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    Clinical Trial Results:
    Use of Esmolol for Tight Heart Rate Control for 24 Hours in Patients with Acute ST Elevation Myocardial Infarction: The BEtA-Blocker Therapy in Acute Myocardial Infarction (BEAT-AMI) Trial Study Title: Herzfrequenzkontrolle nach akutem Myokardinfarkt ("Heart rate control after acute myocardial infarct") Study Short Title: STEMI

    Summary
    EudraCT number
    		 2011-000911-26
    Trial protocol
    		 DE  
    Global end of trial date
    24 Feb 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    18 Sep 2021
    First version publication date
    18 Sep 2021
    Other versions
    Summary report(s)
    		 STEMI_Summary_report

    Trial information

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    Trial identification
    Sponsor protocol code
    Uni-Koeln-1392
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 DRKS number: DKRS00000766
    Sponsors
    Sponsor organisation name
    University of Cologne
    Sponsor organisation address
    Albertus-Magnus-Platz, Cologne, Germany, 50923
    Public contact
    Priv.-Doz. Dr. Er, Klinikum Guetersloh, Department of Internal Medicine 1, +49 54218324402, Fikret.Er@klinikum-guetersloh.de
    Scientific contact
    Priv.-Doz. Dr. Er, Klinikum Guetersloh, Department of Internal Medicine 1, +49 54218324402, Fikret.Er@klinikum-guetersloh.de
    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
    19 Feb 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    24 Feb 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Feb 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy and safety of esmolol-induced heart rate control as compared with placebo when used in addition to standard medical therapy in patients with acute ST elevation myocardial infarction (STEMI) in reducing final infarct size reflected by Troponin T release.
    Protection of trial subjects
    The trial was conducted according to Good Clinical Practice guidelines, the applicable local laws, and in accordance with the ethical principles that have their origins in the Declaration of Helsinki. The competent authorities approved the trial as required by national regulations. Regulatory authorities were notified of the trial and amendments as required by national regulations.
    Background therapy
    		 After successful percutaneous coronary intervention (PCI) all patients are getting treated in line with current national and international cardiology Guidelines. This Treatment usually consists of an ACE inhibitor, an oral beta blocker, Aspirin, an ADP receptor antagonist, a statine as well as unfractioned heparin.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    13 Oct 2011
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 100
    Worldwide total number of subjects
    100
    EEA total number of subjects
    100
    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)
    50
    From 65 to 84 years
    50
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Date of first enrollment (FPFV): 13.10.2011 Date of last completed (LPLV): 24.02.2014

    Pre-assignment
    Screening details
    		 Patients admitted with acute ST elevation myocardial infarction were screened. Subjects underwent timely successful percutaneous intervention were identified. Eligible subjects were included and randomly allocated to receive esmolol or placebo for 24 Hours.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Subject
    Blinding implementation details
    Because study drug esmolol has an obvious effect on heart rate and blood pressure and due to safety reasons drug-administrating physician was not blinded. Follow up data acquisition was strictly performed in a blinded manner of physician and patient.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Esmolol
    Arm description
    		 24 hours tight heart rate Control with intravenous esmolol infusion
    Arm type
    		 Experimental

    Investigational medicinal product name
    Esmolol
    Investigational medicinal product code
    Other name
    Brevibloc
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Successive, body-weight adapted i.v. administration, maximal dose 200μg/kg kg/min as maintenance dose

    Arm title
    		 Placebo
    Arm description
    		 24 hours intravenous placebo infusion
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo (NaCl 0,9%)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    250ml Infusionslösung

    Number of subjects in period 1
    		Esmolol Placebo
    Started
    50
    50
    Completed
    50
    50

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Esmolol
    Reporting group description
    		 24 hours tight heart rate Control with intravenous esmolol infusion

    Reporting group title
    Placebo
    Reporting group description
    		 24 hours intravenous placebo infusion

    Reporting group values
    		 Esmolol Placebo Total
    Number of subjects
    		 50 50 100
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 57.9 ( 11.2 ) 61.4 ( 12.2 ) -
    Gender categorical
    Units: Subjects
        Female
    		 9 14 23
        Male
    		 41 36 77

    End points

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    End points reporting groups
    Reporting group title
    Esmolol
    Reporting group description
    		 24 hours tight heart rate Control with intravenous esmolol infusion

    Reporting group title
    Placebo
    Reporting group description
    		 24 hours intravenous placebo infusion

    Primary: Maximum change in Troponin-T-concentration from baseline to 48 hours

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    End point title
    		 Maximum change in Troponin-T-concentration from baseline to 48 hours [1]
    End point description
    ITT population
    End point type
    Primary
    End point timeframe
    48 hours post baseline
    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: For statistical analysis see attached summary report
    End point values
    		 Esmolol Placebo
    Number of subjects analysed
    50 [2]
    50 [3]
    Units: ng/ml
        arithmetic mean (standard error)
    2.3 ( 3.1 )
    3.8 ( 4.5 )
    Notes
    [2] - ITT population
    [3] - ITT population
    No statistical analyses for this end point

    Secondary: Time to peak Troponin T

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    End point title
    		 Time to peak Troponin T
    End point description
    End point type
    Secondary
    End point timeframe
    baseline to 48h
    End point values
    		 Esmolol Placebo
    Number of subjects analysed
    50
    50
    Units: hours
        arithmetic mean (standard deviation)
    14 ( 11.8 )
    9.6 ( 8.7 )
    No statistical analyses for this end point

    Secondary: Area unter the Curve (AUC) of Troponin T release

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    End point title
    		 Area unter the Curve (AUC) of Troponin T release
    End point description
    End point type
    Secondary
    End point timeframe
    baseline to 48h
    End point values
    		 Esmolol Placebo
    Number of subjects analysed
    50
    50
    Units: ng*h/ml
        arithmetic mean (standard deviation)
    90.6 ( 108.3 )
    119.1 ( 114.4 )
    No statistical analyses for this end point

    Secondary: Mean heart rate during study intervention

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    End point title
    		 Mean heart rate during study intervention
    End point description
    Heart rate was measuread at 0, 6, 12, 18 and 24 hours.
    End point type
    Secondary
    End point timeframe
    mean value from a 24 hours period
    End point values
    		 Esmolol Placebo
    Number of subjects analysed
    50
    50
    Units: beats per minute (bpm)
        arithmetic mean (standard deviation)
    68.1 ( 9.3 )
    72.6 ( 11.3 )
    No statistical analyses for this end point

    Secondary: Area under the curve (AUC) NT-proBNP

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    End point title
    		 Area under the curve (AUC) NT-proBNP
    End point description
    NT-proBNP: N-terminal pro brain natriuretic peptide.
    End point type
    Secondary
    End point timeframe
    within 0h (baseline) to 48 hours
    End point values
    		 Esmolol Placebo
    Number of subjects analysed
    50
    50
    Units: pg*h/ml
        arithmetic mean (standard deviation)
    48873.6 ( 38371.8 )
    86331.8 ( 101952.6 )
    No statistical analyses for this end point

    Secondary: 6-minute walk test

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    End point title
    		 6-minute walk test
    End point description
    End point type
    Secondary
    End point timeframe
    6 weeks and 6 months
    End point values
    		 Esmolol Placebo
    Number of subjects analysed
    50 [4]
    49 [5]
    Units: meter
    arithmetic mean (standard deviation)
        6 weeks
    517.3 ( 114.5 )
    456.0 ( 146.4 )
        6 months
    494.9 ( 150.2 )
    450.0 ( 146.9 )
    Notes
    [4] - 49 for 6 weeks, 50 for 6 months
    [5] - 49 for 6 weeks, 48 for 6 months
    No statistical analyses for this end point

    Secondary: Echocardiography-ejection fraction

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    End point title
    		 Echocardiography-ejection fraction
    End point description
    End point type
    Secondary
    End point timeframe
    post baseline, after 6 weeks, after 6 months
    End point values
    		 Esmolol Placebo
    Number of subjects analysed
    50 [6]
    50 [7]
    Units: percent volume/volume
    arithmetic mean (standard deviation)
        post-intervention
    58.8 ( 10.2 )
    55.0 ( 11.7 )
        after 6 weeks
    62.5 ( 8.8 )
    58.6 ( 9.3 )
        change in ejection fr.: post-int. to 6 w.
    3.5 ( 7.5 )
    3.3 ( 9.6 )
        after 6 months
    61.7 ( 9.6 )
    60.1 ( 10.1 )
        change in ejection fr.: post-int. to 6 mths.
    2.9 ( 9.3 )
    4.4 ( 10.0 )
    Notes
    [6] - 49 for: ejection fr. after 6 w. and for change in ejection fr. from post-int. to 6 weeks
    [7] - 49 for ejection fr. after 6 weeks and change post-int. to 6 w. 48 for 6 mths. values
    No statistical analyses for this end point

    Secondary: Rehospitalisation

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    End point title
    		 Rehospitalisation
    End point description
    End point type
    Secondary
    End point timeframe
    6 weeks and 6 months after baseline
    End point values
    		 Esmolol Placebo
    Number of subjects analysed
    50 [8]
    49
    Units: Events
        6 weeks
    7
    7
        6 months
    13
    13
    Notes
    [8] - 49 for 6 weeks, 50 for 6 months
    No statistical analyses for this end point

    Secondary: quality of life test

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    End point title
    		 quality of life test
    End point description
    Change in score between baseline and timepoint
    End point type
    Secondary
    End point timeframe
    6 weeks and 6 months
    End point values
    		 Esmolol Placebo
    Number of subjects analysed
    50 [9]
    49
    Units: score
    arithmetic mean (standard deviation)
        6 weeks after baseline
    0.0 ( 0.1 )
    0.0 ( 0.2 )
        6 months after baseline
    -0.1 ( 0.1 )
    0.0 ( 0.2 )
    Notes
    [9] - 49 for 6 weeks, 50 for 6 months
    No statistical analyses for this end point

    Secondary: Repeat PCI

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    End point title
    		 Repeat PCI
    End point description
    PCI: percoutaneous coronary intervention
    End point type
    Secondary
    End point timeframe
    PCI 6 weeks and 6 months after baseline
    End point values
    		 Esmolol Placebo
    Number of subjects analysed
    50
    49
    Units: Events
        6 weeks
    4
    1
        6 months
    8
    5
    No statistical analyses for this end point

    Secondary: Reinfarction

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    End point title
    		 Reinfarction
    End point description
    End point type
    Secondary
    End point timeframe
    6 weeks and 6 months after baseline
    End point values
    		 Esmolol Placebo
    Number of subjects analysed
    50 [10]
    49
    Units: number of subjects with reinfarction
        6 weeks
    0
    0
        6 months
    1
    1
    Notes
    [10] - 49 for6 weeks time point, 50 for 6 months timepoint
    No statistical analyses for this end point

    Secondary: Reintervention

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    End point title
    		 Reintervention
    End point description
    End point type
    Secondary
    End point timeframe
    6 weeks and 6 months after baseline
    End point values
    		 Esmolol Placebo
    Number of subjects analysed
    50 [11]
    49
    Units: Events
        6 weeks
    4
    1
        6 months
    8
    5
    Notes
    [11] - 49 for 6 weeks, 50 for 60 months
    No statistical analyses for this end point

    Secondary: Apoplex during follow-up

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    End point title
    		 Apoplex during follow-up
    End point description
    End point type
    Secondary
    End point timeframe
    6 weeks and 6 months after baseline
    End point values
    		 Esmolol Placebo
    Number of subjects analysed
    49
    49 [12]
    Units: Study events
        6 weeks
    0
    0
        6 months
    0
    1
    Notes
    [12] - 49 subjects at 6 weeks timepoint, 48 subjects at 6 months timepoint
    No statistical analyses for this end point

    Secondary: Angina pectoris during follow-up

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    End point title
    		 Angina pectoris during follow-up
    End point description
    CCS: Canadian Cardiovascular Society
    End point type
    Secondary
    End point timeframe
    post-intervention, after 6 weeks, after 6 months
    End point values
    		 Esmolol Placebo
    Number of subjects analysed
    50 [13]
    50 [14]
    Units: Events
        Angina pectoris post-intervention CCS1/2
    49
    40
        Angina pectoris post-invervention CCS3/4
    1
    10
        Angina pectoris after 6 weeks CCS 1/2
    47
    43
        Angina pectoris after 6 weeks CCS 3/4
    2
    6
        Angina pectoris after 6 months CCS 1/2
    47
    41
        Angina pectoris after 6 months CCS 3/4
    3
    8
    Notes
    [13] - 50 post intervention, 49 after 6 weeks, 50 after 6 months
    [14] - 50 post-intervention, 49 after 6 weeks, 49 after 6 months
    No statistical analyses for this end point

    Secondary: Death from any cause

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    End point title
    		 Death from any cause
    End point description
    End point type
    Secondary
    End point timeframe
    entire study
    End point values
    		 Esmolol Placebo
    Number of subjects analysed
    50
    50
    Units: number of subjects
    0
    1
    No statistical analyses for this end point

    Secondary: Time to peak concentration NT-proBNP

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    End point title
    		 Time to peak concentration NT-proBNP
    End point description
    End point type
    Secondary
    End point timeframe
    baseline to 48 hours
    End point values
    		 Esmolol Placebo
    Number of subjects analysed
    50
    50
    Units: hours
        arithmetic mean (standard deviation)
    28.7 ( 16 )
    27.1 ( 11.3 )
    No statistical analyses for this end point

    Secondary: Neuropsychological status

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    End point title
    		 Neuropsychological status
    End point description
    change in visual analogue scale (VAS) status compare to baseline
    End point type
    Secondary
    End point timeframe
    6 weeks, 6 months
    End point values
    		 Esmolol Placebo
    Number of subjects analysed
    50 [15]
    49
    Units: mm (visual analogue scale)
    arithmetic mean (standard deviation)
        6 weeks
    -1.7 ( 16.3 )
    1.8 ( 18.4 )
        6 months
    2.7 ( 17.6 )
    0.4 ( 18.9 )
    Notes
    [15] - 49 for 6 weeks, 50 for months
    No statistical analyses for this end point

    Secondary: Area unter the Curve (AUC) creatinine kinase

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    End point title
    		 Area unter the Curve (AUC) creatinine kinase
    End point description
    End point type
    Secondary
    End point timeframe
    from baseline to 48 hours
    End point values
    		 Esmolol Placebo
    Number of subjects analysed
    50
    50
    Units: ng*h/ml
        arithmetic mean (standard deviation)
    37152.1 ( 43683.0 )
    43576.4 ( 38663.1 )
    No statistical analyses for this end point

    Secondary: Time to peak creatinine kinase

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    End point title
    		 Time to peak creatinine kinase
    End point description
    End point type
    Secondary
    End point timeframe
    baseline to 48 hours
    End point values
    		 Esmolol Placebo
    Number of subjects analysed
    50
    50
    Units: hours
        arithmetic mean (standard deviation)
    14.4 ( 11.5 )
    10.0 ( 8.6 )
    No statistical analyses for this end point

    Secondary: Area under the curve (AUC) creatinine kinase MB

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    End point title
    		 Area under the curve (AUC) creatinine kinase MB
    End point description
    End point type
    Secondary
    End point timeframe
    baseline to 48 hours
    End point values
    		 Esmolol Placebo
    Number of subjects analysed
    50
    50
    Units: U*h/l
        arithmetic mean (standard deviation)
    3674.7 ( 3892.3 )
    4909.1 ( 4076.3 )
    No statistical analyses for this end point

    Secondary: Time to peak creatinine kinase MB

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    End point title
    		 Time to peak creatinine kinase MB
    End point description
    End point type
    Secondary
    End point timeframe
    baseline to 48 hours
    End point values
    		 Esmolol Placebo
    Number of subjects analysed
    50
    50
    Units: hours
        arithmetic mean (standard deviation)
    11.1 ( 7.9 )
    8.6 ( 3.7 )
    No statistical analyses for this end point

    Secondary: Change in endothelial progenitor cells CD34

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    End point title
    		 Change in endothelial progenitor cells CD34
    End point description
    End point type
    Secondary
    End point timeframe
    from baseline to 24 hours
    End point values
    		 Esmolol Placebo
    Number of subjects analysed
    50
    49
    Units: counts
        arithmetic mean (standard deviation)
    130.9 ( 50.4 )
    63.0 ( 47.2 )
    No statistical analyses for this end point

    Secondary: Change in endothelial progenitor cells KDR

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    End point title
    		 Change in endothelial progenitor cells KDR
    End point description
    End point type
    Secondary
    End point timeframe
    baseline to 24 hours
    End point values
    		 Esmolol Placebo
    Number of subjects analysed
    50
    49
    Units: counts
        arithmetic mean (standard deviation)
    40.6 ( 25.7 )
    18.7 ( 21.5 )
    No statistical analyses for this end point

    Secondary: Change in endothelial progenitor cells CD133

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    End point title
    		 Change in endothelial progenitor cells CD133
    End point description
    End point type
    Secondary
    End point timeframe
    baseline to 48 hours
    End point values
    		 Esmolol Placebo
    Number of subjects analysed
    50
    49
    Units: counts
        arithmetic mean (standard deviation)
    104.0 ( 47.2 )
    49.4 ( 37.7 )
    No statistical analyses for this end point

    Secondary: Change in endothelial progenitor cells CD117

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    End point title
    		 Change in endothelial progenitor cells CD117
    End point description
    End point type
    Secondary
    End point timeframe
    baseline to 24 hours
    End point values
    		 Esmolol Placebo
    Number of subjects analysed
    50
    49
    Units: counts
        arithmetic mean (standard deviation)
    119.6 ( 48.5 )
    56.1 ( 45.8 )
    No statistical analyses for this end point

    Secondary: Echocardiography-wall motion abnormality

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    End point title
    		 Echocardiography-wall motion abnormality
    End point description
    End point type
    Secondary
    End point timeframe
    post-intervention, 6 weeks and 6 months after intervention
    End point values
    		 Esmolol Placebo
    Number of subjects analysed
    50 [16]
    50 [17]
    Units: patients
        post-intervention
    39
    46
        after 6 weeks
    34
    43
        after 6 months
    35
    44
    Notes
    [16] - 49 for 6 weeks values
    [17] - 49 for 6 weeks and 6 months values
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    AEs from Baseline Visite 1 (0h) to Follow-up Visite 3(6mth)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.0
    Frequency threshold for reporting non-serious adverse events: 0%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: For Advers Event listing see attached summary report - safety

    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
    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.

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