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    Clinical Trial Results:
    Effects of an Angiotensin Receptor Antagonist Candesartan versus a calcium channel blocker Amlodipine on Microvascular Rarefaction, Endothelial Dysfunction and Microalbuminuria in Essential Hypertension

    Summary
    EudraCT number
    2008-005432-32
    Trial protocol
    GB  
    Global end of trial date
    14 Jul 2014

    Results information
    Results version number
    v1(current)
    This version publication date
    09 Nov 2019
    First version publication date
    09 Nov 2019
    Other versions
    Summary report(s)
    Effects of Candesartan versus Amlodipine on Capillary Rarefaction, Pulse Wave Velocity and Central Blood Pressure in Patients with Essential Hypertension

    Trial information

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    Trial identification
    Sponsor protocol code
    08.0113
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    St George's University of London
    Sponsor organisation address
    Cranmer Terrace, London, United Kingdom,
    Public contact
    Joint Research Office, St George's University of London, 0044 02087254986,
    Scientific contact
    Joint Research Office, St George's University of London, 0044 02087254986,
    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
    02 Jan 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    14 Jul 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Jul 2014
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To evaluate the effects of controlling blood pressure with candesartan 8-16 mg od versus amlodipine 5-10 mg od on microvascular capillary rarefaction in patients with mild-to-moderate essential hypertension.
    Protection of trial subjects
    Number of patients still receiving treatment at time of early termination in the MS concerned by the declaration and their proposed management; 0 The consequences of early termination for the evaluation of the results and for overall risk benefit assessment of the investigational medicinal product. There will be insufficient data collected to reach primary objective: to evaluate the effects of controlling BP with Candesartan vs Amlodipine in improving the microvascular capillary rarefaction in patients with mild to moderate essential hypertension or to answer secondary objectives of change in basal capillary density, improvement in pulse wave velocity, change in aortic augmentation index, and reduction in microalbuminuria
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    19 Aug 2008
    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
    United Kingdom: 18
    Worldwide total number of subjects
    18
    EEA total number of subjects
    18
    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)
    18
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    Patients will attend the Blood Pressure Unit at St. George’s, University of London, on 4 occasions over a period of 10 weeks. Each visit will last about 30-45 minutes. At each visit we will measure blood pressure, pulse rate and body weight.

    Period 1
    Period 1 title
    Recruitment (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    Not blinded
    Blinding implementation details
    n/a

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    arm 1
    Arm description
    After 2-week single-blind placebo run-in period, patients will be randomised to 8-weeks treatment with either Candesartan 8 mg od (with forced titration to 16 mg od after 2 wks) or Amlodipine 5 mg od (with forced titration to 10 mg od after 2 wks). Blood pressure will be measured in the same arm, with an automatic oscillometric sphygmo-manometer (OMRON HEM705CP) with appropriate cuff size. Sitting and standing BP will be taken as the mean of the last 2 out of 3 readings
    Arm type
    Experimental

    Investigational medicinal product name
    Candesartan
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Unknown use
    Dosage and administration details
    Candesartan 8 mg capsules

    Investigational medicinal product name
    Amlodipine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Unknown use
    Dosage and administration details
    Amlodipine 5 mg

    Arm title
    Arm 2
    Arm description
    Placebo lactose capsules
    Arm type
    Placebo

    Investigational medicinal product name
    lactose
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Unknown use
    Dosage and administration details
    Placebo lactose capsules

    Number of subjects in period 1
    arm 1 Arm 2
    Started
    9
    9
    Completed
    9
    9

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    arm 1
    Reporting group description
    After 2-week single-blind placebo run-in period, patients will be randomised to 8-weeks treatment with either Candesartan 8 mg od (with forced titration to 16 mg od after 2 wks) or Amlodipine 5 mg od (with forced titration to 10 mg od after 2 wks). Blood pressure will be measured in the same arm, with an automatic oscillometric sphygmo-manometer (OMRON HEM705CP) with appropriate cuff size. Sitting and standing BP will be taken as the mean of the last 2 out of 3 readings

    Reporting group title
    Arm 2
    Reporting group description
    Placebo lactose capsules

    Primary: The increase in maximal capillary density at the end of 8 weeks treatment

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    End point title
    The increase in maximal capillary density at the end of 8 weeks treatment
    End point description
    End point type
    Primary
    End point timeframe
    8 weeks treatment
    End point values
    arm 1 Arm 2
    Number of subjects analysed
    9
    9
    Units: mm2
        number (not applicable)
    0
    0
    Statistical analysis title
    ANOVA
    Statistical analysis description
    The study will have a power of 80% (ß= 0.20) to detect a difference of 8 in capillary density before and after treatment at a level of significance of =0.05. ANOVA for repeated measures and Student t Test would be used to compare maximal capillary density before and after treatment. A level of significance of =0.05 will be used. All measurements outlined in Section 10.3 of the protocol will be performed before randomization, at 4 weeks and at the end of the study treatment at 8 weeks. Ur
    Comparison groups
    arm 1 v Arm 2
    Number of subjects included in analysis
    18
    Analysis specification
    Post-hoc
    Analysis type
    other
    P-value
    = 0.05
    Method
    ANOVA
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    All adverse events will be recorded in the hospital notes in the first instance. A record of all AEs, whether related or unrelated to the treatment will also be kept in the CRF and the Sponsor’s AE Log.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    SMPC
    Dictionary version
    1
    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: n/a

    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
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
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