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    Clinical Trial Results:
    Modeling of lipoprotein in patients with familial hypercholesterolemia compared to healthy subjects

    Summary
    EudraCT number
    		 2014-005473-36
    Trial protocol
    		 DE  
    Global end of trial date
    05 Feb 2020

    Results information
    Results version number
    		 v2(current)
    This version publication date
    15 Jun 2022
    First version publication date
    21 Jan 2021
    Other versions
    		 v1
    Version creation reason
    • Changes to summary attachments
    There seemed to be a problem with the status (although it was finalized, it wasn't accepted as final in an other portal) To check if we made a mistake we try to update the results (although not necessary)
    Summary report(s)
    		 paper

    Trial information

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    Trial identification
    Sponsor protocol code
    Dezember2014Version2
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 U1111-1163-5436
    Other trial identifiers
    		 DRKS: DRKS00007125
    Sponsors
    Sponsor organisation name
    Universitätsklinikum Freiburg, Institut für klinische Chemie und Laboratoriumsmedizin
    Sponsor organisation address
    Hugstetter Str 55, Freiburg, Germany, 79106
    Public contact
    medical director, Universitätsklinikum Freiburg, Institut für klinische Chemie und Laboratoriumsmedizin, +49 761 270 35160, karl.winkler@uniklinik-freiburg.de
    Scientific contact
    medical director, Universitätsklinikum Freiburg, Institut für klinische Chemie und Laboratoriumsmedizin, +49 761 270 35160, karl.winkler@uniklinik-freiburg.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
    05 Feb 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    05 Feb 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Feb 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objective is to develope a mathematical model describing the lipoproteins of low density (LDL) in healthy probands and patients with familial hypercholesterinemia based on clinical data
    Protection of trial subjects
    Study was part of regular patient treatment. Hence Protection=regular protection in patient treatment
    Background therapy
    		 the protocol doesn't prescripe a background therapy
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Mar 2015
    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: 12
    Worldwide total number of subjects
    12
    EEA total number of subjects
    12
    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)
    12
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Time-span of recruitment: 09.10.2015 -05.02.2020 All patients were recruited in the lipid ambulance of the university hospital Freiburg, Germany

    Pre-assignment
    Screening details
    		 no screening, patients of the lipid ambulance of the university hospital Freiburg, Germany, who fulfilled the inclusion criteria were included (given written consent)

    Period 1
    Period 1 title
    baseline
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Atorvastatin
    Arm description
    		 no Atorvastatin at baseline, start of Atorvastatin thearpy directly after baseline-visit. visite 1 (~12 weeks after baseline visit)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Atorvastatin
    Investigational medicinal product code
    C10AA05
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    one 40mg tablet per day

    Number of subjects in period 1
    		Atorvastatin
    Started
    12
    Completed
    6
    Not completed
    6
         wrong sample treatment
    1
         Consent withdrawn by subject
    2
         Protocol deviation
    3
    Period 2
    Period 2 title
    final visit
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Atorvastatin
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Atorvastatin
    Investigational medicinal product code
    C10AA05
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    one 40mg tablet per day

    Number of subjects in period 2
    		Atorvastatin
    Started
    6
    Completed
    6

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    baseline
    Reporting group description
    		 -

    Reporting group values
    		 baseline Total
    Number of subjects
    		 12 12
    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
        median (inter-quartile range (Q1-Q3))
    		 35.5 (26 to 42) -
    Gender categorical
    Units: Subjects
        Female
    		 0 0
        Male
    		 12 12

    End points

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    End points reporting groups
    Reporting group title
    Atorvastatin
    Reporting group description
    		 no Atorvastatin at baseline, start of Atorvastatin thearpy directly after baseline-visit. visite 1 (~12 weeks after baseline visit)
    Reporting group title
    Atorvastatin
    Reporting group description
    		 -

    Primary: Difference of Apolipoprotein-B100 in LDL due to atorvastatin

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    End point title
    		 Difference of Apolipoprotein-B100 in LDL due to atorvastatin
    End point description
    End point type
    Primary
    End point timeframe
    3-6 month
    End point values
    		 Atorvastatin Atorvastatin
    Number of subjects analysed
    6
    6
    Units: mg/dl
        median (inter-quartile range (Q1-Q3))
    126.7 (112.2 to 144.8)
    70.9 (59.6 to 87.7)
    Statistical analysis title
    		 Wilcoxon signed rank test
    Statistical analysis description
    Check if Atorvastatin thearpy leads to the expected reduction in LDL Apolipoprotein B
    Comparison groups
    Atorvastatin v Atorvastatin
    Number of subjects included in analysis
    12
    Analysis specification
    Post-hoc
    Analysis type
    		 other
    P-value
    		 = 0.028
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Primary: Estimation of the fractional catabolic rate (FCR) of Apolipoprotein B in LDL

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    End point title
    		 Estimation of the fractional catabolic rate (FCR) of Apolipoprotein B in LDL
    End point description
    estimation of FCR using a mathematical model based on the lipid composition of LDL and other lipoproteinfractions (especially HDL)
    End point type
    Primary
    End point timeframe
    3-6 month
    End point values
    		 Atorvastatin Atorvastatin
    Number of subjects analysed
    6
    6
    Units: arbitrary
        median (inter-quartile range (Q1-Q3))
    0.0065 (0.0007 to 0.0148)
    0.0142 (0.0134 to 0.0338)
    Statistical analysis title
    		 Wilcoxon signed rank test
    Comparison groups
    Atorvastatin v Atorvastatin
    Number of subjects included in analysis
    12
    Analysis specification
    Post-hoc
    Analysis type
    P-value
    		 = 0.028
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    during baseline and final visit (3-6 month)
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10.0
    Reporting groups
    Reporting group title
    inflammation in the mouth
    Reporting group description
    		 inflammation in the mouth/tounge

    Serious adverse events
    		 inflammation in the mouth
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 1 (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
    		 inflammation in the mouth
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 1 (100.00%)
    Gastrointestinal disorders
    Inflammation
    Additional description: inflammation in the mouth/tounge
         subjects affected / exposed
    1 / 1 (100.00%)
         occurrences all number
    1

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/30670016
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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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