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
  Purpose

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.


Condition Intervention Phase
Pulmonary Hypertension, Persistent, of the Newborn
Other: non-interventional
Phase 2

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: A Follow Up Investigation For Patients Completing Study A1481276 To Investigate Developmental Progress 12 And 24 Months Following Completion Of Sildenafil Treatment

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Number of Participants With Physical Examination Abnormalities at Month 12 [ Time Frame: Month 12 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Overall Survival at Month 12 [ Time Frame: Month 12 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 1
Study Start Date: November 2012
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: non-interventional
    non-interventional
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.

  Eligibility

Ages Eligible for Study:   up to 1 Year
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01801982

Locations
United Kingdom
Great Ormond Street Hospital, Paediatric Intensive Care
London, United Kingdom, WC1N 3JH
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01801982     History of Changes
Other Study ID Numbers: A1481283, 2010-021266-30
Study First Received: January 8, 2013
Results First Received: December 2, 2014
Last Updated: December 2, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
PPHN; development progress after PPHN; developmental progress after sildenafil.

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Persistent Fetal Circulation Syndrome
Cardiovascular Diseases
Infant, Newborn, Diseases
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases
Sildenafil
Cardiovascular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Therapeutic Uses
Urological Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on August 30, 2015