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    Clinical Trial Results:
    A Phase 2, Double-blind, Active-controlled, Dose-titrating Efficacy and Safety Study of Firibastat (QGC001) Compared to Ramipril Administered Orally, Twice Daily, Over 12 Weeks to Prevent Left Ventricular Dysfunction after Acute Myocardial Infarction

    Summary
    EudraCT number
    2018-003146-17
    Trial protocol
    DE   SK   HU   ES   GB  
    Global end of trial date
    08 Jul 2021

    Results information
    Results version number
    v1(current)
    This version publication date
    18 Dec 2022
    First version publication date
    18 Dec 2022
    Other versions
    Summary report(s)
    CSR Synopsis

    Trial information

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    Trial identification
    Sponsor protocol code
    QGC001-2QG4
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT03715998
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Quantum Genomics
    Sponsor organisation address
    33 rue Marbeuf, Paris, France,
    Public contact
    Clinical Project Manager, Quantum Genomics, mariette.codou@quantum-genomics.com
    Scientific contact
    Clinical Project Manager, Quantum Genomics, mariette.codou@quantum-genomics.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
    27 Jul 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    08 Jul 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Jul 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Comparison of the effects of twice daily (bis in die [BID]) oral administration of 2 doses of firibastat to those of BID oral administration of ramipril on the change from Baseline in left ventricular ejection fraction (LVEF) assessed by cardiac magnetic resonance imaging (CMRI) on Day 84
    Protection of trial subjects
    If symptomatic hypotension, symptomatic orthostatic hypotension, or cardiogenic shock occur, the treatment will be discontinued for the remainder of the study, and the event will be recorded as an AE leading to discontinuation. In case a skin reaction is concomitant to fever, blisters on the skin, and/or the mucous membranes of the mouth, nose, eyes and genitals, peeling and shedding skin, which may suggest erythema multiforme or Stevens-Johnson syndrome, the treatment must be immediately discontinued.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    15 Feb 2019
    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
    France: 40
    Country: Number of subjects enrolled
    Poland: 74
    Country: Number of subjects enrolled
    Germany: 11
    Country: Number of subjects enrolled
    Spain: 28
    Country: Number of subjects enrolled
    Hungary: 67
    Country: Number of subjects enrolled
    Slovakia: 70
    Country: Number of subjects enrolled
    United Kingdom: 5
    Worldwide total number of subjects
    295
    EEA total number of subjects
    290
    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)
    206
    From 65 to 84 years
    84
    85 years and over
    5

    Subject disposition

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    Recruitment
    Recruitment details
    A total of 295 male and female patients with a diagnosis of first acute anterior MI were randomized. The patients had a primary percutaneous coronary intervention (PCI) of the index-MI-related artery within 24 hours after MI. Patients were randomly assigned to 1 of the 3 treatment groups in a 1:1:1 ratio.

    Pre-assignment
    Screening details
    The population for this study corresponds to adults patients with a first acute anterior MI treated with primary PCI and signed an ICF.

    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
    Subject, Investigator, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    Patients were randomly assigned to 1 of the following 3 treatment groups in a 1:1:1 ratio: • Group 1: Patients received 50 mg firibastat BID for 2 weeks and then 100 mg BID for 10 weeks. • Group 2: Patients received 250 mg firibastat BID for 2 weeks and then 500 mg BID for 10 weeks. • Group 3: Patients received 2.5 mg ramipril BID for 2 weeks and then 5 mg BID for 10 weeks. IP was produced in order to maintain the blind (similar bottles with similar caps). IP allocation via IRT.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Firibastat 100 mg BID
    Arm description
    50 mg firibastat BID for 2 weeks and then 100 mg BID for 10 weeks
    Arm type
    Experimental

    Investigational medicinal product name
    Firibastat
    Investigational medicinal product code
    QGC001
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Firibastat 100 mg BID (2 caps of 50mg twice a day)

    Arm title
    Firibastat 500mg BID
    Arm description
    250 mg firibastat BID for 2 weeks and then 500 mg BID for 10 weeks
    Arm type
    Experimental

    Investigational medicinal product name
    Firibastat
    Investigational medicinal product code
    QGC001
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Firibastat 500 mg BID (2 caps of 250mg twice a day)

    Arm title
    Ramipril 5 mg BID
    Arm description
    2.5 mg ramipril BID for 2 weeks and then 5 mg BID for 10 weeks.
    Arm type
    Active comparator

    Investigational medicinal product name
    Ramipril
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Rapmipril 2.5mg 2 caps twice a day

    Number of subjects in period 1
    Firibastat 100 mg BID Firibastat 500mg BID Ramipril 5 mg BID
    Started
    98
    99
    98
    Completed
    81
    80
    88
    Not completed
    17
    19
    10
         Adverse event, serious fatal
    2
    1
    1
         Adverse event, non-fatal
    5
    10
    5
         Subject decision
    9
    6
    2
         Pregnancy
    1
    -
    -
         Lost to follow-up
    -
    1
    1
         Protocol deviation
    -
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Firibastat 100 mg BID
    Reporting group description
    50 mg firibastat BID for 2 weeks and then 100 mg BID for 10 weeks

    Reporting group title
    Firibastat 500mg BID
    Reporting group description
    250 mg firibastat BID for 2 weeks and then 500 mg BID for 10 weeks

    Reporting group title
    Ramipril 5 mg BID
    Reporting group description
    2.5 mg ramipril BID for 2 weeks and then 5 mg BID for 10 weeks.

    Reporting group values
    Firibastat 100 mg BID Firibastat 500mg BID Ramipril 5 mg BID Total
    Number of subjects
    98 99 98 295
    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)
    74 64 68 206
        From 65-84 years
    22 33 29 84
        85 years and over
    2 2 1 5
    Gender categorical
    Units: Subjects
        Female
    30 23 25 78
        Male
    68 76 73 217

    End points

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    End points reporting groups
    Reporting group title
    Firibastat 100 mg BID
    Reporting group description
    50 mg firibastat BID for 2 weeks and then 100 mg BID for 10 weeks

    Reporting group title
    Firibastat 500mg BID
    Reporting group description
    250 mg firibastat BID for 2 weeks and then 500 mg BID for 10 weeks

    Reporting group title
    Ramipril 5 mg BID
    Reporting group description
    2.5 mg ramipril BID for 2 weeks and then 5 mg BID for 10 weeks.

    Subject analysis set title
    mITT
    Subject analysis set type
    Modified intention-to-treat
    Subject analysis set description
    The mITT population included 229 patients (77.6% of the randomized population) who received at least 1 dose of the IP and who had at least 1 baseline (before or within 8 hours of taking the first IP) and 1 post-baseline efficacy assessment (LVEF), with 72 (73.5%) patients in the firibastat 100 mg BID group, 77 (77.8%) patients in the firibastat 500 mg BID group and 80 (81.6%) patients in the ramipril group.

    Subject analysis set title
    ITT
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    The ITT population included all randomized population (N=295) for each treatment groups, with 98 patients in the firibastat 100 mg BID group, 99 patients in the firibastat 500 mg BID group and 98 patients in the ramipril group

    Subject analysis set title
    Safety
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    The safety population included 294 patients (99.7% of the randomized population) who received at least one dose of the IP, with 98 (100%) patients in the firibastat 100 mg BID group, 98 (99.0%) patients in the firibastat 500 mg BID group and 98 (100%) patients in the ramipril group

    Subject analysis set title
    PP
    Subject analysis set type
    Per protocol
    Subject analysis set description
    The PP population included 170 patients (57.6% of the randomized population) without major protocol deviations, with 56 (57.1%) patients in the firibastat 100 mg BID group, 48 (48.5%) patients in the firibastat 500 mg BID group and 66 (67.3%) patients in the ramipril group

    Primary: Change from Baseline to Day 84 in LVEF

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    End point title
    Change from Baseline to Day 84 in LVEF
    End point description
    Change from Baseline to Day 84 in LVEF assessed by CMRI (central reading)
    End point type
    Primary
    End point timeframe
    84 days
    End point values
    Firibastat 100 mg BID Firibastat 500mg BID Ramipril 5 mg BID mITT
    Number of subjects analysed
    72
    77
    80
    229
    Units: % of Left Ventricular Ejection Fraction
        arithmetic mean (standard deviation)
    5.6 ( 1.2 )
    5.3 ( 1.1 )
    5.7 ( 1.1 )
    -0.36 ( 1.32 )
    Statistical analysis title
    Primary analysis of the primary efficacy endpoint
    Comparison groups
    Firibastat 100 mg BID v Firibastat 500mg BID v Ramipril 5 mg BID
    Number of subjects included in analysis
    229
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.789
    Method
    ANCOVA
    Confidence interval

    Secondary: Left-ventricule End-Diastolic Volume

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    End point title
    Left-ventricule End-Diastolic Volume
    End point description
    Change from Baseline to Day 84 in left-ventricular end-diastolic and end-systolic volumes assessed by CMRI (centralized reading).
    End point type
    Secondary
    End point timeframe
    Day 84
    End point values
    Firibastat 100 mg BID Firibastat 500mg BID Ramipril 5 mg BID mITT
    Number of subjects analysed
    72
    77
    80
    229
    Units: mL
        arithmetic mean (standard deviation)
    14.2 ( 4.5 )
    12.7 ( 4.3 )
    9.4 ( 4.4 )
    3.29 ( 5.13 )
    Statistical analysis title
    Analysis of the Secondary Efficacy endpoint
    Statistical analysis description
    9.2.2.1 Change in left-ventricular end-diastolic and end-systolic volumes at EOT
    Comparison groups
    Firibastat 100 mg BID v Firibastat 500mg BID v Ramipril 5 mg BID
    Number of subjects included in analysis
    229
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.521
    Method
    ANCOVA
    Confidence interval

    Secondary: Left-ventricule End-systolic Volume

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    End point title
    Left-ventricule End-systolic Volume
    End point description
    Change from Baseline to Day 84 in left-ventricular end-systolic volumes assessed by CMRI (centralized reading).
    End point type
    Secondary
    End point timeframe
    Day 84
    End point values
    Firibastat 100 mg BID Firibastat 500mg BID Ramipril 5 mg BID mITT
    Number of subjects analysed
    72
    77
    80
    229
    Units: mL
        arithmetic mean (standard deviation)
    -0.5 ( 3.3 )
    -0.4 ( 3.2 )
    -3.1 ( 3.2 )
    2.75 ( 3.82 )
    Statistical analysis title
    Analysis of the Secondary Efficacy endpoint
    Comparison groups
    Firibastat 100 mg BID v Firibastat 500mg BID v Ramipril 5 mg BID
    Number of subjects included in analysis
    229
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.473
    Method
    ANCOVA
    Confidence interval

    Secondary: MACE (i.e., cardiovascular deaths, new MIs, and cardiac hospitalizations)

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    End point title
    MACE (i.e., cardiovascular deaths, new MIs, and cardiac hospitalizations)
    End point description
    Major cardiac events as adjudicated by an independent committee by treatment group
    End point type
    Secondary
    End point timeframe
    Day 84
    End point values
    Firibastat 100 mg BID Firibastat 500mg BID Ramipril 5 mg BID Safety
    Number of subjects analysed
    98
    98
    98
    294
    Units: Event
    10
    8
    6
    24
    No statistical analyses for this end point

    Secondary: Change from Baseline in NT-proBNP,

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    End point title
    Change from Baseline in NT-proBNP,
    End point description
    End point type
    Secondary
    End point timeframe
    Day 84
    End point values
    Firibastat 100 mg BID Firibastat 500mg BID Ramipril 5 mg BID mITT
    Number of subjects analysed
    62
    71
    70
    229
    Units: pg/ml
        arithmetic mean (standard deviation)
    -1360.0 ( 1381.7 )
    -1596.4 ( 2279.6 )
    -1735.6 ( 2326.5 )
    246.8 ( 127 )
    Statistical analysis title
    Analysis of the Secondary Efficacy endpoint
    Comparison groups
    Firibastat 100 mg BID v Firibastat 500mg BID v Ramipril 5 mg BID
    Number of subjects included in analysis
    203
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.053
    Method
    ANCOVA
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From ICF signature to end of treatment
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    24
    Reporting groups
    Reporting group title
    Firibastat 100mg
    Reporting group description
    -

    Reporting group title
    Firibastat 500mg
    Reporting group description
    -

    Reporting group title
    Ramipril 5 mg
    Reporting group description
    -

    Serious adverse events
    Firibastat 100mg Firibastat 500mg Ramipril 5 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    11 / 98 (11.22%)
    18 / 98 (18.37%)
    10 / 98 (10.20%)
         number of deaths (all causes)
    2
    1
    1
         number of deaths resulting from adverse events
    2
    1
    1
    Vascular disorders
    Aortic aneurysm
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 98 (1.02%)
    0 / 98 (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
    Hypertensive crisis
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 98 (1.02%)
    0 / 98 (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
    General disorders and administration site conditions
    Chest pain or chest disconfort
         subjects affected / exposed
    1 / 98 (1.02%)
    1 / 98 (1.02%)
    3 / 98 (3.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Death
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 98 (0.00%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Vascular stent thrombosis
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 98 (0.00%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dry throat
         subjects affected / exposed
    0 / 98 (0.00%)
    0 / 98 (0.00%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    0 / 98 (0.00%)
    0 / 98 (0.00%)
    1 / 98 (1.02%)
         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 / 98 (0.00%)
    1 / 98 (1.02%)
    0 / 98 (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
    Investigations
    Electrocardiogram QT prolonged
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 98 (1.02%)
    0 / 98 (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
    Injury, poisoning and procedural complications
    Limb injury
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 98 (1.02%)
    0 / 98 (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
    Periprocedural myocardial infarction
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 98 (0.00%)
    0 / 98 (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
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 98 (1.02%)
    0 / 98 (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
    Aortic valve incompetence
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 98 (0.00%)
    0 / 98 (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
    Cardiac arrest
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 98 (0.00%)
    0 / 98 (0.00%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Cardiac failure
         subjects affected / exposed
    1 / 98 (1.02%)
    2 / 98 (2.04%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Cardiac tamponade
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 98 (0.00%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Coronary artery syndrome
    Additional description: ae
         subjects affected / exposed
    2 / 98 (2.04%)
    1 / 98 (1.02%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Myocardial infarction
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 98 (0.00%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pericardial Effusion
         subjects affected / exposed
    0 / 98 (0.00%)
    0 / 98 (0.00%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pericarditis
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 98 (1.02%)
    0 / 98 (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
    Ventricule rupture
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 98 (0.00%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 98 (1.02%)
    0 / 98 (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
    Ischaemic stroke
         subjects affected / exposed
    1 / 98 (1.02%)
    1 / 98 (1.02%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anemia
         subjects affected / exposed
    0 / 98 (0.00%)
    0 / 98 (0.00%)
    2 / 98 (2.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Retinal detachment
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 98 (0.00%)
    0 / 98 (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
    Skin and subcutaneous tissue disorders
    Drug eruption
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 98 (1.02%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rash maculo-papular
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 98 (0.00%)
    0 / 98 (0.00%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 98 (1.02%)
    2 / 98 (2.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Endocrine disorders
    Hyperplasia Adrenal
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 98 (1.02%)
    0 / 98 (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
    Spinal pain
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 98 (1.02%)
    0 / 98 (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
    Infections and infestations
    COVID-19
         subjects affected / exposed
    1 / 98 (1.02%)
    3 / 98 (3.06%)
    0 / 98 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Staphylococcal bacteraemia
         subjects affected / exposed
    0 / 98 (0.00%)
    0 / 98 (0.00%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 98 (0.00%)
    0 / 98 (0.00%)
    1 / 98 (1.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Firibastat 100mg Firibastat 500mg Ramipril 5 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 98 (4.08%)
    13 / 98 (13.27%)
    19 / 98 (19.39%)
    Cardiac disorders
    Chest disconfort
         subjects affected / exposed
    0 / 98 (0.00%)
    0 / 98 (0.00%)
    5 / 98 (5.10%)
         occurrences all number
    0
    0
    5
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 98 (1.02%)
    1 / 98 (1.02%)
    5 / 98 (5.10%)
         occurrences all number
    1
    1
    6
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    0 / 98 (0.00%)
    8 / 98 (8.16%)
    3 / 98 (3.06%)
         occurrences all number
    0
    9
    3
    Infections and infestations
    COVID-19
         subjects affected / exposed
    3 / 98 (3.06%)
    4 / 98 (4.08%)
    6 / 98 (6.12%)
         occurrences all number
    3
    4
    6

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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