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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01720524
First received: September 17, 2012
Last updated: July 21, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Pulmonary Hypertension, Familial Persistent, of the Newborn
Drug: placebo
Drug: iv sildenafil
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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 Long Term Follow-Up Investigation Of Developmental Progress 12 And 24 Months After Completion Of Study Treatment

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Time on inhaled nitric oxide treatment after initiation of iv study drug [ Time Frame: Day 14 or hospital discharge ] [ Designated as safety issue: No ]
  • Treatment failure rate, defined as need for additional treatment targeting persistent pulmonary hypertension of the newborn. [ Time Frame: day 14 or hospital discharge ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to final weaning of mechanical ventilation for persistent pulmonary hypertension of the newborn [ Time Frame: Day 14 or hospital discharge ] [ Designated as safety issue: No ]
  • Time from initiation of study drug to treatment failure [ Time Frame: Day 14 or hospital discharge ] [ Designated as safety issue: No ]
  • Change in oxygenation parameters at 6, 12, and 24 hours from baseline [ Time Frame: Day 14 or hospital discharge ] [ Designated as safety issue: No ]
  • Sildenafil plasma concentrations and corresponding PK parameters [ Time Frame: Day 14 or hospital discharge ] [ Designated as safety issue: No ]
  • Safety parameters: incidence and severity of adverse events and abnormal laboratory parameters [ Time Frame: Day 14 or hospital discharge ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 64
Study Start Date: July 2013
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: placebo
iv placebo of normal saline or 10% dextrose
Drug: placebo
IV placebo or 0.9% sodium chloride or 10% dextrose. Infusion rate based on weight.
Experimental: sildenafil
Active study drug
Drug: iv sildenafil
loading dose of 0.1 mg/kg over 30 minutes followed by maintenance dose of 0.03 mg/kg/h. To infuse minimum 48 hours and maximum of 14 days.
Other Name: revatio

  Eligibility

Ages Eligible for Study:   up to 72 Hours
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01720524

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

  Hide Study Locations
Locations
United States, Alabama
University Hospital Women and Infants Center Recruiting
Birmingham, Alabama, United States, 35249
COA/The Children's Hospital of Alabama NICU Recruiting
Birmingham, Alabama, United States, 35249
United States, Arkansas
Arkansas Children's Hospital Recruiting
Little Rock, Arkansas, United States, 72202
United States, California
Loma Linda University Pediatric High Risk Clinic Recruiting
Bernadino, California, United States, 92408
Loma Linda University Medical Center Recruiting
Loma Linda, California, United States, 92354
UC Davis Children's Hospital Recruiting
Sacramento, California, United States, 95817
United States, District of Columbia
Childrens National Medical Center Recruiting
Washington, District of Columbia, United States, 20010
United States, Illinois
Ann & Robert H. Lurie Children's Hospital of Chicago Not yet recruiting
Chicago, Illinois, United States, 60611
United States, Indiana
Riley Hospital for Children at IU Health Methodist Hospital Recruiting
Indianapolis, Indiana, United States, 46202
Riley Hospital for Children at IU Health Recruiting
Indianapolis, Indiana, United States, 46202
United States, Kentucky
University of Louisville Recruiting
Louisville, Kentucky, United States, 40202
Kosair Children's Hospital Recruiting
Louisville, Kentucky, United States, 40202
Neonatal Follow Up Clinic Recruiting
Louisville, Kentucky, United States, 40202
United States, Missouri
Children's Mercy Hospitals & Clinics Not yet recruiting
Kansas City, Missouri, United States, 64108
United States, North Carolina
Duke University Medical Center (DUMC) Recruiting
Durham, North Carolina, United States, 27710
United States, Oklahoma
The University of Oklahoma Health Sciences Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
OU Neonatal Intensive Care Unit at Children's Hospital Recruiting
Oklahoma City, Oklahoma, United States, 73104
OU Follow-Up Program, PREMIEr Clinic, Children's Hospital Recruiting
Oklahoma City, Oklahoma, United States, 73104
Medical Director and Neonatologist Henry Zarrow Neonatal Intensive Care Unit at Saint Francis Recruiting
Tulsa, Oklahoma, United States, 74136
United States, Tennessee
Vanderbilt Children's Hospital Recruiting
Nashville, Tennessee, United States, 37232
United States, Washington
Seattle Children's Research Institute Not yet recruiting
Seattle, Washington, United States, 98101
Seattle Childrens Hospital Not yet recruiting
Seattle, Washington, United States, 98105
Austria
Medizinische Universitat Innsbruck Recruiting
Innsbruck, Austria, 6020
Belgium
UZ Leuven Recruiting
Leuven, Vlaams Brabant / Belgium, Belgium, 3000
Universitair Ziekenhuis Antwerpen Recruiting
Edegem, Belgium, 2650
UZ Gent Recruiting
Gent, Belgium, 9000
Canada, Quebec
The Montreal Children¿s Hospital Recruiting
Montreal, Quebec, Canada, H3H 1P3
C.H.U.Q. - Chul Recruiting
Sainte-Foy, Quebec, Canada, G1V 4G2
Denmark
Aarhus Universitetshospital, Skejby Recruiting
Aarhus N, Denmark, 8200
Neonatalklinikken Rigshospitalet Recruiting
Copenhagen, Denmark, 2100
Odense Universitetshospital, H.C. Andersen Bornehospital Recruiting
Odense C, Denmark, 5000
Odense Universitetshospital Recruiting
Odense C, Denmark, 5000
France
CHU de Caen Recruiting
Caen Cedex 9, France, 14033
Centre Hospitalier et Régional de Lille, Recruiting
Lille, France, 59037
Hôpital de la Conception Assistance Publique-Hôpitaux de Marseille Not yet recruiting
Marseille, France, 13385
CHU de Nantes Not yet recruiting
Nantes, France, 44000
Hopital Necker Enfant Malades Not yet recruiting
Paris, France, 75015
CHU Robert Debré Recruiting
Paris, France, 75019
Germany
Universitatsklinikum Heidelberg Recruiting
Heidelberg, Germany, 69112
Kinderkrankenhaus St. Marien Recruiting
Landshut, Germany, 84036
Universitatsklinikum Leipzig AoR Recruiting
Leipzig, Germany, 04103
Universitätsklinikum Mannheim Recruiting
Mannheim, Germany, 68163
Italy
Istituto Clinico di Pediatria Preventiva e Neonatologia Recruiting
Bologna, NAP, Italy, 40138
Neonatologia e Terapia Intensiva Neonatale Azienda Ospedaliera Spedali Civili di Brescia Recruiting
Brescia, NAP, Italy, 25123
Neonatologia e Terapia Intensiva Neonatale Azienda Ospedaliero-Universitaria Careggi Recruiting
Firenze, NAP, Italy, 50134
PU A.Gemelli Recruiting
Roma, NAP, Italy, 00168
Farmacia-Azienda Ospedaliero Universitaria Careggi Recruiting
Firenze, Italy, 50134
Neonatologia Fondazione IRCCS Policlinico San Matteo Recruiting
Pavia, Italy, 27100
Farmacia-Policlinico Universitario A. Gemelli Recruiting
Roma, Italy, 00168
Netherlands
Radboud University Nijmegen Medical Centre Recruiting
Nijmegen, Netherlands, 6525 GA
ErasmusMC, Sophia Children's hospital Recruiting
Rotterdam, Netherlands, 3015 CN
Norway
Haukeland University Hospital Recruiting
Hordaland, Norway, 5021
Rikshospitalet, University Hospital Recruiting
Oslo, Norway, 0027
Neonatal Center Recruiting
Tromso, Norway, 9038
Spain
Hospital Gregorio Maranon/Unidad Neonatal Recruiting
Madrid, Spain, 28007
H.U.P.La Fe Recruiting
Valencia, Spain, 46026
Sweden
Karolinska University Hospital and Institute Recruiting
Stockholm, Sweden, 171 76
United Kingdom
St. Michael's Hospital Recruiting
Bristol, United Kingdom, BS2 8EG
Leeds Teaching Hospitals NHS Trust Not yet recruiting
Leeds, United Kingdom, LS13EX
Glenfield Hospital Recruiting
Leicester, United Kingdom, LE3 9QP
Great Ormond Street Hospital, Paediatric Intensive Care Recruiting
London, United Kingdom, WC1N 3JH
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01720524     History of Changes
Other Study ID Numbers: A1481316, 2012-002619-24
Study First Received: September 17, 2012
Last Updated: July 21, 2014
Health Authority: European Union: European Medicines Agency

Keywords provided by Pfizer:
persistent pulmonary hypertension
newborn
neonates
iv sildenafil
hypoxic respiratory failure and at risk of persistent pulmonary hypertension of the newborn

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Persistent Fetal Circulation Syndrome
Respiratory Insufficiency
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Infant, Newborn, Diseases
Respiration Disorders
Sildenafil
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 24, 2014