Trial Outcomes & Findings for A Non-Interventional Follow Up Study For Subjects Who Received Sildenafil for Persistent Pulmonary Hypertension of the Newborn (PPHN) (NCT NCT01801982)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

1 participants

Primary outcome timeframe

Month 12

Results posted on

2021-02-01

Participant Flow

All participants who received sildenafil treatment during study A1481276 (NCT01069861) were eligible for enrollment in this study.

Participant milestones

Participant milestones
Measure	Sildenafil Participants who received intravenous (IV) sildenafil treatment in study A1481276 (NCT01069861) were followed-up for safety, up to Month 24.
Overall Study STARTED	1
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Sildenafil Participants who received intravenous (IV) sildenafil treatment in study A1481276 (NCT01069861) were followed-up for safety, up to Month 24.
Overall Study Lost to Follow-up	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sildenafil n=1 Participants Participants who received intravenous (IV) sildenafil treatment in study A1481276 (NCT01069861) were followed-up for safety, up to Month 24.
Age, Continuous	1.2 years STANDARD_DEVIATION NA • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Month 12

Population: Full Analysis Set (FAS) included all enrolled participants.

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.

Outcome measures

Outcome measures
Measure	Sildenafil n=1 Participants Participants who received intravenous (IV) sildenafil treatment in study A1481276 (NCT01069861) were followed-up for safety, up to Month 24.
Number of Participants With Physical Examination Abnormalities at Month 12	0 participants

PRIMARY outcome

Timeframe: Month 24

Population: Data was not possible to report as participant lost to follow-up at Month 24 (Visit 2) after Month 12 follow-up (Visit 1).

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.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Month 12

Population: Full Analysis Set (FAS) included all enrolled participants.

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.

Outcome measures

Outcome measures
Measure	Sildenafil n=1 Participants Participants who received intravenous (IV) sildenafil treatment in study A1481276 (NCT01069861) were followed-up for safety, up to Month 24.
Number of Participants With Clinically Significant Medical History at Month 12	0 participants

PRIMARY outcome

Timeframe: Month 24

Population: Data was not possible to report as participant lost to follow-up at Month 24 (Visit 2) after Month 12 follow-up (Visit 1).

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Month 12

Population: Full Analysis Set (FAS) included all enrolled participants.

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.

Outcome measures

Outcome measures
Measure	Sildenafil n=1 Participants Participants who received intravenous (IV) sildenafil treatment in study A1481276 (NCT01069861) were followed-up for safety, up to Month 24.
Overall Survival at Month 12	1 participants

SECONDARY outcome

Timeframe: Month 24

Population: Data was not possible to report as participant lost to follow-up at Month 24 (Visit 2) after Month 12 follow-up (Visit 1).

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to Month 12

Population: FAS included all enrolled participants.

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.

Outcome measures

Outcome measures
Measure	Sildenafil n=1 Participants Participants who received intravenous (IV) sildenafil treatment in study A1481276 (NCT01069861) were followed-up for safety, up to Month 24.
Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)	0 participants

Adverse Events

Sildenafil

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER