 Hours
• Healthy volunteers: Not accepted

Summary

Sildenafil is efficacious in newborns with persistent pulmonary hypertension and its use will reduce the need for inhaled nitric oxide.

Detailed description

Letter to investigator dated 18 June 2012 that study was to be terminated. Study terminated due to evolved and widespread use of standard of care, relevance of study questioned. No safety reasons or issues.

Conditions

• PPHN
• Persistent Pulmonary Hypertension of the Newborn
• Hypoxic Respiratory Failure

Interventions

Type	Name	Description
DRUG	sildanefil	Intravenous sildenafil citrate will be administered as a loading dose of 0.1 mg/kg given over 30 minutes. This will be followed by a maintenance treatment consisting of an intravenous infusion of 0.03 mg/kg/hr. The duration of the infusion will be determined by the need of the individual patient, but will be reviewed at Day 7 if still ongoing, and will not continue past Day 14.

Timeline

• Start date: 2010-12-01
• Primary completion: 2011-11-01
• Completion: 2011-11-01
• First posted: 2010-02-17
• Last updated: 2021-02-01
• Results posted: 2012-12-03

Locations

1 site across 1 country: United Kingdom