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    Clinical Trial Results:
    A Placebo-controlled, double-blind, Randomized, dose finding phase II study on OMT-28 in MaIntenance of Sinus rhythm after Electrical cardioversion in patients with persistent Atrial Fibrillation (PROMISE-AF)

    Summary
    EudraCT number
    		 2018-001626-26
    Trial protocol
    		 CZ   BG   HU  
    Global end of trial date
    08 Apr 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    31 Dec 2020
    First version publication date
    31 Dec 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    OMT28-C0201
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    OMEICOS Therapeutics GmbH
    Sponsor organisation address
    Robert-Rössle-Straße 10, Berlin, Germany, 13125
    Public contact
    Sponsor's medical expert, OMEICOS Therapeutics GmbH, +49 30948948 10, r.fischer@omeicos.com
    Scientific contact
    Sponsor's medical expert, OMEICOS Therapeutics GmbH, +49 30948948 10, r.fischer@omeicos.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
    17 Aug 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Apr 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the efficacy of three different doses of OMT-28 administered once daily versus placebo in the maintenance of normal sinus rhythm after electrical direct current cardioversion (DCC) in patients with persistent AF treated with an appropriate anticoagulant therapy.
    Protection of trial subjects
    The study aims to minimize potential risks to patients based on the proposed inclusion/exclusion criteria and safety monitoring, including use of the insertable cardiac monitor (ICM), and by establishing an internal Data Monitoring Committee (DMC) responsible for ensuring patient safety.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    19 Mar 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
    Bulgaria: 12
    Country: Number of subjects enrolled
    Czechia: 15
    Country: Number of subjects enrolled
    Hungary: 16
    Country: Number of subjects enrolled
    Ukraine: 93
    Worldwide total number of subjects
    136
    EEA total number of subjects
    43
    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)
    74
    From 65 to 84 years
    61
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 There were 25 enrolling sites across Ukraine, Bulgaria, Hungary, and Czech Republic. Patients were screened at 21 sites. Four sites were activated but did not recruit any patients.

    Pre-assignment
    Screening details
    		 The first patient for study OMT28-C0201 was screened into the study on 19 Mar 2019 and the last patient completed the study on 08 Apr 2020. There were 167 patients screened for the study at 21 centers (3 in Bulgaria, 2 in Czech Republic, 4 in Hungary, and 12 in Ukraine).

    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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Participants received once-daily Placebo from Visit 3 (Day 1) to Visit 8 (Day 99 ± 3 days): 102 days
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo for OMT 28
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Patients will take from Visit 3 (Day 1) to Visit 8 (Day 99 ± 3 days): 102 days

    Arm title
    		 4 mg OMT-28
    Arm description
    		 Participants received once-daily 4 mg OMT-28 from Visit 3 (Day 1) to Visit 8 (Day 99 ± 3 days): 102 days
    Arm type
    		 Experimental

    Investigational medicinal product name
    OMT-28 / 4 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Patients are taking from Visit 3 (Day 1) to Visit 8 (Day 99 ± 3 days): 102 days 4 mg OMT-28 per day

    Arm title
    		 12 mg OMT-28
    Arm description
    		 Participants received once-daily 12 mg OMT-28 from Visit 3 (Day 1) to Visit 8 (Day 99 ± 3 days): 102 days
    Arm type
    		 Experimental

    Investigational medicinal product name
    OMT-28 / 12 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Patients will take from Visit 3 (Day 1) to Visit 8 (Day 99 ± 3 days): 102 days 12 mg per day

    Arm title
    		 24 mg OMT-28
    Arm description
    		 Participants received once-daily 24 mg OMT-28 from Visit 3 (Day 1) to Visit 8 (Day 99 ± 3 days): 102 days
    Arm type
    		 Experimental

    Investigational medicinal product name
    24 mg OMT-28
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Patients will take from Visit 3 (Day 1) to Visit 8 (Day 99 ± 3 days): 102 days

    Number of subjects in period 1 [1]
    		Placebo 4 mg OMT-28 12 mg OMT-28 24 mg OMT-28
    Started
    31
    33
    34
    34
    Completed
    28
    31
    31
    30
    Not completed
    3
    2
    3
    4
         Adverse event, serious fatal
    1
    -
    -
    -
         Consent withdrawn by subject
    -
    -
    1
    1
         Physician decision
    -
    -
    1
    1
         Adverse event, non-fatal
    1
    1
    -
    2
         Lost to follow-up
    1
    -
    -
    -
         Sponsor decision
    -
    1
    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: 4 patients were randomised but did not receive investigational treatment: Placebo: Reason: inclusion/exclusion criteria not met: 2: 4 mg OMT-28: Reason: withdrawal by patient: 1 12 mg OMT-28: - 24 mg OMT-28 : Reason: withdrawal by patient: 1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received once-daily Placebo from Visit 3 (Day 1) to Visit 8 (Day 99 ± 3 days): 102 days

    Reporting group title
    4 mg OMT-28
    Reporting group description
    		 Participants received once-daily 4 mg OMT-28 from Visit 3 (Day 1) to Visit 8 (Day 99 ± 3 days): 102 days

    Reporting group title
    12 mg OMT-28
    Reporting group description
    		 Participants received once-daily 12 mg OMT-28 from Visit 3 (Day 1) to Visit 8 (Day 99 ± 3 days): 102 days

    Reporting group title
    24 mg OMT-28
    Reporting group description
    		 Participants received once-daily 24 mg OMT-28 from Visit 3 (Day 1) to Visit 8 (Day 99 ± 3 days): 102 days

    Reporting group values
    		 Placebo 4 mg OMT-28 12 mg OMT-28 24 mg OMT-28 Total
    Number of subjects
    		 31 33 34 34 132
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 65.0 ( 9.14 ) 62.6 ( 8.85 ) 61.3 ( 9.59 ) 63.8 ( 10.17 ) -
    Gender categorical
    Units: Subjects
        Female
    		 11 13 12 13 49
        Male
    		 20 20 22 21 83
    Race
    Units: Subjects
        White
    		 31 33 34 34 132
        Other
    		 0 0 0 0 0
    Ethnicity
    Units: Subjects
        Not Hispanic or Latino
    		 29 33 33 34 129
        Unknown
    		 1 0 1 0 2
        Hispanic or Latino
    		 1 0 0 0 1
    Height
    Units: cm
        arithmetic mean (standard deviation)
    		 174.3 ( 9.92 ) 172.5 ( 10.77 ) 172.6 ( 7.60 ) 172.4 ( 9.91 ) -
    Body Weight
    Units: kg
        arithmetic mean (standard deviation)
    		 89.12 ( 16.839 ) 94.88 ( 20.731 ) 93.02 ( 19.491 ) 92.81 ( 17.795 ) -
    Body Mass Index
    Units: kg/m2
        arithmetic mean (standard deviation)
    		 29.11 ( 3.695 ) 31.74 ( 5.914 ) 31.21 ( 6.079 ) 31.18 ( 5.253 ) -
    Left Ventricular Ejection Fraction
    Units: percent
        arithmetic mean (standard deviation)
    		 57.7 ( 5.96 ) 55.6 ( 7.65 ) 54.9 ( 7.58 ) 56.7 ( 8.48 ) -
    Left Atrium Size
    Units: mm
        arithmetic mean (standard deviation)
    		 44.0 ( 5.27 ) 45.5 ( 2.97 ) 45.4 ( 4.47 ) 44.9 ( 4.95 ) -

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received once-daily Placebo from Visit 3 (Day 1) to Visit 8 (Day 99 ± 3 days): 102 days

    Reporting group title
    4 mg OMT-28
    Reporting group description
    		 Participants received once-daily 4 mg OMT-28 from Visit 3 (Day 1) to Visit 8 (Day 99 ± 3 days): 102 days

    Reporting group title
    12 mg OMT-28
    Reporting group description
    		 Participants received once-daily 12 mg OMT-28 from Visit 3 (Day 1) to Visit 8 (Day 99 ± 3 days): 102 days

    Reporting group title
    24 mg OMT-28
    Reporting group description
    		 Participants received once-daily 24 mg OMT-28 from Visit 3 (Day 1) to Visit 8 (Day 99 ± 3 days): 102 days

    Primary: Primary endpoint: Post-DCC Daily Mean AF Burden (%)

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    End point title
    		 Primary endpoint: Post-DCC Daily Mean AF Burden (%)
    End point description
    Post-DCC Daily Mean AF Burden (%), defined as individual mean of all daily AF burden values per patient recorded from the day after the first DCC up to and including the day of last dose.
    End point type
    Primary
    End point timeframe
    Assessment of AF Burden was done continuously from Visit 2 (implantation of ICM device) to Last Follow-up Visit (or extrapolation of the device, when it occurred).
    End point values
    		 Placebo 4 mg OMT-28 12 mg OMT-28 24 mg OMT-28
    Number of subjects analysed
    24
    19
    21
    21
    Units: percent
        median (standard deviation)
    12.3 ( 39.3 )
    57.8 ( 41.4 )
    80.7 ( 44.6 )
    91.3 ( 45.5 )
    Statistical analysis title
    		 OMT-28 4 mg vs. Placebo
    Comparison groups
    Placebo v 4 mg OMT-28
    Number of subjects included in analysis
    43
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Median difference (final values)
    Point estimate
    11.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.0294
         upper limit
    		 55
    Statistical analysis title
    		 OMT-28 12 mg vs. Placebo
    Comparison groups
    Placebo v 12 mg OMT-28
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Median difference (final values)
    Point estimate
    3.33
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.578
         upper limit
    		 71.1
    Statistical analysis title
    		 OMT-28 24 mg vs. Placebo
    Comparison groups
    Placebo v 24 mg OMT-28
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Median difference (final values)
    Point estimate
    14.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.00662
         upper limit
    		 79.2

    Secondary: Secondary Endpoint: Recurrence of Persistent AF (Yes/No)

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    End point title
    		 Secondary Endpoint: Recurrence of Persistent AF (Yes/No)
    End point description
    Recurrence of Persistent AF (Yes/No), defined as at least 1 instance of persistent AF from the day after the first DCC up to and including the day of the last dose.
    End point type
    Secondary
    End point timeframe
    The DMC met 4 times, ie, when 10%, 25%, 50%, and 75% of patients completed the 3-month treatment phase, and reviewed the data in an unblinded manner.
    End point values
    		 Placebo 4 mg OMT-28 12 mg OMT-28 24 mg OMT-28
    Number of subjects analysed
    24
    19
    21
    21
    Units: subjects
        Yes
    9
    12
    11
    13
        No
    15
    7
    10
    8
    No statistical analyses for this end point

    Secondary: Secondary endpoint: Recurrence Rate (RecR) of Persistent AF (%)

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    End point title
    		 Secondary endpoint: Recurrence Rate (RecR) of Persistent AF (%)
    End point description
    Recurrence Rate (RecR) of Persistent AF (%), defined as percentage of patients with recurrence of persistent AF
    End point type
    Secondary
    End point timeframe
    The DMC met 4 times, ie, when 10%, 25%, 50%, and 75% of patients completed the 3-month treatment phase, and reviewed the data in an unblinded manner.
    End point values
    		 Placebo 4 mg OMT-28 12 mg OMT-28 24 mg OMT-28
    Number of subjects analysed
    24
    19
    21
    21
    Units: percent
    number (not applicable)
        Yes
    37.5
    63.2
    52.4
    61.9
        No
    62.5
    36.8
    47.6
    38.1
    No statistical analyses for this end point

    Secondary: Secondary endpoint: Time to Recurrence (TTR) of Persistent AF (days)

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    End point title
    		 Secondary endpoint: Time to Recurrence (TTR) of Persistent AF (days)
    End point description
    Time to Recurrence (TTR) of Persistent AF (days), defined as time from successful DCC on Visit 4 to the first recurrence of persistent AF.
    End point type
    Secondary
    End point timeframe
    The DMC met 4 times, ie, when 10%, 25%, 50%, and 75% of patients completed the 3-month treatment phase, and reviewed the data in an unblinded manner.
    End point values
    		 Placebo 4 mg OMT-28 12 mg OMT-28 24 mg OMT-28
    Number of subjects analysed
    24
    19
    21
    21
    Units: day
    median (confidence interval 95%)
        days
    88.5 (36.0 to 91.0)
    37.0 (8.00 to 91.0)
    55.0 (14.0 to 89.0)
    15.0 (4.00 to 91.0)
    No statistical analyses for this end point

    Secondary: Secondary pharmacokinetic (PK) endpoints: Plasma concentration of OMT-28 and its metabolites

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    End point title
    		 Secondary pharmacokinetic (PK) endpoints: Plasma concentration of OMT-28 and its metabolites [1]
    End point description
    Plasma concentration of OMT-28 (at each timepoint; Visit 3 to Visit 9) and its metabolites (specific timepoints; Visit 3 and Visit 6, 1 to 2 hours post-dose). Next to OMT-28, plasma concentration of metabolites were measured at the same time points, but these results are not reported here.
    End point type
    Secondary
    End point timeframe
    Visits 3 to 8 trough levels (pre-dose), Visit 3 (first dose) and Visit 6 (steady state) within 15-45 minutes, 1-2 hours, and 2.5-8 hours post-dose. Visit 9 (Follow-up).
    Notes
    [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Placebo arm not reported for PK data
    End point values
    		 4 mg OMT-28 12 mg OMT-28 24 mg OMT-28
    Number of subjects analysed
    33
    34
    34
    Units: ng/ml
    arithmetic mean (standard deviation)
        Visit 3 (post-dose, 1-2 h)
    283 ( 153 )
    930 ( 492 )
    2020 ( 886 )
        Visit 4
    319 ( 299 )
    672 ( 443 )
    1590 ( 1230 )
        Visit 5
    274 ( 160 )
    869 ( 566 )
    1700 ( 1030 )
        Visit 6
    332 ( 177 )
    1020 ( 726 )
    2190 ( 1390 )
        Visit 6 (post-dose, 1-2 h)
    561 ( 255 )
    1770 ( 771 )
    4180 ( 2020 )
        Visit 7
    319 ( 205 )
    768 ( 511 )
    1860 ( 1280 )
        Visit 8
    293 ( 172 )
    791 ( 665 )
    2150 ( 1360 )
        Visit 9
    9.60 ( 24.2 )
    76.2 ( 309 )
    154 ( 634 )
    No statistical analyses for this end point

    Secondary: Secondary pharmacokinetic (PK) endpoints: Plasma concentration of OMT-28 and its metabolites - Population Pharmacokinetic Analysis of Exposure (AUC)

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    End point title
    		 Secondary pharmacokinetic (PK) endpoints: Plasma concentration of OMT-28 and its metabolites - Population Pharmacokinetic Analysis of Exposure (AUC) [2]
    End point description
    Briefly, a 2-compartmental popPK model with first-order absorption and lag time was successfully developed. The OMT-28 exposure after oral dosing was characterized by a moderately fast but variable absorption, followed by a clear 2-compartmental curvature and slow accumulation of concentrations.
    End point type
    Secondary
    End point timeframe
    Visits 3 to 8 trough levels (pre-dose), Visit 3 (first dose) and Visit 6 (steady state) within 15-45 minutes, 1-2 hours, and 2.5-8 hours post-dose. Visit 9 (Follow-up).
    Notes
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Placebo arm not reported for PK data
    End point values
    		 4 mg OMT-28 12 mg OMT-28 24 mg OMT-28
    Number of subjects analysed
    33
    34
    34
    Units: mg*h/L
    number (not applicable)
        AUC
    9.11
    28.6
    64
    No statistical analyses for this end point

    Secondary: Secondary pharmacokinetic (PK) endpoints: Plasma concentration of OMT-28 and its metabolites - Population Pharmacokinetic Analysis of Exposure (Cmax)

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    End point title
    		 Secondary pharmacokinetic (PK) endpoints: Plasma concentration of OMT-28 and its metabolites - Population Pharmacokinetic Analysis of Exposure (Cmax) [3]
    End point description
    Briefly, a 2-compartmental popPK model with first-order absorption and lag time was successfully developed. The OMT-28 exposure after oral dosing was characterized by a moderately fast but variable absorption, followed by a clear 2-compartmental curvature and slow accumulation of concentrations.
    End point type
    Secondary
    End point timeframe
    Visits 3 to 8 trough levels (pre-dose), Visit 3 (first dose) and Visit 6 (steady state) within 15-45 minutes, 1-2 hours, and 2.5-8 hours post-dose. Visit 9 (Follow-up).
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Placebo arm not reported for PK data
    End point values
    		 4 mg OMT-28 12 mg OMT-28 24 mg OMT-28
    Number of subjects analysed
    33
    34
    34
    Units: ng/mL
    number (not applicable)
        Cmax
    558
    1770
    3898
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Day 1 Visit 3, Day 8 (±3 days) Visit 4, Day 15 (±3 days) Visit 5, Day 43 (±3 days) Visit 6, Day 71 (±3 days) Visit 7, Day 99 (±3 days) Visit 8, Follow-up/ ET (28 ± 3 days after last dose of study drug) Visit 9
    Adverse event reporting additional description
    All clinical AEs occurring after the patient signed the ICF and up to 30 days after the last dose of study medication, whether observed by the Investigator or reported by the patient, were recorded on the AE eCRF page.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received once-daily Placebo from Visit 3 (Day 1) to Visit 8 (Day 99 ± 3 days): 102 days

    Reporting group title
    4 mg OMT-28
    Reporting group description
    		 Participants received once-daily 4 mg OMT-28 from Visit 3 (Day 1) to Visit 8 (Day 99 ± 3 days): 102 days

    Reporting group title
    12 mg OMT-28
    Reporting group description
    		 Participants received once-daily 12 mg OMT-28 from Visit 3 (Day 1) to Visit 8 (Day 99 ± 3 days): 102 days

    Reporting group title
    24 mg OMT-28
    Reporting group description
    		 Participants received once-daily 24 mg OMT-28 from Visit 3 (Day 1) to Visit 8 (Day 99 ± 3 days): 102 days

    Serious adverse events
    		 Placebo 4 mg OMT-28 12 mg OMT-28 24 mg OMT-28
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 31 (9.68%)
    0 / 33 (0.00%)
    4 / 34 (11.76%)
    2 / 34 (5.88%)
         number of deaths (all causes)
    1
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Cardiac disorders
    Hypertension
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (0.00%)
    1 / 34 (2.94%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 33 (0.00%)
    2 / 34 (5.88%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure chronic
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 33 (0.00%)
    1 / 34 (2.94%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sinus arrest
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 33 (0.00%)
    0 / 34 (0.00%)
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anemia
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (0.00%)
    0 / 34 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemorrhagic stroke
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (0.00%)
    0 / 34 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 33 (0.00%)
    0 / 34 (0.00%)
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Colorectal adenocarcinoma
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (0.00%)
    0 / 34 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (0.00%)
    0 / 34 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (0.00%)
    0 / 34 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Liver injury
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 33 (0.00%)
    1 / 34 (2.94%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1.5%
    Non-serious adverse events
    		 Placebo 4 mg OMT-28 12 mg OMT-28 24 mg OMT-28
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2 / 31 (6.45%)
    5 / 33 (15.15%)
    8 / 34 (23.53%)
    12 / 34 (35.29%)
    Investigations
    Blood uric acid increased
         subjects affected / exposed
    0 / 31 (0.00%)
    2 / 33 (6.06%)
    0 / 34 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    2
    0
    0
    INR increased
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 33 (0.00%)
    0 / 34 (0.00%)
    2 / 34 (5.88%)
         occurrences all number
    0
    0
    0
    2
    Cardiac disorders
    Atrioventricular block first degree
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (0.00%)
    3 / 34 (8.82%)
    1 / 34 (2.94%)
         occurrences all number
    1
    0
    3
    1
    Bradycardia
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 33 (0.00%)
    2 / 34 (5.88%)
    2 / 34 (5.88%)
         occurrences all number
    1
    0
    2
    2
    Tachycardia
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 33 (0.00%)
    0 / 34 (0.00%)
    2 / 34 (5.88%)
         occurrences all number
    0
    0
    0
    2
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 33 (0.00%)
    0 / 34 (0.00%)
    2 / 34 (5.88%)
         occurrences all number
    0
    0
    0
    2
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 33 (0.00%)
    2 / 34 (5.88%)
    2 / 34 (5.88%)
         occurrences all number
    0
    0
    2
    2
    Metabolism and nutrition disorders
    Hyperkalaemia
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 33 (3.03%)
    1 / 34 (2.94%)
    3 / 34 (8.82%)
         occurrences all number
    0
    1
    1
    3
    Glucose tolerance impaired
         subjects affected / exposed
    0 / 31 (0.00%)
    2 / 33 (6.06%)
    1 / 34 (2.94%)
    0 / 34 (0.00%)
         occurrences all number
    0
    2
    1
    0

    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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