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Trial record 1 of 1 for:    NCT01720524
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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

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ClinicalTrials.gov Identifier: NCT01720524
Recruitment Status : Active, not recruiting
First Posted : November 2, 2012
Last Update Posted : July 18, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE September 17, 2012
First Posted Date  ICMJE November 2, 2012
Last Update Posted Date July 18, 2019
Actual Study Start Date  ICMJE August 5, 2013
Actual Primary Completion Date October 17, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 31, 2012)
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01720524 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 31, 2012)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: September 24, 2015)
  • 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)
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study To Evaluate Safety And Efficacy Of IV Sildenafil In The Treatment Of Neonates With Persistent Pulmonary Hypertension Of The Newborn
Official Title  ICMJE 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
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Pulmonary Hypertension, Familial Persistent, of the Newborn
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Placebo Comparator: placebo
    iv placebo of normal saline or 10% dextrose
    Intervention: Drug: placebo
  • Experimental: sildenafil
    Active study drug
    Intervention: Drug: iv sildenafil
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: February 22, 2019)
59
Original Estimated Enrollment  ICMJE
 (submitted: October 31, 2012)
64
Estimated Study Completion Date  ICMJE December 15, 2020
Actual Primary Completion Date October 17, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 4 Days   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Canada,   Denmark,   France,   Germany,   Italy,   Netherlands,   Norway,   Spain,   Sweden,   United Kingdom,   United States
Removed Location Countries Austria
 
Administrative Information
NCT Number  ICMJE NCT01720524
Other Study ID Numbers  ICMJE A1481316
2012-002619-24 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date July 2019

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