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    Clinical Trial Results:
    Tracleer - Therapie bei Patienten mit Downsyndrom und Eisenmengerreaktion: Verträglichkeit und hämodynamische Wirkungen.

    Summary
    EudraCT number
    		 2005-005584-28
    Trial protocol
    		 AT  
    Global end of trial date
    30 Jun 2006

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 Dec 2021
    First version publication date
    13 Dec 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    Version 1 4.11.2005
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medical University Innsbruck
    Sponsor organisation address
    Christoph-Probst-Platz 1, Innrain 52, Innsbruck, Austria, 6020
    Public contact
    Univ.Prof. Dr. Ralf Geiger, Paediatrics III, Anichstrasse 35, 6020 Innsbruck, +43 (0)512-504-23510, ralf.geiger@tirol-kliniken.at
    Scientific contact
    Univ.Prof. Dr. Ralf Geiger, Paediatrics III, Anichstrasse 35, 6020 Innsbruck, +43 (0)512-504-23510, ralf.geiger@tirol-kliniken.at
    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?
    Yes
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    30 Jun 2006
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Jun 2006
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    1. Dokumentation der Effekte von Tracleer auf die systemische Sauerstoffsättigung bei Patienten mit Downsyndrom und Eisenmenger-Reaktion
    Protection of trial subjects
    Trial has never been started.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    13 Mar 2006
    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
    Austria: 99999
    Worldwide total number of subjects
    99999
    EEA total number of subjects
    99999
    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)
    99999
    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
    		 Trial has never been started. "99999" is a value for 0 participants.

    Pre-assignment
    Screening details
    		 Trial has never been started. "99999" is a value for 0 participants.

    Period 1
    Period 1 title
    Treatment (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    Trial has never been started. "99999" is a value for 0 participants.

    Arms
    Arm title
    		 Tracleer
    Arm description
    		 Trial has never been started. "99999" is a value for 0 participants.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tracleer
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Trial has never been started, administration details are not available.

    Number of subjects in period 1
    		Tracleer
    Started
    99999
    Completed
    99999

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Treatment
    Reporting group description
    		 -

    Reporting group values
    		 Treatment Total
    Number of subjects
    		 99999 99999
    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)
    		 0 0
        Children (2-11 years)
    		 99999 99999
        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
    Units: years
        arithmetic mean (standard deviation)
    		 0 ( 0 ) -
    Gender categorical
    Units: Subjects
        Female
    		 99999 99999
        Male
    		 0 0

    End points

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    End points reporting groups
    Reporting group title
    Tracleer
    Reporting group description
    		 Trial has never been started. "99999" is a value for 0 participants.

    Primary: Systemic oxygen saturation

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    End point title
    		 Systemic oxygen saturation [1]
    End point description
    Effects of Tracleer on systemic oxygen saturation
    End point type
    Primary
    End point timeframe
    N/A
    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: Trial has never been started. Therefore no statistical analysis has been done.
    End point values
    		 Tracleer
    Number of subjects analysed
    99999 [2]
    Units: N/A
        number (not applicable)
    99999
    Notes
    [2] - Trial has never been started. "99999" is a value for 0 participants.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    13.03.2006- 30.06.2006
    Adverse event reporting additional description
    Trial has never been started, therefore no AEs and SAEs have been reported.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    2.0
    Reporting groups
    Reporting group title
    Tracleer
    Reporting group description
    		 Trial has never been started. "99999" is a value for 0 participants.

    Serious adverse events
    		 Tracleer
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 99999 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Tracleer
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 99999 (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: Trial has never been started, therefore no AEs and SAEs have been reported.

    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.
    Trial has never been started. "99999" is a value for 0 participants.
    For support, Contact us.
    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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