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

Completed · Phase 3 · Has a placebo group

Conditions studied: Pulmonary Hypertension, Familial Persistent, of the Newborn

In brief

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.

Key facts

Study ID

NCT01720524

Run by

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

People needed

59

Starts

2013-08-05

Expected to finish

2020-09-28

Last updated by the study team

2021-08-16

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Neonates with persistent pulmonary hypertension of the newborn
• Age <=96 hours and >=34 weeks gestational age
• Oxygenation Index >15 and <60
• Concurrent treatment with inhaled nitric oxide and >=50% oxygen

You may not qualify if…

• Prior or immediate need for extracorporeal membrane oxygenation or cardiopulmonary resuscitation
• Expected duration of mechanical ventilation <48 hours
• Profound hypoxemia
• Life-threatening or lethal congenital anomaly

Where it is running

• Arkansas Children's Hospital — Little Rock, Arkansas, United States
• University of California Davis Medical Center — Sacramento, California, United States
• University of California Davis — Sacramento, California, United States
• University of California Davis Medical Center — Sacramento, California, United States
• Children´s National Medical Center — Washington D.C., District of Columbia, United States
• Indiana University Health Methodist Hospital — Indianapolis, Indiana, United States
• Riley Hospital for Children at IU Health — Indianapolis, Indiana, United States
• Sydney and Lois Eskenazi Hospital — Indianapolis, Indiana, United States
• Children's Mercy Hospitals & Clinics — Kansas City, Missouri, United States
• Duke University Medical Center (DUMC) — Durham, North Carolina, United States
• Fairview Hospital — Cleveland, Ohio, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• OU Follow-Up Program, PREMIEr Clinic, Children's Hospital — Oklahoma City, Oklahoma, United States
• OU Neonatal Intensive Care Unit at Children's Hospital — Oklahoma City, Oklahoma, United States
• The University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States
• Henry Zarrow Neonatal Intensive Care Unit, Children's Hospital at Saint Francis — Tulsa, Oklahoma, United States
• Warren Cancer Research Foundation — Tulsa, Oklahoma, United States
• Vanderbilt Children's Hospital — Nashville, Tennessee, United States
• Seattle Children's Research Institute — Seattle, Washington, United States
• Seattle Childrens Hospital — Seattle, Washington, United States
• Universitair Ziekenhuis Antwerpen — Edegem, Belgium
• UZ Gent — Ghent, Belgium
• CHUL du CHU de Quebec — Québec, Quebec, Canada
• Aarhus Universitetshospital, Skejby — Aarhus N, Denmark
• Neonatalklinikken Rigshospitalet, 5024 — Copenhagen Ø, Denmark

Full record on ClinicalTrials.gov

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