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    Clinical Trial Results:
    Phase III Study Evaluating the Efficacy and Safety of Olmesartan Medoxomil/Hydrochlorothiazide 40/12.5 mg Combination Therapy versus Olmesartan Medoxomil 40 mg Monotherapy in Patients with Essential Hypertension

    Summary
    EudraCT number
    2006-005556-32
    Trial protocol
    DK   DE   CZ   IT  
    Global end of trial date
    28 May 2008

    Results information
    Results version number
    v1(current)
    This version publication date
    15 Nov 2018
    First version publication date
    15 Nov 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CS866CM-B-E303
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Menarini Ricerche S.p.A.
    Sponsor organisation address
    Via Sette Santi, 1, Florence, Italy, 50131
    Public contact
    Corporate Clinical Sciences, Menarini Ricerche S.p.A., +39 05556809990, acapriati@menarini-ricerche.it
    Scientific contact
    Corporate Clinical Sciences, Menarini Ricerche S.p.A., +39 05556809990, acapriati@menarini-ricerche.it
    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 May 2008
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    28 May 2008
    Global end of trial reached?
    Yes
    Global end of trial date
    28 May 2008
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the anti-hypertensive effect of Olmesartan Medoxomil/Hydrochlorothiazide (OM/HCTZ) 40/12.5 mg combination therapy compared to Olmesartan Medoxomil (OM) 40 mg monotherapy in lowering sitting diastolic blood pressure (dBP) in hypertensive patients after 8 weeks of double-blind treatment (from baseline to the end of the first double-blind treatment phase of the study).
    Protection of trial subjects
    If any event(s) related to the conduct of the study or the development of the IMP which affected the safety of the study participants, the sponsor and the investigator were to take appropriate urgent safety measures to protect the patients against any immediate hazard. The CAs and IRB/ECs were to be informed forthwith about these new events and the measures taken. For patients participating in the study, Menarini Ricerche S.p.A. had stipulated an insurance policy in accordance with local regulatory requirements.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    03 Jul 2007
    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
    Poland: 152
    Country: Number of subjects enrolled
    Czech Republic: 161
    Country: Number of subjects enrolled
    Denmark: 62
    Country: Number of subjects enrolled
    Germany: 137
    Country: Number of subjects enrolled
    Italy: 76
    Country: Number of subjects enrolled
    Romania: 145
    Country: Number of subjects enrolled
    Israel: 53
    Country: Number of subjects enrolled
    Croatia: 60
    Worldwide total number of subjects
    846
    EEA total number of subjects
    793
    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)
    665
    From 65 to 84 years
    181
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    Patients were to be screened for eligibility. Eligible patients were entered into a two-phase pre-randomisation period consisting of a) 2 weeks for tapering off the current anti-hypertension treatment and a b) 2 weeks single-blinded placebo run-in phase.

    Period 1
    Period 1 title
    Phase A
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    OM 40 mg
    Arm description
    -
    Arm type
    Experimental

    Investigational medicinal product name
    Olmesartan Medoxomil
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Tablet containing 40 mg Olmesartan, once daily for 8 weeks

    Arm title
    OM/HCTZ 40/12.5 mg
    Arm description
    -
    Arm type
    Experimental

    Investigational medicinal product name
    Olmesartan Medoxomil/Hydrochlorothiazide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Tablet containing 40 mg Olmesartan Medoxomil and 12.5 mg Hydrochlorothiazide, once daily for 8 weeks

    Number of subjects in period 1 [1]
    OM 40 mg OM/HCTZ 40/12.5 mg
    Started
    282
    556
    Completed
    268
    523
    Not completed
    14
    33
         BP out of specifications
    2
    -
         Consent withdrawn by subject
    7
    18
         unk
    2
    6
         Adverse event, non-fatal
    2
    9
         Lost to follow-up
    1
    -
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Reported data are from ITT population. Eight patients were randomized and but did not provide efficacy data and are therefore not considered in the baseline number.
    Period 2
    Period 2 title
    Phase B
    Is this the baseline period?
    No
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    OM 40 mg responders
    Arm description
    Patients that received 40 mg OM in Phase A and responded to treatment
    Arm type
    Experimental

    Investigational medicinal product name
    Olmesartan Medoxomil
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Tablet containing 40 mg Olmesartan, once daily for 8 weeks

    Arm title
    OM 40 mg non-responders
    Arm description
    Patients that received 40 mg OM in Phase A and did not respond to treatment
    Arm type
    Experimental

    Investigational medicinal product name
    Olmesartan Medoxomil/Hydrochlorothiazide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Tablet containing 40 mg Olmesartan Medoxomil and 12.5 mg Hydrochlorothiazide, once daily for 8 weeks

    Arm title
    OM/HCTZ 40/12.5 mg responders
    Arm description
    Patients that received OM/HCTZ 40/12.5 mg in Phase A and responded to treatment
    Arm type
    Experimental

    Investigational medicinal product name
    Olmesartan Medoxomil/Hydrochlorothiazide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Tablet containing 40 mg Olmesartan Medoxomil and 12.5 mg Hydrochlorothiazide, once daily for 8 weeks

    Arm title
    OM/HCTZ 40/12.5 mg non responders
    Arm description
    Patients that received OM/HCTZ 40/12.5 mg in Phase A and did not respond to treatment
    Arm type
    Experimental

    Investigational medicinal product name
    OM/HCTZ 40/25 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Tablet containing 40 mg olmesartan medoxomil and 25 mg hydrochlorothiazide, once daily for 8 weeks

    Number of subjects in period 2
    OM 40 mg responders OM 40 mg non-responders OM/HCTZ 40/12.5 mg responders OM/HCTZ 40/12.5 mg non responders
    Started
    129
    139
    336
    187
    Completed
    128
    137
    333
    186
    Not completed
    1
    2
    3
    1
         Consent withdrawn by subject
    -
    2
    -
    1
         unk
    -
    -
    1
    -
         Adverse event, non-fatal
    1
    -
    1
    -
         Lost to follow-up
    -
    -
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    OM 40 mg
    Reporting group description
    -

    Reporting group title
    OM/HCTZ 40/12.5 mg
    Reporting group description
    -

    Reporting group values
    OM 40 mg OM/HCTZ 40/12.5 mg Total
    Number of subjects
    282 556 838
    Age categorical
    Units: Subjects
        18 years or older
    282 556 838
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    56.0 ± 11.5 55.4 ± 10.6 -
    Gender categorical
    Units: Subjects
        Female
    127 264 391
        Male
    155 292 447
    Smoking habits
    Units: Subjects
        Smoker
    45 119 164
        Non-smoker
    186 334 520
        Ex-smoker
    51 103 154
    Alcohol consumption
    Units: Subjects
        None
    91 186 277
        Sporadic
    174 333 507
        Regular
    17 37 54
    Trough sitting dBP
    sitting diastolic blood pressure at baseline
    Units: mmHG
        arithmetic mean (standard deviation)
    104.5 ± 4.0 104.6 ± 4.2 -
    Trough sitting sBP
    Sitting systolic blood pressure
    Units: mmHg
        arithmetic mean (standard deviation)
    168.0 ± 7.7 168.5 ± 8.4 -
    BMI
    Body Mass Index
    Units: kg/m²
        arithmetic mean (standard deviation)
    29.67 ± 4.8 29.18 ± 4.7 -

    End points

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    End points reporting groups
    Reporting group title
    OM 40 mg
    Reporting group description
    -

    Reporting group title
    OM/HCTZ 40/12.5 mg
    Reporting group description
    -
    Reporting group title
    OM 40 mg responders
    Reporting group description
    Patients that received 40 mg OM in Phase A and responded to treatment

    Reporting group title
    OM 40 mg non-responders
    Reporting group description
    Patients that received 40 mg OM in Phase A and did not respond to treatment

    Reporting group title
    OM/HCTZ 40/12.5 mg responders
    Reporting group description
    Patients that received OM/HCTZ 40/12.5 mg in Phase A and responded to treatment

    Reporting group title
    OM/HCTZ 40/12.5 mg non responders
    Reporting group description
    Patients that received OM/HCTZ 40/12.5 mg in Phase A and did not respond to treatment

    Primary: dBP change after 8 weeks Phase A

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    End point title
    dBP change after 8 weeks Phase A
    End point description
    Reduction in Mean Trough Sitting dBP (mmHg) from Baseline (Week 0) to Week 8
    End point type
    Primary
    End point timeframe
    Eight weeks
    End point values
    OM 40 mg OM/HCTZ 40/12.5 mg
    Number of subjects analysed
    282
    556
    Units: mmHG
        arithmetic mean (standard deviation)
    -15.8 ± 9.71
    -18.9 ± 9.32
    Statistical analysis title
    dBP change after 8 weeks (Phase A)
    Comparison groups
    OM 40 mg v OM/HCTZ 40/12.5 mg
    Number of subjects included in analysis
    838
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Confidence interval

    Primary: sBP change after 8 weeks Phase A

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    End point title
    sBP change after 8 weeks Phase A
    End point description
    Reduction in Mean Trough Sitting sBP (mmHg) from Baseline (Week 0) to Week 8
    End point type
    Primary
    End point timeframe
    Eight weeks
    End point values
    OM 40 mg OM/HCTZ 40/12.5 mg
    Number of subjects analysed
    282
    556
    Units: mmHg
        arithmetic mean (standard deviation)
    -26.5 ± 14.56
    -31.9 ± 14.76
    Statistical analysis title
    sBP change after 8 weeks (Phase A)
    Comparison groups
    OM 40 mg v OM/HCTZ 40/12.5 mg
    Number of subjects included in analysis
    838
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Confidence interval

    Secondary: dBP change after 8 weeks Phase B

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    End point title
    dBP change after 8 weeks Phase B
    End point description
    Reduction in trough sitting diastolic blood pressure after 8 weeks of additional treatment, depending on Phase A treatment and outcome (responder/non-responder).
    End point type
    Secondary
    End point timeframe
    Eight weeks
    End point values
    OM 40 mg responders OM 40 mg non-responders OM/HCTZ 40/12.5 mg responders OM/HCTZ 40/12.5 mg non responders
    Number of subjects analysed
    129
    139
    336
    187
    Units: mmHg
        arithmetic mean (standard deviation)
    -0.5 ± 6.95
    -9.3 ± 7.91
    -0.3 ± 6.68
    -8.0 ± 8.56
    Statistical analysis title
    dBP change after 8 weeks (Phase B)
    Comparison groups
    OM 40 mg responders v OM 40 mg non-responders v OM/HCTZ 40/12.5 mg responders v OM/HCTZ 40/12.5 mg non responders
    Number of subjects included in analysis
    791
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Confidence interval

    Secondary: sBP change after 8 weeks Phase B

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    End point title
    sBP change after 8 weeks Phase B
    End point description
    Reduction in trough sitting systolic blood pressure after 8 weeks of additional treatment, depending on Phase A treatment and outcome (responder/non-responder).
    End point type
    Secondary
    End point timeframe
    Eight weeks
    End point values
    OM 40 mg responders OM 40 mg non-responders OM/HCTZ 40/12.5 mg responders OM/HCTZ 40/12.5 mg non responders
    Number of subjects analysed
    129
    139
    336
    187
    Units: mmHg
        arithmetic mean (standard deviation)
    -0.5 ± 6.95
    -12.4 ± 11.64
    -0.4 ± 9.32
    -12.1 ± 12.69
    Statistical analysis title
    sBP change after 8 weeks (Phase B)
    Comparison groups
    OM 40 mg responders v OM 40 mg non-responders v OM/HCTZ 40/12.5 mg responders v OM/HCTZ 40/12.5 mg non responders
    Number of subjects included in analysis
    791
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    ANCOVA
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    from first double-blinded study dose (start of Phase A) to EOS visit (end of Phase B)
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    11
    Reporting groups
    Reporting group title
    Phase B OM/HCTZ 40/12.5 mg non-responders
    Reporting group description
    -

    Reporting group title
    Phase B OM/HCTZ 40/12.5 mg responders
    Reporting group description
    -

    Reporting group title
    Phase B OM 40 mg non-responders
    Reporting group description
    -

    Reporting group title
    Phase B OM 40 mg responders
    Reporting group description
    -

    Reporting group title
    Phase A OM/HCTZ 40/12.5 mg
    Reporting group description
    -

    Reporting group title
    Phase A OM 40 mg
    Reporting group description
    -

    Serious adverse events
    Phase B OM/HCTZ 40/12.5 mg non-responders Phase B OM/HCTZ 40/12.5 mg responders Phase B OM 40 mg non-responders Phase B OM 40 mg responders Phase A OM/HCTZ 40/12.5 mg Phase A OM 40 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 188 (0.53%)
    3 / 336 (0.89%)
    0 / 139 (0.00%)
    2 / 129 (1.55%)
    4 / 561 (0.71%)
    5 / 285 (1.75%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Uterine leiomyoma
         subjects affected / exposed
    0 / 188 (0.00%)
    0 / 336 (0.00%)
    0 / 139 (0.00%)
    0 / 129 (0.00%)
    1 / 561 (0.18%)
    0 / 285 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Duodenal ulcer
         subjects affected / exposed
    0 / 188 (0.00%)
    0 / 336 (0.00%)
    0 / 139 (0.00%)
    0 / 129 (0.00%)
    0 / 561 (0.00%)
    1 / 285 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Anal fissure
    Additional description: worsening and surgery
         subjects affected / exposed
    1 / 188 (0.53%)
    0 / 336 (0.00%)
    0 / 139 (0.00%)
    0 / 129 (0.00%)
    0 / 561 (0.00%)
    0 / 285 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Humerus fracture
         subjects affected / exposed
    0 / 188 (0.00%)
    1 / 336 (0.30%)
    0 / 139 (0.00%)
    0 / 129 (0.00%)
    0 / 561 (0.00%)
    0 / 285 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Upper limb fracture
         subjects affected / exposed
    0 / 188 (0.00%)
    1 / 336 (0.30%)
    0 / 139 (0.00%)
    0 / 129 (0.00%)
    0 / 561 (0.00%)
    0 / 285 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial flutter
         subjects affected / exposed
    0 / 188 (0.00%)
    0 / 336 (0.00%)
    0 / 139 (0.00%)
    0 / 129 (0.00%)
    0 / 561 (0.00%)
    1 / 285 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Ischaemic cerebral infarction
         subjects affected / exposed
    0 / 188 (0.00%)
    0 / 336 (0.00%)
    0 / 139 (0.00%)
    0 / 129 (0.00%)
    1 / 561 (0.18%)
    0 / 285 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    0 / 188 (0.00%)
    0 / 336 (0.00%)
    0 / 139 (0.00%)
    0 / 129 (0.00%)
    0 / 561 (0.00%)
    1 / 285 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Brain contusion
         subjects affected / exposed
    0 / 188 (0.00%)
    1 / 336 (0.30%)
    0 / 139 (0.00%)
    0 / 129 (0.00%)
    0 / 561 (0.00%)
    0 / 285 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastritis
         subjects affected / exposed
    0 / 188 (0.00%)
    0 / 336 (0.00%)
    0 / 139 (0.00%)
    0 / 129 (0.00%)
    1 / 561 (0.18%)
    0 / 285 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    0 / 188 (0.00%)
    0 / 336 (0.00%)
    0 / 139 (0.00%)
    0 / 129 (0.00%)
    0 / 561 (0.00%)
    1 / 285 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 188 (0.00%)
    0 / 336 (0.00%)
    0 / 139 (0.00%)
    0 / 129 (0.00%)
    0 / 561 (0.00%)
    1 / 285 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Incontinence
         subjects affected / exposed
    0 / 188 (0.00%)
    0 / 336 (0.00%)
    0 / 139 (0.00%)
    0 / 129 (0.00%)
    0 / 561 (0.00%)
    1 / 285 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Palpitations
         subjects affected / exposed
    0 / 188 (0.00%)
    1 / 336 (0.30%)
    0 / 139 (0.00%)
    0 / 129 (0.00%)
    0 / 561 (0.00%)
    0 / 285 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chest pain
         subjects affected / exposed
    0 / 188 (0.00%)
    1 / 336 (0.30%)
    0 / 139 (0.00%)
    0 / 129 (0.00%)
    0 / 561 (0.00%)
    0 / 285 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Osteoarthritis
         subjects affected / exposed
    0 / 188 (0.00%)
    0 / 336 (0.00%)
    0 / 139 (0.00%)
    1 / 129 (0.78%)
    0 / 561 (0.00%)
    0 / 285 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Diverticulitis
         subjects affected / exposed
    0 / 188 (0.00%)
    0 / 336 (0.00%)
    0 / 139 (0.00%)
    0 / 129 (0.00%)
    1 / 561 (0.18%)
    0 / 285 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia viral
         subjects affected / exposed
    0 / 188 (0.00%)
    0 / 336 (0.00%)
    0 / 139 (0.00%)
    0 / 129 (0.00%)
    0 / 561 (0.00%)
    1 / 285 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Parotid abscess
         subjects affected / exposed
    0 / 188 (0.00%)
    0 / 336 (0.00%)
    0 / 139 (0.00%)
    0 / 129 (0.00%)
    0 / 561 (0.00%)
    1 / 285 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Erysipeloid
    Additional description: Erysipel B / Erysipel Crus Left
         subjects affected / exposed
    0 / 188 (0.00%)
    0 / 336 (0.00%)
    0 / 139 (0.00%)
    1 / 129 (0.78%)
    0 / 561 (0.00%)
    0 / 285 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    Phase B OM/HCTZ 40/12.5 mg non-responders Phase B OM/HCTZ 40/12.5 mg responders Phase B OM 40 mg non-responders Phase B OM 40 mg responders Phase A OM/HCTZ 40/12.5 mg Phase A OM 40 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    24 / 188 (12.77%)
    38 / 336 (11.31%)
    21 / 139 (15.11%)
    22 / 129 (17.05%)
    41 / 561 (7.31%)
    42 / 285 (14.74%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    2 / 188 (1.06%)
    2 / 336 (0.60%)
    0 / 139 (0.00%)
    0 / 129 (0.00%)
    0 / 561 (0.00%)
    0 / 285 (0.00%)
         occurrences all number
    2
    2
    0
    0
    0
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 188 (0.00%)
    0 / 336 (0.00%)
    0 / 139 (0.00%)
    0 / 129 (0.00%)
    10 / 561 (1.78%)
    0 / 285 (0.00%)
         occurrences all number
    0
    0
    0
    0
    10
    0
    Headache
         subjects affected / exposed
    1 / 188 (0.53%)
    2 / 336 (0.60%)
    2 / 139 (1.44%)
    1 / 129 (0.78%)
    9 / 561 (1.60%)
    6 / 285 (2.11%)
         occurrences all number
    1
    2
    2
    1
    9
    6
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    0 / 188 (0.00%)
    1 / 336 (0.30%)
    0 / 139 (0.00%)
    2 / 129 (1.55%)
    0 / 561 (0.00%)
    0 / 285 (0.00%)
         occurrences all number
    0
    1
    0
    2
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 188 (0.00%)
    0 / 336 (0.00%)
    0 / 139 (0.00%)
    0 / 129 (0.00%)
    2 / 561 (0.36%)
    5 / 285 (1.75%)
         occurrences all number
    0
    0
    0
    0
    2
    5
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 188 (1.06%)
    1 / 336 (0.30%)
    0 / 139 (0.00%)
    0 / 129 (0.00%)
    0 / 561 (0.00%)
    0 / 285 (0.00%)
         occurrences all number
    2
    1
    0
    0
    0
    0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    2 / 188 (1.06%)
    2 / 336 (0.60%)
    0 / 139 (0.00%)
    2 / 129 (1.55%)
    6 / 561 (1.07%)
    3 / 285 (1.05%)
         occurrences all number
    2
    2
    0
    2
    6
    3
    Nasopharyngitis
         subjects affected / exposed
    0 / 188 (0.00%)
    2 / 336 (0.60%)
    2 / 139 (1.44%)
    2 / 129 (1.55%)
    14 / 561 (2.50%)
    5 / 285 (1.75%)
         occurrences all number
    0
    2
    2
    2
    14
    5
    Metabolism and nutrition disorders
    Hypercholesterolaemia
         subjects affected / exposed
    2 / 188 (1.06%)
    2 / 336 (0.60%)
    1 / 139 (0.72%)
    1 / 129 (0.78%)
    0 / 561 (0.00%)
    0 / 285 (0.00%)
         occurrences all number
    2
    2
    1
    1
    0
    0
    Hypertriglyceridaemia
         subjects affected / exposed
    0 / 188 (0.00%)
    4 / 336 (1.19%)
    1 / 139 (0.72%)
    0 / 129 (0.00%)
    0 / 561 (0.00%)
    0 / 285 (0.00%)
         occurrences all number
    0
    4
    1
    0
    0
    0

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    12 Oct 2007
    Non-substantial amendment: to detail the electronic SUSAR reporting to the EMEA and to all CAs where electronic submission was in place.

    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
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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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