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

Launched by PFIZER'S UPJOHN HAS MERGED WITH MYLAN TO FORM VIATRIS INC. · Oct 31, 2012

Trial Information

Current as of June 20, 2025

Completed

Keywords

Persistent Pulmonary Hypertension Newborn Neonates Iv Sildenafil Hypoxic Respiratory Failure And At Risk Of Persistent Pulmonary Hypertension Of The Newborn

ClinConnect Summary

No description provided

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 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
  • Exclusion Criteria:
  • 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

About Pfizer's Upjohn Has Merged With Mylan To Form Viatris Inc.

Viatris Inc. is a global healthcare company formed from the merger of Pfizer's Upjohn division and Mylan, dedicated to providing access to high-quality medicines, including generics and specialty pharmaceuticals. With a strong commitment to innovation and patient-centric solutions, Viatris leverages a diverse portfolio and extensive global reach to address the evolving healthcare needs of patients worldwide. The company aims to create sustainable healthcare solutions by combining expertise in pharmaceutical development, manufacturing, and distribution, ultimately enhancing patient outcomes and improving overall health systems.

Locations

Sacramento, California, United States

Cleveland, Ohio, United States

Sacramento, California, United States

Cleveland, Ohio, United States

Gent, , Belgium

Little Rock, Arkansas, United States

Oklahoma City, Oklahoma, United States

Nashville, Tennessee, United States

Kansas City, Missouri, United States

Leicester, , United Kingdom

Stockholm, , Sweden

Leipzig, , Germany

Durham, North Carolina, United States

Bristol, , United Kingdom

Edegem, , Belgium

Madrid, , Spain

Paris, , France

Indianapolis, Indiana, United States

Nijmegen, , Netherlands

Tulsa, Oklahoma, United States

Seattle, Washington, United States

Aarhus N, , Denmark

Indianapolis, Indiana, United States

Washington, District Of Columbia, United States

Indianapolis, Indiana, United States

Oklahoma City, Oklahoma, United States

Oklahoma City, Oklahoma, United States

Tulsa, Oklahoma, United States

Seattle, Washington, United States

Quebec, , Canada

Copenhagen ø, , Denmark

Lille, , France

Lille, , France

Marseille, , France

Paris, , France

Pavia, , Italy

Rotterdam, , Netherlands

Bergen, Haukeland, Norway

Esplugues De Llobregat, Barcelona / Spain, Spain

Leicester, , United Kingdom

London, , United Kingdom

Patients applied

0 patients applied

Trial Officials

Pfizer CT.gov Call Center

Study Director

Pfizer

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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