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    Clinical Trial Results:
    A multicenter, randomized, double-blind, double-dummy, parallel-group, active-controlled study to evaluate the efficacy and safety of finerenone compared to eplerenone on morbidity and mortality in patients with chronic heart failure and reduced ejection fraction after recent heart failure decompensation and additional risk factors, either type 2 diabetes mellitus or chronic kidney disease or both.

    Summary
    EudraCT number
    		 2015-002168-17
    Trial protocol
    		 SE   DK   IE   CZ   DE   FI   GB   AT   HU   NL   PT   ES   LT   BG   PL   GR   IT  
    Global end of trial date
    11 Mar 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    03 Dec 2019
    First version publication date
    03 Dec 2019
    Other versions
    Summary report(s)
    		 Withdrawn Statement

    Trial information

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    Trial identification
    Sponsor protocol code
    BAY94-8862/16275
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Bayer AG
    Sponsor organisation address
    Kaiser Wilhelm Allee, Leverkusen, Germany, D-51368
    Public contact
    Therapeutic Area Head, Bayer AG, clinical-trials-contact@bayer.com
    Scientific contact
    Therapeutic Area Head, Bayer AG, clinical-trials-contact@bayer.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    11 Mar 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Mar 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Demonstrate the superiority of finerenone to eplerenone in delaying time to first occurrence of the composite endpoint, defined as cardiovascular (CV) death or hospitalization for heart failure (HF), in patients with chronic heart failure (CHF) (NYHA class II–IV) and reduced ejection fraction after recent heart failure decompensation who have additional risk factors, i.e. type 2 diabetes mellitus (T2DM) and/or or chronic kidney disease (CKD).
    Protection of trial subjects
    N/A
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    11 Mar 2016
    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: 99999
    Worldwide total number of subjects
    99999
    EEA total number of subjects
    99999
    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)
    99999
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 99999 is "Not applicable" value or 0 subjects, this trial was discontinued with no subjects enrolled in the trial.

    Pre-assignment
    Screening details
    		 N/A

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Overall Trial
    Arm description
    		 99999 is "Not applicable" value or 0 subjects, this trial was discontinued with no subjects enrolled in the trial.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BAY 94-8862 IR tablet 10 mg
    Investigational medicinal product code
    Other name
    Finerenone
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    10 mg finerenone tablet once daily (OD) in the morning OR 20 mg finerenone tablet OD in the morning

    Investigational medicinal product name
    BAY 94-8862 IR tablet 20 mg
    Investigational medicinal product code
    Other name
    Finerenone
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    10 mg finerenone tablet once daily (OD) in the morning OR 20 mg finerenone tablet OD in the morning

    Number of subjects in period 1
    		Overall Trial
    Started
    99999
    Completed
    99999

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall Trial
    Reporting group description
    		 99999 is "Not applicable" value or 0 subjects, this trial was discontinued with no subjects enrolled in the trial.

    Reporting group values
    		 Overall Trial Total
    Number of subjects
    		 99999 99999
    Age categorical
    Units: Subjects
    Age continuous
    99999 is "Not applicable" value or 0 subjects, this trial was discontinued with no subjects enrolled in the trial
    Units: years
        arithmetic mean (standard deviation)
    		 0 ( 0 ) -
    Gender categorical
    99999 is "Not applicable" value or 0 subjects, this trial was discontinued with no subjects enrolled in the trial
    Units: Subjects
        Female
    		 99999 99999
        Male
    		 0 0

    End points

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    End points reporting groups
    Reporting group title
    Overall Trial
    Reporting group description
    		 99999 is "Not applicable" value or 0 subjects, this trial was discontinued with no subjects enrolled in the trial.

    Primary: Time to the first occurrence of the primary composite endpoint, consisting of the following components: - Cardiovascular (CV) death - Hospitalization for Heart failure (HF)

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    End point title
    		 Time to the first occurrence of the primary composite endpoint, consisting of the following components: - Cardiovascular (CV) death - Hospitalization for Heart failure (HF) [1]
    End point description
    99999 is "Not applicable" value or 0 subjects, this trial was discontinued with no subjects enrolled in the trial.
    End point type
    Primary
    End point timeframe
    N/A
    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: No subjects were enrolled in the trial. Consequently, no results are available for this trial.
    End point values
    		 Overall Trial
    Number of subjects analysed
    99999 [2]
    Units: 99999
    99999
    Notes
    [2] - 99999 is "Not applicable" value or 0 subjects, this trial was discontinued with no subjects enrolled
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    N/A
    Adverse event reporting additional description
    99999 is "Not applicable" value or 0 subjects, this trial was discontinued with no subjects enrolled in the trial.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    0
    Reporting groups
    Reporting group title
    Overall Trial
    Reporting group description
    		 99999 is "Not applicable" value or 0 subjects, this trial was discontinued with no subjects enrolled in the trial.

    Serious adverse events
    		 Overall Trial
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 99999 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Overall Trial
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 99999 (0.00%)
    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: No subjects were enrolled in the trial. Consequently, no results are available for this trial.

    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.
    99999 is "Not applicable" value or 0 subjects, this trial was discontinued with no subjects enrolled in the trial. Consequently, no results are available for this trial.
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    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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