Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   39233   clinical trials with a EudraCT protocol, of which   6427   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A Local, Multicentre, Open Label Access Study, To Provide Sildenafil citrate Therapy For Subjects Who Completed A1481156 Study And Are Judged By The Investigator To Derive Clinical Benefit From Continued Treatment With Sildenafil citrate For Subjects In India

    Summary
    EudraCT number
    2015-002238-37
    Trial protocol
    Outside EU/EEA  
    Global end of trial date
    26 Aug 2014

    Results information
    Results version number
    v1(current)
    This version publication date
    15 Mar 2016
    First version publication date
    16 Jul 2015
    Other versions

    Trial information

    Close Top of page
    Trial identification
    Sponsor protocol code
    A1481304
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01582438
    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 Jan 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    26 Aug 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Aug 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To provide Sildenafil citrate therapy to the paediatric subjects who had completed Study A1481156 for the treatment of PAH in India and were judged by the Investigator to derive clinical benefit from continued treatment with Sildenafil citrate citrate. The study medication was to be supplied as long as the Investigator felt that the subject continued to derive benefit from the treatment.
    Protection of trial subjects
    This study was designed and monitored in accordance with Pfizer's and the CRO’s standard operating procedures (SOPs), which comply with the ethical principles of Good Clinical Practice (GCP) as required by the major regulatory authorities, and in accordance with the Declaration of Helsinki.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    12 Nov 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    India: 4
    Worldwide total number of subjects
    4
    EEA total number of subjects
    0
    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)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    2
    Adults (18-64 years)
    2
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    Close Top of page
    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    Total 4 subjects were enrolled in single site in India. Subjects who had completed A1481156 were enrolled.

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

    Arms
    Arm title
    Sildenafil citrate
    Arm description
    Paediatric subjects who completed Study A1481156 received Sildenafil citrate as assigned by the investigator for the treatment of pulmonary arterial hypertension up to 21 months.
    Arm type
    Expanded access

    Investigational medicinal product name
    Sildenafil citrate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Paediatric subjects were administered with Sildenafil citrate 20 milligram (mg) tablets for children with body weight greater than (>) 20 kilogram (kg), and 10 mg for children with body weight less than or equal to <=20 kg, thrice daily up to 21 months.

    Number of subjects in period 1
    Sildenafil citrate
    Started
    4
    Completed
    4

    Baseline characteristics

    Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Sildenafil citrate
    Reporting group description
    Paediatric subjects who completed Study A1481156 received Sildenafil citrate as assigned by the investigator for the treatment of pulmonary arterial hypertension up to 21 months.

    Reporting group values
    Sildenafil citrate Total
    Number of subjects
    4 4
    Age categorical
    Units: Subjects
        Adolescents (12-17 years)
    2 2
        Adults (18-64 years)
    2 2
    Gender categorical
    Units: Subjects
        Female
    3 3
        Male
    1 1

    End points

    Close Top of page
    End points reporting groups
    Reporting group title
    Sildenafil citrate
    Reporting group description
    Paediatric subjects who completed Study A1481156 received Sildenafil citrate as assigned by the investigator for the treatment of pulmonary arterial hypertension up to 21 months.

    Primary: Subjects With Clinical Benefit on Usage of Continued Sildenafil Citrate

    Close Top of page
    End point title
    Subjects With Clinical Benefit on Usage of Continued Sildenafil Citrate [1]
    End point description
    Sildenafil citrate therapy was provided to paediatric subjects for the treatment of PAH and were judged by the investigator to derive clinical benefit from continued treatment with the study drug. It was to be supplied for the treatment of PAH as long as the investigator felt that the subject continued to derive benefits from the treatment.
    End point type
    Primary
    End point timeframe
    Up to 21 months
    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: No statistical analysis was performed for this study.
    End point values
    Sildenafil citrate
    Number of subjects analysed
    0 [2]
    Units: subjects
        number (not applicable)
    Notes
    [2] - No efficacy analysis was performed for this study.
    No statistical analyses for this end point

    Adverse events

    Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Baseline up to 21 months
    Adverse event reporting additional description
    Same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both the events. Version was not captured, here 0.0 is mentioned for dictionary version.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    0.0
    Reporting groups
    Reporting group title
    Sildenafil citrate
    Reporting group description
    Paediatric subjects who completed Study A1481156 received Sildenafil citrate as assigned by the investigator for the treatment of pulmonary arterial hypertension up to 21 months.

    Serious adverse events
    Sildenafil citrate
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 4 (25.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Infections and infestations
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 4 (25.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    Sildenafil citrate
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 4 (75.00%)
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    2 / 4 (50.00%)
         occurrences all number
    2
    Rhinitis allergic
         subjects affected / exposed
    1 / 4 (25.00%)
         occurrences all number
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 4 (25.00%)
         occurrences all number
    1
    Intermittent headache
         subjects affected / exposed
    1 / 4 (25.00%)
         occurrences all number
    1
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 4 (25.00%)
         occurrences all number
    1
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    1 / 4 (25.00%)
         occurrences all number
    1

    More information

    Close Top of page

    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
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2021 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA