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

Tracking Information

First Received Date ^ICMJE

September 17, 2012

Last Updated Date

May 22, 2013

Start Date ^ICMJE

May 2013

Estimated Primary Completion Date

May 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

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

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

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 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

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 Arm (s)

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

Not yet recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

July 2016

Estimated Primary Completion Date

May 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

up to 72 Hours

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Location Countries ^ICMJE

Germany, Sweden

Administrative Information

NCT Number ^ICMJE

NCT01720524

Other Study ID Numbers ^ICMJE

A1481316, 2012-002619-24

Has Data Monitoring Committee

Yes

Responsible Party

Pfizer

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

May 2013

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

To Top