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    Clinical Trial Results:
    A Follow Up Investigation For Patients Completing Study A1481276 To Investigate Developmental Progress 12 And 24 Months Following Completion Of Sildenafil Treatment

    Summary
    EudraCT number
    		 2010-021266-30
    Trial protocol
    		 GB  
    Global end of trial date
    19 Jan 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    05 Jan 2017
    First version publication date
    05 Jan 2017
    Other versions
    Summary report(s)
    		 A1481283_Public Disclosure Synopsis

    Trial information

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    Trial identification
    Sponsor protocol code
    A1481283
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01801982
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Pfizer, Inc.
    Sponsor organisation address
    235 E 42nd Street, New York, United States, NY 10017
    Public contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer, Inc., 001  800-­718-­1021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer, Inc., 001  800-­718-­1021, ClinicalTrials.gov_Inquiries@pfizer.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    12 May 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Jan 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To monitor the developmental progress of persistent pulmonary hypertension of the newborn (PPHN) subjects treated with sildenafil in study A1481276 (NCT01069861), at 12 and 24 months after completion of sildenafil treatment.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Council for Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trials subjects were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    26 Nov 2011
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 24 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 1
    Worldwide total number of subjects
    1
    EEA total number of subjects
    1
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    1
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 This study was conducted at a single site in United Kingdom. Study started on 26 Nov 2011 and completed on 19 Jan 2014.

    Period 1
    Period 1 title
    Over All (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Sildenafil
    Arm description
    		 Subjects who received intravenous sildenafil treatment in study A1481276 (NCT01069861) were followed-up for safety, up to Month 24.
    Arm type
    		 Follow up

    Investigational medicinal product name
    Sildenafil
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received intravenous sildenafil treatment in study A1481276 (NCT01069861).

    Number of subjects in period 1
    		Sildenafil
    Started
    1
    Completed
    0
    Not completed
    1
         Lost to follow-up
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Over All
    Reporting group description
    		 Subjects who received intravenous sildenafil treatment in study A1481276 (NCT01069861) were followed-up for safety, up to Month 24.

    Reporting group values
    		 Over All Total
    Number of subjects
    		 1 1
    Age Categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 1 1
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 0 0
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age Continuous
    Here, 99999 signifies standard deviation was not estimable as only 1 subject was evaluated.
    Units: years
        arithmetic mean (standard deviation)
    		 1.2 ( 99999 ) -
    Gender Categorical
    Units: Subjects
        Female
    		 1 1
        Male
    		 0 0

    End points

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    End points reporting groups
    Reporting group title
    Sildenafil
    Reporting group description
    		 Subjects who received intravenous sildenafil treatment in study A1481276 (NCT01069861) were followed-up for safety, up to Month 24.

    Primary: Number of Subjects With Physical Examination Abnormalities at Month 12

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    End point title
    		 Number of Subjects With Physical Examination Abnormalities at Month 12 [1]
    End point description
    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. Full analysis set (FAS) included all enrolled subjects.
    End point type
    Primary
    End point timeframe
    Month 12
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be analyzed for this endpoint.
    End point values
    		 Sildenafil
    Number of subjects analysed
    1
    Units: subjects
        number (not applicable)
    0
    No statistical analyses for this end point

    Primary: Number of Subjects With Physical Examination Abnormalities at Month 24

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    End point title
    		 Number of Subjects With Physical Examination Abnormalities at Month 24 [2]
    End point description
    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.
    End point type
    Primary
    End point timeframe
    Month 24
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be analyzed for this endpoint.
    End point values
    		 Sildenafil
    Number of subjects analysed
    0 [3]
    Units: subjects
        number (not applicable)
    Notes
    [3] - Data was not possible to report as subject lost to follow-up at Month 24 after Month 12 follow-up.
    No statistical analyses for this end point

    Primary: Number of Subjects With Clinically Significant Medical History at Month 12

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    End point title
    		 Number of Subjects With Clinically Significant Medical History at Month 12 [4]
    End point description
    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. FAS included all enrolled subjects.
    End point type
    Primary
    End point timeframe
    Month 12
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be analyzed for this endpoint.
    End point values
    		 Sildenafil
    Number of subjects analysed
    1
    Units: subjects
        number (not applicable)
    0
    No statistical analyses for this end point

    Primary: Number of Subjects With Clinically Significant Medical History at Month 24

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    End point title
    		 Number of Subjects With Clinically Significant Medical History at Month 24 [5]
    End point description
    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.
    End point type
    Primary
    End point timeframe
    Month 24
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be analyzed for this endpoint.
    End point values
    		 Sildenafil
    Number of subjects analysed
    0 [6]
    Units: subjects
        number (not applicable)
    Notes
    [6] - Data was not possible to report as subject lost to follow-up at Month 24 after Month 12 follow-up.
    No statistical analyses for this end point

    Secondary: Overall Survival at Month 12

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    End point title
    		 Overall Survival at Month 12
    End point description
    Overall survival was the duration from enrollment to death. For subjects who are alive, overall survival was censored at the last contact. Number of subjects who were alive at Month 12 was to be reported. FAS included all enrolled subjects.
    End point type
    Secondary
    End point timeframe
    Month 12
    End point values
    		 Sildenafil
    Number of subjects analysed
    1
    Units: subjects
        number (not applicable)
    1
    No statistical analyses for this end point

    Secondary: Overall Survival at Month 24

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    End point title
    		 Overall Survival at Month 24
    End point description
    Overall survival was the duration from enrollment to death. For subjects who are alive, overall survival was censored at the last contact. Number of subjects who were alive at Month 24 was to be reported.
    End point type
    Secondary
    End point timeframe
    Month 24
    End point values
    		 Sildenafil
    Number of subjects analysed
    0 [7]
    Units: subjects
        number (not applicable)
    Notes
    [7] - Data was not possible to report as subject lost to follow-up at Month 24 after Month 12 follow-up.
    No statistical analyses for this end point

    Secondary: Number of Subjects With Adverse Events (AE) and Serious Adverse Events (SAE)

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    End point title
    		 Number of Subjects With Adverse Events (AE) and Serious Adverse Events (SAE)
    End point description
    An AE was any untoward medical occurrence attributed to a subject who received study drug without regard to possibility of causal relationship. An SAE is 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. FAS included all enrolled subjects.
    End point type
    Secondary
    End point timeframe
    Day 1 up to Month 24
    End point values
    		 Sildenafil
    Number of subjects analysed
    1
    Units: subjects
        number (not applicable)
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Day 1 up to Month 24
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 NA
    Dictionary version
    0.0
    Reporting groups
    Reporting group title
    Sildenafil
    Reporting group description
    		 Subjects who received intravenous sildenafil treatment in study A1481276 (NCT01069861) were followed-up for safety, up to Month 24.

    Serious adverse events
    		 Sildenafil
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 1 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Sildenafil
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 1 (0.00%)
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: No non-serious adverse event occurred in this study.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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