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

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ClinicalTrials.gov Identifier: NCT01801982
Recruitment Status : Completed
First Posted : March 1, 2013
Results First Posted : December 10, 2014
Last Update Posted : December 10, 2014
Sponsor:
Information provided by (Responsible Party):
Pfizer

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.

Condition or disease Intervention/treatment
Pulmonary Hypertension, Persistent, of the Newborn Other: 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.

Study Type : Observational
Actual Enrollment : 1 participants
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
Study Start Date : November 2012
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources


Intervention Details:
    Other: non-interventional
    non-interventional


Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   up to 1 Year   (Child)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01801982     History of Changes
Other Study ID Numbers: A1481283
2010-021266-30 ( EudraCT Number )
First Posted: March 1, 2013    Key Record Dates
Results First Posted: December 10, 2014
Last Update Posted: December 10, 2014
Last Verified: December 2014

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

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