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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 currently recruiting participants.
Verified October 2017 by Pfizer
Sponsor:
ClinicalTrials.gov Identifier:
NCT01720524
First Posted: November 2, 2012
Last Update Posted: November 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Pfizer
September 17, 2012
November 2, 2012
November 1, 2017
August 2013
July 2018   (Final data collection date for primary outcome measure)
  • Time on inhaled nitric oxide treatment after initiation of iv study drug [ Time Frame: Day 14 or hospital discharge ]
  • Treatment failure rate, defined as need for additional treatment targeting persistent pulmonary hypertension of the newborn. [ Time Frame: day 14 or hospital discharge ]
Same as current
Complete list of historical versions of study NCT01720524 on ClinicalTrials.gov Archive Site
  • Time to final weaning of mechanical ventilation for persistent pulmonary hypertension of the newborn [ Time Frame: Day 14 or hospital discharge ]
  • Time from initiation of study drug to treatment failure [ Time Frame: Day 14 or hospital discharge ]
  • Change in oxygenation parameters at 6, 12, and 24 hours from baseline [ Time Frame: Day 14 or hospital discharge ]
  • Sildenafil plasma concentrations and corresponding PK parameters [ Time Frame: Day 14 or hospital discharge ]
  • Safety parameters: incidence and severity of adverse events and abnormal laboratory parameters [ Time Frame: Day 14 or hospital discharge ]
Same as current
  • Developmental progress of subjects as assessed by Bayley Scales of Infant Development and Behavior Questionnaire [ Time Frame: Months 12 and 24 after completion of study treatment ]
    Bayley Scales of Infant Development is a standard series of measurements to assess motor (fine and gross), language (expressive and comprehensive), and cognitive development of infants and toddlers, ages 0-3 years. Bayley Questionnaire for Parent/Caregiver is used to assess Social-Emotional and Adaptive Behavior development of toddlers, ages 0-3 years
  • Safety, assessed by adverse events and survival [ Time Frame: At 12 and 24 months after completion of study treatment ]
  • Neurological progress of subjects as assessed by the Neurology Optimality Score, also known as the Hammersmith Infant Neurological Examination [ Time Frame: Months 12 and 24 after end of study treatment ]
    The Hammersmith Infant Neurological Examination is a standard scoring examination to assess development of cranial nerve, posture, movement, tone, reflexes and reaction, and global neurological status, ages 0-18 months
  • Visual status of subjects as assessed by eye examinations of the anterior and posterior segments [ Time Frame: Months 12 and 24 after completion of study treatment. ]
    Standard age-appropriate ophthalmological examinations will be used to assess general eye status, visual acuity (with Teller cards and fix and follow), pupil response and fundus examination, and refraction measured.
  • Audiological status of subjects as assessed by Physiological and Behavioral tests [ Time Frame: Months 12 and 24 after completion of study treatment ]
    Standard developmentally appropriate audiological examinations suited to the individual subject will be used to assess auditory system function (physical tests: tympanometry, acoustic reflex, otoacoustic emissions) and hearing sensitivity (behavioral test: visual reinforcement audiometry)
Not Provided
 
A Study To Evaluate Safety And Efficacy Of IV Sildenafil In The Treatment Of Neonates With Persistent Pulmonary Hypertension Of The Newborn
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Pulmonary Hypertension, Familial Persistent, of the Newborn
  • 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.
    Other Name: revatio
  • Placebo Comparator: placebo
    iv placebo of normal saline or 10% dextrose
    Intervention: Drug: placebo
  • Experimental: sildenafil
    Active study drug
    Intervention: Drug: iv sildenafil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
64
August 2020
July 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
up to 4 Days   (Child)
No
Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com
Belgium,   Canada,   Denmark,   France,   Germany,   Italy,   Netherlands,   Norway,   Spain,   Sweden,   United Kingdom,   United States
Austria
 
NCT01720524
A1481316
2012-002619-24 ( EudraCT Number )
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP