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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

Last updated on April 19, 2018

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Study Location
Arkansas Children's Hospital
Little Rock, Arkansas, 72202 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Familial Persistent Pulmonary Hypertension
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0-4
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Neonates with persistent pulmonary hypertension of the newborn

- Age =34 weeks gestational age

- Oxygenation Index >15 and

- Concurrent treatment with inhaled nitric oxide and >=50% oxygen

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Prior or immediate need for extracorporeal membrane oxygenation or cardiopulmonary
resuscitation

- Expected duration of mechanical ventilation

- Profound hypoxemia

- Life-threatening or lethal congenital anomaly

NCT01720524
Pfizer
Recruiting
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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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 [email protected]
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
November 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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