Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

January 8, 2013
December 2, 2014
November 2012
December 2013   (final data collection date for primary outcome measure)
  • 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.
  • Physical Examination (Bayley Neurological Assessments, Ophthalmology Exam, Hearing) [ Time Frame: at 12 months ] [ Designated as safety issue: No ]
  • Physical Examination (Bayley Neurological Assessments, Ophthalmology Exam, Hearing) [ Time Frame: at 24 months ] [ Designated as safety issue: No ]
  • Medical History, to include clinically relevant hospital admissions [ Time Frame: at 12 months ] [ Designated as safety issue: No ]
  • Medical History, to include clinically relevant hospital admissions [ Time Frame: at 24 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01801982 on ClinicalTrials.gov Archive Site
  • 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.
  • Overall Survival (OS) [ Time Frame: at 12 months ] [ Designated as safety issue: Yes ]
  • Overall Survival (OS) [ Time Frame: at 24 months ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
A Non-Interventional Follow Up Study For Subjects Who Received Sildenafil for Persistent Pulmonary Hypertension of the Newborn (PPHN)
A Follow Up Investigation For Patients Completing Study A1481276 To Investigate Developmental Progress 12 And 24 Months Following Completion Of Sildenafil Treatment

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.

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.

Observational
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

Pulmonary Hypertension, Persistent, of the Newborn
Other: non-interventional
non-interventional
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1
December 2013
December 2013   (final data collection date for primary outcome measure)

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.
Both
up to 1 Year
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01801982
A1481283, 2010-021266-30
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP