A Non-Interventional Follow Up Study For Subjects Who Received Sildenafil for Persistent Pulmonary Hypertension of the Newborn (PPHN)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Pfizer

ClinicalTrials.gov Identifier:

NCT01801982

First received: January 8, 2013

Last updated: December 2, 2014

Last verified: December 2014

History of Changes

Tracking Information

First Received Date ^ICMJE

January 8, 2013

Last Updated Date

December 2, 2014

Start Date ^ICMJE

November 2012

Primary Completion Date

December 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Number of Participants With Physical Examination Abnormalities at Month 12 [ Time Frame: Month 12 ]
Physical examinations included height, weight, head circumference, general appearance, skin examination, abdominal examination, respiratory system, neurological examination, hearing and ophthalmology assessments. Physical examination abnormalities were based on investigator discretion.
Number of Participants With Physical Examination Abnormalities at Month 24 [ Time Frame: Month 24 ]
Physical examinations included height, weight, head circumference, general appearance, skin examination, abdominal examination, respiratory system, neurological examination, hearing and ophthalmology assessments. Physical examination abnormalities were based on investigator discretion.
Number of Participants With Clinically Significant Medical History at Month 12 [ Time Frame: Month 12 ]
Criteria for clinically significant medical history included any hospital admissions or any medications given since discharge from Study A1481276 (NCT01069861) that were considered clinically significant by the investigator.
Number of Participants With Clinically Significant Medical History at Month 24 [ Time Frame: Month 24 ]
Criteria for clinically significant medical history included any hospital admissions or any medications given since discharge from Study A1481276 (NCT01069861) that were considered clinically significant by the investigator.

Original Primary Outcome Measures ^ICMJE

Physical Examination (Bayley Neurological Assessments, Ophthalmology Exam, Hearing) [ Time Frame: at 12 months ]
Physical Examination (Bayley Neurological Assessments, Ophthalmology Exam, Hearing) [ Time Frame: at 24 months ]
Medical History, to include clinically relevant hospital admissions [ Time Frame: at 12 months ]
Medical History, to include clinically relevant hospital admissions [ Time Frame: at 24 months ]

Change History

Complete list of historical versions of study NCT01801982 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Overall Survival at Month 12 [ Time Frame: Month 12 ]
Overall survival was the duration from enrollment to death. For participants who are alive, overall survival was censored at the last contact. Number of participants who were alive at Month 12 was to be reported.
Overall Survival at Month 24 [ Time Frame: Month 24 ]
Overall survival was the duration from enrollment to death. For participants who are alive, overall survival was censored at the last contact. Number of participants who were alive at Month 24 was to be reported.
Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) [ Time Frame: Up to Month 12 ]
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

Original Secondary Outcome Measures ^ICMJE

Overall Survival (OS) [ Time Frame: at 12 months ]
Overall Survival (OS) [ Time Frame: at 24 months ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

A Non-Interventional Follow Up Study For Subjects Who Received Sildenafil for Persistent Pulmonary Hypertension of the Newborn (PPHN)

Official Title ^ICMJE

A Follow Up Investigation For Patients Completing Study A1481276 To Investigate Developmental Progress 12 And 24 Months Following Completion Of Sildenafil Treatment

Brief Summary

This single center study will monitor the developmental progress of PPHN patients who received iv sildenafil in study A1481276. Two visits will be conducted, at 12 and 24 months following the end of study drug infusion.

Detailed Description

This study will monitor developmental progress of PPHN patients for 2 years following study treatment, using Bayley III and Hammersmith tools. Data will be explored with descriptive statistics.

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

Pediatric patients who took part in study A1481276 following PPHN treatment with IV sildenafil

Condition ^ICMJE

Pulmonary Hypertension, Persistent, of the Newborn

Intervention ^ICMJE

Other: non-interventional

non-interventional

Study Groups/Cohorts

Not Provided

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

Completed

Enrollment ^ICMJE

Completion Date

December 2013

Primary Completion Date

December 2013 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Any subject who received sildenafil treatment in study A1481276.
Signed and dated informed consent document by legal guardian.

Exclusion Criteria:

Any subject who did not receive sildenafil treatment during study A1481276.

Sex/Gender

Sexes Eligible for Study:

All

Ages

up to 1 Year (Child)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United Kingdom

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT01801982

Other Study ID Numbers ^ICMJE

A1481283
2010-021266-30 ( EudraCT Number )

Has Data Monitoring Committee

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

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

December 2014

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

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