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   44335   clinical trials with a EudraCT protocol, of which   7366   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:
    The AT1 receptor antagonist losartan for the prevention of excessive aortic root dilatation in children and adolescents with Marfan syndrom

    Summary
    EudraCT number
    		 2009-016139-36
    Trial protocol
    		 AT  
    Global end of trial date
    12 Nov 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    30 Jan 2025
    First version publication date
    30 Jan 2025
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    V1,11.05.2009
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medical University of Vienna
    Sponsor organisation address
    Waehringer Guertel 18-20, Vienna, Austria, 1090
    Public contact
    Medical University of Vienna Division of Pediatric Cardiology, Medical University of Vienna Division of Pediatric Cardiology, +43 14040032170, christiane.pees@meduniwien.ac.at
    Scientific contact
    Medical University of Vienna Division of Pediatric Cardiology, Medical University of Vienna Division of Pediatric Cardiology, +43 14040032170, christiane.pees@meduniwien.ac.at
    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
    12 Nov 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    12 Nov 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Nov 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The efficacy of the medication Losartan on the increase of the aorticroot diameter and vascular wall stiffness
    Protection of trial subjects
    No painfull investigations, only echocardiography during routine check-ups
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    16 Sep 2009
    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
    Austria: 35
    Worldwide total number of subjects
    35
    EEA total number of subjects
    35
    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)
    2
    Children (2-11 years)
    14
    Adolescents (12-17 years)
    19
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 During clinical outpatient visit check-up for aortic root diameter z-Score >3 inclusion if patients and parents consented to medication (all) and as well study participation , between Z-score 0-2 if patients and parents were as well willing to take medication, then asking for study participation, if not normal routine observation of aortic size

    Pre-assignment
    Screening details
    		 clinically confirmed diagnosis of Marfan syndrome (Ghent criteria)

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

    Arms
    Arm title
    		 losartan group
    Arm description
    		 all patients receiving losartan treatment and consented to study participation
    Arm type
    		 Active comparator

    Investigational medicinal product name
    losartan
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    starting dosage 0,2 mg/kg BID, augmentation weekly up to max 2 mg/kg/d or 150 mg total

    Number of subjects in period 1
    		losartan group
    Started
    35
    Completed
    27
    Not completed
    8
         Lost to follow-up
    3
         aortic root replacement operation
    5

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    losartan group
    Reporting group description
    		 all patients receiving losartan treatment and consented to study participation

    Reporting group values
    		 losartan group Total
    Number of subjects
    		 35 35
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 2 2
        Children (2-11 years)
    		 14 14
        Adolescents (12-17 years)
    		 19 19
        Adults (18-64 years)
    		 0 0
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 12 12
        Male
    		 23 23
    Subject analysis sets

    Subject analysis set title
    efficacy of losartan in relation to aortic root growth
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    all 6 to 12 months echocardiographic investigation of ascending aortic diameters, normalisation of diameters regarding patients weight and height and calculation of the elasticity of the ascending aortic tissue

    Subject analysis set title
    Analysis after 3 years of follow-up
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    3 years increase of Z-Score of the aortic root diameter

    Subject analysis set title
    Analysis after 6 years of follow-up
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    all 6 to 12 months echocardiographic investigation of ascending aortic diameters, normalisation of diameters regarding patients weight and height and calculation of the elasticity of the ascending aortic tissue

    Subject analysis sets values
    		 efficacy of losartan in relation to aortic root growth Analysis after 3 years of follow-up Analysis after 6 years of follow-up
    Number of subjects
    35
    29
    28
    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)
    2
        Children (2-11 years)
    14
        Adolescents (12-17 years)
    19
        Adults (18-64 years)
    0
        From 65-84 years
    0
        85 years and over
    0
    Age continuous
    Units:
        
    ( )
    ( )
    ( )
    Gender categorical
    Units: Subjects
        Female
    12
        Male
    23

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    losartan group
    Reporting group description
    		 all patients receiving losartan treatment and consented to study participation

    Subject analysis set title
    efficacy of losartan in relation to aortic root growth
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    all 6 to 12 months echocardiographic investigation of ascending aortic diameters, normalisation of diameters regarding patients weight and height and calculation of the elasticity of the ascending aortic tissue

    Subject analysis set title
    Analysis after 3 years of follow-up
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    3 years increase of Z-Score of the aortic root diameter

    Subject analysis set title
    Analysis after 6 years of follow-up
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    all 6 to 12 months echocardiographic investigation of ascending aortic diameters, normalisation of diameters regarding patients weight and height and calculation of the elasticity of the ascending aortic tissue

    Primary: efficacy of losartan treatment on aortic root dilatation/growth

    		 Close Top of page
    End point title
    		 efficacy of losartan treatment on aortic root dilatation/growth
    End point description
    End point type
    Primary
    End point timeframe
    Z-Score of aortic root diameter and its increase at 3 and 6 years of follow-up
    End point values
    		 Analysis after 3 years of follow-up Analysis after 6 years of follow-up
    Number of subjects analysed
    29
    28
    Units: Z-Score of aortic root diameter
        arithmetic mean (standard error)
    -0.004 ( 0.17 )
    0.15 ( 0.13 )
    Statistical analysis title
    		 Analysis primary endpoint
    Comparison groups
    Analysis after 3 years of follow-up v Analysis after 6 years of follow-up
    Number of subjects included in analysis
    57
    Analysis specification
    Post-hoc
    Analysis type
    		 equivalence
    P-value
    		 ≤ 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Adverse events

    		 Close Top of page
    Adverse events information [1]
    Timeframe for reporting adverse events
    2009-2024
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    27
    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: no adverse events related to medication

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    05 Mar 2013
    Prolongation of follow-up period from 3 up to 10 years

    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-Sat May 10 01:08:05 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA