Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43861   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    COR-1, an anti-ß1 receptor antibody cyclopeptide in heart failure: a phase II, multicentre, randomised, double-blind and placebo controlled study with parallel groups

    Summary
    EudraCT number
    		 2010-022579-68
    Trial protocol
    		 DE  
    Global end of trial date
    28 Aug 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Jul 2016
    First version publication date
    15 Jul 2016
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    COR-1/02; 54452840HFA2002
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01391507
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    CorImmun GbmbH
    Sponsor organisation address
    Johnson & Johnson Platz 1, Neuss, Germany, 41470
    Public contact
    Clinical Registry group, Janssen-Cilag International N.V, +31 715242166, ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry group, Janssen-Cilag International N.V, +31 715242166, ClinicalTrialsEU@its.jnj.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
    28 Aug 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    28 Aug 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Aug 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective is to investigate whether intravenous COR-1 administration every 4 weeks in addition to standard therapy enhances cardiac function at rest in patients with heart failure due to DCM, compared to standard therapy alone after 6 months.
    Protection of trial subjects
    Safety data, including but not limited to adverse events, serious adverse events, treatment discontinuation, changes in vital signs, electrocardiogram (ECG) parameters, echocardiography parameters, circulating anti-1-AR autoantibodies, laboratory values, and use of concomitant medications were summarized in summary tables and/or frequency tabulations were analysed throughout the study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    25 Oct 2011
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 1 Years
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 36
    Worldwide total number of subjects
    36
    EEA total number of subjects
    36
    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)
    23
    From 65 to 84 years
    13
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 36 participants were enrolled in the study. Ten participants were randomized to placebo and 8, 6, and 12 participants were randomized to JNJ-54452840 20 mg, 80 mg, and 160 mg, respectively.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Matching placebo (0.9 percent sodium chloride solution) was administered intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion in pre-filled syringe
    Routes of administration
    Intravenous use
    Dosage and administration details
    Matching placebo (0.9 percent sodium chloride solution) was administered intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.

    Arm title
    		 COR-1 20 mg
    Arm description
    		 COR-1 (JNJ-54452840) was administered at a dose of 20 milligram (mg) intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
    Arm type
    		 Experimental

    Investigational medicinal product name
    COR-1
    Investigational medicinal product code
    Other name
    JNJ-54452840
    Pharmaceutical forms
    Solution for injection/infusion in pre-filled syringe
    Routes of administration
    Intravenous use
    Dosage and administration details
    COR-1 (JNJ-54452840) was administered at a dose of 20 milligrams (mg) intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.

    Arm title
    		 COR-1 80 mg
    Arm description
    		 COR-1 was administered at a dose of 80 milligram (mg) intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
    Arm type
    		 Experimental

    Investigational medicinal product name
    COR-1
    Investigational medicinal product code
    Other name
    JNJ-54452840
    Pharmaceutical forms
    Solution for injection/infusion in pre-filled syringe
    Routes of administration
    Intravenous use
    Dosage and administration details
    COR-1 (JNJ-54452840) was administered at a dose of 80 milligrams (mg) intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.

    Arm title
    		 COR-1 160 mg
    Arm description
    		 COR-1 was administered at a dose of 160 milligram (mg) intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
    Arm type
    		 Experimental

    Investigational medicinal product name
    COR-1
    Investigational medicinal product code
    Other name
    JNJ-54452840
    Pharmaceutical forms
    Solution for injection/infusion in pre-filled syringe
    Routes of administration
    Intravenous use
    Dosage and administration details
    COR-1 was administered at a dose of160 milligram (mg) intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.

    Number of subjects in period 1
    		Placebo COR-1 20 mg COR-1 80 mg COR-1 160 mg
    Started
    10
    8
    6
    12
    Completed
    6
    4
    2
    5
    Not completed
    4
    4
    4
    7
         Adverse event, serious fatal
    -
    -
    -
    1
         Consent withdrawn by subject
    1
    2
    1
    1
         Adverse event, non-fatal
    -
    -
    1
    -
         Other
    -
    -
    2
    -
         Protocol Violation
    2
    1
    -
    3
         Adverse event, serious non-fatal
    1
    1
    -
    2

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Matching placebo (0.9 percent sodium chloride solution) was administered intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.

    Reporting group title
    COR-1 20 mg
    Reporting group description
    		 COR-1 (JNJ-54452840) was administered at a dose of 20 milligram (mg) intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.

    Reporting group title
    COR-1 80 mg
    Reporting group description
    		 COR-1 was administered at a dose of 80 milligram (mg) intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.

    Reporting group title
    COR-1 160 mg
    Reporting group description
    		 COR-1 was administered at a dose of 160 milligram (mg) intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.

    Reporting group values
    		 Placebo COR-1 20 mg COR-1 80 mg COR-1 160 mg Total
    Number of subjects
    		 10 8 6 12 36
    Title for AgeCategorical
    Units: subjects
        Children (2-11 years)
    		 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0
        Adults (18-64 years)
    		 7 6 3 7 23
        From 65 to 84 years
    		 3 2 3 5 13
        85 years and over
    		 0 0 0 0 0
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    		 59.4 ± 9.61 57.5 ± 10.92 62 ± 13.59 59.8 ± 11.88 -
    Title for Gender
    Units: subjects
        Female
    		 3 2 1 2 8
        Male
    		 7 6 5 10 28

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Matching placebo (0.9 percent sodium chloride solution) was administered intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.

    Reporting group title
    COR-1 20 mg
    Reporting group description
    		 COR-1 (JNJ-54452840) was administered at a dose of 20 milligram (mg) intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.

    Reporting group title
    COR-1 80 mg
    Reporting group description
    		 COR-1 was administered at a dose of 80 milligram (mg) intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.

    Reporting group title
    COR-1 160 mg
    Reporting group description
    		 COR-1 was administered at a dose of 160 milligram (mg) intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.

    Primary: Change From Baseline in Left Ventricular Ejection Fraction (LVEF) at Month 6

    		 Close Top of page
    End point title
    		 Change From Baseline in Left Ventricular Ejection Fraction (LVEF) at Month 6 [1]
    End point description
    The LVEF is a fraction of blood (in percent) pumped out of the left ventricle of the heart (the main pumping chamber). Ejection fraction percentages greater than (>) 55% are considered normal. It wasmeasured by biplane echocardiography (central assessment).
    End point type
    Primary
    End point timeframe
    Baseline and Month 6
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Inferential Statistical analysis was not reported.
    End point values
    		 Placebo COR-1 20 mg COR-1 80 mg COR-1 160 mg
    Number of subjects analysed
    10
    8
    6
    12
    Units: participants
    arithmetic mean (standard deviation)
        Baseline
    35.4 ± 11.72
    29.4 ± 12.6
    35 ± 13.42
    32.4 ± 10.77
        Change at Month 6
    -1.6 ± 5.94
    0.8 ± 5.55
    5.4 ± 10.11
    -0.9 ± 3.09
    No statistical analyses for this end point

    Primary: Change From Baseline in Local Left Ventricular Ejection Fraction (LVEF) at Month 9

    		 Close Top of page
    End point title
    		 Change From Baseline in Local Left Ventricular Ejection Fraction (LVEF) at Month 9 [2]
    End point description
    The LVEF is a measure of how much blood is pumped out of the left ventricle of the heart (the main pumping chamber). Ejection fraction percentages greater than (>) 55% are considered normal. It was measured by biplane echocardiography (local assessment).
    End point type
    Primary
    End point timeframe
    Baseline and Month 9
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses for this end point.
    End point values
    		 Placebo COR-1 20 mg COR-1 80 mg COR-1 160 mg
    Number of subjects analysed
    10
    8
    6
    12
    Units: participants
    arithmetic mean (standard deviation)
        Baseline
    32.6 ± 5.78
    33.6 ± 9.77
    35.3 ± 8.57
    32.5 ± 9.27
        Change at Month 9
    -0.8 ± 4.39
    -1.9 ± 5.99
    3.8 ± 4.02
    -1.8 ± 3.13
    No statistical analyses for this end point

    Primary: Change From Baseline in N-Terminal Pro B-Type Natriuretic Peptide (NTProBNP) Level at Month 6

    		 Close Top of page
    End point title
    		 Change From Baseline in N-Terminal Pro B-Type Natriuretic Peptide (NTProBNP) Level at Month 6 [3]
    End point description
    The NT-ProBNP is a biomarker (a biologic molecule) that has been shown to predict cardiac events.
    End point type
    Primary
    End point timeframe
    Baseline and Month 6
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses for this end point.
    End point values
    		 Placebo COR-1 20 mg COR-1 80 mg COR-1 160 mg
    Number of subjects analysed
    10
    8
    6
    12
    Units: Participants
    arithmetic mean (standard deviation)
        Baseline
    5678 ± 9347.1
    2215.9 ± 1692.1
    971.4 ± 665.1
    2299.4 ± 2024.1
        Change at Month 6
    -805.7 ± 1241
    1363.4 ± 3948.7
    392.8 ± 295.7
    1109.6 ± 2130.6
    No statistical analyses for this end point

    Secondary: Change From Baseline in Central Transmitral Flow Velocity Time Integral (VTI) at Month 6

    		 Close Top of page
    End point title
    		 Change From Baseline in Central Transmitral Flow Velocity Time Integral (VTI) at Month 6
    End point description
    Transmitral flow VTI measures how blood flows through the heart. This was measured by echocardiogram. Most of the values for transmitral flow VTI were not provided in the reports from central core echocardiographic laboratory due to technical reasons. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. Standard deviation was not reported since only 1 participant was evaluable for this arm group i.e Change at Month 6.
    End point type
    Secondary
    End point timeframe
    Baseline and Month 6
    End point values
    		 Placebo COR-1 20 mg COR-1 80 mg COR-1 160 mg
    Number of subjects analysed
    2
    1
    0 [4]
    0 [5]
    Units: Participants
    arithmetic mean (standard deviation)
        Baseline
    45 ± 31.11
    21 ± 0.99999
    ±
    ±
        Change at Month 6
    0 ± 0
    0 ± 0.99999
    ±
    ±
    Notes
    [4] - None of the participant was evaluable.
    [5] - None of the participant was evaluable.
    No statistical analyses for this end point

    Secondary: Change From Baseline in Central Tissue E-Wave Doppler Mitral Annular Velocity at Month 6

    		 Close Top of page
    End point title
    		 Change From Baseline in Central Tissue E-Wave Doppler Mitral Annular Velocity at Month 6
    End point description
    Tissue doppler mitral annular velocity is a measure of how well the heart fills with blood. This was measured by echocardiogram. Most of the values for E-wave were not provided in the reports from central core echocardiographic laboratory due to technical reasons. Standard deviation was not reported since only 1 participant was evaluable for this arm group i.e COR-1 80 mg.
    End point type
    Secondary
    End point timeframe
    Baseline and Month 6
    End point values
    		 Placebo COR-1 20 mg COR-1 80 mg COR-1 160 mg
    Number of subjects analysed
    5
    5
    1
    4
    Units: Participants
    arithmetic mean (standard deviation)
        Baseline
    5.6 ± 1.52
    5.2 ± 1.1
    4 ± 99999
    5.8 ± 1.71
        Change at Month 6
    -0.2 ± 0.45
    0 ± 0
    0 ± 99999
    0 ± 0
    No statistical analyses for this end point

    Secondary: Change From Baseline in Distance Walked During Six-minute Walk Test at Month 6

    		 Close Top of page
    End point title
    		 Change From Baseline in Distance Walked During Six-minute Walk Test at Month 6
    End point description
    A standardized 6-minute walk test was performed and the distance covered in 6 minutes was measured.
    End point type
    Secondary
    End point timeframe
    Baseline and Month 6
    End point values
    		 Placebo COR-1 20 mg COR-1 80 mg COR-1 160 mg
    Number of subjects analysed
    10
    8
    6
    12
    Units: Participants
    arithmetic mean (standard deviation)
        Baseline
    421.1 ± 113.29
    451.1 ± 51.2
    395.2 ± 81.3
    420.7 ± 109.77
        Change at Month 6
    38.7 ± 63.11
    -8.7 ± 104.35
    12.8 ± 57.7
    2.4 ± 41.01
    No statistical analyses for this end point

    Secondary: Number of Participants With New York Heart Association (NYHA) Classification of Disease Progression

    		 Close Top of page
    End point title
    		 Number of Participants With New York Heart Association (NYHA) Classification of Disease Progression
    End point description
    Disease progression (morbidity) was measured by the NYHA classification. The NYHA classification assesses the severity of symptoms of heart failure as judged by the investigator and is comprised of 4 stages. Stage I- No symptoms/limitation in ordinary physical activity (for example, shortness of breath when walking, climbing stairs); Stage II-Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity; Stage III- Marked limitation in activity due to symptoms, even during less-than-ordinary activity, (for example, walking short distances [20-100 m]), comfortable only
    End point type
    Secondary
    End point timeframe
    Baseline and Month 6
    End point values
    		 Placebo COR-1 20 mg COR-1 80 mg COR-1 160 mg
    Number of subjects analysed
    10
    8
    6
    12
    Units: number of participants
        Baseline: Stage II (n= 10, 8, 6, 12)
    7
    8
    3
    7
        Baseline: Stage III (n= 10, 8, 6, 12)
    3
    0
    3
    5
        Month 6: Stage I (n= 7, 7, 5, 8)
    1
    1
    0
    0
        Month 6: Stage II (n= 7, 7, 5, 8)
    3
    4
    3
    6
        Month 6: Stage III (n= 7, 7, 5, 8)
    3
    2
    2
    2
    No statistical analyses for this end point

    Secondary: Change From Baseline in Minnesota Living With Heart Failure Questionnaire Score at Month 6

    		 Close Top of page
    End point title
    		 Change From Baseline in Minnesota Living With Heart Failure Questionnaire Score at Month 6
    End point description
    Minnesota living with heart failure questionnaire is a self-administered, disease-specific measure of health related quality of life (QOL) that assesses participant’s perceptions of the influence of heart failure on physical, socioeconomic and psychological aspects of life. Participants responded to 21 items using a six-point response scale (0-5). The total summary score can range from 0-105 with a lower score reflecting better heart failure related QOL.
    End point type
    Secondary
    End point timeframe
    Baseline and Month 6
    End point values
    		 Placebo COR-1 20 mg COR-1 80 mg COR-1 160 mg
    Number of subjects analysed
    7
    7
    5
    11
    Units: Participants
    arithmetic mean (standard deviation)
        Baseline
    23.7 ± 11.57
    21.4 ± 12.9
    33.2 ± 23.9
    25.9 ± 25.27
        Change at Month 6
    3.3 ± 10.7
    3.3 ± 16.26
    1.8 ± 9.5
    2.4 ± 20.5
    No statistical analyses for this end point

    Secondary: Change From Baseline in Holter Electrocardiography (ECG) Parameters (Heart Rate) at Month 6

    		 Close Top of page
    End point title
    		 Change From Baseline in Holter Electrocardiography (ECG) Parameters (Heart Rate) at Month 6
    End point description
    A Holter monitor is a portable device which monitors the electrical activity (electrocardiography) of the heart. Mean heart rate, maximum heart rate and minimum heart rate were evaluated. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.
    End point type
    Secondary
    End point timeframe
    Baseline and Month 6
    End point values
    		 Placebo COR-1 20 mg COR-1 80 mg COR-1 160 mg
    Number of subjects analysed
    7
    7
    5
    11
    Units: Participants
    arithmetic mean (standard deviation)
        Baseline: Mean Heart Rate
    74.6 ± 7
    76.9 ± 10.92
    84.2 ± 11.43
    75.3 ± 8.59
        Change at Month 6: Mean Heart Rate
    1.3 ± 6.68
    -0.9 ± 3.63
    -5.8 ± 10.18
    1.4 ± 6.97
        Baseline: Maximum Heart Rate
    126.4 ± 18.28
    130.3 ± 33.26
    123 ± 15.26
    125.1 ± 35.23
        Change at Month 6: Maximum Heart
    -0.8 ± 15.24
    5.4 ± 40.15
    0 ± 25.3
    -2 ± 31.56
        Baseline: Minimum Heart Rate
    51.6 ± 11.54
    59.3 ± 13.12
    66 ± 4.16
    58.7 ± 6.65
        Change at Month 6: Minimum Heart
    0.5 ± 3.39
    0.1 ± 3.93
    -7.8 ± 4.5
    -2.3 ± 10.09
    No statistical analyses for this end point

    Secondary: Number of Participants With Holter Electrocardiography (ECG) Parameters

    		 Close Top of page
    End point title
    		 Number of Participants With Holter Electrocardiography (ECG) Parameters
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline and Month 6
    End point values
    		 Placebo COR-1 20 mg COR-1 80 mg COR-1 160 mg
    Number of subjects analysed
    7
    7
    5
    11
    Units: number of participants
        Baseline: No block
    7
    7
    5
    7
        Baseline: AV block I
    0
    0
    0
    3
        Baseline: AV block II
    0
    0
    0
    0
        Baseline: AV block III
    0
    0
    0
    0
        Baseline: Sinus rhythm
    5
    4
    4
    7
        Baseline: Atrial fibrillation
    0
    0
    0
    0
        Baseline:Atrial fibrillation- paroxysmal/persisten
    2
    1
    1
    1
        Baseline: Other
    0
    2
    0
    2
        Baseline; AV junctional, 0-240/24h
    5
    6
    4
    6
        Baseline: AV junctional, 241-1000/24h
    2
    0
    0
    3
        Baseline: AV junctional, 1001-2400/24h
    0
    0
    1
    1
        Baseline: Ventricular, 0-240/24h
    1
    1
    1
    4
        Baseline: Ventricular, 241-1000/24h
    2
    2
    2
    1
        Baseline: Ventricular, 1001-2400/24h
    4
    3
    2
    5
        Baseline: 0 No VES
    0
    1
    0
    0
        Baseline: I Occasional individual VES (<30/h)
    3
    0
    1
    4
        Baseline: II Frequent VES (>30/h)
    0
    2
    0
    0
        Baseline: IIIa Polymorphous VES
    1
    0
    0
    1
        Baseline: IIIb Ventricular bigeminy
    0
    0
    0
    1
        Baseline: IVa Couplets, repetitive VES
    1
    2
    2
    1
        Baseline: IVb Runs, repetitive VES
    2
    2
    1
    3
        Baseline: V Early occurring VES(R-on T phenomenon)
    0
    0
    0
    0
        Baseline: II, IIIa, IVa, IVb
    0
    0
    1
    0
        Baseline: Normal
    2
    0
    2
    1
        Baseline: Abnormal, NCS
    5
    5
    1
    8
        Baseline: Abnormal, CS
    0
    2
    2
    1
        Month 6: No block
    6
    7
    5
    5
        Month 6: AV block I
    0
    0
    0
    1
        Month 6: AV block II
    0
    0
    0
    1
        Month 6: AV block III
    0
    0
    0
    0
        Month 6: Sinus rhythm
    2
    4
    3
    6
        Month 6: Atrial fibrillation
    0
    0
    0
    0
        Month 6: Atrial fibrillation paroxysma/persistent
    2
    2
    1
    0
        Month 6: Other
    2
    1
    1
    1
        Month 6: AV junctional, 0-240/24h
    5
    5
    4
    4
        Month 6: AV junctional, 241-1000/24h
    1
    2
    1
    1
        Month 6: AV junctional, 1001-2400/24h
    0
    0
    0
    2
        Month 6: Ventricular, 0-240/24h
    2
    2
    1
    2
        Month 6: Ventricular, 241-1000/24h
    0
    2
    1
    1
        Month 6: Ventricular, 1001-2400/24h
    4
    3
    3
    4
        Month 6: 0 No VES
    0
    1
    0
    0
        Month 6: I Occasional individual VES (<30/h)
    2
    0
    2
    2
        Month 6: II Frequent VES (>30/h)
    0
    0
    0
    1
        Month 6: IIIa Polymorphous VES
    2
    3
    1
    1
        Month 6: IVa Couplets, repetitive VES
    1
    1
    0
    1
        Month 6: IVb Runs, repetitive VES
    1
    1
    1
    2
        Month 6: V Early occurring VES (R-on Tphenomenon)
    0
    0
    0
    0
        Month 6: II, IIIa, IVa, IVb
    0
    1
    1
    0
        Month 6: Normal
    0
    0
    1
    1
        Month 6: Abnormal, NCS
    6
    6
    3
    5
        Month 6: Abnormal, CS
    0
    1
    1
    1
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Timeframe for AE
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo intravenously once per visit

    Reporting group title
    160 mg COR-1
    Reporting group description
    		 -

    Reporting group title
    80 mg COR-1
    Reporting group description
    		 -

    Reporting group title
    20 mg COR-1
    Reporting group description
    		 -

    Serious adverse events
    		 Placebo 160 mg COR-1 80 mg COR-1 20 mg COR-1
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 7 (14.29%)
    6 / 11 (54.55%)
    1 / 5 (20.00%)
    1 / 7 (14.29%)
         number of deaths (all causes)
    0
    1
    0
    0
         number of deaths resulting from adverse events
    Investigations
    Ejection Fraction Decreased
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 11 (9.09%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Weight Increased
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (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
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Ovarian Cancer
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    1 / 7 (14.29%)
         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
    Prostate Cancer
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 11 (9.09%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac Failure
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 7 (14.29%)
    2 / 11 (18.18%)
    1 / 5 (20.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 6
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Cardiogenic Shock
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 11 (9.09%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Heart Valve Incompetence
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 11 (9.09%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sinus Arrest
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 11 (9.09%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    Haemodialysis
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 11 (9.09%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Nervous system disorders
    Loss of Consciousness
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 11 (9.09%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Presyncope
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 11 (9.09%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Cardiac Death
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 11 (9.09%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (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
    Pulmonary Oedema
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 11 (9.09%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Psychiatric disorders
    Mental Disorder
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 11 (9.09%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal Failure
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 11 (9.09%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Infections and infestations
    Lobar Pneumonia
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 11 (9.09%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 11 (9.09%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo 160 mg COR-1 80 mg COR-1 20 mg COR-1
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 7 (57.14%)
    8 / 11 (72.73%)
    5 / 5 (100.00%)
    7 / 7 (100.00%)
    Vascular disorders
    Venous Insufficiency
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Surgical and medical procedures
    Wisdom Teeth Removal
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 11 (9.09%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    0
    General disorders and administration site conditions
    Asthenia
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 11 (9.09%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Chest Pain
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 11 (9.09%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Fatigue
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 11 (9.09%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Injection Site Haematoma
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    0
    General Physical Health Deterioration
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 11 (9.09%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Oedema Peripheral
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 11 (0.00%)
    2 / 5 (40.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    2
    0
    Pyrexia
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 7 (14.29%)
    1 / 11 (9.09%)
    1 / 5 (20.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    2
    1
    0
    Reproductive system and breast disorders
    Gynaecomastia
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 11 (9.09%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 7 (0.00%)
    2 / 11 (18.18%)
    0 / 5 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    2
    0
    1
    Rhonchi
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Psychiatric disorders
    Hallucination
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 11 (9.09%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Mental Disorder
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 11 (9.09%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Investigations
    Blood Creatine Increased
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    1
    Blood Potassium Increased
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 11 (9.09%)
    0 / 5 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    1
    0
    1
    Blood Pressure Decreased
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    1
    Carotid Bruit
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    1 / 5 (20.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Glomerular Filtration Rate Abnormal
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    1 / 5 (20.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Heart Rate Increased
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 7 (14.29%)
    1 / 11 (9.09%)
    1 / 5 (20.00%)
    1 / 7 (14.29%)
         occurrences all number
    1
    2
    1
    1
    Hepatic Enzyme Increased
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    1 / 5 (20.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Prostatic Specific Antigen Increased
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 11 (9.09%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Weight Increased
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Injury, poisoning and procedural complications
    Excoriation
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Face Injury
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Fall
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Overdose
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Traumatic Haematoma
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Cardiac disorders
    Arrhythmia
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    1
    Bradycardia
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    1
    Cardiac Failure
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    1
    0
    0
    2
    Palpitations
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    1
    Sinus Bradycardia
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    1
    Tachycardia
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    1
    Ventricular Extrasystoles
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 11 (9.09%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Nervous system disorders
    Aura
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 11 (9.09%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Dysgeusia
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 11 (9.09%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Dizziness
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    1
    Paraesthesia
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 11 (9.09%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Headache
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 7 (14.29%)
    1 / 11 (9.09%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Presyncope
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    1 / 5 (20.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Sciatica
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 7 (14.29%)
    1 / 11 (9.09%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Syncope
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    3
    0
    0
    0
    Ear and labyrinth disorders
    Vertigo
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 11 (9.09%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Gastrointestinal disorders
    Abdominal Pain Lower
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    1
    Abdominal Pain Upper
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Anal Inflammation
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 11 (9.09%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Diarrhoea
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 7 (0.00%)
    2 / 11 (18.18%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Nausea
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 7 (14.29%)
    1 / 11 (9.09%)
    0 / 5 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    1
    2
    0
    2
    Toothache
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    1 / 5 (20.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Hepatobiliary disorders
    Hepatomegaly
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 11 (9.09%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Skin and subcutaneous tissue disorders
    Erythema
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    2
    Renal and urinary disorders
    Renal Impairment
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 11 (0.00%)
    1 / 5 (20.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 7 (14.29%)
    1 / 11 (9.09%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    2
    1
    0
    0
    Back Pain
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Joint Swelling
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    2
    Musculoskeletal Pain
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Pain in Extremity
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 11 (0.00%)
    1 / 5 (20.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Infections and infestations
    Acute Tonsillitis
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Cystitis
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Influenza
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 11 (9.09%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Nasopharyngitis
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 11 (9.09%)
    2 / 5 (40.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    2
    2
    1
    Oral Herpes
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    1
    Respiratory Tract Infection
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Rhinitis
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    1
    Sinusitis
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 11 (9.09%)
    1 / 5 (20.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    1
    1
    1
    Staphylococcal Infection
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    1 / 5 (20.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    3
    0
    Metabolism and nutrition disorders
    Decreased Appetite
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    1
    Gout
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    1 / 5 (20.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Hyponatraemia
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    1 / 5 (20.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    1
    0

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    17 May 2011
    Amendment Version 2.0 addressed and/or corrected procedural issues only. It was written by CorImmun and finalized before any subjects were enrolled in the study.
    28 Jul 2011
    Amendment Version 3.0 was finalized by CorImmun before any subjects were randomized in the study and it addressed concerns raised by the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM). At the request of BfArM, the protocol was amended to edit the exclusion criteria and to add cytokine analysis, additional laboratory analysis at 2 visits, and additional safety measures, including the management of allergic reactions.
    28 Jun 2012
    Amendment Version 4.0 was written by JRD to document the acquisition of CorImmun by Janssen-Cilag GmbH as of 27 June 2012. In addition to editorial changes for clarity, major changes to the protocol included the modification of the study design to a pilot study as well as a decrease in the sample size to up to 60 randomized subjects. These changes were implemented as the original study was unable to meet the study objectives even if enrollment were to have continued to the planned sample size of 160 evaluable subjects.
    15 Oct 2012
    Major changes in Amendment Version 5.0 included the unblinding of the sponsor (CorImmun delegated this responsibility to JRD) as well as the discontinuation of further enrollment. These changes were introduced to give Janssen Research & Development LLC the opportunity to facilitate the planning of future studies by allowing for the proactive incorporation of any information obtained from this study. In addition, the follow-up visit 12-months after the treatment period was deleted and a requirement for cardiac monitoring (eg, telemetry) beginning a minimum of 15 minutes before the start of dosing to a minimum of 1 hour after dosing was added.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Fri Apr 26 06:46:34 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA