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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

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pulmonary Hypertension, Familial Persistent, of the Newborn

Intervention: placebo (Drug); iv sildenafil (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021

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.

Clinical Details

Official title: A Multi-centre, Randomized, Placebo-controlled, Double-blind, Two-armed, Parallel Group Study To Evaluate Efficacy And Safety Of Iv Sildenafil In The Treatment Of Neonates With Persistent Pulmonary Hypertension Of The Newborn (Pphn) Or Hypoxic Respiratory Failure And At Risk For Pphn, With A Long Term Follow-up Investigation Of Developmental Progress 12 And 24 Months After Completion Of Study Treatment

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome:

Time on inhaled nitric oxide treatment after initiation of iv study drug

Treatment failure rate, defined as need for additional treatment targeting persistent pulmonary hypertension of the newborn.

Secondary outcome:

Time to final weaning of mechanical ventilation for persistent pulmonary hypertension of the newborn

Time from initiation of study drug to treatment failure

Change in oxygenation parameters at 6, 12, and 24 hours from baseline

Sildenafil plasma concentrations and corresponding PK parameters

Safety parameters: incidence and severity of adverse events and abnormal laboratory parameters

Eligibility

Minimum age: N/A. Maximum age: 4 Days. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Neonates with persistent pulmonary hypertension of the newborn

- Age <=72 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

Locations and Contacts

Pfizer CT.gov Call Center, Phone: 1-800-718-1021

Medizinische Universitat Innsbruck, Innsbruck 6020, Austria; Recruiting

Universitair Ziekenhuis Antwerpen, Edegem 2650, Belgium; Recruiting

UZ Gent, Gent 9000, Belgium; Recruiting

Aarhus Universitetshospital, Skejby, Aarhus N 8200, Denmark; Recruiting

Neonatalklinikken Rigshospitalet, Copenhagen 2100, Denmark; Recruiting

CHU de Caen, Caen Cedex 9 14033, France; Recruiting

Centre Hospitalier et Regional de Lille - Hopital Jeanne de Flandre, Lille 59037, France; Recruiting

Centre Hospitalier et Régional de Lille,, Lille 59037, France; Recruiting

Hôpital de la Conception Assistance Publique-Hôpitaux de Marseille, Marseille 13385, France; Recruiting

CHU Robert Debré, Paris 75019, France; Recruiting

Hopital Necker Enfant Malades, Paris 75015, France; Recruiting

Universitatsklinikum Leipzig AoR, Leipzig 04103, Germany; Recruiting

Universitätsklinikum Mannheim, Mannheim 68167, Germany; Recruiting

A.O. Spedali Civili, Brescia 25123, Italy; Recruiting

Fondazione IRCCS Policlinico San Matteo - c/o C.U.R.M, Pavia 27100, Italy; Recruiting

Neonatologia Fondazione IRCCS Policlinico San Matteo, Pavia 27100, Italy; Recruiting

Radboud University Nijmegen Medical Centre, Nijmegen 6525 GA, Netherlands; Recruiting

Erasmus MC, Sophia Children's hospital, Rotterdam 3015 GN, Netherlands; Recruiting

Haukeland University Hospital, Hordaland 5021, Norway; Recruiting

Rikshospitalet, University Hospital, Oslo 0027, Norway; Recruiting

Hospital Universitari Vall d'Hebron, Barcelona 08035, Spain; Recruiting

Hospital Gregorio Maranon/Unidad Neonatal, Madrid 28007, Spain; Recruiting

H.U.P.La Fe, Valencia 46026, Spain; Recruiting

Karolinska University Hospital and Institute, Stockholm 171 76, Sweden; Recruiting

St. Michael's Hospital, Bristol BS2 8EG, United Kingdom; Recruiting

Leeds Teaching Hospitals NHS Trust, Leeds LS13EX, United Kingdom; Recruiting

Glenfield Hospital, University Hospitals of Leicester NHS Trust, Leicester LE3 9QP, United Kingdom; Recruiting

Great Ormond Street Hospital, Paediatric Intensive Care, London WC1N 3JH, United Kingdom; Recruiting

Children¿s of Alabama, Birmingham, Alabama 35233, United States; Recruiting

COA/The Children's Hospital of Alabama NICU, Birmingham, Alabama 35249, United States; Recruiting

University Hospital Women and Infants Center, Birmingham, Alabama 35249, United States; Recruiting

University of Alabama at Birmingham, Birmingham, Alabama 35233, United States; Recruiting

Arkansas Children's Hospital, Little Rock, Arkansas 72202, United States; Recruiting

Universitaetsklinikum Heidelberg - Zentrum für Kinder- und Jugendmedizin, Heidelberg, Baden-Wuerttemberg 69120, Germany; Recruiting

Hospital San Joan de Deu, Esplugues de Llobregat, Barcelona / Spain 08950, Spain; Recruiting

Loma Linda University Pediatric High Risk Clinic, Bernadino, California 92408, United States; Recruiting

Loma Linda University Medical Center, Loma Linda, California 92354, United States; Recruiting

UC Davis Children's Hospital, Sacramento, California 95817, United States; Recruiting

Childrens National Medical Center, Washington, District of Columbia 20010, United States; Recruiting

Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, Illinois 60611, United States; Recruiting

Indiana University Health Methodist Hospital, Indianapolis, Indiana 46202, United States; Recruiting

Riley Hospital for Children at IU Health, Indianapolis, Indiana 46202, United States; Recruiting

Sydney and Lois Eskenazi Hospital, Indianapolis, Indiana 46202, United States; Recruiting

Kosair Children's Hospital, Louisville, Kentucky 40202, United States; Recruiting

Neonatal Follow Up Clinic, Louisville, Kentucky 40202, United States; Recruiting

ULP Speech and Audiology, Louisville, Kentucky 40202, United States; Recruiting

University of Louisville, Louisville, Kentucky 40202, United States; Recruiting

Children's Mercy Hospitals & Clinics, Kansas City, Missouri 64108, United States; Recruiting

Neonatologia e Terapia Intensiva Neonatale Azienda Ospedaliera Spedali Civili di Brescia, Brescia, NAP 25123, Italy; Recruiting

Duke University Medical Center (DUMC), Durham, North Carolina 27710, United States; Recruiting

OU Follow-Up Program, PREMIEr Clinic, Children's Hospital, Oklahoma City, Oklahoma 73104, United States; Recruiting

OU Neonatal Intensive Care Unit at Children's Hospital, Oklahoma City, Oklahoma 73104, United States; Recruiting

The University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma 73104, United States; Recruiting

Medical Director and Neonatologist Henry Zarrow Neonatal Intensive Care Unit at Saint Francis, Tulsa, Oklahoma 74136, United States; Terminated

Warren Cancer Research Foundation, Tulsa, Oklahoma 74136, United States; Terminated

The Hospital for Sick Children, Toronto, Ontario M5G 1X8, Canada; Recruiting

The Montreal Children¿s Hospital, Montreal, Quebec H3H 1P3, Canada; Recruiting

C.H.U.Q. - Chul, Sainte-Foy, Quebec G1V 4G2, Canada; Recruiting

Vanderbilt Children's Hospital, Nashville, Tennessee 37232, United States; Recruiting

UZ Leuven, Leuven, Vlaams Brabant / Belgium 3000, Belgium; Recruiting

Seattle Childrens Hospital, Seattle, Washington 98105, United States; Recruiting

Additional Information

To obtain contact information for a study center near you, click here.

Starting date: August 2013
Last updated: June 15, 2015

Page last updated: August 23, 2015

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