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    Clinical Trial Results:
    Cardiac effects of inhibition of the renin angiotensin system with losartan in patients with hypertrophic cardiomyopathy.

    Summary
    EudraCT number
    		 2011-001191-19
    Trial protocol
    		 DK  
    Global end of trial date
    15 Apr 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    02 Jul 2021
    First version publication date
    02 Jul 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    2011-400
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01447654
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Rigshospitalet
    Sponsor organisation address
    Blegdamsvej 9, København Ø, Denmark, 2100
    Public contact
    Henning Bundgaard, Hjertemedicinsk klinik B, 2142, Rigshospitalet, +45 35450512, henningbundgaard@dadlnet.dk
    Scientific contact
    Henning Bundgaard, Hjertemedicinsk klinik B, 2142, Rigshospitalet, +45 35450512, henningbundgaard@dadlnet.dk
    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
    29 Jun 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    15 Apr 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Apr 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess whether treatment with losartan reduces left ventricular mass in patients with hypertrophic cardiomyopathy.
    Protection of trial subjects
    None.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Nov 2011
    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
    Denmark: 133
    Worldwide total number of subjects
    133
    EEA total number of subjects
    133
    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)
    110
    From 65 to 84 years
    23
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment period: Dec 1, 2011, and May 1, 2013.

    Pre-assignment
    Screening details
    		 318 patients were screened.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    100 mg per day

    Arm title
    		 Losartan
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Losartan
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    100 mg per day

    Number of subjects in period 1
    		Placebo Losartan
    Started
    69
    64
    Completed
    69
    64

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Treatment period
    Reporting group description
    		 -

    Reporting group values
    		 Treatment period Total
    Number of subjects
    		 133 133
    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)
    		 52 ( 13 ) -
    Gender categorical
    Units: Subjects
        Female
    		 47 47
        Male
    		 86 86

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    Losartan
    Reporting group description
    		 -

    Primary: Left ventricular mass

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    End point title
    		 Left ventricular mass
    End point description
    End point type
    Primary
    End point timeframe
    12 months
    End point values
    		 Placebo Losartan
    Number of subjects analysed
    66
    58
    Units: g/m2
        arithmetic mean (standard deviation)
    -4 ( 12 )
    -6 ( 13 )
    Statistical analysis title
    		 Primary endpoint
    Comparison groups
    Placebo v Losartan
    Number of subjects included in analysis
    124
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    12 months
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 SUSAR
    Dictionary version
    1
    Reporting groups
    Reporting group title
    Adverse event
    Reporting group description
    		 -

    Serious adverse events
    		 Adverse event
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 133 (1.50%)
         number of deaths (all causes)
    2
         number of deaths resulting from adverse events
    0
    General disorders and administration site conditions
    Death
         subjects affected / exposed
    2 / 133 (1.50%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 2
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Adverse event
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 133 (2.26%)
    Skin and subcutaneous tissue disorders
    Angiooedema
         subjects affected / exposed
    1 / 133 (0.75%)
         occurrences all number
    1
    Renal and urinary disorders
    Renal impairment
         subjects affected / exposed
    1 / 133 (0.75%)
         occurrences all number
    1
    Psychiatric disorders
    Hyperkalemia
         subjects affected / exposed
    1 / 133 (0.75%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    29 Jan 2012
    Change in randomization process. Change in acceptables leves of Creatinin and lever enzymes

    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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    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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