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

PHASE3CompletedINTERVENTIONAL
Enrollment

59

Participants

Timeline

Start Date

August 5, 2013

Primary Completion Date

October 17, 2018

Study Completion Date

September 28, 2020

Conditions
Pulmonary Hypertension, Familial Persistent, of the Newborn
Interventions
DRUG

placebo

IV placebo or 0.9% sodium chloride or 10% dextrose. Infusion rate based on weight.

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.

Trial Locations (42)

2100

Neonatalklinikken Rigshospitalet, 5024, Copenhagen Ø

2650

Universitair Ziekenhuis Antwerpen, Edegem

5000

Haukeland University Hospital, Bergen

8200

Aarhus Universitetshospital, Skejby, Aarhus N

9000

UZ Gent, Ghent

13385

Hôpital de la Conception Assistance Publique-Hôpitaux de Marseille, Marseille

20010

Children´s National Medical Center, Washington D.C.

27100

Neonatologia Fondazione IRCCS Policlinico San Matteo, Pavia

27710

Duke University Medical Center (DUMC), Durham

28007

Hospital General Universitario Gregorio Marañon, Madrid

37232

Vanderbilt Children's Hospital, Nashville

44111

Fairview Hospital, Cleveland

44195

Cleveland Clinic, Cleveland

46202

Indiana University Health Methodist Hospital, Indianapolis

Riley Hospital for Children at IU Health, Indianapolis

Sydney and Lois Eskenazi Hospital, Indianapolis

59037

Centre Hospitalier et Regional de Lille - Hopital Jeanne de Flandre, Lille

Centre Hospitalier et Régional de Lille,, Lille

64108

Children's Mercy Hospitals & Clinics, Kansas City

72202

Arkansas Children's Hospital, Little Rock

73104

OU Follow-Up Program, PREMIEr Clinic, Children's Hospital, Oklahoma City

OU Neonatal Intensive Care Unit at Children's Hospital, Oklahoma City

The University of Oklahoma Health Sciences Center, Oklahoma City

74136

Henry Zarrow Neonatal Intensive Care Unit, Children's Hospital at Saint Francis, Tulsa

Warren Cancer Research Foundation, Tulsa

75019

CHU Robert Debré, Paris

75743

Hopital NECKER - Enfants Malades, Paris

95817

University of California Davis Medical Center, Sacramento

University of California Davis, Sacramento

95825

University of California Davis Medical Center, Sacramento

98101

Seattle Children's Research Institute, Seattle

98105

Seattle Childrens Hospital, Seattle

G1V 4G2

CHUL du CHU de Quebec, Québec

04103

University Hospital of Leipzig, Leipzig

6525 GA

Radboud University Nijmegen Medical Centre, Nijmegen

3015 CN

Erasmus MC, Sophia Children's hospital, Rotterdam

08950

Hospital Sant Joan de Deu, Esplugues de Llobregat

171 76

Karolinska University Hospital, Stockholm

BS2 8EG

St. Michael's Hospital, Bristol

LE1 5WW

Leicester Royal Infirmary, Leicester

LE3 9QP

Glenfield Hospital, University Hospitals of Leicester NHS Trust, Leicester

WC1N 3JH

Great Ormond Street Hospital NHS Foundation Trust, London

All Listed Sponsors
lead

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

INDUSTRY

NCT01720524 - A Study To Evaluate Safety And Efficacy Of IV Sildenafil In The Treatment Of Neonates With Persistent Pulmonary Hypertension Of The Newborn | Biotech Hunter | Biotech Hunter