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    Clinical Trial Results:
    Olmesartan + Amlodipine treatment in diabetic patients: evaluating blood pressure control after 48 hours from the last administration (missed dose).

    Summary
    EudraCT number
    2010-018774-21
    Trial protocol
    ES   FR   DE   GR   IT  
    Global end of trial date
    15 May 2014

    Results information
    Results version number
    v1(current)
    This version publication date
    26 Feb 2016
    First version publication date
    06 Aug 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    MeIn/08/OLMAML-Hyp/001
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Menarini International Operations Luxembourg S.A.
    Sponsor organisation address
    1, Avenue de la Gare, Luxembourg, Luxembourg, L-1611
    Public contact
    Medical Scientific Management, Menarini International Operations Luxembourg S.A., +352 264976,
    Scientific contact
    Menarini Corporate Medical Department, Menarini Industrie Farmaceutiche Riunite, +39 05556801,
    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
    15 May 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    15 May 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine whether the Olmesartan (OLM) 20-40 mg + Amlodipine (AML) 5-10 mg combination was at least as effective as the Perindopril (PER) 4-8 mg + Amlodipine 5-10 mg combination in reducing office diastolic blood pressure after 24 weeks of treatment, at 48 hours from last administration (missed dose).
    Protection of trial subjects
    The study was conducted in accordance with the Declaration of Helsinki, Good Clinical Practice (GCP) guidelines and local law requirements.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    03 Dec 2010
    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: 14
    Country: Number of subjects enrolled
    Greece: 25
    Country: Number of subjects enrolled
    Spain: 34
    Country: Number of subjects enrolled
    Italy: 187
    Worldwide total number of subjects
    260
    EEA total number of subjects
    260
    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)
    187
    From 65 to 84 years
    73
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Total recruitment period (first patient in to last patient in): about 152 weeks (03/12/2010-31/10/2013).

    Pre-assignment
    Screening details
    The pre-assignment period was a run-in period, open-label, during which the eligible patients took one Amlodipine 5 mg tablet every day for 7 or 14 days (for 1 or 2 weeks), depending on previous subject’s treatment(s).

    Pre-assignment period milestones
    Number of subjects started
    335 [1]
    Number of subjects completed
    260

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    Inclusion or exclusion criteria not met: 62
    Reason: Number of subjects
    Adverse event, non-fatal: 4
    Reason: Number of subjects
    Consent withdrawn by subject: 8
    Reason: Number of subjects
    missing reason: 1
    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: All the 335 patients screened for the study entered a pre-randomization run-in period of 7-14 days with Amlodipine 5 mg once a day (pre-assignment period). Out of these 335 subjects, 260 were randomized to one of the two study treatments, hence entering in baseline period (=period 1) population.
    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    The “double-dummy” technique with matching placebo guaranteed the maintenance of the clinical study double-blind conditions. No blinding was used during the run-in period, when all patients received amlodipine 5mg tablet once-a-day.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    OLM/AML
    Arm description
    Olmesartan 20 mg + Amlodipine 5 mg FDC coated tablets, once a day, by oral route Olmesartan 40 mg + Amlodipine 5 mg FDC coated tablets, once a day, by oral route Olmesartan 40 mg + Amlodipine 10 mg FDC coated tablets, once a day, by oral route For the first 12 weeks of randomised double-blind treatment, patients randomized to OLM/AML received a combination of Olmesartan 20 mg + Amlodipine 5 mg once-daily. In patients not normalised by treatment after 12 weeks the dose of drug treatment was up-titrated to Olmesartan 40 mg + Amlodipine 5 mg once-daily. In patients not yet normalised after additional 6 weeks of treatment (week 18) the dose of drug treatment was further up-titrated to Olmesartan 40 mg + Amlodipine 10 mg once-daily. At visit 6a patients received placebo treatment (one capsule and one tablet) in a single blind for 1 day.
    Arm type
    Experimental

    Investigational medicinal product name
    Olmesartan + amlodipine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    For the first 12 weeks of randomised double-blind treatment, patients randomized to OLM/AML received a combination of Olmesartan 20 mg + Amlodipine 5 mg once-daily. In patients not normalised by treatment after 12 weeks the dose of drug treatment was up-titrated to Olmesartan 40 mg + Amlodipine 5 mg once-daily. In patients not yet normalised after additional 6 weeks of treatment (week 18) the dose of drug treatment was further up-titrated to Olmesartan 40 mg + Amlodipine 10 mg once-daily. At visit 6a patients received placebo treatment (one capsule and one tablet) in a single blind for 1 day. All drugs were administered orally, in the morning, at breakfast time, with a glass of water.

    Arm title
    PER/AML
    Arm description
    Perindopril /Amlodipine fixed dose capsule, once a day, by oral route Perindopril 4mg/Amlodipine 5 mg fixed dose capsule Perindopril 8mg/Amlodipine 5 mg fixed dose capsule Perindopril 8mg/Amlodipine 10 mg fixed dose capsule For the first 12 weeks of randomised double-blind treatment, patients randomized to PER/AML received Perindopril 4 mg + Amlodipine 5 mg once-daily. In patients not normalised by treatment after 12 weeks the dose of drug treatment was up-titrated to Perindopril 8 mg + Amlodipine 5 mg once-daily. In patients not yet normalised after additional 6 weeks of treatment (week 18) the dose of drug treatment was further up-titrated to Perindopril 8 mg + Amlodipine 10 mg once-daily. At visit 6a patients received placebo treatment (one placebo capsule and one placebo tablet) in a single blind for 1 day
    Arm type
    Active comparator

    Investigational medicinal product name
    Perindopril and amlodipine fixed combination
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    For the first 12 weeks of randomised double-blind treatment, patients randomized to PER/AML received Perindopril 4 mg + Amlodipine 5 mg once-daily. In patients not normalised by treatment after 12 weeks the dose of drug treatment was be up-titrated to Perindopril 8 mg + Amlodipine 5 mg once-daily. In patients not yet normalised after additional 6 weeks of treatment (week 18) the dose of drug treatment was further up-titrated to Perindopril 8 mg + Amlodipine 10 mg once-daily. At visit 6a patients received placebo treatment (one placebo capsule and one placebo tablet) in a single blind for 1 day. All drugs were administered orally, in the morning, at breakfast time, with a glass of water.

    Number of subjects in period 1
    OLM/AML PER/AML
    Started
    128
    132
    FInal placebo dosing at Visit 6
    111
    110
    Completed
    111
    110
    Not completed
    17
    22
         Consent withdrawn by subject
    3
    6
         SBP or DBP out of allowed range
    5
    -
         Adverse event, non-fatal
    4
    3
         Poor compliance
    2
    4
         Inclusion or exclusion criteria not met
    3
    3
         Investigator decision
    -
    1
         SBP or DBP out of the allowed ranges
    -
    5

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    OLM/AML
    Reporting group description
    Olmesartan 20 mg + Amlodipine 5 mg FDC coated tablets, once a day, by oral route Olmesartan 40 mg + Amlodipine 5 mg FDC coated tablets, once a day, by oral route Olmesartan 40 mg + Amlodipine 10 mg FDC coated tablets, once a day, by oral route For the first 12 weeks of randomised double-blind treatment, patients randomized to OLM/AML received a combination of Olmesartan 20 mg + Amlodipine 5 mg once-daily. In patients not normalised by treatment after 12 weeks the dose of drug treatment was up-titrated to Olmesartan 40 mg + Amlodipine 5 mg once-daily. In patients not yet normalised after additional 6 weeks of treatment (week 18) the dose of drug treatment was further up-titrated to Olmesartan 40 mg + Amlodipine 10 mg once-daily. At visit 6a patients received placebo treatment (one capsule and one tablet) in a single blind for 1 day.

    Reporting group title
    PER/AML
    Reporting group description
    Perindopril /Amlodipine fixed dose capsule, once a day, by oral route Perindopril 4mg/Amlodipine 5 mg fixed dose capsule Perindopril 8mg/Amlodipine 5 mg fixed dose capsule Perindopril 8mg/Amlodipine 10 mg fixed dose capsule For the first 12 weeks of randomised double-blind treatment, patients randomized to PER/AML received Perindopril 4 mg + Amlodipine 5 mg once-daily. In patients not normalised by treatment after 12 weeks the dose of drug treatment was up-titrated to Perindopril 8 mg + Amlodipine 5 mg once-daily. In patients not yet normalised after additional 6 weeks of treatment (week 18) the dose of drug treatment was further up-titrated to Perindopril 8 mg + Amlodipine 10 mg once-daily. At visit 6a patients received placebo treatment (one placebo capsule and one placebo tablet) in a single blind for 1 day

    Reporting group values
    OLM/AML PER/AML Total
    Number of subjects
    128 132 260
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    91 96 187
        From 65-84 years
    37 36 73
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    58.91 ( 7.47 ) 59.18 ( 7.29 ) -
    Gender categorical
    Units: Subjects
        Female
    41 47 88
        Male
    87 85 172
    Subject analysis sets

    Subject analysis set title
    OLM/AML - safety
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    The safety population set included all randomised patients who had taken at least one dose of study medication.

    Subject analysis set title
    PER/AML - safety
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    The safety population set included all randomised patients who had taken at least one dose of study medication.

    Subject analysis set title
    OLM/AML - FAS
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    “Full Analysis Set” (FAS): according to the “Intention-to-Treat” (ITT) principle, this set included all randomised patients who took at least one dose of the study medication and with a baseline and at least one post-baseline efficacy assessment of sitting ODBP.

    Subject analysis set title
    PER/AML - FAS
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    “Full Analysis Set” (FAS): according to the “Intention-to-Treat” (ITT) principle, this set included all randomised patients who took at least one dose of the study medication and with a baseline and at least one post-baseline efficacy assessment of sitting ODBP.

    Subject analysis sets values
    OLM/AML - safety PER/AML - safety OLM/AML - FAS PER/AML - FAS
    Number of subjects
    128
    132
    126
    130
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    91
    96
    91
    94
        From 65-84 years
    37
    36
    35
    36
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    58.91 ( 7.47 )
    59.18 ( 7.29 )
    58.78 ( 7.46 )
    59.26 ( 7.32 )
    Gender categorical
    Units: Subjects
        Female
    41
    47
    40
    47
        Male
    87
    85
    86
    83

    End points

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    End points reporting groups
    Reporting group title
    OLM/AML
    Reporting group description
    Olmesartan 20 mg + Amlodipine 5 mg FDC coated tablets, once a day, by oral route Olmesartan 40 mg + Amlodipine 5 mg FDC coated tablets, once a day, by oral route Olmesartan 40 mg + Amlodipine 10 mg FDC coated tablets, once a day, by oral route For the first 12 weeks of randomised double-blind treatment, patients randomized to OLM/AML received a combination of Olmesartan 20 mg + Amlodipine 5 mg once-daily. In patients not normalised by treatment after 12 weeks the dose of drug treatment was up-titrated to Olmesartan 40 mg + Amlodipine 5 mg once-daily. In patients not yet normalised after additional 6 weeks of treatment (week 18) the dose of drug treatment was further up-titrated to Olmesartan 40 mg + Amlodipine 10 mg once-daily. At visit 6a patients received placebo treatment (one capsule and one tablet) in a single blind for 1 day.

    Reporting group title
    PER/AML
    Reporting group description
    Perindopril /Amlodipine fixed dose capsule, once a day, by oral route Perindopril 4mg/Amlodipine 5 mg fixed dose capsule Perindopril 8mg/Amlodipine 5 mg fixed dose capsule Perindopril 8mg/Amlodipine 10 mg fixed dose capsule For the first 12 weeks of randomised double-blind treatment, patients randomized to PER/AML received Perindopril 4 mg + Amlodipine 5 mg once-daily. In patients not normalised by treatment after 12 weeks the dose of drug treatment was up-titrated to Perindopril 8 mg + Amlodipine 5 mg once-daily. In patients not yet normalised after additional 6 weeks of treatment (week 18) the dose of drug treatment was further up-titrated to Perindopril 8 mg + Amlodipine 10 mg once-daily. At visit 6a patients received placebo treatment (one placebo capsule and one placebo tablet) in a single blind for 1 day

    Subject analysis set title
    OLM/AML - safety
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    The safety population set included all randomised patients who had taken at least one dose of study medication.

    Subject analysis set title
    PER/AML - safety
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    The safety population set included all randomised patients who had taken at least one dose of study medication.

    Subject analysis set title
    OLM/AML - FAS
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    “Full Analysis Set” (FAS): according to the “Intention-to-Treat” (ITT) principle, this set included all randomised patients who took at least one dose of the study medication and with a baseline and at least one post-baseline efficacy assessment of sitting ODBP.

    Subject analysis set title
    PER/AML - FAS
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    “Full Analysis Set” (FAS): according to the “Intention-to-Treat” (ITT) principle, this set included all randomised patients who took at least one dose of the study medication and with a baseline and at least one post-baseline efficacy assessment of sitting ODBP.

    Primary: Change from baseline in office brachial sitting DBP

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    End point title
    Change from baseline in office brachial sitting DBP
    End point description
    The office DBP measurement was done at the brachial artery level, after 24 weeks of active treatment, when patients were in sitting position, at 48h from the last administration (missed dose).
    End point type
    Primary
    End point timeframe
    At Visit 6b (or alternatively at early withdrawal)
    End point values
    OLM/AML - FAS PER/AML - FAS
    Number of subjects analysed
    126
    130
    Units: mmHg
        arithmetic mean (standard deviation)
    -11.71 ( 9.25 )
    -10.5 ( 8.76 )
    Statistical analysis title
    OLM/AML vs PER/AML
    Comparison groups
    OLM/AML - FAS v PER/AML - FAS
    Number of subjects included in analysis
    256
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [1]
    P-value
    = 0.058
    Method
    Mixed models analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    0.886
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.129
         upper limit
    2.902
    Notes
    [1] - The statistical analyses were aimed to assess the non-inferiority and safety of combination Olmesartan + Amlodipine in comparison with Perindopril + Amlodipine.

    Secondary: Change from baseline in sitting office SBP

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    End point title
    Change from baseline in sitting office SBP
    End point description
    The office SBP measurement was done after 24 weeks of active treatment, when patients were in sitting position, at 48h from the last administration (missed dose).
    End point type
    Secondary
    End point timeframe
    At Visit 6b (or alternatively at early withdrawal)
    End point values
    OLM/AML - FAS PER/AML - FAS
    Number of subjects analysed
    126
    130
    Units: mmHg
        arithmetic mean (standard deviation)
    -16.35 ( 15.3 )
    -12.32 ( 12.81 )
    Statistical analysis title
    OLM/AML vs PER/AML
    Comparison groups
    OLM/AML - FAS v PER/AML - FAS
    Number of subjects included in analysis
    256
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [2]
    P-value
    = 0.012
    Method
    Mixed models analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    3.129
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.112
         upper limit
    6.369
    Notes
    [2] - The statistical analyses were aimed to assess the non-inferiority and safety of combination Olmesartan + Amlodipine in comparison with Perindopril + Amlodipine.

    Secondary: Change from baseline of sitting office SBP

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    End point title
    Change from baseline of sitting office SBP
    End point description
    The office SBP measurement was done after 24 weeks of active treatment.
    End point type
    Secondary
    End point timeframe
    At Visit 6a (or alternatively at early withdrawal)
    End point values
    OLM/AML - FAS PER/AML - FAS
    Number of subjects analysed
    126
    130
    Units: mmHg
        arithmetic mean (standard deviation)
    -19.61 ( 14.72 )
    -15.8 ( 12.92 )
    Statistical analysis title
    OLM/AML vs PER/AML
    Comparison groups
    OLM/AML - FAS v PER/AML - FAS
    Number of subjects included in analysis
    256
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [3]
    P-value
    = 0.012
    Method
    Mixed models analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    2.713
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.521
         upper limit
    5.947
    Notes
    [3] - The statistical analyses were aimed to assess the non-inferiority and safety of combination Olmesartan + Amlodipine in comparison with Perindopril + Amlodipine.

    Secondary: Change from baseline in sitting office DBP

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    End point title
    Change from baseline in sitting office DBP
    End point description
    The office DBP measurement was done after 24 weeks of active treatment.
    End point type
    Secondary
    End point timeframe
    At Visit 6a (or alternatively at early withdrawal)
    End point values
    OLM/AML - FAS PER/AML - FAS
    Number of subjects analysed
    126
    130
    Units: mmHg
        arithmetic mean (standard deviation)
    -14.15 ( 8.79 )
    -13.18 ( 8.81 )
    Statistical analysis title
    OLM/AML vs PER/AML
    Comparison groups
    OLM/AML - FAS v PER/AML - FAS
    Number of subjects included in analysis
    256
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [4]
    P-value
    = 0.058
    Method
    Mixed models analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    0.695
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.316
         upper limit
    2.705
    Notes
    [4] - The statistical analyses were aimed to assess the non-inferiority and safety of combination Olmesartan + Amlodipine in comparison with Perindopril + Amlodipine.

    Secondary: Change from baseline in sitting office pulse pressure

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    End point title
    Change from baseline in sitting office pulse pressure
    End point description
    The pulse pressure measurement was done after 24 weeks of active treatment at 48h from the last administration (missed dose).
    End point type
    Secondary
    End point timeframe
    At Visit 6b (or alternatively at early withdrawal)
    End point values
    OLM/AML - FAS PER/AML - FAS
    Number of subjects analysed
    126
    130
    Units: mmHg
        arithmetic mean (standard deviation)
    -4.64 ( 11.53 )
    -1.82 ( 11.26 )
    Statistical analysis title
    OLM/AML vs PER/AML
    Comparison groups
    OLM/AML - FAS v PER/AML - FAS
    Number of subjects included in analysis
    256
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [5]
    P-value
    = 0.099
    Method
    Mixed models analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    2.194
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.341
         upper limit
    4.729
    Notes
    [5] - The statistical analyses were aimed to assess the non-inferiority and safety of combination Olmesartan + Amlodipine in comparison with Perindopril + Amlodipine.

    Secondary: Change from baseline in sitting office pulse pressure

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    End point title
    Change from baseline in sitting office pulse pressure
    End point description
    The pulse pressure measurement was done after 24 weeks of active treatment at 48h from the last administration (missed dose).
    End point type
    Secondary
    End point timeframe
    At Visit 6a (or alternatively at early withdrawal)
    End point values
    OLM/AML - FAS PER/AML - FAS
    Number of subjects analysed
    126
    130
    Units: mmHg
        arithmetic mean (standard deviation)
    -5.46 ( 12.08 )
    -2.62 ( 11.44 )
    Statistical analysis title
    OLM/AML vs PER/AML
    Comparison groups
    PER/AML - FAS v OLM/AML - FAS
    Number of subjects included in analysis
    256
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [6]
    P-value
    = 0.099
    Method
    Mixed models analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    1.967
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.562
         upper limit
    4.496
    Notes
    [6] - The statistical analyses were aimed to assess the non-inferiority and safety of combination Olmesartan + Amlodipine in comparison with Perindopril + Amlodipine.

    Secondary: Percentage of subjects with office sitting BP < 130/80 mmHg

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    End point title
    Percentage of subjects with office sitting BP < 130/80 mmHg
    End point description
    Rate of normalized subjects with Office sitting blood pressure <130/80 at V6a vs. baseline
    End point type
    Secondary
    End point timeframe
    At Visit 6a (or alternatively at early withdrawal)
    End point values
    OLM/AML - FAS PER/AML - FAS
    Number of subjects analysed
    122
    125
    Units: percent
        number (not applicable)
    23.77
    20
    Statistical analysis title
    OLM/AML vs PER/AML
    Comparison groups
    OLM/AML - FAS v PER/AML - FAS
    Number of subjects included in analysis
    247
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority
    P-value
    = 0.5388
    Method
    Fisher exact
    Parameter type
    Risk difference (RD)
    Point estimate
    0.0377
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.0654
         upper limit
    0.1408

    Secondary: Percentage of subjects with office sitting BP < 130/80 mmHg

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    End point title
    Percentage of subjects with office sitting BP < 130/80 mmHg
    End point description
    Rate of normalized subjects with Office sitting blood pressure <130/80 at V6b vs. baseline.
    End point type
    Secondary
    End point timeframe
    At Visit 6b (or alternatively at early withdrawal)
    End point values
    OLM/AML - FAS PER/AML - FAS
    Number of subjects analysed
    120
    125
    Units: percent
        number (not applicable)
    7.5
    10.4
    Statistical analysis title
    OLM/AML vs PER/AML
    Comparison groups
    PER/AML - FAS v OLM/AML - FAS
    Number of subjects included in analysis
    245
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [7]
    P-value
    = 0.5056
    Method
    Fisher exact
    Parameter type
    Risk difference (RD)
    Point estimate
    -0.029
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.1003
         upper limit
    0.0423
    Notes
    [7] - The statistical analyses were aimed to assess the non-inferiority and safety of combination Olmesartan + Amlodipine in comparison with Perindopril + Amlodipine.

    Secondary: Percentage of subjects with a sitting office SBP reduction of at least 20 mmHg or a sitting office DBP reduction of at least 10 mmHg

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    End point title
    Percentage of subjects with a sitting office SBP reduction of at least 20 mmHg or a sitting office DBP reduction of at least 10 mmHg
    End point description
    Rate of responders subjects at V6a vs. baseline
    End point type
    Secondary
    End point timeframe
    At Visit 6a (or alternatively at early withdrawal)
    End point values
    OLM/AML - FAS PER/AML - FAS
    Number of subjects analysed
    122
    125
    Units: percent
        number (not applicable)
    79.51
    72.8
    Statistical analysis title
    OLM/AML vs PER/AML
    Comparison groups
    OLM/AML - FAS v PER/AML - FAS
    Number of subjects included in analysis
    247
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [8]
    P-value
    = 0.2351
    Method
    Fisher exact
    Parameter type
    Risk difference (RD)
    Point estimate
    0.0671
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.0388
         upper limit
    0.173
    Notes
    [8] - The statistical analyses were aimed to assess the non-inferiority and safety of combination Olmesartan + Amlodipine in comparison with Perindopril + Amlodipine.

    Secondary: Percentage of subjects with a sitting office SBP reduction of at least 20 mmHg or a sitting office DBP reduction of at least 10 mmHg

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    End point title
    Percentage of subjects with a sitting office SBP reduction of at least 20 mmHg or a sitting office DBP reduction of at least 10 mmHg
    End point description
    Rate of responders subjects at V6b vs. baseline.
    End point type
    Secondary
    End point timeframe
    At Visit 6b (or alternatively at early withdrawal)
    End point values
    OLM/AML - FAS PER/AML - FAS
    Number of subjects analysed
    120
    125
    Units: percent
        number (not applicable)
    64.17
    60
    Statistical analysis title
    OLM/AML vs PER/AML
    Comparison groups
    OLM/AML - FAS v PER/AML - FAS
    Number of subjects included in analysis
    245
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [9]
    P-value
    = 0.5134
    Method
    Fisher exact
    Parameter type
    Risk difference (RD)
    Point estimate
    0.0417
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.0797
         upper limit
    0.1631
    Notes
    [9] - The statistical analyses were aimed to assess the non-inferiority and safety of combination Olmesartan + Amlodipine in comparison with Perindopril + Amlodipine.

    Secondary: Change from baseline in (aortic) central SBP

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    End point title
    Change from baseline in (aortic) central SBP
    End point description
    End point type
    Secondary
    End point timeframe
    At Visit 6a (or alternatively at early withdrawal)
    End point values
    OLM/AML - FAS PER/AML - FAS
    Number of subjects analysed
    34
    41
    Units: mmHg
        arithmetic mean (standard deviation)
    -19.96 ( 13.29 )
    -12.91 ( 14.17 )
    Statistical analysis title
    OLM/AML vs PER/AML
    Comparison groups
    PER/AML - FAS v OLM/AML - FAS
    Number of subjects included in analysis
    75
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [10]
    P-value
    = 0.007
    Method
    Mixed models analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    6.591
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.452
         upper limit
    12.73
    Notes
    [10] - The statistical analyses were aimed to assess the non-inferiority and safety of combination Olmesartan + Amlodipine in comparison with Perindopril + Amlodipine.

    Secondary: Change from baseline in (aortic) central SBP

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    End point title
    Change from baseline in (aortic) central SBP
    End point description
    End point type
    Secondary
    End point timeframe
    At Visit 6b (or alternatively at early withdrawal)
    End point values
    OLM/AML - FAS PER/AML - FAS
    Number of subjects analysed
    34
    41
    Units: mmHg
        arithmetic mean (standard deviation)
    -16.99 ( 13.84 )
    -8.31 ( 16.12 )
    Statistical analysis title
    OLM/AML vs PER/AML
    Comparison groups
    OLM/AML - FAS v PER/AML - FAS
    Number of subjects included in analysis
    75
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [11]
    P-value
    = 0.007
    Method
    Mixed models analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    8.155
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.861
         upper limit
    14.45
    Notes
    [11] - The statistical analyses were aimed to assess the non-inferiority and safety of combination Olmesartan + Amlodipine in comparison with Perindopril + Amlodipine.

    Secondary: Change from baseline in (aortic) central DBP

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    End point title
    Change from baseline in (aortic) central DBP
    End point description
    End point type
    Secondary
    End point timeframe
    At Visit 6a (or alternatively at early withdrawal)
    End point values
    OLM/AML - FAS PER/AML - FAS
    Number of subjects analysed
    34
    41
    Units: mmHg
        arithmetic mean (standard deviation)
    -13.32 ( 9.95 )
    -11.12 ( 8.33 )
    Statistical analysis title
    OLM/AML vs PER/AML
    Comparison groups
    OLM/AML - FAS v PER/AML - FAS
    Number of subjects included in analysis
    75
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [12]
    P-value
    = 0.076
    Method
    Mixed models analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    2.292
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.705
         upper limit
    6.288
    Notes
    [12] - The statistical analyses were aimed to assess the non-inferiority and safety of combination Olmesartan + Amlodipine in comparison with Perindopril + Amlodipine.

    Secondary: Change from baseline in (aortic) central DBP

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    End point title
    Change from baseline in (aortic) central DBP
    End point description
    End point type
    Secondary
    End point timeframe
    At Visit 6b (or alternatively at early withdrawal)
    End point values
    OLM/AML - FAS PER/AML - FAS
    Number of subjects analysed
    34
    41
    Units: mmHg
        arithmetic mean (standard deviation)
    -12.14 ( 8.32 )
    -7.06 ( 8.13 )
    Statistical analysis title
    OLM/AML vs PER/AML
    Comparison groups
    OLM/AML - FAS v PER/AML - FAS
    Number of subjects included in analysis
    75
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [13]
    P-value
    = 0.076
    Method
    Mixed models analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    4.194
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.106
         upper limit
    8.282
    Notes
    [13] - The statistical analyses were aimed to assess the non-inferiority and safety of combination Olmesartan + Amlodipine in comparison with Perindopril + Amlodipine.

    Secondary: Change from baseline in central pulse pressure

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    End point title
    Change from baseline in central pulse pressure
    End point description
    Change in central pulse pressure after 24 weeks of treatment
    End point type
    Secondary
    End point timeframe
    At Visit 6a (or alternatively at early withdrawal)
    End point values
    OLM/AML - FAS PER/AML - FAS
    Number of subjects analysed
    31
    38
    Units: mmHg
        arithmetic mean (standard deviation)
    -6.73 ( 10.67 )
    -1.89 ( 10.01 )
    Statistical analysis title
    OLM/AML vs PER/AML
    Comparison groups
    OLM/AML - FAS v PER/AML - FAS
    Number of subjects included in analysis
    69
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [14]
    P-value
    = 0.051
    Method
    Mixed models analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    4.242
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.353
         upper limit
    8.837
    Notes
    [14] - The statistical analyses were aimed to assess the non-inferiority and safety of combination Olmesartan + Amlodipine in comparison with Perindopril + Amlodipine.

    Secondary: Change from baseline in central pulse pressure

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    End point title
    Change from baseline in central pulse pressure
    End point description
    Change in central pulse pressure at 48 hours from last administration (missed dose)
    End point type
    Secondary
    End point timeframe
    At Visit 6b (or alternatively at early withdrawal)
    End point values
    OLM/AML - FAS PER/AML - FAS
    Number of subjects analysed
    31
    38
    Units: mmHg
        arithmetic mean (standard deviation)
    -5.02 ( 10.53 )
    -1.37 ( 11.86 )
    Statistical analysis title
    OLM/AML vs PER/AML
    Comparison groups
    OLM/AML - FAS v PER/AML - FAS
    Number of subjects included in analysis
    69
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [15]
    P-value
    = 0.051
    Method
    Mixed models analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    3.944
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.759
         upper limit
    8.646
    Notes
    [15] - The statistical analyses were aimed to assess the non-inferiority and safety of combination Olmesartan + Amlodipine in comparison with Perindopril + Amlodipine.

    Secondary: Change from baseline in P1 height

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    End point title
    Change from baseline in P1 height
    End point description
    Change in P1 height (outgoing pressure wave) after 24 weeks of treatment
    End point type
    Secondary
    End point timeframe
    At Visit 6a (or alternatively at early withdrawal)
    End point values
    OLM/AML - FAS PER/AML - FAS
    Number of subjects analysed
    34
    41
    Units: mmHg
        arithmetic mean (standard deviation)
    -3.73 ( 5.84 )
    -0.56 ( 5.9 )
    Statistical analysis title
    OLM/AML vs PER/AML
    Comparison groups
    OLM/AML - FAS v PER/AML - FAS
    Number of subjects included in analysis
    75
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [16]
    P-value
    = 0.125
    Method
    Mixed models analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    2.554
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.331
         upper limit
    5.438
    Notes
    [16] - The statistical analyses were aimed to assess the non-inferiority and safety of combination Olmesartan + Amlodipine in comparison with Perindopril + Amlodipine.

    Secondary: Change from baseline in P1 height

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    End point title
    Change from baseline in P1 height
    End point description
    Change in P1 height (outgoing pressure wave) at 48 hours from last administration (missed dose)
    End point type
    Secondary
    End point timeframe
    At Visit 6b (or alternatively at early withdrawal)
    End point values
    OLM/AML - FAS PER/AML - FAS
    Number of subjects analysed
    34
    41
    Units: mmHg
        arithmetic mean (standard deviation)
    -2.71 ( 5.97 )
    -0.95 ( 8.06 )
    Statistical analysis title
    OLM/AML vs PER/AML
    Comparison groups
    OLM/AML - FAS v PER/AML - FAS
    Number of subjects included in analysis
    75
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [17]
    P-value
    = 0.125
    Method
    Mixed models analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    1.766
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.187
         upper limit
    4.719
    Notes
    [17] - The statistical analyses were aimed to assess the non-inferiority and safety of combination Olmesartan + Amlodipine in comparison with Perindopril + Amlodipine.

    Secondary: Change from baseline in ΔP

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    End point title
    Change from baseline in ΔP
    End point description
    Change in ΔP (augmentation) after 24 weeks of treatment
    End point type
    Secondary
    End point timeframe
    At Visit 6a (or alternatively at early withdrawal)
    End point values
    OLM/AML - FAS PER/AML - FAS
    Number of subjects analysed
    31
    38
    Units: mmHg
        arithmetic mean (standard deviation)
    -3.51 ( 6 )
    -1.29 ( 5.43 )
    Statistical analysis title
    OLM/AML vs PER/AML
    Comparison groups
    OLM/AML - FAS v PER/AML - FAS
    Number of subjects included in analysis
    69
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [18]
    P-value
    = 0.016
    Method
    Mixed models analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    2.197
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.252
         upper limit
    4.646
    Notes
    [18] - The statistical analyses were aimed to assess the non-inferiority and safety of combination Olmesartan + Amlodipine in comparison with Perindopril + Amlodipine.

    Secondary: Change from baseline in ΔP

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    End point title
    Change from baseline in ΔP
    End point description
    Change in ΔP (augmentation) at 48 hours from last administration (missed dose)
    End point type
    Secondary
    End point timeframe
    At Visit 6b (or alternatively at early withdrawal)
    End point values
    OLM/AML - FAS PER/AML - FAS
    Number of subjects analysed
    31
    38
    Units: mmHg
        arithmetic mean (standard deviation)
    -2.78 ( 6.04 )
    -0.21 ( 5.24 )
    Statistical analysis title
    OLM/AML vs PER/AML
    Comparison groups
    OLM/AML - FAS v PER/AML - FAS
    Number of subjects included in analysis
    69
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [19]
    P-value
    = 0.016
    Method
    Mixed models analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    2.776
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.263
         upper limit
    5.289
    Notes
    [19] - The statistical analyses were aimed to assess the non-inferiority and safety of combination Olmesartan + Amlodipine in comparison with Perindopril + Amlodipine.

    Secondary: Change from baseline in Augmentation Index

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    End point title
    Change from baseline in Augmentation Index
    End point description
    Change in Augmentation Index after 24 weeks of treatment
    End point type
    Secondary
    End point timeframe
    At Visit 6a (or alternatively at early withdrawal)
    End point values
    OLM/AML - FAS PER/AML - FAS
    Number of subjects analysed
    34
    41
    Units: percent
        arithmetic mean (standard deviation)
    -3.64 ( 7.57 )
    -1.16 ( 6.89 )
    Statistical analysis title
    OLM/AML vs PER/AML
    Comparison groups
    OLM/AML - FAS v PER/AML - FAS
    Number of subjects included in analysis
    75
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [20]
    P-value
    = 0.012
    Method
    Mixed models analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    2.407
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.074
         upper limit
    5.888
    Notes
    [20] - The statistical analyses were aimed to assess the non-inferiority and safety of combination Olmesartan + Amlodipine in comparison with Perindopril + Amlodipine.

    Secondary: Change from baseline in Augmentation Index

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    End point title
    Change from baseline in Augmentation Index
    End point description
    Change in Augmentation Index at 48 hours from last administration (missed dose)
    End point type
    Secondary
    End point timeframe
    At Visit 6b (or alternatively at early withdrawal)
    End point values
    OLM/AML - FAS PER/AML - FAS
    Number of subjects analysed
    34
    41
    Units: percent
        arithmetic mean (standard deviation)
    -3.19 ( 8.61 )
    1.19 ( 6.76 )
    Statistical analysis title
    OLM/AML vs PER/AML
    Comparison groups
    OLM/AML - FAS v PER/AML - FAS
    Number of subjects included in analysis
    75
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [21]
    P-value
    = 0.012
    Method
    Mixed models analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    4.179
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.587
         upper limit
    7.772
    Notes
    [21] - The statistical analyses were aimed to assess the non-inferiority and safety of combination Olmesartan + Amlodipine in comparison with Perindopril + Amlodipine.

    Secondary: Change from baseline in pulse pressure amplification

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    End point title
    Change from baseline in pulse pressure amplification
    End point description
    Change in pulse pressure amplification after 24 weeks of treatment
    End point type
    Secondary
    End point timeframe
    At Visit 6a (or alternatively at early withdrawal)
    End point values
    OLM/AML - FAS PER/AML - FAS
    Number of subjects analysed
    34
    41
    Units: ratio
        arithmetic mean (standard deviation)
    0.05 ( 0.09 )
    0.0091 ( 0.11 )
    Statistical analysis title
    OLM/AML vs PER/AML
    Comparison groups
    OLM/AML - FAS v PER/AML - FAS
    Number of subjects included in analysis
    75
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [22]
    P-value
    = 0.024
    Method
    Mixed models analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    -0.02796
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.0792
         upper limit
    0.0232
    Notes
    [22] - The statistical analyses were aimed to assess the non-inferiority and safety of combination Olmesartan + Amlodipine in comparison with Perindopril + Amlodipine.

    Secondary: Change from baseline in pulse pressure amplification

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    End point title
    Change from baseline in pulse pressure amplification
    End point description
    Change in pulse pressure amplification at 48 hours from last administration (missed dose)
    End point type
    Secondary
    End point timeframe
    At Visit 6b (or alternatively at early withdrawal)
    End point values
    OLM/AML - FAS PER/AML - FAS
    Number of subjects analysed
    34
    41
    Units: ratio
        arithmetic mean (standard deviation)
    0.04 ( 0.13 )
    -0.02 ( 0.12 )
    Statistical analysis title
    OLM/AML vs PER/AML
    Comparison groups
    OLM/AML - FAS v PER/AML - FAS
    Number of subjects included in analysis
    75
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [23]
    P-value
    = 0.024
    Method
    Mixed models analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    -0.05236
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.1052
         upper limit
    0.0005
    Notes
    [23] - The statistical analyses were aimed to assess the non-inferiority and safety of combination Olmesartan + Amlodipine in comparison with Perindopril + Amlodipine.

    Secondary: Change from baseline in PWV

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    End point title
    Change from baseline in PWV
    End point description
    Change in Pulse wave velocity after 24 weeks of treatment
    End point type
    Secondary
    End point timeframe
    At Visit 6a (or alternatively at early withdrawal)
    End point values
    OLM/AML - FAS PER/AML - FAS
    Number of subjects analysed
    27
    29
    Units: m/sec
        arithmetic mean (standard deviation)
    -0.92 ( 1.04 )
    -0.48 ( 1 )
    Statistical analysis title
    OLM/AML vs PER/AML
    Comparison groups
    OLM/AML - FAS v PER/AML - FAS
    Number of subjects included in analysis
    56
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [24]
    P-value
    = 0.0815
    Method
    Mixed models analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    0.7849
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.058
         upper limit
    1.512
    Notes
    [24] - The statistical analyses were aimed to assess the non-inferiority and safety of combination Olmesartan + Amlodipine in comparison with Perindopril + Amlodipine.

    Secondary: Change from baseline in PWV

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    End point title
    Change from baseline in PWV
    End point description
    Change in Pulse wave velocity at 48 hours from last administration (missed dose)
    End point type
    Secondary
    End point timeframe
    At Visit 6b (or alternatively at early withdrawal)
    End point values
    OLM/AML - FAS PER/AML - FAS
    Number of subjects analysed
    27
    29
    Units: m/sec
        arithmetic mean (standard deviation)
    -0.53 ( 1.46 )
    0.21 ( 1.86 )
    Statistical analysis title
    OLM/AML vs PER/AML
    Comparison groups
    OLM/AML - FAS v PER/AML - FAS
    Number of subjects included in analysis
    56
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [25]
    P-value
    = 0.0815
    Method
    Mixed models analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    0.9259
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.214
         upper limit
    1.638
    Notes
    [25] - The statistical analyses were aimed to assess the non-inferiority and safety of combination Olmesartan + Amlodipine in comparison with Perindopril + Amlodipine.

    Other pre-specified: Percentage of normalized subjects with office sitting blood pressure <140/85 mmHg

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    End point title
    Percentage of normalized subjects with office sitting blood pressure <140/85 mmHg
    End point description
    Exploratory endpoint established before unblinding
    End point type
    Other pre-specified
    End point timeframe
    At Visit 6a (or alternatively at early withdrawal)
    End point values
    OLM/AML - FAS PER/AML - FAS
    Number of subjects analysed
    122
    125
    Units: percent
        number (not applicable)
    50
    44
    Statistical analysis title
    OLM/AML vs PER/AML
    Comparison groups
    OLM/AML - FAS v PER/AML - FAS
    Number of subjects included in analysis
    247
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [26]
    P-value
    = 0.3735
    Method
    Fisher exact
    Parameter type
    Risk difference (RD)
    Point estimate
    0.06
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.0643
         upper limit
    0.1843
    Notes
    [26] - The statistical analyses were aimed to assess the non-inferiority and safety of combination Olmesartan + Amlodipine in comparison with Perindopril + Amlodipine.

    Other pre-specified: Percentage of normalized subjects with office sitting blood pressure <140/85 mmHg

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    End point title
    Percentage of normalized subjects with office sitting blood pressure <140/85 mmHg
    End point description
    Exploratory endpoint established before unblinding
    End point type
    Other pre-specified
    End point timeframe
    At Visit 6b (or alternatively at early withdrawal)
    End point values
    OLM/AML - FAS PER/AML - FAS
    Number of subjects analysed
    120
    125
    Units: percent
        number (not applicable)
    33.33
    29.6
    Statistical analysis title
    OLM/AML vs PER/AML
    Comparison groups
    OLM/AML - FAS v PER/AML - FAS
    Number of subjects included in analysis
    245
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [27]
    P-value
    = 0.5827
    Method
    Fisher exact
    Parameter type
    Risk difference (RD)
    Point estimate
    0.0373
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.0789
         upper limit
    0.1536
    Notes
    [27] - The statistical analyses were aimed to assess the non-inferiority and safety of combination Olmesartan + Amlodipine in comparison with Perindopril + Amlodipine.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Safety measurements are recorded at each visit from Visit 2 to Visit 6b.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    11.4
    Reporting groups
    Reporting group title
    OLM/AML - safety
    Reporting group description
    -

    Reporting group title
    PER/AML - safety
    Reporting group description
    -

    Serious adverse events
    OLM/AML - safety PER/AML - safety
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 128 (0.78%)
    2 / 132 (1.52%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Surgical and medical procedures
    Prostate transurethral resection
         subjects affected / exposed
    0 / 128 (0.00%)
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Removal of kidney stone
         subjects affected / exposed
    0 / 128 (0.00%)
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Ischaemic stroke
         subjects affected / exposed
    1 / 128 (0.78%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    OLM/AML - safety PER/AML - safety
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    31 / 128 (24.22%)
    37 / 132 (28.03%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Naevus cell naevus
         subjects affected / exposed
    0 / 128 (0.00%)
    1 / 132 (0.76%)
         occurrences all number
    0
    1
    Vascular disorders
    Flushing
         subjects affected / exposed
    0 / 128 (0.00%)
    1 / 132 (0.76%)
         occurrences all number
    0
    1
    Thrombophlebitis of the leg
         subjects affected / exposed
    1 / 128 (0.78%)
    0 / 132 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Peripheral oedema
         subjects affected / exposed
    8 / 128 (6.25%)
    11 / 132 (8.33%)
         occurrences all number
    8
    11
    Asthenia
         subjects affected / exposed
    2 / 128 (1.56%)
    2 / 132 (1.52%)
         occurrences all number
    2
    2
    Fever
         subjects affected / exposed
    0 / 128 (0.00%)
    2 / 132 (1.52%)
         occurrences all number
    0
    2
    Fatigue
         subjects affected / exposed
    0 / 128 (0.00%)
    1 / 132 (0.76%)
         occurrences all number
    0
    1
    Microlithiasis
         subjects affected / exposed
    0 / 128 (0.00%)
    1 / 132 (0.76%)
         occurrences all number
    0
    1
    Chest pain non-specific
         subjects affected / exposed
    0 / 128 (0.00%)
    1 / 132 (0.76%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    2 / 128 (1.56%)
    4 / 132 (3.03%)
         occurrences all number
    2
    4
    Dry cough
         subjects affected / exposed
    0 / 128 (0.00%)
    2 / 132 (1.52%)
         occurrences all number
    0
    2
    Itching throat
         subjects affected / exposed
    0 / 128 (0.00%)
    1 / 132 (0.76%)
         occurrences all number
    0
    1
    Psychiatric disorders
    Emotional distress
         subjects affected / exposed
    2 / 128 (1.56%)
    0 / 132 (0.00%)
         occurrences all number
    2
    0
    Anxiety disorder
         subjects affected / exposed
    0 / 128 (0.00%)
    1 / 132 (0.76%)
         occurrences all number
    0
    1
    Insomnia
         subjects affected / exposed
    0 / 128 (0.00%)
    1 / 132 (0.76%)
         occurrences all number
    0
    1
    Restlessness
         subjects affected / exposed
    1 / 128 (0.78%)
    0 / 132 (0.00%)
         occurrences all number
    1
    0
    Sleep disorder
         subjects affected / exposed
    1 / 128 (0.78%)
    0 / 132 (0.00%)
         occurrences all number
    1
    0
    Stress
         subjects affected / exposed
    1 / 128 (0.78%)
    0 / 132 (0.00%)
         occurrences all number
    1
    0
    Transient Insomnia
         subjects affected / exposed
    0 / 128 (0.00%)
    1 / 132 (0.76%)
         occurrences all number
    0
    1
    Injury, poisoning and procedural complications
    Closed dislocation of finger
         subjects affected / exposed
    0 / 128 (0.00%)
    1 / 132 (0.76%)
         occurrences all number
    0
    1
    Knee sprain
         subjects affected / exposed
    1 / 128 (0.78%)
    0 / 132 (0.00%)
         occurrences all number
    1
    0
    Sprained ankle
         subjects affected / exposed
    0 / 128 (0.00%)
    1 / 132 (0.76%)
         occurrences all number
    0
    1
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    2 / 128 (1.56%)
    2 / 132 (1.52%)
         occurrences all number
    2
    2
    Palpitations aggravated
         subjects affected / exposed
    1 / 128 (0.78%)
    2 / 132 (1.52%)
         occurrences all number
    1
    6
    Atrial fibrillation
         subjects affected / exposed
    0 / 128 (0.00%)
    1 / 132 (0.76%)
         occurrences all number
    0
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    4 / 128 (3.13%)
    1 / 132 (0.76%)
         occurrences all number
    5
    2
    Headache
         subjects affected / exposed
    3 / 128 (2.34%)
    1 / 132 (0.76%)
         occurrences all number
    3
    1
    Lumbosacral root pain
         subjects affected / exposed
    1 / 128 (0.78%)
    1 / 132 (0.76%)
         occurrences all number
    1
    1
    Burning sensation in face
         subjects affected / exposed
    0 / 128 (0.00%)
    1 / 132 (0.76%)
         occurrences all number
    0
    1
    Headache aggravated
         subjects affected / exposed
    1 / 128 (0.78%)
    0 / 132 (0.00%)
         occurrences all number
    1
    0
    Paraesthesia hand
         subjects affected / exposed
    1 / 128 (0.78%)
    0 / 132 (0.00%)
         occurrences all number
    1
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 128 (0.78%)
    0 / 132 (0.00%)
         occurrences all number
    1
    0
    Eye disorders
    Ventricular arrhythmia
         subjects affected / exposed
    0 / 128 (0.00%)
    1 / 132 (0.76%)
         occurrences all number
    0
    1
    Abnormal vision
         subjects affected / exposed
    1 / 128 (0.78%)
    0 / 132 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    1 / 128 (0.78%)
    0 / 132 (0.00%)
         occurrences all number
    1
    0
    Dyspepsia
         subjects affected / exposed
    0 / 128 (0.00%)
    1 / 132 (0.76%)
         occurrences all number
    0
    1
    Dyspepsia aggravated
         subjects affected / exposed
    0 / 128 (0.00%)
    1 / 132 (0.76%)
         occurrences all number
    0
    1
    Gastritis
         subjects affected / exposed
    0 / 128 (0.00%)
    1 / 132 (0.76%)
         occurrences all number
    0
    1
    Stomach pain
         subjects affected / exposed
    1 / 128 (0.78%)
    0 / 132 (0.00%)
         occurrences all number
    1
    0
    Hepatobiliary disorders
    Hepatic steatosis
         subjects affected / exposed
    1 / 128 (0.78%)
    0 / 132 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Dermatitis
         subjects affected / exposed
    1 / 128 (0.78%)
    0 / 132 (0.00%)
         occurrences all number
    1
    0
    Itch
         subjects affected / exposed
    1 / 128 (0.78%)
    0 / 132 (0.00%)
         occurrences all number
    1
    0
    Renal and urinary disorders
    Nycturia
         subjects affected / exposed
    0 / 128 (0.00%)
    1 / 132 (0.76%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Neck pain
         subjects affected / exposed
    0 / 128 (0.00%)
    2 / 132 (1.52%)
         occurrences all number
    0
    2
    Acking joints
         subjects affected / exposed
    0 / 128 (0.00%)
    1 / 132 (0.76%)
         occurrences all number
    0
    1
    Cramps of lower extremities
         subjects affected / exposed
    1 / 128 (0.78%)
    0 / 132 (0.00%)
         occurrences all number
    1
    0
    Muscle cramps
         subjects affected / exposed
    0 / 128 (0.00%)
    1 / 132 (0.76%)
         occurrences all number
    0
    1
    Pain knee
         subjects affected / exposed
    0 / 128 (0.00%)
    1 / 132 (0.76%)
         occurrences all number
    0
    1
    Shoulder pain
         subjects affected / exposed
    0 / 128 (0.00%)
    1 / 132 (0.76%)
         occurrences all number
    0
    1
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    3 / 128 (2.34%)
    1 / 132 (0.76%)
         occurrences all number
    3
    1
    Bronchitis acute
         subjects affected / exposed
    1 / 128 (0.78%)
    0 / 132 (0.00%)
         occurrences all number
    1
    0
    Common cold
         subjects affected / exposed
    1 / 128 (0.78%)
    0 / 132 (0.00%)
         occurrences all number
    1
    0
    Flu
         subjects affected / exposed
    1 / 128 (0.78%)
    0 / 132 (0.00%)
         occurrences all number
    1
    0
    Pulpitis
         subjects affected / exposed
    1 / 128 (0.78%)
    0 / 132 (0.00%)
         occurrences all number
    1
    0
    Respiratory infection
         subjects affected / exposed
    0 / 128 (0.00%)
    1 / 132 (0.76%)
         occurrences all number
    0
    1
    Urinary tract infection
         subjects affected / exposed
    1 / 128 (0.78%)
    0 / 132 (0.00%)
         occurrences all number
    1
    0
    Metabolism and nutrition disorders
    Diabetes mellitus inadequate control
         subjects affected / exposed
    0 / 128 (0.00%)
    1 / 132 (0.76%)
         occurrences all number
    0
    1
    Hyperlipidaemia
         subjects affected / exposed
    0 / 128 (0.00%)
    1 / 132 (0.76%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    24 Jan 2011
    Amendment 1 was implemented in order to: - clarify how to manage the inclusion of patients taking Beta-blockers; - clarify how to perform PWV; - modify the exclusion criterion based on creatinine values, adding correct values; - correct definition of responder patients; - notify the change of the responsible person for co-ordination of monitoring activities at CRO
    29 Jun 2011
    Amendment 2 was implemented in order to: - allow inclusion of patients already treated with a combination therapy; - withdraw patients with SBP/DBP lower than 120/70; - clarify that previous HbA1c assessment was not necessary and that it could be analysed at V1 to be available at V2 before randomization; - correct typing errors.
    09 Jul 2012
    Amendment 3 was implemented in order to: - modify study phase from III to IV, Olmesartan + Amlodipine at all different dosages used in the study being available on Italian market; - add 30 Italian sites in the study, after the closure of all other sites located in France, Germany, Greece, Switzerland and Spain, due to low recruitment rate; - better describe Perindopril treatment and placebo; - change formulation for Perindopril + Amlodipine and related placebo from encapsulated in DB capsules size AA for oral use to tablets; - better describe study drugs packaging and labelling; - remind placebo administration at V6a; - turn CBP into optional assessment at V2, V4, V5, V6a and V6b or withdrawal, maintaining centralized reading; - correct typing errors; - notify the change of the responsible person for co-ordination of monitoring activities at CRO

    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.
    No limitations or caveats are applicable to this summary.
    For support, Contact us.
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