A Study To Evaluate Safety And Efficacy Of IV Sildenafil In The Treatment Of Neonates With Persistent Pulmonary Hypertension Of The Newborn

NCT01720524 ↗

Phase 3 Completed 59 enrolled Viatris Inc.

RandomizedParallel-groupDouble-blindTreatment

Summary

This study will evaluate whether IV sildenafil can reduce the time on inhaled nitric oxide treatment and reduce the failure rate of available treatments for persistent pulmonary hypertension of the newborn.

Timeline

Start: 2013-08-05
Primary completion: 2018-10-17
Completion: 2020-09-28

Outcome

Missed primary endpoint

registry analysis (superiority test); IV Sildenafil vs Placebo; p = 0.9850; Least square (LS) mean difference 0.0 (95% CI -2.08 to 2.04); ANCOVA NCT01720524 ↗

registry analysis (superiority test); IV Sildenafil vs Placebo; p = 0.4935; Difference in percentage 7.6 (95% CI -14.1 to 29.3); Chi-squared NCT01720524 ↗

release “newborns with Persistent Pulmonary Hypertension (PPHN) did not meet its primary efficacy endpoint” pfizer.com ↗

Publications

Pierce CM, Zhang MH, Jonsson B, Iorga D, Cheruvu N, Balagtas CC, Steinhorn RH. Efficacy and Safety of IV Sildenafil in the Treatment of Newborn Infants with, or at Risk of, Persistent Pulmonary Hypertension of the Newborn (PPHN): A Multicenter, Randomized, Placebo-Controlled Trial. J Pediatr. 2021 Oct;237:154-161.e3. doi: 10.1016/j.jpeds.2021.05.051. Epub 2021 May 27.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Sildenafil	Unknown	0.03 mg/kg	Intravenous