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

NCT01801982 | Completed Results

• 2 other identifiers: A14812832010-021266-30
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Hypertension, Persistent, of the Newborn

Keywords

PPHN; development progress after PPHN; developmental progress after sildenafil.

Outcome Measures

Primary Outcomes (4)

• Number of Participants With Physical Examination Abnormalities at 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.

  Month 12

• Number of Participants With Physical Examination Abnormalities at 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.

  Month 24

• Number of Participants With Clinically Significant Medical History at 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.

  Month 12

• Number of Participants With Clinically Significant Medical History at 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.

  Month 24

Secondary Outcomes (3)

• Overall Survival at Month 12

  Month 12

• Overall Survival at Month 24

  Month 24

• Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)

  Up to Month 12

Interventions

non-interventional OTHER

non-interventional

Eligibility Criteria

• Age: 0 Years - 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.: lead

Study Sites (1)

Great Ormond Street Hospital, Paediatric Intensive Care

London, WC1N 3JH, United Kingdom

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Limitations and Caveats

Results at Month 24 were not reported as the participant lost to follow-up after Month 12.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2013
• First Posted: March 1, 2013
• Study Start: November 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: February 1, 2021
• Results First Posted: December 10, 2014

Record last verified: 2021-01

Locations

GB (1)