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    Clinical Trial Results:
    A randomized, double-blind, placebo-controlled, multi-centre, sequential design, phase IIa study to evaluate safety and tolerability of epicardial injections of AZD8601 during coronary artery bypass grafting surgery

    Summary
    EudraCT number
    		 2017-002690-19
    Trial protocol
    		 FI   NL   DE  
    Global end of trial date
    23 Jul 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Jul 2022
    First version publication date
    16 Jul 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    D9150C00003
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AstraZeneca
    Sponsor organisation address
    Astraalléen, Södertälje, Sweden,
    Public contact
    Global Clinical LEad, AstraZeneca, +1 18772409479, information.center@astrazeneca.com
    Scientific contact
    Global Clinical Lead, AstraZeneca, +1 18772409479, information.center@astrazeneca.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?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    23 Jul 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    23 Jul 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Jul 2021
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To investigate safety and tolerability of AZD8601 following epicardial injection in patients undergoing Coronary Artery Bypass Grafting (CABG) surgery with moderately impaired systolic function.
    Protection of trial subjects
    This study was performed in compliance with International Council for Harmonisation (ICH) Good Clinical Practice, including the archiving of essential documents.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    05 Feb 2017
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Finland: 8
    Country: Number of subjects enrolled
    Germany: 3
    Worldwide total number of subjects
    11
    EEA total number of subjects
    11
    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)
    3
    From 65 to 84 years
    8
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This study was conducted at 4 clinical research centers in Finland and Germany First subject enrolled (First subject first visit/first consent signed date): 5 February 2017. Last subject last visit: 30 June 2020.

    Pre-assignment
    Screening details
    		 This study was performed in compliance with International Council for Harmonisation (ICH) Good Clinical Practice, including the archiving of essential documents.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer, Data analyst, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 AZD8601 3mg
    Arm description
    		 AZD8601 3mg
    Arm type
    		 Experimental

    Investigational medicinal product name
    AZD8601
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Other use
    Dosage and administration details
    Solution for epicardial injection

    Arm title
    		 Placebo
    Arm description
    		 Placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for injection, Injection
    Routes of administration
    Other use
    Dosage and administration details
    Solution for epicardial injection

    Number of subjects in period 1
    		AZD8601 3mg Placebo
    Started
    7
    4
    Completed
    7
    4

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    AZD8601 3mg
    Reporting group description
    		 AZD8601 3mg

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Reporting group values
    		 AZD8601 3mg Placebo Total
    Number of subjects
    		 7 4 11
    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)
    		 2 1 3
        From 65-84 years
    		 5 3 8
        85 years and over
    		 0 0 0
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 68.3 ( 5.8 ) 67.8 ( 10.8 ) -
    Sex: Female, Male
    Units: Participants
        Female
    		 0 2 2
        Male
    		 7 2 9
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0
        Asian
    		 0 0 0
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Black or African American
    		 0 0 0
        White
    		 7 4 11
        More than one race
    		 0 0 0
        Unknown or Not Reported
    		 0 0 0
    Subject analysis sets

    Subject analysis set title
    AZD8601
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    AZD8601

    Subject analysis set title
    Placebo
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Placebo

    Subject analysis set title
    AZD8601
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    AZD8601

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

    Subject analysis sets values
    		 AZD8601 Placebo AZD8601 Placebo
    Number of subjects
    7
    4
    7
    4
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    7 ( )
    ( )
    ( )
    ( )
    Sex: Female, Male
    Units: Participants
        Female
        Male
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
        Asian
        Native Hawaiian or Other Pacific Islander
        Black or African American
        White
        More than one race
        Unknown or Not Reported

    End points

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    End points reporting groups
    Reporting group title
    AZD8601 3mg
    Reporting group description
    		 AZD8601 3mg

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Subject analysis set title
    AZD8601
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    AZD8601

    Subject analysis set title
    Placebo
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Placebo

    Subject analysis set title
    AZD8601
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    AZD8601

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

    Primary: Number of subjects with Adverse Events

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    End point title
    		 Number of subjects with Adverse Events [1]
    End point description
    End point type
    Primary
    End point timeframe
    From dose to end of follow up
    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: Analyses for the primary endpoint Adverse Event are described in the Adverse Event section.
    End point values
    		 AZD8601 3mg Placebo
    Number of subjects analysed
    7
    4
    Units: Participants
    7
    4
    No statistical analyses for this end point

    Primary: Pulse rate (vital sign)

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    End point title
    		 Pulse rate (vital sign) [2]
    End point description
    End point type
    Primary
    End point timeframe
    From dosing to end of follow up
    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: There are no statistical analyses for safety endpoints, only descriptive statistics which are presented here.
    End point values
    		 AZD8601 3mg Placebo
    Number of subjects analysed
    7
    4
    Units: beats/min
    arithmetic mean (standard deviation)
        Baseline
    63.1 ( 10.42 )
    62.6 ( 6.04 )
        Day 1
    81.3 ( 7.38 )
    75.2 ( 4.20 )
        Day 2
    85.2 ( 6.54 )
    81.1 ( 7.01 )
        Day 3
    83.6 ( 8.38 )
    82.4 ( 6.80 )
        Day 4
    81.9 ( 14.54 )
    75.3 ( 7.63 )
        Visit 5 (Day 30)
    74.3 ( 13.33 )
    65.5 ( 6.81 )
        Visit 6 (Day 91)
    66.9 ( 15.05 )
    70.8 ( 7.18 )
        Visit 7 (Day 182)
    63.6 ( 15.62 )
    61.0 ( 2.16 )
    No statistical analyses for this end point

    Primary: Number of subjects with an ECG determined to be abnormal and clinically significant

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    End point title
    		 Number of subjects with an ECG determined to be abnormal and clinically significant [3]
    End point description
    End point type
    Primary
    End point timeframe
    Baseline to end of follow up
    Notes
    [3] - 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: There are no statistical analyses for safety endpoints, only descriptive statistics which are presented here.
    End point values
    		 AZD8601 3mg Placebo
    Number of subjects analysed
    7
    4
    Units: Participants
        Baseline
    0
    0
        End of treatment
    1
    0
    No statistical analyses for this end point

    Primary: Number of subjects with high values of Leucocytes, Particle Concentration

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    End point title
    		 Number of subjects with high values of Leucocytes, Particle Concentration [4]
    End point description
    End point type
    Primary
    End point timeframe
    Baseline to end of follow up
    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: There are no statistical analyses for safety endpoints, only descriptive statistics which are presented here.
    End point values
    		 AZD8601 3mg Placebo
    Number of subjects analysed
    7
    4
    Units: Number of subjects
        Baseline
    0
    0
        Maximum value during treatment
    3
    1
    No statistical analyses for this end point

    Primary: Oxygen saturation (vital sign)

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    End point title
    		 Oxygen saturation (vital sign) [5]
    End point description
    End point type
    Primary
    End point timeframe
    From dosing to end of follow up
    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: There are no statistical analyses for safety endpoints, only descriptive statistics which are presented here.
    End point values
    		 AZD8601 3mg Placebo
    Number of subjects analysed
    7
    4
    Units: Percent
    arithmetic mean (standard deviation)
        Baseline
    96.0 ( 0 )
    100.0 ( 0 )
        Day 1
    97.6 ( 4.46 )
    99.3 ( 0.80 )
        Day 2
    97.7 ( 1.68 )
    97.4 ( 2.42 )
        Day 3
    95.6 ( 2.14 )
    96.6 ( 3.60 )
        Day 4
    95.7 ( 1.85 )
    95.8 ( 3.74 )
    No statistical analyses for this end point

    Primary: Systolic blood pressure (vital sign)

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    End point title
    		 Systolic blood pressure (vital sign) [6]
    End point description
    End point type
    Primary
    End point timeframe
    From baseline to end of follow up
    Notes
    [6] - 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: There are no statistical analyses for safety endpoints, only descriptive statistics which are presented here.
    End point values
    		 AZD8601 3mg Placebo
    Number of subjects analysed
    7
    4
    Units: mmHg
    arithmetic mean (standard deviation)
        Baseline
    141.4 ( 24.42 )
    141.7 ( 23.32 )
        Day 1
    113.5 ( 5.67 )
    116.8 ( 12.53 )
        Day 2
    118.1 ( 11.98 )
    104.8 ( 4.39 )
        Day 3
    118.5 ( 8.04 )
    100.8 ( 10.82 )
        Day 4
    129.1 ( 116.63 )
    109.0 ( 6.48 )
        Visit 5 (Day 30)
    135.9 ( 17.56 )
    134.5 ( 29.49 )
        Visit 6 (Day 91)
    146.3 ( 11.76 )
    163.0 ( 35.39 )
        Visit 7 (Day 182)
    142.3 ( 13.00 )
    147.3 ( 34.07 )
    No statistical analyses for this end point

    Primary: Number of subjects with high values of Erythrocytes, Particle Concentration

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    End point title
    		 Number of subjects with high values of Erythrocytes, Particle Concentration [7]
    End point description
    End point type
    Primary
    End point timeframe
    Baseline to end of follow up
    Notes
    [7] - 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: There are no statistical analyses for safety endpoints, only descriptive statistics which are presented here.
    End point values
    		 AZD8601 3mg Placebo
    Number of subjects analysed
    7
    4
    Units: Number of subjects
        Baseline
    0
    0
        Maximum value during treatment
    0
    0
    No statistical analyses for this end point

    Primary: Diastolic blood pressure (vital sign)

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    End point title
    		 Diastolic blood pressure (vital sign) [8] [9]
    End point description
    End point type
    Primary
    End point timeframe
    From baseline to end of follow up
    Notes
    [8] - 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: There are no statistical analyses for safety endpoints, only descriptive statistics which are presented here.
    [9] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The arms in the baseline period are the same as the arms in the Overall Study.
    End point values
    		 Placebo AZD8601
    Number of subjects analysed
    4
    7
    Units: mmHg
    arithmetic mean (standard deviation)
        Baseline
    74.5 ( 23.57 )
    82.1 ( 17.95 )
        Day 1
    62.0 ( 7.63 )
    59.2 ( 6.52 )
        Day 2
    58.0 ( 5.12 )
    59.2 ( 10.62 )
        Day 3
    56.9 ( 2.83 )
    63.7 ( 8.64 )
        Day 4
    66.8 ( 5.91 )
    73.7 ( 11.07 )
        Visit 5 (Day 30)
    83.5 ( 14.55 )
    78.1 ( 10.16 )
        Visit 6 (Day 91)
    93.8 ( 16.62 )
    80.0 ( 7.09 )
        Visit 7 (Day 182)
    83.5 ( 19.60 )
    79.4 ( 8.06 )
    No statistical analyses for this end point

    Primary: Haemoglobin

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    End point title
    		 Haemoglobin [10] [11]
    End point description
    End point type
    Primary
    End point timeframe
    Baseline to end of follow up
    Notes
    [10] - 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: There are no statistical analyses for safety endpoints, only descriptive statistics which are presented here.
    [11] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The arms in the baseline period are the same as the arms in the Overall Study.
    End point values
    		 Placebo AZD8601
    Number of subjects analysed
    4
    7
    Units: Number of subjects
        Baseline
    0
    0
        Maximum value during treatment
    0
    0
    No statistical analyses for this end point

    Primary: Erythrocyte, Volume Fraction

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    End point title
    		 Erythrocyte, Volume Fraction [12] [13]
    End point description
    End point type
    Primary
    End point timeframe
    Baseline to end of follow up
    Notes
    [12] - 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: There are no statistical analyses for safety endpoints, only descriptive statistics which are presented here.
    [13] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The arms in the baseline period are the same as the arms in the Overall Study.
    End point values
    		 Placebo AZD8601
    Number of subjects analysed
    4
    7
    Units: Number of subjects
        Baseline
    0
    0
        Maximum value during treatment
    0
    0
    No statistical analyses for this end point

    Primary: Erythrocytes, Mean Cell Volume

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    End point title
    		 Erythrocytes, Mean Cell Volume [14] [15]
    End point description
    End point type
    Primary
    End point timeframe
    Baseline to end of follow up
    Notes
    [14] - 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: There are no statistical analyses for safety endpoints, only descriptive statistics which are presented here.
    [15] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The arms in the baseline period are the same as the arms in the Overall Study.
    End point values
    		 Placebo AZD8601
    Number of subjects analysed
    4
    7
    Units: Number of subjects
        Baseline
    0
    0
        Maximum value during treatment
    0
    1
    No statistical analyses for this end point

    Primary: Mean Cell Hemoglobin

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    End point title
    		 Mean Cell Hemoglobin [16] [17]
    End point description
    End point type
    Primary
    End point timeframe
    Baseline to end of follow up
    Notes
    [16] - 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: There are no statistical analyses for safety endpoints, only descriptive statistics which are presented here.
    [17] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The arms in the baseline period are the same as the arms in the Overall Study.
    End point values
    		 Placebo AZD8601
    Number of subjects analysed
    4
    7
    Units: Number of subjects
        Baseline
    0
    1
        Maximum value during treatment
    0
    0
    No statistical analyses for this end point

    Primary: Mean Cell Hemoglobin Conc.

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    End point title
    		 Mean Cell Hemoglobin Conc. [18] [19]
    End point description
    End point type
    Primary
    End point timeframe
    Baseline to end of follow up
    Notes
    [18] - 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: There are no statistical analyses for safety endpoints, only descriptive statistics which are presented here.
    [19] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The arms in the baseline period are the same as the arms in the Overall Study.
    End point values
    		 Placebo AZD8601
    Number of subjects analysed
    4
    7
    Units: Number of subjects
        Baseline
    0
    0
        Maximum value during treatment
    0
    0
    No statistical analyses for this end point

    Primary: Neutrophils

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    End point title
    		 Neutrophils [20] [21]
    End point description
    End point type
    Primary
    End point timeframe
    Baseline to end of follow up
    Notes
    [20] - 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: There are no statistical analyses for safety endpoints, only descriptive statistics which are presented here.
    [21] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The arms in the baseline period are the same as the arms in the Overall Study.
    End point values
    		 Placebo AZD8601
    Number of subjects analysed
    4
    7
    Units: Number of subjects
        Baseline
    0
    0
        Maximum value during treatment
    0
    2
    No statistical analyses for this end point

    Primary: Lymphocytes

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    End point title
    		 Lymphocytes [22] [23]
    End point description
    End point type
    Primary
    End point timeframe
    Baseline to end of follow up
    Notes
    [22] - 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: There are no statistical analyses for safety endpoints, only descriptive statistics which are presented here.
    [23] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The arms in the baseline period are the same as the arms in the Overall Study.
    End point values
    		 Placebo AZD8601
    Number of subjects analysed
    4
    7
    Units: Number of subjects
        Baseline
    0
    0
        Maximum value during treatment
    0
    0
    No statistical analyses for this end point

    Primary: Monocytes

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    End point title
    		 Monocytes [24] [25]
    End point description
    End point type
    Primary
    End point timeframe
    Baseline to end of follow up
    Notes
    [24] - 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: There are no statistical analyses for safety endpoints, only descriptive statistics which are presented here.
    [25] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The arms in the baseline period are the same as the arms in the Overall Study.
    End point values
    		 Placebo AZD8601
    Number of subjects analysed
    4
    7
    Units: Number of subjects
        Baseline
    0
    0
        Maximum value during treatment
    1
    0
    No statistical analyses for this end point

    Primary: Eosinophils

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    End point title
    		 Eosinophils [26] [27]
    End point description
    End point type
    Primary
    End point timeframe
    Baseline to end of follow up
    Notes
    [26] - 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: There are no statistical analyses for safety endpoints, only descriptive statistics which are presented here.
    [27] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The arms in the baseline period are the same as the arms in the Overall Study.
    End point values
    		 Placebo AZD8601
    Number of subjects analysed
    4
    7
    Units: Number of subjects
        Baseline
    0
    0
        Maximum value during treatment
    0
    0
    No statistical analyses for this end point

    Primary: Basophils

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    End point title
    		 Basophils [28] [29]
    End point description
    End point type
    Primary
    End point timeframe
    Baseline to end of follow up
    Notes
    [28] - 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: There are no statistical analyses for safety endpoints, only descriptive statistics which are presented here.
    [29] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The arms in the baseline period are the same as the arms in the Overall Study.
    End point values
    		 Placebo AZD8601
    Number of subjects analysed
    4
    7
    Units: Number of subjects
        Baseline
    0
    0
        Maximum value during treatment
    0
    0
    No statistical analyses for this end point

    Primary: Platelets

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    End point title
    		 Platelets [30] [31]
    End point description
    End point type
    Primary
    End point timeframe
    Baseline to end of follow up
    Notes
    [30] - 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: There are no statistical analyses for safety endpoints, only descriptive statistics which are presented here.
    [31] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The arms in the baseline period are the same as the arms in the Overall Study.
    End point values
    		 Placebo AZD8601
    Number of subjects analysed
    4
    7
    Units: Number of subjects
        Baseline
    0
    0
        Maximum value during treatment
    0
    0
    No statistical analyses for this end point

    Primary: Reticulocytes

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    End point title
    		 Reticulocytes [32] [33]
    End point description
    End point type
    Primary
    End point timeframe
    Baseline to end of follow up
    Notes
    [32] - 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: There are no statistical analyses for safety endpoints, only descriptive statistics which are presented here.
    [33] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The arms in the baseline period are the same as the arms in the Overall Study.
    End point values
    		 Placebo AZD8601
    Number of subjects analysed
    4
    7
    Units: Number of subjects
        Baseline
    1
    1
        Maximum value during treatment
    1
    1
    No statistical analyses for this end point

    Primary: Prothrombin Complex INR

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    End point title
    		 Prothrombin Complex INR [34] [35]
    End point description
    End point type
    Primary
    End point timeframe
    Baseline to end of follow up
    Notes
    [34] - 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: There are no statistical analyses for safety endpoints, only descriptive statistics which are presented here.
    [35] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The arms in the baseline period are the same as the arms in the Overall Study.
    End point values
    		 Placebo AZD8601
    Number of subjects analysed
    4
    7
    Units: Number of subjects
        Baseline
    0
    0
        Maximum value during treatment
    0
    0
    No statistical analyses for this end point

    Primary: Activated Partial Thromboplastin Time

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    End point title
    		 Activated Partial Thromboplastin Time [36] [37]
    End point description
    End point type
    Primary
    End point timeframe
    Baseline to end of follow up
    Notes
    [36] - 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: There are no statistical analyses for safety endpoints, only descriptive statistics which are presented here.
    [37] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The arms in the baseline period are the same as the arms in the Overall Study.
    End point values
    		 Placebo AZD8601
    Number of subjects analysed
    4
    7
    Units: Number of subjects
        Baseline
    0
    0
        Maximum value during treatment
    0
    0
    No statistical analyses for this end point

    Primary: Fibrinogen

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    End point title
    		 Fibrinogen [38] [39]
    End point description
    End point type
    Primary
    End point timeframe
    Baseline to end of follow up
    Notes
    [38] - 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: There are no statistical analyses for safety endpoints, only descriptive statistics which are presented here.
    [39] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The arms in the baseline period are the same as the arms in the Overall Study.
    End point values
    		 Placebo AZD8601
    Number of subjects analysed
    4
    7
    Units: Number of subjects
        Baseline
    0
    0
        Maximum value during treatment
    3
    3
    No statistical analyses for this end point

    Primary: Sodium

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    End point title
    		 Sodium [40] [41]
    End point description
    End point type
    Primary
    End point timeframe
    Baseline to end of follow up
    Notes
    [40] - 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: There are no statistical analyses for safety endpoints, only descriptive statistics which are presented here.
    [41] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The arms in the baseline period are the same as the arms in the Overall Study.
    End point values
    		 Placebo AZD8601
    Number of subjects analysed
    4
    7
    Units: Number of subjects
        Baseline
    0
    0
        Maximum value during treatment
    0
    0
    No statistical analyses for this end point

    Primary: Potassium

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    End point title
    		 Potassium [42] [43]
    End point description
    End point type
    Primary
    End point timeframe
    Baseline to end of follow up
    Notes
    [42] - 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: There are no statistical analyses for safety endpoints, only descriptive statistics which are presented here.
    [43] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The arms in the baseline period are the same as the arms in the Overall Study.
    End point values
    		 Placebo AZD8601
    Number of subjects analysed
    4
    7
    Units: Number of subjects
        Baseline
    0
    0
        Maximum value during treatment
    0
    0
    No statistical analyses for this end point

    Primary: Urea

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    End point title
    		 Urea [44] [45]
    End point description
    End point type
    Primary
    End point timeframe
    Baseline to end of follow up
    Notes
    [44] - 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: There are no statistical analyses for safety endpoints, only descriptive statistics which are presented here.
    [45] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The arms in the baseline period are the same as the arms in the Overall Study.
    End point values
    		 Placebo AZD8601
    Number of subjects analysed
    4
    7
    Units: Number of subjects
        Baseline
    1
    0
        Maximum value during treatment
    0
    0
    No statistical analyses for this end point

    Primary: Creatinine

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    End point title
    		 Creatinine [46] [47]
    End point description
    End point type
    Primary
    End point timeframe
    Baseline to end of follow up
    Notes
    [46] - 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: There are no statistical analyses for safety endpoints, only descriptive statistics which are presented here.
    [47] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The arms in the baseline period are the same as the arms in the Overall Study.
    End point values
    		 Placebo AZD8601
    Number of subjects analysed
    4
    7
    Units: Number of subjects
        Baseline
    1
    1
        Maximum value during treatment
    1
    1
    No statistical analyses for this end point

    Primary: Albumin

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    End point title
    		 Albumin [48] [49]
    End point description
    End point type
    Primary
    End point timeframe
    Baseline to end of follow up
    Notes
    [48] - 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: There are no statistical analyses for safety endpoints, only descriptive statistics which are presented here.
    [49] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The arms in the baseline period are the same as the arms in the Overall Study.
    End point values
    		 Placebo AZD8601
    Number of subjects analysed
    4
    7
    Units: Number of subjects
        Baseline
    0
    0
        Maximum value during treatment
    0
    0
    No statistical analyses for this end point

    Primary: Calcium

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    End point title
    		 Calcium [50] [51]
    End point description
    End point type
    Primary
    End point timeframe
    Baseline to end of follow up
    Notes
    [50] - 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: There are no statistical analyses for safety endpoints, only descriptive statistics which are presented here.
    [51] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The arms in the baseline period are the same as the arms in the Overall Study.
    End point values
    		 Placebo AZD8601
    Number of subjects analysed
    4
    7
    Units: Number of subjects
        Baseline
    0
    0
        Maximum value during treatment
    0
    0
    No statistical analyses for this end point

    Primary: Phosphate

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    End point title
    		 Phosphate [52] [53]
    End point description
    End point type
    Primary
    End point timeframe
    Baseline to end of follow up
    Notes
    [52] - 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: There are no statistical analyses for safety endpoints, only descriptive statistics which are presented here.
    [53] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The arms in the baseline period are the same as the arms in the Overall Study.
    End point values
    		 Placebo AZD8601
    Number of subjects analysed
    4
    7
    Units: Number of subjects
        Baseline
    0
    0
        Maximum value during treatment
    0
    0
    No statistical analyses for this end point

    Primary: Alkaline Phosphatase

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    End point title
    		 Alkaline Phosphatase [54] [55]
    End point description
    End point type
    Primary
    End point timeframe
    Baseline to end of follow up
    Notes
    [54] - 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: There are no statistical analyses for safety endpoints, only descriptive statistics which are presented here.
    [55] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The arms in the baseline period are the same as the arms in the Overall Study.
    End point values
    		 Placebo AZD8601
    Number of subjects analysed
    4
    7
    Units: Number of subjects
        Baseline
    1
    0
        Maximum value during treatment
    1
    0
    No statistical analyses for this end point

    Primary: Alanine Aminotransferase

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    End point title
    		 Alanine Aminotransferase [56] [57]
    End point description
    End point type
    Primary
    End point timeframe
    Baseline to end of follow up
    Notes
    [56] - 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: There are no statistical analyses for safety endpoints, only descriptive statistics which are presented here.
    [57] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The arms in the baseline period are the same as the arms in the Overall Study.
    End point values
    		 Placebo AZD8601
    Number of subjects analysed
    4
    7
    Units: Number of subjects
        Baseline
    1
    0
        Maximum value during treatment
    0
    0
    No statistical analyses for this end point

    Primary: Aspartate Aminotransferase

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    End point title
    		 Aspartate Aminotransferase [58] [59]
    End point description
    End point type
    Primary
    End point timeframe
    Baseline to end of follow up
    Notes
    [58] - 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: There are no statistical analyses for safety endpoints, only descriptive statistics which are presented here.
    [59] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The arms in the baseline period are the same as the arms in the Overall Study.
    End point values
    		 Placebo AZD8601
    Number of subjects analysed
    4
    7
    Units: Number of subjects
        Baseline
    1
    1
        Maximum value during treatment
    1
    0
    No statistical analyses for this end point

    Primary: Bilirubin, Total

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    End point title
    		 Bilirubin, Total [60] [61]
    End point description
    End point type
    Primary
    End point timeframe
    Baseline to end of follow up
    Notes
    [60] - 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: There are no statistical analyses for safety endpoints, only descriptive statistics which are presented here.
    [61] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The arms in the baseline period are the same as the arms in the Overall Study.
    End point values
    		 Placebo AZD8601
    Number of subjects analysed
    4
    7
    Units: Number of subjects
        Baseline
    0
    0
        Maximum value during treatment
    0
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events are summarized from the first dose of IP dose throughout the treatment period and including the follow-up period.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Reporting group title
    AZD8601 3mg
    Reporting group description
    		 AZD8601 3mg

    Serious adverse events
    		 Placebo AZD8601 3mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 4 (25.00%)
    3 / 7 (42.86%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Incision site impaired healing
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 7 (14.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Incision site inflammation
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 7 (14.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular graft occlusion
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 7 (14.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Embolic cerebral infarction
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 7 (14.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 7 (14.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coagulopathy
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 7 (14.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Skin necrosis
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Placebo AZD8601 3mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 4 (100.00%)
    7 / 7 (100.00%)
    Vascular disorders
    Hypotension
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    1
    Feeling cold
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    1
    Non-cardiac chest pain
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Pyrexia
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Reproductive system and breast disorders
    Gynaecomastia
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    1 / 4 (25.00%)
    1 / 7 (14.29%)
         occurrences all number
    1
    1
    Pleural effusion
         subjects affected / exposed
    2 / 4 (50.00%)
    0 / 7 (0.00%)
         occurrences all number
    2
    0
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Investigations
    Liver function test increased
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Injury, poisoning and procedural complications
    Procedural pain
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    2 / 4 (50.00%)
    2 / 7 (28.57%)
         occurrences all number
    2
    2
    Left ventricular dysfunction
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    1
    Sinus bradycardia
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    1
    Tachycardia
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    1
    Ventricular arrhythmia
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    1
    Ventricular extrasystoles
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 4 (25.00%)
    1 / 7 (14.29%)
         occurrences all number
    1
    1
    Embolic cerebral infarction
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    1
    Syncope
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    2 / 4 (50.00%)
    1 / 7 (14.29%)
         occurrences all number
    2
    1
    Coagulopathy
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    1
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    1
    Eye disorders
    Cataract
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Dyspepsia
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    1
    Nausea
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Pain in extremity
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    1
    Myalgia
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Wound infection
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Urinary tract infection
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Metabolism and nutrition disorders
    Dyslipidaemia
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    26 Feb 2018
    Number of countries updated to reflect the current situation where the study initially will be conducted in 1 country but with the possibility to expand to further countries. Change to Lead Investigator and their designation. Correction to Visit 1 time window to earliest 3 months and latest 15 days before surgery (Day - 90 to -15). Clarification that Visit 3 is from Day from -1 to 4. Inclusion criterion 4 corrected to “Indication for elective CABG surgery enrolled at least 15 days before the planned surgery.” Table 1 updated with assessments that were identified as incorrect or missing in Table compared to text. Table 1 of CSP, Text updated to allow Visit 1 and Visit 2 on the same day except for the PET assessment.
    08 May 2018
    Table 1 of CSP modification of timepoints for several assessments or sample collections. Removed optional nature of LAD CFVR. Updated text for SAE reporting.
    22 Jan 2019
    Adjustment to text regarding number of sites and study timelines in synopsis and Section 1.4. Other administrative changes. Time window between Visit 2 and Visit 3 adjusted. Exploratory gyrocardiography assessment was removed from the study protocol. AZ activity app for the digital 6-min walk test was not applicable for the newly added country Germany but remained optional in other participating countries. Minor adjustments made to urinalysis. CSP adjusted to allow patients to be enrolled at one site and, if needed, to perform the 15O PET assessment at another, named site. Table 1, for blood pressure and pulse oximetry number of assessments on Day 1 corrected from 4 to 3.
    27 Feb 2020
    Expected study duration extended to Q1 2022 in the Synopsis. Local ethics committee requested that the safety review procedure included external experts. Study specific stopping criteria added. An unblinded DMG was added. Added that if a patient was referred to another hospital for the 15O PET assessment, CT could also be performed there.

    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
    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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