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    Clinical Trial Results:
    Effect of acetazolamide on the incidence of high altitude pulmonary edema at 4559 m

    Summary
    EudraCT number
    		 2017-005166-22
    Trial protocol
    		 AT  
    Global end of trial date
    08 Aug 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    11 Nov 2019
    First version publication date
    11 Nov 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    M2018
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    UK für Anästhesiologie und Intensivmedizin
    Sponsor organisation address
    Muellner Hauptstr. 48, Salzburg, Austria, 5020
    Public contact
    Sekretariat, UK für Anästhesiologie und allgemeine Intensivmedizin, 0043 057255 57794, ma.berger@salk.at
    Scientific contact
    Sekretariat, UK für Anästhesiologie und allgemeine Intensivmedizin, 0043 057255 57794, ma.berger@salk.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?
    No
    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
    25 Oct 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    08 Aug 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Aug 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Does acetazolamide reduce the incidence of high altitude pulmoanry edema after rapid and active ascent to 4559 m?
    Protection of trial subjects
    Subjects were assessed at least once a day with respect to their physical condition. An investigator was available for the subjects 24 hours per day.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Jun 2019
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Scientific research
    Long term follow-up duration
    		 10 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Austria: 13
    Worldwide total number of subjects
    13
    EEA total number of subjects
    13
    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)
    0
    Adults (18-64 years)
    13
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 physical fitness (VO2max), history of HAPE

    Pre-assignment period milestones
    Number of subjects started
    		 22 [1]
    Number of subjects completed
    		 13

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 exclusion after preinvestigation: 9
    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 9 dropouts after pre-investigation was completed
    Period 1
    Period 1 title
    High altitude part
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Data analyst

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    PL1
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    T.I.D.

    Arm title
    		 Verum Arm
    Arm description
    		 Acetazolamide
    Arm type
    		 Active comparator

    Investigational medicinal product name
    PR1
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    250 mg T.I.D.

    Number of subjects in period 1
    		Placebo Verum Arm
    Started
    6
    7
    Completed
    6
    7
    Period 2
    Period 2 title
    Pre-investigation
    Is this the baseline period?
    		 Yes [2]
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Data analyst

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    PL1
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    T.I.D.

    Arm title
    		 Verum Arm
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    PR1
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    250 mg T.I.D.

    Notes
    [2] - Period 1 is not the baseline period. It is expected that period 1 will be the baseline period.
    Justification: We mixed up the order while entering the data. We entered the high altitude data prior to the baseline investigation data.
    Number of subjects in period 2
    		Placebo Verum Arm
    Started
    6
    7
    Completed
    6
    7

    Baseline characteristics

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

    Reporting group title
    Verum Arm
    Reporting group description
    		 -

    Reporting group values
    		 Placebo Verum Arm Total
    Number of subjects
    		 6 7 13
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 6 7 13
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 57 ( 6 ) 56 ( 5 ) -
    Gender categorical
    Units: Subjects
        Female
    		 1 1 2
        Male
    		 5 6 11
    High altitude pulmonary edema susceptibility
    History of HAPE was assessed
    Units: Subjects
        HAPE - S
    		 6 7 13
    Subject analysis sets

    Subject analysis set title
    Placebo
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Placebo

    Subject analysis set title
    Verum Arm
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Verum Arm

    Subject analysis sets values
    		 Placebo Verum Arm
    Number of subjects
    6
    7
    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)
    0
    0
        Adolescents (12-17 years)
    0
    0
        Adults (18-64 years)
    6
    7
        From 65-84 years
    0
    0
        85 years and over
    0
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    57 ( 6 )
    56 ( 5 )
    Gender categorical
    Units: Subjects
        Female
    1
    1
        Male
    5
    6
    High altitude pulmonary edema susceptibility
    History of HAPE was assessed
    Units: Subjects
        HAPE - S
    6
    7

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    Verum Arm
    Reporting group description
    		 Acetazolamide
    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    Verum Arm
    Reporting group description
    		 -

    Subject analysis set title
    Placebo
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Placebo

    Subject analysis set title
    Verum Arm
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Verum Arm

    Primary: Incidence of HAPE

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    End point title
    		 Incidence of HAPE
    End point description
    End point type
    Primary
    End point timeframe
    3 days at high altitude
    End point values
    		 Placebo Verum Arm
    Number of subjects analysed
    6
    7
    Units: full numbers
    4
    3
    Statistical analysis title
    		 Incidence HAPE
    Comparison groups
    Placebo v Verum Arm
    Number of subjects included in analysis
    13
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.05
    Method
    		 Chi-squared corrected
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    whole study duration
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    Verum Arm
    Reporting group description
    		 -

    Serious adverse events
    		 Placebo Verum Arm
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 7 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Placebo Verum Arm
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 7 (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 adverse events to report.

    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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