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    Clinical Trial Results:
    A 12-week, Randomized, Single-Blind, Placebo-controlled, Multi-centre, Parallel Group, Phase IIa Study to Evaluate Efficacy, Safety and Tolerability of Oral AZD5718 After 4- and 12-Weeks of Treatment in Patients with Coronary Artery Disease (CAD)

    Summary
    EudraCT number
    2017-001582-25
    Trial protocol
    SE   DK   FI  
    Global end of trial date
    08 Apr 2020

    Results information
    Results version number
    v1(current)
    This version publication date
    15 Apr 2021
    First version publication date
    15 Apr 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    D7550C00003
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    AstraZeneca
    Sponsor organisation address
    Forskargatan 18, Södertälje, Sweden, 15185
    Public contact
    Global Clinical Lead, AstraZeneca, +1 877-240-9479, information.center@astrazeneca.com
    Scientific contact
    Global Clinical Lead, AstraZeneca, +1 887-240-9479, 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
    08 Apr 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    08 Apr 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Apr 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the PD effect of AZD5718 by assessment of u-LTE4 at 4 weeks in CAD patients
    Protection of trial subjects
    Before the start of the clinical study, the clinical study protocol (CSP), informed consent documents (ICDs) and other relevant documents were submitted to the Regulatory Authority for review and approval by AstraZeneca. The study was performed in accordance with ethical principles that had their origin in the Declaration of Helsinki and were consistent with International Council for Harmonisation (ICH) Good Clinical Practice (GCP) and the AstraZeneca policy on Bioethics and Human Biological Samples. The subjects were informed of the nature, significance, implications and risks of the trial before the study. Informed consent was freely given and evidenced in writing. Before signing of the ICD, the subject was given an opportunity to discuss any issues concerning the study with a physician who had suitable knowledge of the study and to have all questions answered openly and honestly.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    30 Oct 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
    Denmark: 50
    Country: Number of subjects enrolled
    Finland: 17
    Country: Number of subjects enrolled
    Sweden: 61
    Worldwide total number of subjects
    128
    EEA total number of subjects
    128
    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)
    78
    From 65 to 84 years
    50
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    The study was conducted in 3 countries at 9 sites; 3 in Denmark, 2 in Finland and 4 in Sweden.

    Pre-assignment
    Screening details
    Participants underwent a screening visit between 2 and 27 days before receiving the first dose of IP.

    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
    AZD5718 (Dose A)
    Arm description
    AZD5718 (Dose A)
    Arm type
    Experimental

    Investigational medicinal product name
    AZD5718 (Dose A)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Tablets administered once daily

    Arm title
    AZD5718 (Dose B)
    Arm description
    AZD5718 (Dose B)
    Arm type
    Experimental

    Investigational medicinal product name
    AZD5718 (Dose B)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Tablets administered once daily

    Arm title
    Placebo
    Arm description
    Placebo
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Tablets administered once daily

    Number of subjects in period 1
    AZD5718 (Dose A) AZD5718 (Dose B) Placebo
    Started
    52
    25
    51
    Completed
    50
    24
    51
    Not completed
    2
    1
    0
         Not willing to perform visits or take IP
    1
    -
    -
         Not willing to perform v4b-v4c or take IP
    1
    -
    -
         Randomized by mistake
    -
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    AZD5718 (Dose A)
    Reporting group description
    AZD5718 (Dose A)

    Reporting group title
    AZD5718 (Dose B)
    Reporting group description
    AZD5718 (Dose B)

    Reporting group title
    Placebo
    Reporting group description
    Placebo

    Reporting group values
    AZD5718 (Dose A) AZD5718 (Dose B) Placebo Total
    Number of subjects
    52 25 51 128
    Age categorical
    Units: Subjects
        In utero
    0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0 0
        Newborns (0-27 days)
    0 0 0 0
        Infants and toddlers (28 days-23 months)
    0 0 0 0
        Children (2-11 years)
    0 0 0 0
        Adolescents (12-17 years)
    0 0 0 0
        Adults (18-64 years)
    31 15 32 78
        From 65-84 years
    21 10 19 50
        85 years and over
    0 0 0 0
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    61.9 ± 8.21 61.4 ± 8.12 61.1 ± 8.51 -
    Sex: Female, Male
    Units: Participants
        Female
    7 0 10 17
        Male
    45 25 41 111
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    0 0 0 0
        Asian
    0 0 0 0
        Native Hawaiian or Other Pacific Islander
    0 0 0 0
        Black or African American
    0 0 1 1
        White
    52 25 50 127
        More than one race
    0 0 0 0
        Unknown or Not Reported
    0 0 0 0
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    1 0 0 1
        Not Hispanic or Latino
    51 25 51 127
        Unknown or Not Reported
    0 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    AZD5718 (Dose A)
    Reporting group description
    AZD5718 (Dose A)

    Reporting group title
    AZD5718 (Dose B)
    Reporting group description
    AZD5718 (Dose B)

    Reporting group title
    Placebo
    Reporting group description
    Placebo

    Primary: Change from baseline in Creatinine-normalized u-LTE4 at Week 4

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    End point title
    Change from baseline in Creatinine-normalized u-LTE4 at Week 4
    End point description
    End point type
    Primary
    End point timeframe
    4 weeks
    End point values
    AZD5718 (Dose A) AZD5718 (Dose B) Placebo
    Number of subjects analysed
    49
    24
    50
    Units: Ratio
        geometric mean (geometric coefficient of variation)
    0.04 ± 92.55
    0.09 ± 84.32
    1.09 ± 44.38
    Statistical analysis title
    Change from baseline in u-LTE4 at Week 4
    Statistical analysis description
    Change from baseline in Creatinine-normalised u-LTE4 at Week 4. Comparison between AZD5718 (Dose A) and Placebo.
    Comparison groups
    AZD5718 (Dose A) v Placebo
    Number of subjects included in analysis
    99
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Mixed models analysis
    Parameter type
    Ratio
    Point estimate
    0.04
    Confidence interval
         level
    95%
         sides
    1-sided
         lower limit
    -
         upper limit
    0.05
    Statistical analysis title
    Change from baseline in u-LTE4 at Week 4
    Statistical analysis description
    Change from baseline in Creatinine-normalised u-LTE4 at Week 4. Comparison between AZD5718 (Dose B) and Placebo.
    Comparison groups
    AZD5718 (Dose B) v Placebo
    Number of subjects included in analysis
    74
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Mixed models analysis
    Parameter type
    Ratio
    Point estimate
    0.08
    Confidence interval
         level
    95%
         sides
    1-sided
         lower limit
    -
         upper limit
    0.1

    Secondary: Change from baseline in Creatinine-normalized u-LTE4 at Week 12

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    End point title
    Change from baseline in Creatinine-normalized u-LTE4 at Week 12
    End point description
    End point type
    Secondary
    End point timeframe
    12 weeks
    End point values
    AZD5718 (Dose A) AZD5718 (Dose B) Placebo
    Number of subjects analysed
    29
    18
    36
    Units: Ratio
        geometric mean (geometric coefficient of variation)
    0.04 ± 83.69
    0.10 ± 71.11
    1.10 ± 49.12
    Statistical analysis title
    Change from baseline in u-LTE4 at Week 12
    Statistical analysis description
    Change from baseline in Creatinine-normalised u-LTE4 at Week 12. Comparison between AZD5718 (Dose A) and Placebo
    Comparison groups
    AZD5718 (Dose A) v Placebo
    Number of subjects included in analysis
    65
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    < 0.001
    Method
    Mixed models analysis
    Parameter type
    Ratio
    Point estimate
    0.04
    Confidence interval
         level
    95%
         sides
    1-sided
         lower limit
    -
         upper limit
    0.05
    Statistical analysis title
    Change from baseline in u-LTE4 at Week 12
    Statistical analysis description
    Change from baseline in Creatinine-normalised u-LTE4 at Week 12. Comparison between AZD5718 (Dose B) and Placebo.
    Comparison groups
    AZD5718 (Dose B) v Placebo
    Number of subjects included in analysis
    54
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Mixed models analysis
    Parameter type
    Ratio
    Point estimate
    0.09
    Confidence interval
         level
    95%
         sides
    1-sided
         lower limit
    -
         upper limit
    0.12

    Secondary: Change from baseline in CFVR at Week 12

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    End point title
    Change from baseline in CFVR at Week 12
    End point description
    End point type
    Secondary
    End point timeframe
    12 weeks
    End point values
    AZD5718 (Dose A) AZD5718 (Dose B) Placebo
    Number of subjects analysed
    16
    11
    24
    Units: Ratio (unitless)
        geometric mean (geometric coefficient of variation)
    0.93 ± 23.64
    0.98 ± 39.53
    1.16 ± 33.46
    No statistical analyses for this end point

    Secondary: Change from baseline in CFVR at Week 4

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    End point title
    Change from baseline in CFVR at Week 4
    End point description
    End point type
    Secondary
    End point timeframe
    4 weeks
    End point values
    AZD5718 (Dose A) AZD5718 (Dose B) Placebo
    Number of subjects analysed
    36
    16
    38
    Units: Ratio (unitless)
        geometric mean (geometric coefficient of variation)
    1.03 ± 28.34
    1.15 ± 31.47
    1.08 ± 33.16
    No statistical analyses for this end point

    Secondary: Summary of plasma concentrations

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    End point title
    Summary of plasma concentrations [1]
    End point description
    End point type
    Secondary
    End point timeframe
    13 months
    Notes
    [1] - 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: No PK measurements were taken for Placebo arm.
    End point values
    AZD5718 (Dose A) AZD5718 (Dose B)
    Number of subjects analysed
    52
    25
    Units: nmol/L
    geometric mean (geometric coefficient of variation)
        Visit 2: 1-8 Hours Post-Dose
    611.88 ± 234.50
    47.88 ± 497.86
        Visit 3: 20-28 Hours Post-Dose
    59.36 ± 90.97
    16.57 ± 127.80
        Visit 4: Pre-Dose
    48.00 ± 68.17
    11.01 ± 60.70
        Visit 4: 0-2 Hours Post-Dose
    339.28 ± 243.04
    38.68 ± 159.56
        Visit 4: 2-4 Hours Post-Dose
    919.22 ± 51.26
    148.64 ± 71.86
        Visit 4: 4-8 Hours Post-Dose
    649.09 ± 49.89
    105.40 ± 52.16
        Visit 4c: Pre-Dose
    65.39 ± 91.52
    13.97 ± 88.12
        Visit 5 - FUP 1 month
    0.51 ± 16.39
    0.50 ± 0.00
    No statistical analyses for this end point

    Secondary: Change from baseline in LAD hyperaemic flow velocity at 4 weeks

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    End point title
    Change from baseline in LAD hyperaemic flow velocity at 4 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    4 weeks
    End point values
    AZD5718 (Dose A) AZD5718 (Dose B) Placebo
    Number of subjects analysed
    36
    16
    38
    Units: m/sec
        arithmetic mean (standard deviation)
    0.02 ± 0.16
    0.04 ± 0.16
    0.03 ± 0.17
    No statistical analyses for this end point

    Secondary: Change from baseline in LVEF at 4 weeks

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    End point title
    Change from baseline in LVEF at 4 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    4 weeks
    End point values
    AZD5718 (Dose A) AZD5718 (Dose B) Placebo
    Number of subjects analysed
    46
    22
    45
    Units: Percent (unitless)
        arithmetic mean (standard deviation)
    -0.23 ± 5.30
    2.70 ± 6.39
    0.48 ± 5.00
    No statistical analyses for this end point

    Secondary: Change from baseline in LV longitudinal early diastolic strain rate at 4 weeks

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    End point title
    Change from baseline in LV longitudinal early diastolic strain rate at 4 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    4 weeks
    End point values
    AZD5718 (Dose A) AZD5718 (Dose B) Placebo
    Number of subjects analysed
    43
    19
    44
    Units: Ratio (unitless)
        geometric mean (geometric coefficient of variation)
    1.02 ± 30.61
    0.98 ± 33.55
    1.03 ± 30.45
    No statistical analyses for this end point

    Secondary: Change from baseline in LV-GLS at rest at Week 4

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    End point title
    Change from baseline in LV-GLS at rest at Week 4
    End point description
    End point type
    Secondary
    End point timeframe
    4 weeks
    End point values
    AZD5718 (Dose A) AZD5718 (Dose B) Placebo
    Number of subjects analysed
    43
    17
    42
    Units: Percent
        arithmetic mean (standard deviation)
    -0.41 ± 3.00
    0.34 ± 2.47
    -0.63 ± 2.61
    No statistical analyses for this end point

    Secondary: Change from baseline in LV-GCS at rest at Week 4

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    End point title
    Change from baseline in LV-GCS at rest at Week 4
    End point description
    End point type
    Secondary
    End point timeframe
    4 weeks
    End point values
    AZD5718 (Dose A) AZD5718 (Dose B) Placebo
    Number of subjects analysed
    39
    16
    34
    Units: Percent
        arithmetic mean (standard deviation)
    0.34 ± 7.24
    1.71 ± 5.40
    -1.88 ± 6.78
    No statistical analyses for this end point

    Secondary: Change from baseline in LAD resting mean diastolic flow velocity at 4 Weeks

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    End point title
    Change from baseline in LAD resting mean diastolic flow velocity at 4 Weeks
    End point description
    End point type
    Secondary
    End point timeframe
    4 weeks
    End point values
    AZD5718 (Dose A) AZD5718 (Dose B) Placebo
    Number of subjects analysed
    36
    16
    38
    Units: Ratio
        geometric mean (geometric coefficient of variation)
    1.01 ± 23.31
    0.92 ± 23.68
    0.99 ± 20.14
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Treatment period.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    21.0
    Reporting groups
    Reporting group title
    AZD5718 (Dose A)
    Reporting group description
    AZD5718 (Dose A)

    Reporting group title
    AZD5718 (Dose B)
    Reporting group description
    AZD5718 (Dose B)

    Reporting group title
    Placebo
    Reporting group description
    Placebo

    Serious adverse events
    AZD5718 (Dose A) AZD5718 (Dose B) Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 52 (7.69%)
    3 / 25 (12.00%)
    4 / 51 (7.84%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 25 (4.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Angina pectoris
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 25 (4.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ventricular fibrillation
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 25 (4.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Gastric cancer
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 25 (0.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 25 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary oedema
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 25 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    2 / 52 (3.85%)
    0 / 25 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 25 (4.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Pancreatitis acute
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 25 (4.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Pain in extremity
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 25 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Post procedural sepsis
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 25 (0.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 3%
    Non-serious adverse events
    AZD5718 (Dose A) AZD5718 (Dose B) Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    27 / 52 (51.92%)
    12 / 25 (48.00%)
    22 / 51 (43.14%)
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    2 / 52 (3.85%)
    1 / 25 (4.00%)
    1 / 51 (1.96%)
         occurrences all number
    2
    1
    1
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 25 (0.00%)
    4 / 51 (7.84%)
         occurrences all number
    0
    0
    4
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    6 / 52 (11.54%)
    4 / 25 (16.00%)
    7 / 51 (13.73%)
         occurrences all number
    6
    4
    7
    Cough
         subjects affected / exposed
    5 / 52 (9.62%)
    0 / 25 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    5
    0
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    4 / 52 (7.69%)
    0 / 25 (0.00%)
    2 / 51 (3.92%)
         occurrences all number
    4
    0
    2
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    5 / 52 (9.62%)
    2 / 25 (8.00%)
    4 / 51 (7.84%)
         occurrences all number
    5
    2
    4
    Headache
         subjects affected / exposed
    1 / 52 (1.92%)
    1 / 25 (4.00%)
    2 / 51 (3.92%)
         occurrences all number
    1
    1
    2
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    3 / 52 (5.77%)
    1 / 25 (4.00%)
    3 / 51 (5.88%)
         occurrences all number
    3
    1
    3
    Fatigue
         subjects affected / exposed
    3 / 52 (5.77%)
    1 / 25 (4.00%)
    0 / 51 (0.00%)
         occurrences all number
    3
    1
    0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    2 / 52 (3.85%)
    1 / 25 (4.00%)
    1 / 51 (1.96%)
         occurrences all number
    2
    1
    1
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    1 / 52 (1.92%)
    1 / 25 (4.00%)
    2 / 51 (3.92%)
         occurrences all number
    1
    1
    2
    Diarrhoea
         subjects affected / exposed
    2 / 52 (3.85%)
    1 / 25 (4.00%)
    4 / 51 (7.84%)
         occurrences all number
    2
    1
    5
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    3 / 52 (5.77%)
    0 / 25 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    3
    0
    1
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    6 / 52 (11.54%)
    4 / 25 (16.00%)
    7 / 51 (13.73%)
         occurrences all number
    6
    4
    7

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    10 Jan 2018
    Version 2.0: • Exploratory objective related to gyrocardiography was removed. • Criterion no 13 updated as follows: NYHA class III-IV heart failure or decompensated heart failure at discharge or hospitalization for exacerbation of chronic heart failure within the previous 3 months from ACS. • Criterion no 16 was updated as follows: Known allergy to adenosine and mannitol, or experience of previous adverse effects of adenosine stress testing. • Criterion no 26 was clarified as follows: Participation in another interventional clinical study with an investigational pharmaceutical product during the last 3 months also including drug eluting stents.
    11 Apr 2018
    Version 3.0: • Treatment period was extended from 4 weeks to 12 weeks and 2 new secondary endpoints were added: u-LTE4 at 12 weeks and CFVR at 12 weeks (Section 9). • The planned total number of patients randomized was increased from 100 to approximately 138 (Section 9.8). • Single futility interim analysis changed to 2 administrative interim analyses for internal decision making. The futility analysis has been removed to be able to evaluate the sustained effect on u-LTE4 at 12 weeks (Section 9.8). • Additional biomarker samples were added at Day 2 after the ACS. • TSH, free T3, free T4 and total T4 were added to the safety laboratory assessments at Visit 2 (baseline at randomization), Visit 4 (4 weeks), Visit 4c (12 weeks) and Visit 5 (Follow-up).
    05 Sep 2018
    Version 4.0: Study sites were provided with the same type of urine dipstick test kits for assessment of glucose, protein, blood and WBC. Urine microscopy was no longer used in the study.
    11 Feb 2019
    Planned LSLV date changed from Q2 2019 to Q1 2020. Time window for Visit 4 and 4c changed from ±2 days to ±3 days.

    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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