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    Clinical Trial Results:
    A randomized, double-blind multicenter study to assess the safety and efficacy of a six month oral treatment with the chymase inhibitor BAY1142524 at a dose of 25 mg BID in comparison to placebo on top of standard of care in patients with reduced leftventricular ejection fraction (LVEF ≤ 45%) after acute myocardial infarction (CHIARA MIA 2)

    Summary
    EudraCT number
    2016-002167-33
    Trial protocol
    CZ   DE   ES  
    Global end of trial date
    04 Sep 2018

    Results information
    Results version number
    v1(current)
    This version publication date
    21 Sep 2019
    First version publication date
    21 Sep 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    16673
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02976467
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Bayer AG
    Sponsor organisation address
    Kaiser Wilhelm Allee, Leverkusen, Germany, D-51368
    Public contact
    Therapeutic Area Head, Bayer AG, clinical-trials-contact@bayer.com
    Scientific contact
    Therapeutic Area Head, Bayer AG, clinical-trials-contact@bayer.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
    04 Sep 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Sep 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Primary objectives: 1. Investigate the change in LVEF from baseline to 6 months after treatment with BAY 1142524 in comparison to placebo and in addition to standard of care therapy, as measured by cardiac MRI. 2. Investigate the change in EDVI from baseline to 6 months after treatment with BAY 1142524 in comparison to placebo and in addition to standard of care as measured by cardiac MRI. 3.Investigate the change in ESVI from baseline to 6 months after treatment with BAY 1142524 in comparison to placebo and in addition to standard of care as measured by cardiac MRI. Secondary objective: 4. Analyze safety and tolerability of 25 mg of BAY 1142524 BID as evidenced by the incidence and severity of AEs.
    Protection of trial subjects
    The conduct of this clinical study met all local legal and regulatory requirements. The study was conducted in accordance with ethical principles that have their origin in the Declaration of Helsinki and the International Council for Harmonization guideline E6: Good Clinical Practice. Before entering the study, the informed consent was read by and explained to all the subjects. Participating subjects signed informed consent form and could withdraw from the study at any time without any disadvantage and without having to provide a reason for this decision. Only investigators qualified by training and experience were selected as appropriate experts to investigate the study drug.
    Background therapy
    Optimized standard of care therapy according to international and/or local guidelines
    Evidence for comparator
    Placebo matching to BAY 1142524, 25 mg immediate release tablet
    Actual start date of recruitment
    12 Dec 2016
    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
    Czech Republic: 18
    Country: Number of subjects enrolled
    Germany: 26
    Country: Number of subjects enrolled
    Israel: 86
    Country: Number of subjects enrolled
    Italy: 31
    Country: Number of subjects enrolled
    Spain: 24
    Worldwide total number of subjects
    185
    EEA total number of subjects
    99
    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)
    144
    From 65 to 84 years
    41
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    The study was conducted at 25 study centers in 5 countries: five study centers in the Czech Republic, four study centers in Germany, six study centers in Israel, five study centers in Italy and five study centers in Spain between 30-Dec2016 (first patient first visit) and 04-Sep-2018 (last patient last visit).

    Pre-assignment
    Screening details
    A total of 185 subjects were screened in the study, of whom 78 subjects were screen failures. A total of 107 subjects were randomized in a 1:1 ratio to the BAY 1142524 arm (54 subjects) and the placebo arm (53 subjects).

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    BAY 1142524
    Arm description
    Efficacy evaluation was performed in the per protocol set (PPS) and full analysis set (FAS). A total of 42 subjects in the BAY 1142524 arm were valid for the PPS and 54 subjects for the FAS.
    Arm type
    Experimental

    Investigational medicinal product name
    BAY 1142524
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    25 mg immediate release tablet

    Arm title
    Placebo
    Arm description
    Efficacy evaluation was performed in the per protocol set (PPS) and full analysis set (FAS). A total of 38 subjects in the placebo arm were valid for the PPS and 53 subjects for the FAS.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo matching to BAY 1142524, 25 mg immediate release tablet

    Number of subjects in period 1 [1]
    BAY 1142524 Placebo
    Started
    54
    53
    Completed
    47
    48
    Not completed
    7
    5
         Not completed study
    7
    4
         1 subject without second MRI evaluation
    -
    1
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Number of subjects reported to be in the baseline period represents: Subjects randomized Number of subjects worldwide represents: Subjects screened / enroled

    Baseline characteristics

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    Subject analysis sets

    Subject analysis set title
    BAY 1142524 / LVEF (PPS) - Change: Baseline vs. Day 168
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Change in Left ventricular ejection fraction (LVEF) from baseline to 6 months (Day 168) after treatment with Placebo in the protocol analysis set (PPS).

    Subject analysis set title
    BAY 1142524 / EDVI (PPS) - Change: Baseline vs. Day 168
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Change in End diastolic volume index (EDVI) from baseline to 6 months (Day 168) after treatment with Placebo in the protocol analysis set (PPS).

    Subject analysis set title
    BAY 1142524 / ESVI (PPS) - Change: Baseline vs. Day 168
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Change in End systolic volume index (ESVI) from baseline to 6 months (Day 168) after treatment with BAY 1142524 in the protocol analysis set (PPS).

    Subject analysis set title
    Placebo / LVEF (PPS) - Change: Baseline vs. Day 168
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Change in Left ventricular ejection fraction (LVEF) from baseline to 6 months (Day 168) after treatment with Placebo in the protocol analysis set (PPS).

    Subject analysis set title
    Placebo / EDVI (PPS) - Change: Baseline vs. Day 168
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Change in End diastolic volume index (EDVI) from baseline to 6 months (Day 168) after treatment with Placebo in the protocol analysis set (PPS).

    Subject analysis set title
    Placebo / ESVI (PPS) - Change: Baseline vs. Day 168
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Change in End systolic volume index (ESVI) from baseline to 6 months (Day 168) after treatment with Placebo in the protocol analysis set (PPS).

    Subject analysis set title
    BAY 1142524 / LVEF (PPS) - Baseline
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Left ventricular ejection fraction (LVEF) at baseline in the protocol analysis set (PPS).

    Subject analysis set title
    BAY 1142524 / EDVI (PPS) - Baseline
    Subject analysis set type
    Per protocol
    Subject analysis set description
    End diastolic volume index (EDVI) at baseline in the protocol analysis set (PPS).

    Subject analysis set title
    BAY 1142524 / ESVI (PPS) - Baseline
    Subject analysis set type
    Per protocol
    Subject analysis set description
    End systolic volume index (ESVI) at baseline in the protocol analysis set (PPS).

    Subject analysis set title
    Placebo / LVEF (PPS) - Baseline
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Left ventricular ejection fraction (LVEF) at baseline in the protocol analysis set (PPS).

    Subject analysis set title
    Placebo / EDVI (PPS) - Baseline
    Subject analysis set type
    Per protocol
    Subject analysis set description
    End diastolic volume index (EDVI) at baseline in the protocol analysis set (PPS).

    Subject analysis set title
    Placebo / ESVI (PPS) - Baseline
    Subject analysis set type
    Per protocol
    Subject analysis set description
    End systolic volume index (ESVI) at baseline in the protocol analysis set (PPS).

    Subject analysis set title
    BAY 1142524 / LVEF (PPS) - Day 168
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Left ventricular ejection fraction (LVEF) at day 168 in the protocol analysis set (PPS).

    Subject analysis set title
    BAY 1142524 / EDVI (PPS) - Day 168
    Subject analysis set type
    Per protocol
    Subject analysis set description
    End diastolic volume index (EDVI) at day 168 in the protocol analysis set (PPS).

    Subject analysis set title
    BAY 1142524 / ESVI (PPS) - Day 168
    Subject analysis set type
    Per protocol
    Subject analysis set description
    End systolic volume index (ESVI) at day 168 in the protocol analysis set (PPS).

    Subject analysis set title
    Placebo / LVEF (PPS) - Day 168
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Left ventricular ejection fraction (LVEF) at day 168 in the protocol analysis set (PPS).

    Subject analysis set title
    Placebo / EDVI (PPS) - Day 168
    Subject analysis set type
    Per protocol
    Subject analysis set description
    End diastolic volume index (EDVI) at day 168 in the protocol analysis set (PPS).

    Subject analysis set title
    Placebo / ESVI (PPS) - Day 168
    Subject analysis set type
    Per protocol
    Subject analysis set description
    End systolic volume index (ESVI) at day 168 in the protocol analysis set (PPS).

    Subject analysis set title
    BAY 1142524 / LVEF (FAS) - Change: Baseline vs. Day 168
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Change in Left ventricular ejection fraction (LVEF) from baseline to 6 months (Day 168) after treatment with Placebo in the full analysis set (FAS).

    Subject analysis set title
    BAY 1142524 / EDVI (FAS) - Change: Baseline vs. Day 168
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Change in End diastolic volume index (EDVI) from baseline to 6 months (Day 168) after treatment with Placebo in the full analysis set (FAS).

    Subject analysis set title
    BAY 1142524 / ESVI (FAS) - Change: Baseline vs. Day 168
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Change in End systolic volume index (ESVI) from baseline to 6 months (Day 168) after treatment with BAY 1142524 in the full analysis set (FAS).

    Subject analysis set title
    Placebo / LVEF (FAS) - Change: Baseline vs. Day 168
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Change in Left ventricular ejection fraction (LVEF) from baseline to 6 months (Day 168) after treatment with Placebo in the full analysis set (FAS).

    Subject analysis set title
    Placebo / EDVI (FAS) - Change: Baseline vs. Day 168
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Change in End diastolic volume index (EDVI) from baseline to 6 months (Day 168) after treatment with Placebo in the full analysis set (FAS).

    Subject analysis set title
    Placebo / ESVI (FAS) - Change: Baseline vs. Day 168
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Change in End systolic volume index (ESVI) from baseline to 6 months (Day 168) after treatment with Placebo in the full analysis set (FAS).

    Subject analysis set title
    BAY 1142524 / LVEF (FAS) - Baseline
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Left ventricular ejection fraction (LVEF) at baseline in the full analysis set (FAS).

    Subject analysis set title
    BAY 1142524 / EDVI (FAS) - Baseline
    Subject analysis set type
    Full analysis
    Subject analysis set description
    End diastolic volume index (EDVI) at baseline in the full analysis set (FAS).

    Subject analysis set title
    BAY 1142524 / ESVI (FAS) - Baseline
    Subject analysis set type
    Full analysis
    Subject analysis set description
    End systolic volume index (ESVI) at baseline in the full analysis set (FAS).

    Subject analysis set title
    Placebo / LVEF (FAS) - Baseline
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Left ventricular ejection fraction (LVEF) at baseline in the full analysis set (FAS).

    Subject analysis set title
    Placebo / EDVI (FAS) - Baseline
    Subject analysis set type
    Full analysis
    Subject analysis set description
    End diastolic volume index (EDVI) at baseline in the full analysis set (FAS).

    Subject analysis set title
    Placebo / ESVI (FAS) - Baseline
    Subject analysis set type
    Full analysis
    Subject analysis set description
    End systolic volume index (ESVI) at baseline in the full analysis set (FAS).

    Subject analysis set title
    BAY 1142524 / LVEF (FAS) - Day 168
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Left ventricular ejection fraction (LVEF) at day 168 in the full analysis set (FAS).

    Subject analysis set title
    BAY 1142524 / EDVI (FAS) - Day 168
    Subject analysis set type
    Full analysis
    Subject analysis set description
    End diastolic volume index (EDVI) at day 168 in the full analysis set (FAS).

    Subject analysis set title
    BAY 1142524 / ESVI (FAS) - Day 168
    Subject analysis set type
    Full analysis
    Subject analysis set description
    End systolic volume index (ESVI) at day 168 in the full analysis set (FAS).

    Subject analysis set title
    Placebo / LVEF (FAS) - Day 168
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Left ventricular ejection fraction (LVEF) at day 168 in the full analysis set (FAS).

    Subject analysis set title
    Placebo / EDVI (FAS) - Day 168
    Subject analysis set type
    Full analysis
    Subject analysis set description
    End systolic volume index (ESVI) at day 168 in the full analysis set (FAS).

    Subject analysis set title
    Placebo / ESVI (FAS) - Day 168
    Subject analysis set type
    Full analysis
    Subject analysis set description
    End systolic volume index (ESVI) at day 168 in the full analysis set (FAS).

    Subject analysis set title
    Per protocol analysis set (PPS) - BAY 1142524
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects valid for per protocol analysis

    Subject analysis set title
    Per protocol analysis set (PPS) - Placebo
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects valid for per protocol analysis

    Subject analysis set title
    Full analysis set (FAS) - BAY 1142524
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Subjects valid for full analysis

    Subject analysis set title
    Full analysis set (FAS) - Placebo
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Subjects valid for full analysis

    Subject analysis set title
    Safety analysis set (SAS) - BAY 1142524
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Subjects valid for safety analysis

    Subject analysis set title
    Safety analysis set (SAS)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Subjects valid for safety analysis

    Subject analysis sets values
    BAY 1142524 / LVEF (PPS) - Change: Baseline vs. Day 168 BAY 1142524 / EDVI (PPS) - Change: Baseline vs. Day 168 BAY 1142524 / ESVI (PPS) - Change: Baseline vs. Day 168 Placebo / LVEF (PPS) - Change: Baseline vs. Day 168 Placebo / EDVI (PPS) - Change: Baseline vs. Day 168 Placebo / ESVI (PPS) - Change: Baseline vs. Day 168 BAY 1142524 / LVEF (PPS) - Baseline BAY 1142524 / EDVI (PPS) - Baseline BAY 1142524 / ESVI (PPS) - Baseline Placebo / LVEF (PPS) - Baseline Placebo / EDVI (PPS) - Baseline Placebo / ESVI (PPS) - Baseline BAY 1142524 / LVEF (PPS) - Day 168 BAY 1142524 / EDVI (PPS) - Day 168 BAY 1142524 / ESVI (PPS) - Day 168 Placebo / LVEF (PPS) - Day 168 Placebo / EDVI (PPS) - Day 168 Placebo / ESVI (PPS) - Day 168 BAY 1142524 / LVEF (FAS) - Change: Baseline vs. Day 168 BAY 1142524 / EDVI (FAS) - Change: Baseline vs. Day 168 BAY 1142524 / ESVI (FAS) - Change: Baseline vs. Day 168 Placebo / LVEF (FAS) - Change: Baseline vs. Day 168 Placebo / EDVI (FAS) - Change: Baseline vs. Day 168 Placebo / ESVI (FAS) - Change: Baseline vs. Day 168 BAY 1142524 / LVEF (FAS) - Baseline BAY 1142524 / EDVI (FAS) - Baseline BAY 1142524 / ESVI (FAS) - Baseline Placebo / LVEF (FAS) - Baseline Placebo / EDVI (FAS) - Baseline Placebo / ESVI (FAS) - Baseline BAY 1142524 / LVEF (FAS) - Day 168 BAY 1142524 / EDVI (FAS) - Day 168 BAY 1142524 / ESVI (FAS) - Day 168 Placebo / LVEF (FAS) - Day 168 Placebo / EDVI (FAS) - Day 168 Placebo / ESVI (FAS) - Day 168 Per protocol analysis set (PPS) - BAY 1142524 Per protocol analysis set (PPS) - Placebo Full analysis set (FAS) - BAY 1142524 Full analysis set (FAS) - Placebo Safety analysis set (SAS) - BAY 1142524 Safety analysis set (SAS)
    Number of subjects
    42
    42
    42
    38
    38
    38
    42
    42
    42
    38
    38
    38
    42
    42
    42
    38
    38
    38
    54
    54
    54
    53
    53
    53
    54
    54
    54
    53
    53
    53
    54
    54
    54
    53
    53
    53
    42
    38
    54
    53
    54
    107
    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)
    35
    35
    35
    33
    33
    33
    35
    35
    35
    33
    33
    33
    35
    35
    35
    33
    33
    33
    45
    45
    45
    44
    44
    44
    45
    45
    45
    44
    44
    44
    45
    45
    45
    44
    44
    44
    35
    33
    45
    44
    45
    44
        From 65-84 years
    7
    7
    7
    5
    5
    5
    7
    7
    7
    5
    5
    5
    7
    7
    7
    5
    5
    5
    9
    9
    9
    9
    9
    9
    9
    9
    9
    9
    9
    9
    9
    9
    9
    9
    9
    9
    7
    5
    9
    9
    9
    9
        85 years and over
    Age Continuous
    Units:
        
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    Gender Categorical
    Units: Subjects
        Female
    4
    4
    4
    8
    8
    8
    4
    4
    4
    8
    8
    8
    4
    4
    4
    8
    8
    8
    5
    5
    5
    9
    9
    9
    5
    5
    5
    9
    9
    9
    5
    5
    5
    9
    9
    9
    4
    8
    5
    9
    5
    9
        Male
    38
    38
    38
    30
    30
    30
    38
    38
    38
    30
    30
    30
    38
    38
    38
    30
    30
    30
    49
    49
    49
    44
    44
    44
    49
    49
    49
    44
    44
    44
    49
    49
    49
    44
    44
    44
    38
    30
    49
    44
    49
    44

    End points

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    End points reporting groups
    Reporting group title
    BAY 1142524
    Reporting group description
    Efficacy evaluation was performed in the per protocol set (PPS) and full analysis set (FAS). A total of 42 subjects in the BAY 1142524 arm were valid for the PPS and 54 subjects for the FAS.

    Reporting group title
    Placebo
    Reporting group description
    Efficacy evaluation was performed in the per protocol set (PPS) and full analysis set (FAS). A total of 38 subjects in the placebo arm were valid for the PPS and 53 subjects for the FAS.

    Subject analysis set title
    BAY 1142524 / LVEF (PPS) - Change: Baseline vs. Day 168
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Change in Left ventricular ejection fraction (LVEF) from baseline to 6 months (Day 168) after treatment with Placebo in the protocol analysis set (PPS).

    Subject analysis set title
    BAY 1142524 / EDVI (PPS) - Change: Baseline vs. Day 168
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Change in End diastolic volume index (EDVI) from baseline to 6 months (Day 168) after treatment with Placebo in the protocol analysis set (PPS).

    Subject analysis set title
    BAY 1142524 / ESVI (PPS) - Change: Baseline vs. Day 168
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Change in End systolic volume index (ESVI) from baseline to 6 months (Day 168) after treatment with BAY 1142524 in the protocol analysis set (PPS).

    Subject analysis set title
    Placebo / LVEF (PPS) - Change: Baseline vs. Day 168
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Change in Left ventricular ejection fraction (LVEF) from baseline to 6 months (Day 168) after treatment with Placebo in the protocol analysis set (PPS).

    Subject analysis set title
    Placebo / EDVI (PPS) - Change: Baseline vs. Day 168
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Change in End diastolic volume index (EDVI) from baseline to 6 months (Day 168) after treatment with Placebo in the protocol analysis set (PPS).

    Subject analysis set title
    Placebo / ESVI (PPS) - Change: Baseline vs. Day 168
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Change in End systolic volume index (ESVI) from baseline to 6 months (Day 168) after treatment with Placebo in the protocol analysis set (PPS).

    Subject analysis set title
    BAY 1142524 / LVEF (PPS) - Baseline
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Left ventricular ejection fraction (LVEF) at baseline in the protocol analysis set (PPS).

    Subject analysis set title
    BAY 1142524 / EDVI (PPS) - Baseline
    Subject analysis set type
    Per protocol
    Subject analysis set description
    End diastolic volume index (EDVI) at baseline in the protocol analysis set (PPS).

    Subject analysis set title
    BAY 1142524 / ESVI (PPS) - Baseline
    Subject analysis set type
    Per protocol
    Subject analysis set description
    End systolic volume index (ESVI) at baseline in the protocol analysis set (PPS).

    Subject analysis set title
    Placebo / LVEF (PPS) - Baseline
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Left ventricular ejection fraction (LVEF) at baseline in the protocol analysis set (PPS).

    Subject analysis set title
    Placebo / EDVI (PPS) - Baseline
    Subject analysis set type
    Per protocol
    Subject analysis set description
    End diastolic volume index (EDVI) at baseline in the protocol analysis set (PPS).

    Subject analysis set title
    Placebo / ESVI (PPS) - Baseline
    Subject analysis set type
    Per protocol
    Subject analysis set description
    End systolic volume index (ESVI) at baseline in the protocol analysis set (PPS).

    Subject analysis set title
    BAY 1142524 / LVEF (PPS) - Day 168
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Left ventricular ejection fraction (LVEF) at day 168 in the protocol analysis set (PPS).

    Subject analysis set title
    BAY 1142524 / EDVI (PPS) - Day 168
    Subject analysis set type
    Per protocol
    Subject analysis set description
    End diastolic volume index (EDVI) at day 168 in the protocol analysis set (PPS).

    Subject analysis set title
    BAY 1142524 / ESVI (PPS) - Day 168
    Subject analysis set type
    Per protocol
    Subject analysis set description
    End systolic volume index (ESVI) at day 168 in the protocol analysis set (PPS).

    Subject analysis set title
    Placebo / LVEF (PPS) - Day 168
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Left ventricular ejection fraction (LVEF) at day 168 in the protocol analysis set (PPS).

    Subject analysis set title
    Placebo / EDVI (PPS) - Day 168
    Subject analysis set type
    Per protocol
    Subject analysis set description
    End diastolic volume index (EDVI) at day 168 in the protocol analysis set (PPS).

    Subject analysis set title
    Placebo / ESVI (PPS) - Day 168
    Subject analysis set type
    Per protocol
    Subject analysis set description
    End systolic volume index (ESVI) at day 168 in the protocol analysis set (PPS).

    Subject analysis set title
    BAY 1142524 / LVEF (FAS) - Change: Baseline vs. Day 168
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Change in Left ventricular ejection fraction (LVEF) from baseline to 6 months (Day 168) after treatment with Placebo in the full analysis set (FAS).

    Subject analysis set title
    BAY 1142524 / EDVI (FAS) - Change: Baseline vs. Day 168
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Change in End diastolic volume index (EDVI) from baseline to 6 months (Day 168) after treatment with Placebo in the full analysis set (FAS).

    Subject analysis set title
    BAY 1142524 / ESVI (FAS) - Change: Baseline vs. Day 168
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Change in End systolic volume index (ESVI) from baseline to 6 months (Day 168) after treatment with BAY 1142524 in the full analysis set (FAS).

    Subject analysis set title
    Placebo / LVEF (FAS) - Change: Baseline vs. Day 168
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Change in Left ventricular ejection fraction (LVEF) from baseline to 6 months (Day 168) after treatment with Placebo in the full analysis set (FAS).

    Subject analysis set title
    Placebo / EDVI (FAS) - Change: Baseline vs. Day 168
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Change in End diastolic volume index (EDVI) from baseline to 6 months (Day 168) after treatment with Placebo in the full analysis set (FAS).

    Subject analysis set title
    Placebo / ESVI (FAS) - Change: Baseline vs. Day 168
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Change in End systolic volume index (ESVI) from baseline to 6 months (Day 168) after treatment with Placebo in the full analysis set (FAS).

    Subject analysis set title
    BAY 1142524 / LVEF (FAS) - Baseline
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Left ventricular ejection fraction (LVEF) at baseline in the full analysis set (FAS).

    Subject analysis set title
    BAY 1142524 / EDVI (FAS) - Baseline
    Subject analysis set type
    Full analysis
    Subject analysis set description
    End diastolic volume index (EDVI) at baseline in the full analysis set (FAS).

    Subject analysis set title
    BAY 1142524 / ESVI (FAS) - Baseline
    Subject analysis set type
    Full analysis
    Subject analysis set description
    End systolic volume index (ESVI) at baseline in the full analysis set (FAS).

    Subject analysis set title
    Placebo / LVEF (FAS) - Baseline
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Left ventricular ejection fraction (LVEF) at baseline in the full analysis set (FAS).

    Subject analysis set title
    Placebo / EDVI (FAS) - Baseline
    Subject analysis set type
    Full analysis
    Subject analysis set description
    End diastolic volume index (EDVI) at baseline in the full analysis set (FAS).

    Subject analysis set title
    Placebo / ESVI (FAS) - Baseline
    Subject analysis set type
    Full analysis
    Subject analysis set description
    End systolic volume index (ESVI) at baseline in the full analysis set (FAS).

    Subject analysis set title
    BAY 1142524 / LVEF (FAS) - Day 168
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Left ventricular ejection fraction (LVEF) at day 168 in the full analysis set (FAS).

    Subject analysis set title
    BAY 1142524 / EDVI (FAS) - Day 168
    Subject analysis set type
    Full analysis
    Subject analysis set description
    End diastolic volume index (EDVI) at day 168 in the full analysis set (FAS).

    Subject analysis set title
    BAY 1142524 / ESVI (FAS) - Day 168
    Subject analysis set type
    Full analysis
    Subject analysis set description
    End systolic volume index (ESVI) at day 168 in the full analysis set (FAS).

    Subject analysis set title
    Placebo / LVEF (FAS) - Day 168
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Left ventricular ejection fraction (LVEF) at day 168 in the full analysis set (FAS).

    Subject analysis set title
    Placebo / EDVI (FAS) - Day 168
    Subject analysis set type
    Full analysis
    Subject analysis set description
    End systolic volume index (ESVI) at day 168 in the full analysis set (FAS).

    Subject analysis set title
    Placebo / ESVI (FAS) - Day 168
    Subject analysis set type
    Full analysis
    Subject analysis set description
    End systolic volume index (ESVI) at day 168 in the full analysis set (FAS).

    Subject analysis set title
    Per protocol analysis set (PPS) - BAY 1142524
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects valid for per protocol analysis

    Subject analysis set title
    Per protocol analysis set (PPS) - Placebo
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects valid for per protocol analysis

    Subject analysis set title
    Full analysis set (FAS) - BAY 1142524
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Subjects valid for full analysis

    Subject analysis set title
    Full analysis set (FAS) - Placebo
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Subjects valid for full analysis

    Subject analysis set title
    Safety analysis set (SAS) - BAY 1142524
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Subjects valid for safety analysis

    Subject analysis set title
    Safety analysis set (SAS)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Subjects valid for safety analysis

    Primary: LVEF (%) - PPS

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    End point title
    LVEF (%) - PPS
    End point description
    End point type
    Primary
    End point timeframe
    Baseline vs. Day 168
    End point values
    BAY 1142524 / LVEF (PPS) - Change: Baseline vs. Day 168 Placebo / LVEF (PPS) - Change: Baseline vs. Day 168 BAY 1142524 / LVEF (PPS) - Baseline Placebo / LVEF (PPS) - Baseline BAY 1142524 / LVEF (PPS) - Day 168 Placebo / LVEF (PPS) - Day 168
    Number of subjects analysed
    42 [1]
    38 [2]
    42 [3]
    38 [4]
    42 [5]
    38 [6]
    Units: percent
        arithmetic mean (full range (min-max))
    3.51 (-7.3 to 16.2)
    3.97 (-5.4 to 16.7)
    39.08 (24.3 to 48.0)
    37.18 (28.0 to 46.6)
    42.59 (24.4 to 59.7)
    41.15 (25.8 to 55.4)
    Notes
    [1] - Left ventricular ejection fraction (LVEF)
    [2] - Left ventricular ejection fraction (LVEF)
    [3] - Left ventricular ejection fraction (LVEF)
    [4] - Left ventricular ejection fraction (LVEF)
    [5] - Left ventricular ejection fraction (LVEF)
    [6] - Left ventricular ejection fraction (LVEF)
    Statistical analysis title
    LVEF (%)
    Comparison groups
    BAY 1142524 / LVEF (PPS) - Change: Baseline vs. Day 168 v Placebo / LVEF (PPS) - Change: Baseline vs. Day 168
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    ANOVA
    Parameter type
    LS-Mean
    Point estimate
    -0.46
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -2.39
         upper limit
    1.47
    Statistical analysis title
    LVEF (%)
    Comparison groups
    BAY 1142524 / LVEF (PPS) - Baseline v Placebo / LVEF (PPS) - Baseline
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    ANOVA
    Parameter type
    LS-Mean
    Point estimate
    1.9
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -0.25
         upper limit
    4.05
    Statistical analysis title
    LVEF (%)
    Comparison groups
    BAY 1142524 / LVEF (PPS) - Day 168 v Placebo / LVEF (PPS) - Day 168
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    ANOVA
    Parameter type
    LS-Mean
    Point estimate
    1.44
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -1.69
         upper limit
    4.56

    Primary: EDVI (mL/m2) - PPS

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    End point title
    EDVI (mL/m2) - PPS
    End point description
    End diastolic volume index (EDVI)
    End point type
    Primary
    End point timeframe
    Baseline vs. Day 168
    End point values
    BAY 1142524 / EDVI (PPS) - Change: Baseline vs. Day 168 Placebo / EDVI (PPS) - Change: Baseline vs. Day 168 BAY 1142524 / EDVI (PPS) - Baseline Placebo / EDVI (PPS) - Baseline BAY 1142524 / EDVI (PPS) - Day 168 Placebo / EDVI (PPS) - Day 168
    Number of subjects analysed
    42 [7]
    38 [8]
    42 [9]
    38 [10]
    42 [11]
    38 [12]
    Units: mL/m2
        arithmetic mean (full range (min-max))
    7.32 (-22.7 to 37.6)
    5.07 (-39.5 to 52.1)
    77.38 (44.7 to 154.6)
    80.02 (53.1 to 109.3)
    84.7 (44.4 to 175.5)
    85.09 (43.6 to 123.7)
    Notes
    [7] - End diastolic volume index (EDVI)
    [8] - End diastolic volume index (EDVI)
    [9] - End diastolic volume index (EDVI)
    [10] - End diastolic volume index (EDVI)
    [11] - End diastolic volume index (EDVI)
    [12] - End diastolic volume index (EDVI)
    Statistical analysis title
    EDVI (mL/m2)
    Comparison groups
    BAY 1142524 / EDVI (PPS) - Change: Baseline vs. Day 168 v Placebo / EDVI (PPS) - Change: Baseline vs. Day 168
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    ANOVA
    Parameter type
    LS-Mean
    Point estimate
    2.25
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -3.78
         upper limit
    8.28
    Statistical analysis title
    EDVI (mL/m2)
    Comparison groups
    BAY 1142524 / EDVI (PPS) - Baseline v Placebo / EDVI (PPS) - Baseline
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    ANOVA
    Parameter type
    LS-Mean
    Point estimate
    -2.64
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -9.24
         upper limit
    3.96
    Statistical analysis title
    EDVI (mL/m2)
    Comparison groups
    BAY 1142524 / EDVI (PPS) - Day 168 v Placebo / EDVI (PPS) - Day 168
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    ANOVA
    Parameter type
    LS-Mean
    Point estimate
    -0.39
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -8.4
         upper limit
    7.62

    Primary: ESVI (mL/m2) - PPS

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    End point title
    ESVI (mL/m2) - PPS
    End point description
    End systolic volume index (ESVI)
    End point type
    Primary
    End point timeframe
    Baseline vs. Day 168
    End point values
    BAY 1142524 / ESVI (PPS) - Change: Baseline vs. Day 168 Placebo / ESVI (PPS) - Change: Baseline vs. Day 168 BAY 1142524 / ESVI (PPS) - Baseline Placebo / ESVI (PPS) - Baseline BAY 1142524 / ESVI (PPS) - Day 168 Placebo / ESVI (PPS) - Day 168
    Number of subjects analysed
    42 [13]
    38 [14]
    42 [15]
    38 [16]
    42 [17]
    38 [18]
    Units: mL/m2
        arithmetic mean (full range (min-max))
    2.29 (-22.8 to 30.2)
    0.57 (-27.8 to 41.9)
    47.33 (26.0 to 89.0)
    50.52 (29.2 to 75.5)
    49.62 (20.5 to 101.9)
    51.09 (19.5 to 82.6)
    Notes
    [13] - End systolic volume index (ESVI)
    [14] - End systolic volume index (ESVI)
    [15] - End systolic volume index (ESVI)
    [16] - End systolic volume index (ESVI)
    [17] - End systolic volume index (ESVI)
    [18] - End systolic volume index (ESVI)
    Statistical analysis title
    ESVI (mL/m2)
    Comparison groups
    BAY 1142524 / ESVI (PPS) - Change: Baseline vs. Day 168 v Placebo / ESVI (PPS) - Change: Baseline vs. Day 168
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    ANOVA
    Parameter type
    LS-Mean
    Point estimate
    1.72
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -3.14
         upper limit
    6.58
    Statistical analysis title
    ESVI (mL/m2)
    Comparison groups
    BAY 1142524 / ESVI (PPS) - Baseline v Placebo / ESVI (PPS) - Baseline
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    ANOVA
    Parameter type
    LS-Mean
    Point estimate
    -3.19
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -7.89
         upper limit
    1.51
    Statistical analysis title
    ESVI (mL/m2)
    Comparison groups
    BAY 1142524 / ESVI (PPS) - Day 168 v Placebo / ESVI (PPS) - Day 168
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    ANOVA
    Parameter type
    LS-Mean
    Point estimate
    -1.47
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -8.01
         upper limit
    5.07

    Primary: LVEF (%) - FAS

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    End point title
    LVEF (%) - FAS
    End point description
    Left ventricular ejection fraction (LVEF)
    End point type
    Primary
    End point timeframe
    Baseline vs. Day 168
    End point values
    BAY 1142524 / LVEF (FAS) - Change: Baseline vs. Day 168 Placebo / LVEF (FAS) - Change: Baseline vs. Day 168 BAY 1142524 / LVEF (FAS) - Baseline Placebo / LVEF (FAS) - Baseline BAY 1142524 / LVEF (FAS) - Day 168 Placebo / LVEF (FAS) - Day 168
    Number of subjects analysed
    47 [19]
    48 [20]
    47 [21]
    48 [22]
    47 [23]
    48 [24]
    Units: percent
        arithmetic mean (full range (min-max))
    3.67 (-7.3 to 16.2)
    4.00 (-5.4 to 16.7)
    39.13 (24.3 to 48.0)
    37.0 (22.9 to 46.6)
    42.8 (24.4 to 59.7)
    41.0 (21.7 to 55.4)
    Notes
    [19] - Left ventricular ejection fraction (LVEF)
    [20] - Left ventricular ejection fraction (LVEF)
    [21] - Left ventricular ejection fraction (LVEF)
    [22] - Left ventricular ejection fraction (LVEF)
    [23] - Left ventricular ejection fraction (LVEF)
    [24] - Left ventricular ejection fraction (LVEF)
    Statistical analysis title
    LVEF (%)
    Comparison groups
    BAY 1142524 / LVEF (FAS) - Change: Baseline vs. Day 168 v Placebo / LVEF (FAS) - Change: Baseline vs. Day 168
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    ANOVA
    Parameter type
    LS-Mean
    Point estimate
    -0.33
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -2.04
         upper limit
    1.38
    Statistical analysis title
    LVEF (%)
    Comparison groups
    BAY 1142524 / LVEF (FAS) - Baseline v Placebo / LVEF (FAS) - Baseline
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    ANOVA
    Parameter type
    LS-Mean
    Point estimate
    2.13
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    0.15
         upper limit
    4.12
    Statistical analysis title
    LVEF (%)
    Comparison groups
    BAY 1142524 / LVEF (FAS) - Day 168 v Placebo / LVEF (FAS) - Day 168
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    ANOVA
    Parameter type
    LS-Mean
    Point estimate
    1.8
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -1.03
         upper limit
    4.64

    Primary: EDVI (mL/m2) - FAS

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    End point title
    EDVI (mL/m2) - FAS
    End point description
    End diastolic volume index (EDVI)
    End point type
    Primary
    End point timeframe
    Baseline vs. Day 168
    End point values
    BAY 1142524 / EDVI (FAS) - Change: Baseline vs. Day 168 Placebo / EDVI (FAS) - Change: Baseline vs. Day 168 BAY 1142524 / EDVI (FAS) - Baseline Placebo / EDVI (FAS) - Baseline BAY 1142524 / EDVI (FAS) - Day 168 Placebo / EDVI (FAS) - Day 168
    Number of subjects analysed
    47 [25]
    48 [26]
    47 [27]
    48 [28]
    47 [29]
    48 [30]
    Units: mL/m2
        arithmetic mean (full range (min-max))
    6.89 (-22.7 to 37.6)
    6.11 (-39.5 to 66.8)
    75.53 (44.7 to 154.6)
    79.24 (53.1 to 117.1)
    82.42 (44.0 to 175.5)
    85.35 (43.6 to 132.6)
    Notes
    [25] - End diastolic volume index (EDVI)
    [26] - End diastolic volume index (EDVI)
    [27] - End diastolic volume index (EDVI)
    [28] - End diastolic volume index (EDVI)
    [29] - End diastolic volume index (EDVI)
    [30] - End diastolic volume index (EDVI)
    Statistical analysis title
    EDVI (mL/m2)
    Comparison groups
    BAY 1142524 / EDVI (FAS) - Change: Baseline vs. Day 168 v Placebo / EDVI (FAS) - Change: Baseline vs. Day 168
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    ANOVA
    Parameter type
    LS-Mean
    Point estimate
    0.78
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -5.01
         upper limit
    6.57
    Statistical analysis title
    EDVI (mL/m2)
    Comparison groups
    BAY 1142524 / EDVI (FAS) - Day 168 v Placebo / EDVI (FAS) - Day 168
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    ANOVA
    Parameter type
    LS-Mean
    Point estimate
    -2.93
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -10.42
         upper limit
    4.56
    Statistical analysis title
    EDVI (mL/m2)
    Comparison groups
    BAY 1142524 / EDVI (FAS) - Baseline v Placebo / EDVI (FAS) - Baseline
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    ANOVA
    Parameter type
    LS-Mean
    Point estimate
    -3.71
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -9.82
         upper limit
    2.4

    Primary: ESVI (mL/m2) - FAS

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    End point title
    ESVI (mL/m2) - FAS
    End point description
    End systolic volume index (ESVI)
    End point type
    Primary
    End point timeframe
    Baseline vs. Day 168
    End point values
    BAY 1142524 / ESVI (FAS) - Change: Baseline vs. Day 168 Placebo / ESVI (FAS) - Change: Baseline vs. Day 168 BAY 1142524 / ESVI (FAS) - Baseline Placebo / ESVI (FAS) - Baseline BAY 1142524 / ESVI (FAS) - Day 168 Placebo / ESVI (FAS) - Day 168
    Number of subjects analysed
    47 [31]
    48 [32]
    47 [33]
    48 [34]
    47 [35]
    48 [36]
    Units: mL/m2
        arithmetic mean (full range (min-max))
    1.89 (-22.8 to 30.2)
    1.35 (-27.8 to 53.2)
    46.14 (26.0 to 89.0)
    50.09 (29.2 to 82.3)
    48.03 (20.5 to 101.9)
    51.45 (19.5 to 102.3)
    Notes
    [31] - End systolic volume index (ESVI)
    [32] - End systolic volume index (ESVI)
    [33] - End systolic volume index (ESVI)
    [34] - End systolic volume index (ESVI)
    [35] - End systolic volume index (ESVI)
    [36] - End systolic volume index (ESVI)
    Statistical analysis title
    ESVI (mL/m2)
    Comparison groups
    BAY 1142524 / ESVI (FAS) - Change: Baseline vs. Day 168 v Placebo / ESVI (FAS) - Change: Baseline vs. Day 168
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    ANOVA
    Parameter type
    LS-Mean
    Point estimate
    0.54
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -4.12
         upper limit
    5.19
    Statistical analysis title
    ESVI (mL/m2)
    Comparison groups
    BAY 1142524 / ESVI (FAS) - Baseline v Placebo / ESVI (FAS) - Baseline
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    ANOVA
    Parameter type
    LS-Mean
    Point estimate
    -3.96
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -8.26
         upper limit
    0.35
    Statistical analysis title
    ESVI (mL/m2)
    Comparison groups
    BAY 1142524 / ESVI (FAS) - Day 168 v Placebo / ESVI (FAS) - Day 168
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    ANOVA
    Parameter type
    LS-Mean
    Point estimate
    -3.42
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -9.57
         upper limit
    2.73

    Secondary: Number of TEAEs

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    End point title
    Number of TEAEs
    End point description
    Treatment emergent adverse event (TEAE): TEAEs were defined as AEs occurring after the start of study drug but no more than 7 days after the stop of study drug.
    End point type
    Secondary
    End point timeframe
    From the first study drug administration until 7 days after the stop of study
    End point values
    BAY 1142524 Placebo Safety analysis set (SAS)
    Number of subjects analysed
    54
    53
    107
    Units: Subjects
    35
    40
    75
    No statistical analyses for this end point

    Secondary: Severity of TEAEs: Mild

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    End point title
    Severity of TEAEs: Mild
    End point description
    Treatment emergent adverse event (TEAE): TEAEs were defined as AEs occurring after the start of study drug but no more than 7 days after the stop of study drug.
    End point type
    Secondary
    End point timeframe
    From the first study drug administration until 7 days after the stop of study
    End point values
    BAY 1142524 Placebo
    Number of subjects analysed
    54
    53
    Units: Subjects
    21
    23
    No statistical analyses for this end point

    Secondary: Severity of TEAEs: Moderate

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    End point title
    Severity of TEAEs: Moderate
    End point description
    Treatment emergent adverse event (TEAE): TEAEs were defined as AEs occurring after the start of study drug but no more than 7 days after the stop of study drug.
    End point type
    Secondary
    End point timeframe
    From the first study drug administration until 7 days after the stop of study
    End point values
    BAY 1142524 Placebo
    Number of subjects analysed
    54
    53
    Units: Subjects
    11
    13
    No statistical analyses for this end point

    Secondary: Severity of TEAEs: Severe

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    End point title
    Severity of TEAEs: Severe
    End point description
    Treatment emergent adverse event (TEAE): TEAEs were defined as AEs occurring after the start of study drug but no more than 7 days after the stop of study drug.
    End point type
    Secondary
    End point timeframe
    From the first study drug administration until 7 days after the stop of study
    End point values
    BAY 1142524 Placebo
    Number of subjects analysed
    54
    53
    Units: Subjects
    3
    4
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    After the start of study drug but no more than 7 days after the stop of study drug.
    Adverse event reporting additional description
    All 107 subjects who received the study drug were included in the safety analysis set.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    21.0
    Reporting groups
    Reporting group title
    BAY 1142524
    Reporting group description
    A total of 42 subjects in the BAY 1142524 arm were valid for the PPS and 54 subjects for the FAS.

    Reporting group title
    Placebo
    Reporting group description
    A total of 38 subjects in the placebo arm were valid for the PPS and 53 subjects for the FAS.

    Serious adverse events
    BAY 1142524 Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    11 / 54 (20.37%)
    9 / 53 (16.98%)
         number of deaths (all causes)
    1
    2
         number of deaths resulting from adverse events
    0
    2
    Surgical and medical procedures
    Angioplasty
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Tonsil cancer
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina pectoris
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina unstable
         subjects affected / exposed
    2 / 54 (3.70%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure congestive
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular extrasystoles
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Left ventricular dysfunction
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute coronary syndrome
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular dysfunction
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary congestion
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary oedema
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Nervous system disorders
    Syncope
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    3 / 54 (5.56%)
    2 / 53 (3.77%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sudden death
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis acute
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 53 (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
    BAY 1142524 Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    34 / 54 (62.96%)
    40 / 53 (75.47%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 54 (0.00%)
    2 / 53 (3.77%)
         occurrences all number
    0
    2
    Hypotension
         subjects affected / exposed
    6 / 54 (11.11%)
    3 / 53 (5.66%)
         occurrences all number
    10
    4
    Peripheral vascular disorder
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Raynaud's phenomenon
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Hot flush
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Surgical and medical procedures
    Bunion operation
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Oral fibroma
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    3 / 54 (5.56%)
    3 / 53 (5.66%)
         occurrences all number
    4
    3
    Chest pain
         subjects affected / exposed
    6 / 54 (11.11%)
    8 / 53 (15.09%)
         occurrences all number
    7
    9
    Fatigue
         subjects affected / exposed
    1 / 54 (1.85%)
    1 / 53 (1.89%)
         occurrences all number
    1
    1
    Gait disturbance
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Hyperthermia
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Oedema peripheral
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Pyrexia
         subjects affected / exposed
    1 / 54 (1.85%)
    2 / 53 (3.77%)
         occurrences all number
    1
    2
    Peripheral swelling
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Exercise tolerance decreased
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Psychiatric disorders
    Anger
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Anxiety
         subjects affected / exposed
    1 / 54 (1.85%)
    1 / 53 (1.89%)
         occurrences all number
    1
    2
    Depressed mood
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Insomnia
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Stress
         subjects affected / exposed
    0 / 54 (0.00%)
    2 / 53 (3.77%)
         occurrences all number
    0
    2
    Somatic symptom disorder
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Reproductive system and breast disorders
    Gynaecomastia
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Nipple pain
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Vaginal haemorrhage
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Injury, poisoning and procedural complications
    Accident
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Head injury
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Face injury
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Contusion
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Joint injury
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Limb injury
         subjects affected / exposed
    1 / 54 (1.85%)
    1 / 53 (1.89%)
         occurrences all number
    1
    1
    Investigations
    Blood creatine phosphokinase increased
         subjects affected / exposed
    1 / 54 (1.85%)
    3 / 53 (5.66%)
         occurrences all number
    1
    4
    Blood potassium increased
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Blood triglycerides increased
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Platelet count decreased
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Weight increased
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Hepatic enzyme increased
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Pancreatic enzymes increased
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Liver function test increased
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Cardiac disorders
    Atrioventricular block second degree
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Bradycardia
         subjects affected / exposed
    1 / 54 (1.85%)
    2 / 53 (3.77%)
         occurrences all number
    1
    2
    Cardiac failure congestive
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Coronary artery stenosis
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Palpitations
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Tachycardia
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Cardiac ventricular thrombosis
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    2 / 54 (3.70%)
    2 / 53 (3.77%)
         occurrences all number
    2
    2
    Dyspnoea
         subjects affected / exposed
    2 / 54 (3.70%)
    4 / 53 (7.55%)
         occurrences all number
    2
    5
    Dyspnoea exertional
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Dyspnoea paroxysmal nocturnal
         subjects affected / exposed
    2 / 54 (3.70%)
    0 / 53 (0.00%)
         occurrences all number
    2
    0
    Epistaxis
         subjects affected / exposed
    1 / 54 (1.85%)
    2 / 53 (3.77%)
         occurrences all number
    1
    3
    Haemoptysis
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Sleep apnoea syndrome
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Oropharyngeal discomfort
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Blood and lymphatic system disorders
    Iron deficiency anaemia
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Leukopenia
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Pancytopenia
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    4 / 54 (7.41%)
    0 / 53 (0.00%)
         occurrences all number
    4
    0
    Headache
         subjects affected / exposed
    1 / 54 (1.85%)
    1 / 53 (1.89%)
         occurrences all number
    1
    1
    Hypoaesthesia
         subjects affected / exposed
    1 / 54 (1.85%)
    2 / 53 (3.77%)
         occurrences all number
    1
    2
    Syncope
         subjects affected / exposed
    2 / 54 (3.70%)
    1 / 53 (1.89%)
         occurrences all number
    2
    1
    Orthostatic intolerance
         subjects affected / exposed
    1 / 54 (1.85%)
    1 / 53 (1.89%)
         occurrences all number
    1
    1
    Eye disorders
    Vision blurred
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    1 / 54 (1.85%)
    1 / 53 (1.89%)
         occurrences all number
    1
    2
    Abdominal pain
         subjects affected / exposed
    1 / 54 (1.85%)
    1 / 53 (1.89%)
         occurrences all number
    1
    1
    Abdominal pain lower
         subjects affected / exposed
    1 / 54 (1.85%)
    1 / 53 (1.89%)
         occurrences all number
    1
    1
    Abdominal pain upper
         subjects affected / exposed
    2 / 54 (3.70%)
    1 / 53 (1.89%)
         occurrences all number
    2
    1
    Chronic gastritis
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Colitis
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Diarrhoea
         subjects affected / exposed
    2 / 54 (3.70%)
    1 / 53 (1.89%)
         occurrences all number
    2
    1
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Gingival bleeding
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Nausea
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Pancreatitis
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Haemorrhoidal haemorrhage
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Erosive duodenitis
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Faeces soft
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Noninfective gingivitis
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Renal cyst
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Strangury
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Dry skin
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Eczema
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Skin irritation
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Umbilical haematoma
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthritis
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Back pain
         subjects affected / exposed
    2 / 54 (3.70%)
    1 / 53 (1.89%)
         occurrences all number
    2
    1
    Muscle spasms
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Myalgia
         subjects affected / exposed
    4 / 54 (7.41%)
    1 / 53 (1.89%)
         occurrences all number
    4
    1
    Myopathy
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Polymyalgia rheumatica
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Musculoskeletal chest pain
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Limb discomfort
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    Diabetes mellitus
         subjects affected / exposed
    2 / 54 (3.70%)
    0 / 53 (0.00%)
         occurrences all number
    2
    0
    Folate deficiency
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Glucose tolerance impaired
         subjects affected / exposed
    1 / 54 (1.85%)
    1 / 53 (1.89%)
         occurrences all number
    1
    1
    Hyperkalaemia
         subjects affected / exposed
    2 / 54 (3.70%)
    1 / 53 (1.89%)
         occurrences all number
    2
    1
    Infections and infestations
    Cystitis
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal infection
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Influenza
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    2 / 54 (3.70%)
    3 / 53 (5.66%)
         occurrences all number
    2
    3
    Pneumonia
         subjects affected / exposed
    1 / 54 (1.85%)
    1 / 53 (1.89%)
         occurrences all number
    1
    1
    Urinary tract infection
         subjects affected / exposed
    1 / 54 (1.85%)
    2 / 53 (3.77%)
         occurrences all number
    1
    2
    Infected dermal cyst
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Candida infection
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    14 Oct 2016
    Amendment 1, Version 2.0, dated 14 OCT 2016, was globally implemented in order to consider the comments and feedbacks from German authority Bundesinstitut für Arzneimittel und Medizinprodukte: - Inclusion of only clinically stable patients after MI and not subjects with MI in an emergency situation. - It was clarified that the assignment of subjects to analysis sets was made during the Validity Review Meeting and documented in the Validity Review Report. Subjects were analyzed according to their actual treatment. - It was clarified that the statistical test was to be performed using a one sided alpha level. - A withdrawal criterion was added regarding subjects suffering from relevant symptomatic hypotension. - The determination of End of Study was modified to be LPLV as requested by the BfArM. - It was clarified which situations required an obligatory termination of the study and which situations required an optional termination of the study by the sponsor. - Physical examination was added in all visits during the treatment to ensure detection of early signs of cardiac decompensation. - Re-screening was deleted in the withdrawal section as this was allowed in this study. - Withdrawal criteria were modified to include information that subjects who required cardiac device implantation during the study had to be withdrawn from the study.
    03 Nov 2016
    Amendment 2, Version 3.0, dated 03 NOV 2016, was globally implemented in order to consider the comments and feedbacks from the Czech Republic (State Institute for Drug Control) and the German BfArM: - An additional visit (14 ± 4 days after first study drug intake) was introduced to improve adherence of the subjects to the study protocol and to check drug accountability. - Premature termination of the study was modified based upon the request by the BfArM.
    15 May 2017
    Amendment 3, Version 4.0, dated 15 MAY 2017, was globally implemented in order to consider feedback from the investigational sites: - Leukocytes and erythrocytes were added for urinalysis parameters. - It was clarified that the breakfast and concomitant medication could be taken at home in the morning of visit 1 in case the subject was not hospitalized anymore. - It was clarified that the blood sample for laboratory safety parameters had to be measured before first study drug administration, but the results were not necessarily required before first study drug administration.
    24 Oct 2017
    Amendment 4, Version 5.0, 24 OCT 2017, was globally implemented as the observed dropout/invalidity rate was higher than originally anticipated: - The number of randomized and enrolled subjects was increased in order to reach the target of 60 valid subjects (30 valid completers per treatment arm)

    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.
    As exploratory outcomes were analyzed: cardiovascular hospitalization mortality, re-hospitalization for heart failure, cardiovascular hospitalization rate, infarct size, wall motility score index, pharmacokinetics and biomarkers
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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