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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

This study is not yet open for participant recruitment.
Verified May 2013 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01720524
First received: September 17, 2012
Last updated: May 22, 2013
Last verified: May 2013
History of Changes
  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:

U.S. FDA Resources

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: May 2013
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: May 2014 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01720524

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

Locations
Germany
Universitatsklinikum Heidelberg Not yet recruiting
Heidelberg, Germany, 69112
Sweden
Karolinska University Hospital and Institute Not yet recruiting
Stockholm, Sweden, 171 76
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

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: May 22, 2013
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 May 23, 2013