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    Clinical Trial Results:
    Patient pREference and satisFaction for pErindopril oRodispersible vs convENtional tablets in daily Clinical practicE. PREFERENCE

    Summary
    EudraCT number
    		 2011-003328-11
    Trial protocol
    		 FR  
    Global end of trial date
    28 Apr 2014

    Results information
    Results version number
    		 v2(current)
    This version publication date
    02 Feb 2017
    First version publication date
    26 Nov 2016
    Other versions
    		 v1
    Version creation reason
    • New data added to full data set
    Some data related to the primary endpoint were not described in the initial version of results published on EudraCT. These new data are added to full data set. Additionally, the name of Sponsor is corrected in the present update

    Trial information

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    Trial identification
    Sponsor protocol code
    DM4-90652-001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Les Laboratoires Servier
    Sponsor organisation address
    50 rue Carnot, Suresnes, France,
    Public contact
    Clinical Studies Department, Les Laboratoires Servier, 33 01 55 72 43 66, clinicaltrials@servier.com
    Scientific contact
    Clinical Studies Department, Les Laboratoires Servier, 33 01 55 72 43 66, clinicaltrials@servier.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
    28 Apr 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    28 Apr 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Apr 2014
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To study, in hypertensive patients, followed in general practice and whose Blood Pressure is well controlled by a monotherapy with tablets of perindopril arginine, their preference and acceptability in favour of the orodispersible form of this medicinal product 1 month after changing the dosage form.
    Protection of trial subjects
    This study was conducted in accordance with Good Clinical Practice standards, ethical principles stated in the Declaration of Helsinki and applicable regulatory requirements. After the subject has ended his/her participation in the trial, the investigator provided appropriate medication and/or arranged access to appropriate care for the patient.
    Background therapy
    		 Before entry in the study patients were treated by their doctor with perindopril arginine 5 or 10 mg per day administered as tablet, and at the same dose for at least 3 months
    Evidence for comparator
    		 -
    Actual start date of recruitment
    22 Feb 2013
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy
    Long term follow-up duration
    		 3 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    France: 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)
    8
    From 65 to 84 years
    4
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 • Adult male or female, without upper limit for the age, with arterial hypertension (systolic blood pressure > 140 mm Hg or diastolic blood pressure > 90 mmHg) previously treated with perindopril arginine as tablet, 5 or 10 mg per day, and at stable dose for at least 3 months

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 12
    Number of subjects completed
    		 12

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

    Arms
    Arm title
    		 Perindopril arginine orodispersible
    Arm description
    		 an orodispersible tablet of perindopril arginine at posology of 5 or 10 mg per day over a maximum period of 3 months.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Perindopril arginine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Orodispersible tablet
    Routes of administration
    Oral use
    Dosage and administration details
    5 or 10 mg/day

    Number of subjects in period 1
    		Perindopril arginine orodispersible
    Started
    12
    Completed
    12

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Perindopril arginine orodispersible
    Reporting group description
    		 an orodispersible tablet of perindopril arginine at posology of 5 or 10 mg per day over a maximum period of 3 months.

    Reporting group values
    		 Perindopril arginine orodispersible Total
    Number of subjects
    		 12 12
    Age categorical
    Of note for one patient the age was missing. However, this patient had an ongoing professional activity and was a senior officer. Therefore, the age of this patient was probably between 18 and 64 years, and was filled in the 18-64 years age category hereafter.
    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)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 8 8
        From 65-84 years
    		 4 4
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 6 6
        Male
    		 6 6

    End points

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    End points reporting groups
    Reporting group title
    Perindopril arginine orodispersible
    Reporting group description
    		 an orodispersible tablet of perindopril arginine at posology of 5 or 10 mg per day over a maximum period of 3 months.

    Primary: Preference for orodispersible versus tablet perindopril arginine form at one month

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    End point title
    		 Preference for orodispersible versus tablet perindopril arginine form at one month [1]
    End point description
    5 questions were included in the questionnaire that was filled in after one month after patient's inclusion - Question 1 : Preference for orodispersible form (versus tablet) ? - Question 2: Is orodispersible form the most convenient ? - Question 3 : Is orodispersible form the most appropriate ? - Question 4: Would you use orodispersible form for a long treatment period ? - Question 5 : Would you use orodispersible form for the further 2 months ? As no statistical analysis of the questionnaire was conducted due to the low number of patients included in the study, the endpoint described hereafter correspond to the answer to the question 1. Of note, the same score was obtained for question 2 and 3; at question 4, six patients responded that they would use the orodispersible perindopril arginine form for a long treatment period and, at question 5, eleven patients responded that they would use orodispersible perindopril arginine form for the further 2 months..
    End point type
    Primary
    End point timeframe
    Over 30 days
    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: A low number of patients could be included in the study (n = 12) compared to the number planned (n = 100), due to difficulty to recruit patients that led to premature study discontinuation. Therefore it had been decided to not carry out statistical analysis of the questionnaires.
    End point values
    		 Perindopril arginine orodispersible
    Number of subjects analysed
    12
    Units: number of patients
    7
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Overall study
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14.1
    Reporting groups
    Reporting group title
    Perindopril arginine orodispersible
    Reporting group description
    		 -

    Serious adverse events
    		 Perindopril arginine orodispersible
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 12 (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
    		 Perindopril arginine orodispersible
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 12 (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: This study was conducted in patients followed by their doctor for which the arterial hypertension was well controlled under perindopril arginine 5 or 10 mgPer Os per day. In the Preference study patients switched to this background therapy to the same product same dose but with an orodispersible form, on a short duration (30 days). It is probably why no non-serious adverse event occured.

    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? Yes
    Date
    Interruption
    Restart date
    28 Apr 2014
    It was decided to stop the study due to difficulty to recruit patients. Therefore only 12 patients out of 100 planned were included (with a duration of almost one year between the first and last included patient) and completed the study.
    -

    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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