Sildenafil Persistent Pulmonary Hypertension of the Newborn (PPHN) follow up study

A FOLLOW UP INVESTIGATION FOR PATIENTS COMPLETING STUDY A1481276 TO INVESTIGATE DEVELOPMENTAL PROGRESS 12 AND 24 MONTHS FOLLOWING COMPLETION OF SILDENAFIL TREATMENT

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-021266-30-GB

Enrollment

Registered

2011-10-04

Start date

2011-12-14

Completion date

Unknown

Last updated

2014-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Persistent pulmonary hypertension of the newborn (PPHN) MedDRA version: 16.1 Level: LLT Classification code 10053592 Term: Newborn persistent pulmonary hypertension System Organ Class: 100000004850

Interventions

Pharmaceutical Form:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Evidence of signed and dated informed consent document indicating that a legally acceptable guardian has been informed of all pertinent aspects of the study. 2. Any patient who received sildenafil treatment during study A1481276. 3. In the opinion of the investigator, the patient is considered appropriate for the study. Are the trial subjects under 18? yes Number of subjects for this age range: 40 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Not Applicable

Design outcomes

Primary

Measure	Time frame
Main Objective: To monitor the developmental progress of PPHN patients treated with sildenafil in study A1481276, 12 and 24 months after completion of sildenafil treatment.;Secondary Objective: To collect 2 year survival data.;Primary end point(s): > Physical examination, to include neurological development assessment, hearing and ophthalmology tests. > Medical history including clinically relevant hospital admissions in the 2 year follow up period.;Timepoint(s) of evaluation of this end point: Physical examination (including neurological development assessment, opthalmology tests and behaviour), medical history including clinically relevant hospital admissions and medications at 1 and 2 years post sildenafil treatment in study A1481276.	—

Measure

Time frame

Main Objective: To monitor the developmental progress of PPHN patients treated with sildenafil in study A1481276, 12 and 24 months after completion of sildenafil treatment.;Secondary Objective: To collect 2 year survival data.;Primary end point(s): > Physical examination, to include neurological development assessment, hearing and ophthalmology tests. > Medical history including clinically relevant hospital admissions in the 2 year follow up period.;Timepoint(s) of evaluation of this end point: Physical examination (including neurological development assessment, opthalmology tests and behaviour), medical history including clinically relevant hospital admissions and medications at 1 and 2 years post sildenafil treatment in study A1481276.

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Secondary

Measure	Time frame
Secondary end point(s): Survival to 2 years.;Timepoint(s) of evaluation of this end point: 1 and 2 years post sildenafil treatment in study A1481276	—

Countries

United Kingdom

Contacts

Public ContactClinical Trials.gov Call Center

Pfizer Inc

ClinicalTrials.govCallCenter@pfizer.com+18007181021

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026