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    Clinical Trial Results:
    The Precision Hypertension Care study

    Summary
    EudraCT number
    		 2015-003049-24
    Trial protocol
    		 SE  
    Global end of trial date
    11 Jun 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Jun 2022
    First version publication date
    27 Jun 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    PHY201501
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Uppsala University
    Sponsor organisation address
    Department of Medical Sciences, Uppsala, Sweden, 75185
    Public contact
    Department of Medical Sciences, Uppsala University, johan.sundstrom@uu.se
    Scientific contact
    Department of Medical Sciences, Uppsala University, johan.sundstrom@uu.se
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    02 Jun 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    11 Jun 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Jun 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To establish the potential for precision hypertension care, by investigating if there is a consistent between-person variation in blood pressure response to the common blood pressure-lowering drug classes of a clinically relevant magnitude, given the within-person variation in blood pressure.
    Protection of trial subjects
    The investigational medicinal products (IMPs) and therapies used in the study are all well known and were not expected to cause a high risk for the study participants. Evidence-based drug titration and target doses were picked for all of the IMPs. The treatment length, 7-9 weeks per treatment arm, was based on the latest guidelines.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    22 Feb 2017
    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
    Sweden: 280
    Worldwide total number of subjects
    280
    EEA total number of subjects
    280
    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)
    150
    From 65 to 84 years
    130
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients were recruited from the SCAPIS study or via advertisement.

    Pre-assignment
    Screening details
    		 391 consenting participants were screened for inclusion/exclusion criteria between February 20, 2017, and May 25, 2020, and 280 participants were randomised.

    Pre-assignment period milestones
    Number of subjects started
    		 391 [1]
    Number of subjects completed
    		 280

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Adverse event, non-fatal: 2
    Reason: Number of subjects
    		 Physician decision: 3
    Reason: Number of subjects
    		 Consent withdrawn by subject: 18
    Reason: Number of subjects
    		 Protocol deviation: 1
    Reason: Number of subjects
    		 Screen failure: 87
    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: Enrollment is defined as patients randomised to a treatment arm. Pre-assignment is the screening period prior to randomisation.
    Period 1
    Period 1 title
    Baseline period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor
    Blinding implementation details
    Investigational products were provided to the patient in inconspicuous packaging, labelled with randomization number by clinical staff. Interpretation of 24h blood pressure and ECG measurements, symptom and treatment preference ratings were performed by persons unaware of the treatment allocation.

    Arms
    Arm title
    		 Total data set
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Candesartan
    Investigational medicinal product code
    Other name
    Atacand
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Week 1-2: 8 mg administered as 1 x 8 mg capsule Week 3-8: 16 mg administered as 1 x 16 mg capsule. For a total treatment period of 7-9 weeks.

    Investigational medicinal product name
    Lisinopril
    Investigational medicinal product code
    Other name
    Zestril
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Week 1-2: 10 mg administered as 1 x 10 mg capsule Week 3-8: 20 mg administered as 1 x 20 mg capsule. For a total treatment period of 7-9 weeks.

    Investigational medicinal product name
    Amlodipin
    Investigational medicinal product code
    Other name
    Norvasc
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Week 1-2: 5 mg administered as 1 x 5 mg capsule Week 3-8: 10 mg administered as 1 x 10 mg capsule. For a total treatment period of 7-9 weeks.

    Investigational medicinal product name
    Hydrochlortiazid
    Investigational medicinal product code
    Other name
    Hydrochlortiazid Evolan
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Week 1-2: 12,5 mg administered as 1 x 12,5mg capsule Week 3-8: 25 mg administered as 1 x 25 mg capsule For a total treatment period of 7-9 weeks.

    Number of subjects in period 1
    		Total data set
    Started
    280
    Completed
    280
    Period 2
    Period 2 title
    Overall trial
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor
    Blinding implementation details
    Investigational products were provided to the patient in inconspicuous packaging, labelled with randomization number by clinical staff.

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Candesartan
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Candesartan
    Investigational medicinal product code
    Other name
    Atacand
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Week 1-2: 8 mg administered as 1 x 8 mg capsule Week 3-8: 16 mg administered as 1 x 16 mg capsule. For a total treatment period of 7-9 weeks.

    Arm title
    		 Lisinopril
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lisinopril
    Investigational medicinal product code
    Other name
    Zestril
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Week 1-2: 10 mg administered as 1 x 10 mg capsule Week 3-8: 20 mg administered as 1 x 20 mg capsule. For a total treatment period of 7-9 weeks.

    Arm title
    		 Amlodipine
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Amlodipin
    Investigational medicinal product code
    Other name
    Norvasc
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Week 1-2: 5 mg administered as 1 x 5 mg capsule Week 3-8: 10 mg administered as 1 x 10 mg capsule. For a total treatment period of 7-9 weeks.

    Arm title
    		 Hydrochlortiazid
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Hydrochlortiazid
    Investigational medicinal product code
    Other name
    Hydrochlortiazid Evolan
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Week 1-2: 12,5 mg administered as 1 x 12,5mg capsule Week 3-8: 25 mg administered as 1 x 25 mg capsule For a total treatment period of 7-9 weeks.

    Number of subjects in period 2
    		Candesartan Lisinopril Amlodipine Hydrochlortiazid
    Started
    280
    280
    280
    280
    Completed
    250
    241
    244
    253
    Not completed
    30
    39
    36
    27
         Consent withdrawn by subject
    2
    4
    -
    6
         Physician decision
    -
    1
    -
    -
         Adverse event, non-fatal
    2
    1
    4
    4
         Tachycard every treatmentperiod. Stop after few we
    -
    -
    -
    1
         Protocol deviation
    26
    33
    32
    16

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Total data set
    Reporting group description
    		 -

    Reporting group values
    		 Total data set Total
    Number of subjects
    		 280 280
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 64 (58 to 70) -
    Gender categorical
    Units: Subjects
        Female
    		 128 128
        Male
    		 152 152
    Daytime systolic blood pressure
    Units: mmHg
        arithmetic mean (standard deviation)
    		 145 ± 11 -
    Daytime diastolic blood pressure
    Units: mmHg
        arithmetic mean (standard deviation)
    		 89 ± 9 -

    End points

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    End points reporting groups
    Reporting group title
    Total data set
    Reporting group description
    		 -
    Reporting group title
    Candesartan
    Reporting group description
    		 -

    Reporting group title
    Lisinopril
    Reporting group description
    		 -

    Reporting group title
    Amlodipine
    Reporting group description
    		 -

    Reporting group title
    Hydrochlortiazid
    Reporting group description
    		 -

    Primary: Daytime systolic blood pressure by treatment

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    End point title
    		 Daytime systolic blood pressure by treatment
    End point description
    The primary analysis set consisted of treatment periods with at least 90% adherence and a valid daytime blood pressure measurement.
    End point type
    Primary
    End point timeframe
    First treatment period with the investigational product.
    End point values
    		 Candesartan Lisinopril Amlodipine Hydrochlortiazid
    Number of subjects analysed
    250
    241
    244
    253
    Units: mmHg
        arithmetic mean (standard deviation)
    131.8 ± 12.8
    129.7 ± 12.7
    130.9 ± 8.6
    136.1 ± 10.3
    Statistical analysis title
    		 Average treatment contrast Lis vs Cand
    Statistical analysis description
    Estimated average treatment contrasts in systolic blood pressure in the trial population. Linear mixed effect model with participant as the only random factor.
    Comparison groups
    Candesartan v Lisinopril
    Number of subjects included in analysis
    491
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0002
    Method
    		 Mixed models analysis
    Confidence interval
    Statistical analysis title
    		 Average treatment contrast Aml vs Cand
    Statistical analysis description
    Estimated average treatment contrasts in systolic blood pressure in the trial population. Linear mixed effect model with participant as the only random factor.
    Comparison groups
    Amlodipine v Candesartan
    Number of subjects included in analysis
    494
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.1847
    Method
    		 Mixed models analysis
    Confidence interval
    Statistical analysis title
    		 Average treatment contrast Hyd vs Cand
    Statistical analysis description
    Estimated average treatment contrasts in systolic blood pressure in the trial population. Linear mixed effect model with participant as the only random factor.
    Comparison groups
    Candesartan v Hydrochlortiazid
    Number of subjects included in analysis
    503
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Confidence interval
    Statistical analysis title
    		 Average treatment contrast Aml vs Lis
    Statistical analysis description
    Estimated average treatment contrasts in systolic blood pressure in the trial population. Linear mixed effect model with participant as the only random factor.
    Comparison groups
    Amlodipine v Lisinopril
    Number of subjects included in analysis
    485
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0179
    Method
    		 Mixed models analysis
    Confidence interval
    Statistical analysis title
    		 Average treatment contrast Hyd vs Lis
    Comparison groups
    Lisinopril v Hydrochlortiazid
    Number of subjects included in analysis
    494
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Confidence interval
    Statistical analysis title
    		 Average treatment contrast Hyd vs Aml
    Statistical analysis description
    Estimated average treatment contrasts in systolic blood pressure in the trial population. Linear mixed effect model with participant as the only random factor.
    Comparison groups
    Amlodipine v Hydrochlortiazid
    Number of subjects included in analysis
    497
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events are presented by allocated treatment in the period of onset, defined as onset date after the Visit 4 date of the preceding period (or randomisation date, for Period 1), and up to and including the Visit 4 date for the period in question.
    Adverse event reporting additional description
    Throughout the study (until visit 3 in last treatment period), patients had access to an electronic diary for reporting symptoms using a validated questionnaire, PERSYVE (only modified section 2.1 in questionnaire was used in this study).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 ICD
    Dictionary version
    11
    Reporting groups
    Reporting group title
    Candesartan
    Reporting group description
    		 -

    Reporting group title
    Lisinopril
    Reporting group description
    		 -

    Reporting group title
    Amlodipine
    Reporting group description
    		 -

    Reporting group title
    Hydrochlortiazid
    Reporting group description
    		 -

    Serious adverse events
    		 Candesartan Lisinopril Amlodipine Hydrochlortiazid
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 264 (0.38%)
    4 / 263 (1.52%)
    2 / 267 (0.75%)
    1 / 268 (0.37%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Vascular disorders
    BB00.Z: Pulmonary thromboembolism, unspecified
         subjects affected / exposed
    1 / 264 (0.38%)
    0 / 263 (0.00%)
    1 / 267 (0.37%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    BA41.1: Acute non-ST elevation myocardial infarction
         subjects affected / exposed
    0 / 264 (0.00%)
    0 / 263 (0.00%)
    0 / 267 (0.00%)
    1 / 268 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    DB10.00: Acute appendicitis with generalised peritonitis
         subjects affected / exposed
    0 / 264 (0.00%)
    1 / 263 (0.38%)
    0 / 267 (0.00%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    DC50.Z: Peritonitis
         subjects affected / exposed
    0 / 264 (0.00%)
    1 / 263 (0.38%)
    0 / 267 (0.00%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    DC70.00: Diverticulitis of small intestine with perforation and abscess
         subjects affected / exposed
    0 / 264 (0.00%)
    1 / 263 (0.38%)
    0 / 267 (0.00%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    LB15.0: Meckel diverticulum with complication
         subjects affected / exposed
    0 / 264 (0.00%)
    1 / 263 (0.38%)
    0 / 267 (0.00%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    MD81: Abdominal or pelvic pain
         subjects affected / exposed
    0 / 264 (0.00%)
    0 / 263 (0.00%)
    1 / 267 (0.37%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    ME24.9Z: Gastrointestinal bleeding, unspecified
         subjects affected / exposed
    0 / 264 (0.00%)
    1 / 263 (0.38%)
    0 / 267 (0.00%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    EB04: Idiopathic angioedema
         subjects affected / exposed
    0 / 264 (0.00%)
    1 / 263 (0.38%)
    0 / 267 (0.00%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    GB54: Tubulo-interstitial nephritis, not specied as acute or chronic
         subjects affected / exposed
    1 / 264 (0.38%)
    0 / 263 (0.00%)
    0 / 267 (0.00%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    GB56.4: Other or unspecified hydronephrosis
         subjects affected / exposed
    1 / 264 (0.38%)
    0 / 263 (0.00%)
    0 / 267 (0.00%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    GB70.0Z: Calculus of kidney, unspecified
         subjects affected / exposed
    1 / 264 (0.38%)
    0 / 263 (0.00%)
    0 / 267 (0.00%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    GC00.1: Infectious cystitis
         subjects affected / exposed
    0 / 264 (0.00%)
    1 / 263 (0.38%)
    0 / 267 (0.00%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    RA01.0: COVID-19, virus identified
         subjects affected / exposed
    0 / 264 (0.00%)
    0 / 263 (0.00%)
    1 / 267 (0.37%)
    0 / 268 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Candesartan Lisinopril Amlodipine Hydrochlortiazid
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    28 / 264 (10.61%)
    40 / 263 (15.21%)
    33 / 267 (12.36%)
    32 / 268 (11.94%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    2A20.4: Polycythaemia vera
         subjects affected / exposed
    1 / 264 (0.38%)
    0 / 263 (0.00%)
    0 / 267 (0.00%)
    0 / 268 (0.00%)
         occurrences all number
    1
    0
    0
    0
    2C30.Z: Melanoma of skin, unspecified
         subjects affected / exposed
    0 / 264 (0.00%)
    0 / 263 (0.00%)
    0 / 267 (0.00%)
    1 / 268 (0.37%)
         occurrences all number
    0
    0
    0
    1
    2E80.02: Deep internal or visceral lipoma
         subjects affected / exposed
    0 / 264 (0.00%)
    1 / 263 (0.38%)
    0 / 267 (0.00%)
    0 / 268 (0.00%)
         occurrences all number
    0
    1
    0
    0
    2E86.0 & XA99N3 & XH1CZ1 : Leiomyoma of uterus
         subjects affected / exposed
    1 / 264 (0.38%)
    0 / 263 (0.00%)
    0 / 267 (0.00%)
    0 / 268 (0.00%)
         occurrences all number
    1
    0
    0
    0
    2E90.5: Benign neoplasm of oropharynx
         subjects affected / exposed
    1 / 264 (0.38%)
    0 / 263 (0.00%)
    0 / 267 (0.00%)
    0 / 268 (0.00%)
         occurrences all number
    1
    0
    0
    0
    2F31.1: Benign non-mesenchymal neoplasm of uterus, corpus uteri
         subjects affected / exposed
    0 / 264 (0.00%)
    0 / 263 (0.00%)
    1 / 267 (0.37%)
    0 / 268 (0.00%)
         occurrences all number
    0
    0
    1
    0
    2F90.Y & XA07S: Neoplasm of unknown behaviour of parotid salivary glands
         subjects affected / exposed
    0 / 264 (0.00%)
    0 / 263 (0.00%)
    1 / 267 (0.37%)
    0 / 268 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Vascular disorders
    BD70.2: Thrombophlebitis migrans
         subjects affected / exposed
    0 / 264 (0.00%)
    0 / 263 (0.00%)
    1 / 267 (0.37%)
    0 / 268 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Surgical and medical procedures
    QF01.Y: Other specified acquired absence of organs
         subjects affected / exposed
    0 / 264 (0.00%)
    1 / 263 (0.38%)
    0 / 267 (0.00%)
    0 / 268 (0.00%)
         occurrences all number
    0
    1
    0
    0
    General disorders and administration site conditions
    MA10.2: Abnormal level of unspecified serum enzyme
         subjects affected / exposed
    0 / 264 (0.00%)
    0 / 263 (0.00%)
    1 / 267 (0.37%)
    0 / 268 (0.00%)
         occurrences all number
    0
    0
    1
    0
    MA18.4: Low haemoglobin
         subjects affected / exposed
    0 / 264 (0.00%)
    1 / 263 (0.38%)
    0 / 267 (0.00%)
    0 / 268 (0.00%)
         occurrences all number
    0
    1
    0
    0
    ME86.3: Symptom or complaint of the chest
         subjects affected / exposed
    1 / 264 (0.38%)
    0 / 263 (0.00%)
    0 / 267 (0.00%)
    0 / 268 (0.00%)
         occurrences all number
    1
    0
    0
    0
    MG29.00: Ankle oedema
         subjects affected / exposed
    0 / 264 (0.00%)
    1 / 263 (0.38%)
    0 / 267 (0.00%)
    0 / 268 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Immune system disorders
    4A8Z: Allergic or hypersensitivity conditions of unspecified type
         subjects affected / exposed
    0 / 264 (0.00%)
    0 / 263 (0.00%)
    0 / 267 (0.00%)
    1 / 268 (0.37%)
         occurrences all number
    0
    0
    0
    1
    Reproductive system and breast disorders
    GA30.1: Postmenopausal uterine bleeding
         subjects affected / exposed
    1 / 264 (0.38%)
    0 / 263 (0.00%)
    0 / 267 (0.00%)
    0 / 268 (0.00%)
         occurrences all number
    1
    0
    0
    0
    GA90: Hyperplasia of prostate
         subjects affected / exposed
    0 / 264 (0.00%)
    0 / 263 (0.00%)
    0 / 267 (0.00%)
    1 / 268 (0.37%)
         occurrences all number
    0
    0
    0
    1
    GB23.5: Mastodynia
         subjects affected / exposed
    1 / 264 (0.38%)
    0 / 263 (0.00%)
    0 / 267 (0.00%)
    0 / 268 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    MD11.5: Dyspnoea
         subjects affected / exposed
    0 / 264 (0.00%)
    0 / 263 (0.00%)
    1 / 267 (0.37%)
    0 / 268 (0.00%)
         occurrences all number
    0
    0
    1
    0
    MD12: Cough
         subjects affected / exposed
    0 / 264 (0.00%)
    2 / 263 (0.76%)
    1 / 267 (0.37%)
    0 / 268 (0.00%)
         occurrences all number
    0
    3
    1
    0
    MD30.Z: Chest pain, unspecified
         subjects affected / exposed
    0 / 264 (0.00%)
    0 / 263 (0.00%)
    1 / 267 (0.37%)
    0 / 268 (0.00%)
         occurrences all number
    0
    0
    1
    0
    MD36.0: Pain in throat
         subjects affected / exposed
    0 / 264 (0.00%)
    0 / 263 (0.00%)
    1 / 267 (0.37%)
    0 / 268 (0.00%)
         occurrences all number
    0
    0
    1
    0
    CA00: Acute nasopharyngitis
         subjects affected / exposed
    3 / 264 (1.14%)
    1 / 263 (0.38%)
    5 / 267 (1.87%)
    0 / 268 (0.00%)
         occurrences all number
    3
    1
    5
    0
    CA0Y: Other specified upper respiratory tract disorders
         subjects affected / exposed
    0 / 264 (0.00%)
    1 / 263 (0.38%)
    1 / 267 (0.37%)
    0 / 268 (0.00%)
         occurrences all number
    0
    1
    1
    0
    CA40.Z & XK8G: Pneumonia, organism unspecified [Left]
         subjects affected / exposed
    0 / 264 (0.00%)
    1 / 263 (0.38%)
    0 / 267 (0.00%)
    0 / 268 (0.00%)
         occurrences all number
    0
    1
    0
    0
    CA40.Z: Pneumonia, organism unspecified
         subjects affected / exposed
    0 / 264 (0.00%)
    1 / 263 (0.38%)
    0 / 267 (0.00%)
    0 / 268 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Psychiatric disorders
    6B60.0: Dissociative neurological symptom disorder, with visual disturbance
         subjects affected / exposed
    0 / 264 (0.00%)
    0 / 263 (0.00%)
    0 / 267 (0.00%)
    1 / 268 (0.37%)
         occurrences all number
    0
    0
    0
    1
    Injury, poisoning and procedural complications
    0Z: Injuries to the head, unspecified
         subjects affected / exposed
    0 / 264 (0.00%)
    1 / 263 (0.38%)
    0 / 267 (0.00%)
    0 / 268 (0.00%)
         occurrences all number
    0
    1
    0
    0
    NB3Z: Injuries to the thorax, unspecified
         subjects affected / exposed
    0 / 264 (0.00%)
    1 / 263 (0.38%)
    0 / 267 (0.00%)
    0 / 268 (0.00%)
         occurrences all number
    0
    1
    0
    0
    NC32.1 & XA2N25: Fracture of upper end of radius [Radial head]
         subjects affected / exposed
    0 / 264 (0.00%)
    1 / 263 (0.38%)
    0 / 267 (0.00%)
    0 / 268 (0.00%)
         occurrences all number
    0
    1
    0
    0
    NC32.1: Fracture of upper end of radius
         subjects affected / exposed
    0 / 264 (0.00%)
    1 / 263 (0.38%)
    0 / 267 (0.00%)
    0 / 268 (0.00%)
         occurrences all number
    0
    1
    0
    0
    NC53.3Z & XA88S1: Fracture of other metacarpal bone, unspecified [Fifth metacarpal]
         subjects affected / exposed
    0 / 264 (0.00%)
    1 / 263 (0.38%)
    0 / 267 (0.00%)
    0 / 268 (0.00%)
         occurrences all number
    0
    1
    0
    0
    NC54.6Z: Strain or sprain of wrist, unspecified
         subjects affected / exposed
    0 / 264 (0.00%)
    1 / 263 (0.38%)
    0 / 267 (0.00%)
    0 / 268 (0.00%)
         occurrences all number
    0
    1
    0
    0
    NE61: Harmful effects of or exposure to noxious substances, chiefly nonmedicinal as to source, not e
         subjects affected / exposed
    0 / 264 (0.00%)
    2 / 263 (0.76%)
    1 / 267 (0.37%)
    0 / 268 (0.00%)
         occurrences all number
    0
    2
    1
    0
    NF0A.3: Post traumatic wound infection, not elsewhere classified
         subjects affected / exposed
    0 / 264 (0.00%)
    0 / 263 (0.00%)
    1 / 267 (0.37%)
    0 / 268 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Cardiac disorders
    BC81.2Z: Macro reentrant atrial tachycardia, unspecified
         subjects affected / exposed
    0 / 264 (0.00%)
    0 / 263 (0.00%)
    0 / 267 (0.00%)
    1 / 268 (0.37%)
         occurrences all number
    0
    0
    0
    1
    BC81.3Z: Atrial fibrillation, unspecified
         subjects affected / exposed
    1 / 264 (0.38%)
    0 / 263 (0.00%)
    0 / 267 (0.00%)
    2 / 268 (0.75%)
         occurrences all number
    1
    0
    0
    2
    BD11.Z: Left ventricular failure, unspecified
         subjects affected / exposed
    1 / 264 (0.38%)
    0 / 263 (0.00%)
    0 / 267 (0.00%)
    0 / 268 (0.00%)
         occurrences all number
    1
    0
    0
    0
    BD50.Z: Aortic aneurysm or dissection, unspecified
         subjects affected / exposed
    1 / 264 (0.38%)
    0 / 263 (0.00%)
    0 / 267 (0.00%)
    0 / 268 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Nervous system disorders
    8C10.0: Carpal tunnel syndrome
         subjects affected / exposed
    0 / 264 (0.00%)
    0 / 263 (0.00%)
    1 / 267 (0.37%)
    0 / 268 (0.00%)
         occurrences all number
    0
    0
    1
    0
    8C10.1: Lesion of ulnar nerve
         subjects affected / exposed
    0 / 264 (0.00%)
    0 / 263 (0.00%)
    0 / 267 (0.00%)
    1 / 268 (0.37%)
         occurrences all number
    0
    0
    0
    1
    MB40.3: Anaesthesia of skin
         subjects affected / exposed
    0 / 264 (0.00%)
    1 / 263 (0.38%)
    1 / 267 (0.37%)
    1 / 268 (0.37%)
         occurrences all number
    0
    1
    1
    1
    MB47.3: Cramp
         subjects affected / exposed
    1 / 264 (0.38%)
    0 / 263 (0.00%)
    0 / 267 (0.00%)
    0 / 268 (0.00%)
         occurrences all number
    1
    0
    0
    0
    MB48.4: Presyncope
         subjects affected / exposed
    0 / 264 (0.00%)
    1 / 263 (0.38%)
    0 / 267 (0.00%)
    0 / 268 (0.00%)
         occurrences all number
    0
    1
    0
    0
    MB6Y: Headache, unspecified
         subjects affected / exposed
    1 / 264 (0.38%)
    1 / 263 (0.38%)
    0 / 267 (0.00%)
    1 / 268 (0.37%)
         occurrences all number
    1
    1
    0
    1
    Ear and labyrinth disorders
    AA3Z: Otitis externa, unspecified
         subjects affected / exposed
    1 / 264 (0.38%)
    1 / 263 (0.38%)
    0 / 267 (0.00%)
    0 / 268 (0.00%)
         occurrences all number
    1
    1
    0
    0
    AB31.2: Benign positional paroxysmal vertigo
         subjects affected / exposed
    0 / 264 (0.00%)
    0 / 263 (0.00%)
    0 / 267 (0.00%)
    1 / 268 (0.37%)
         occurrences all number
    0
    0
    0
    1
    AB51.Z & XK9K: Acquired hearing impairment, unspecified [Right]
         subjects affected / exposed
    0 / 264 (0.00%)
    0 / 263 (0.00%)
    0 / 267 (0.00%)
    1 / 268 (0.37%)
         occurrences all number
    0
    0
    0
    1
    Eye disorders
    9B10.Z: Cataract, unspecified
         subjects affected / exposed
    0 / 264 (0.00%)
    2 / 263 (0.76%)
    0 / 267 (0.00%)
    0 / 268 (0.00%)
         occurrences all number
    0
    3
    0
    0
    9B8Y: Other specified disorders of the vitreous body
         subjects affected / exposed
    0 / 264 (0.00%)
    1 / 263 (0.38%)
    0 / 267 (0.00%)
    0 / 268 (0.00%)
         occurrences all number
    0
    1
    0
    0
    9D90.Z & XK70: Vision impairment including blindness, unspecified [Unilateral, unspecified]
         subjects affected / exposed
    0 / 264 (0.00%)
    0 / 263 (0.00%)
    1 / 267 (0.37%)
    3 / 268 (1.12%)
         occurrences all number
    0
    0
    1
    3
    9E1Z: Diseases of the visual system, unspecified
         subjects affected / exposed
    1 / 264 (0.38%)
    2 / 263 (0.76%)
    2 / 267 (0.75%)
    0 / 268 (0.00%)
         occurrences all number
    1
    2
    2
    0
    Gastrointestinal disorders
    MD81.12: Pain localised to other parts of lower abdomen
         subjects affected / exposed
    0 / 264 (0.00%)
    0 / 263 (0.00%)
    1 / 267 (0.37%)
    0 / 268 (0.00%)
         occurrences all number
    0
    0
    1
    0
    MD90.0: Nausea
         subjects affected / exposed
    0 / 264 (0.00%)
    2 / 263 (0.76%)
    1 / 267 (0.37%)
    0 / 268 (0.00%)
         occurrences all number
    0
    2
    1
    0
    MD95: Heartburn
         subjects affected / exposed
    0 / 264 (0.00%)
    0 / 263 (0.00%)
    1 / 267 (0.37%)
    0 / 268 (0.00%)
         occurrences all number
    0
    0
    1
    0
    DA09.62: Periapical abscess without sinus
         subjects affected / exposed
    0 / 264 (0.00%)
    0 / 263 (0.00%)
    0 / 267 (0.00%)
    1 / 268 (0.37%)
         occurrences all number
    0
    0
    0
    1
    DA60.Z: Gastric ulcer, unspecified
         subjects affected / exposed
    0 / 264 (0.00%)
    0 / 263 (0.00%)
    0 / 267 (0.00%)
    1 / 268 (0.37%)
         occurrences all number
    0
    0
    0
    1
    Skin and subcutaneous tissue disorders
    EE13.1: Ingrowing nail
         subjects affected / exposed
    0 / 264 (0.00%)
    0 / 263 (0.00%)
    1 / 267 (0.37%)
    0 / 268 (0.00%)
         occurrences all number
    0
    0
    1
    0
    EA90.42: Palmoplantar pustulosis
         subjects affected / exposed
    1 / 264 (0.38%)
    0 / 263 (0.00%)
    0 / 267 (0.00%)
    0 / 268 (0.00%)
         occurrences all number
    1
    0
    0
    0
    ME65.1: Itching of skin
         subjects affected / exposed
    0 / 264 (0.00%)
    0 / 263 (0.00%)
    1 / 267 (0.37%)
    1 / 268 (0.37%)
         occurrences all number
    0
    0
    1
    1
    ME66.6Z: Rash, unspecified
         subjects affected / exposed
    0 / 264 (0.00%)
    2 / 263 (0.76%)
    2 / 267 (0.75%)
    0 / 268 (0.00%)
         occurrences all number
    0
    2
    2
    0
    Renal and urinary disorders
    GB70.0Z: Calculus of kidney, unspecified
         subjects affected / exposed
    1 / 264 (0.38%)
    0 / 263 (0.00%)
    1 / 267 (0.37%)
    1 / 268 (0.37%)
         occurrences all number
    2
    0
    1
    1
    GB71.1: Calculus in urethra
         subjects affected / exposed
    0 / 264 (0.00%)
    1 / 263 (0.38%)
    0 / 267 (0.00%)
    0 / 268 (0.00%)
         occurrences all number
    0
    1
    0
    0
    GC00.1: Infectious cystitis
         subjects affected / exposed
    1 / 264 (0.38%)
    0 / 263 (0.00%)
    0 / 267 (0.00%)
    0 / 268 (0.00%)
         occurrences all number
    1
    0
    0
    0
    GC40.Z: Pelvic organ prolapse, unspecified
         subjects affected / exposed
    0 / 264 (0.00%)
    1 / 263 (0.38%)
    0 / 267 (0.00%)
    0 / 268 (0.00%)
         occurrences all number
    0
    1
    0
    0
    MF50.2Z: Urinary incontinence, unspecified
         subjects affected / exposed
    0 / 264 (0.00%)
    1 / 263 (0.38%)
    0 / 267 (0.00%)
    0 / 268 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Endocrine disorders
    5A00.Z: Hypothyroidism, unspecified
         subjects affected / exposed
    0 / 264 (0.00%)
    0 / 263 (0.00%)
    0 / 267 (0.00%)
    1 / 268 (0.37%)
         occurrences all number
    0
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    FA01.Z & XK9K: Osteoarthritis of knee, unspecified [Right]
         subjects affected / exposed
    0 / 264 (0.00%)
    0 / 263 (0.00%)
    1 / 267 (0.37%)
    0 / 268 (0.00%)
         occurrences all number
    0
    0
    1
    0
    FA2Z: Inflammatory arthropathies, unspecified
         subjects affected / exposed
    0 / 264 (0.00%)
    0 / 263 (0.00%)
    0 / 267 (0.00%)
    1 / 268 (0.37%)
         occurrences all number
    0
    0
    0
    1
    FA71: Torticollis
         subjects affected / exposed
    0 / 264 (0.00%)
    1 / 263 (0.38%)
    0 / 267 (0.00%)
    0 / 268 (0.00%)
         occurrences all number
    0
    1
    0
    0
    FA82: Spinal stenosis
         subjects affected / exposed
    0 / 264 (0.00%)
    0 / 263 (0.00%)
    0 / 267 (0.00%)
    1 / 268 (0.37%)
         occurrences all number
    0
    0
    0
    1
    FB50.Z & XK8G: Bursitis, unspecified
         subjects affected / exposed
    1 / 264 (0.38%)
    0 / 263 (0.00%)
    0 / 267 (0.00%)
    0 / 268 (0.00%)
         occurrences all number
    1
    0
    0
    0
    FB53.0: Adhesive capsulitis of shoulder
         subjects affected / exposed
    0 / 264 (0.00%)
    0 / 263 (0.00%)
    0 / 267 (0.00%)
    1 / 268 (0.37%)
         occurrences all number
    0
    0
    0
    1
    FB55.Z: Enthesopathies, unspecified
         subjects affected / exposed
    0 / 264 (0.00%)
    0 / 263 (0.00%)
    0 / 267 (0.00%)
    2 / 268 (0.75%)
         occurrences all number
    0
    0
    0
    2
    FB56.2: Myalgia
         subjects affected / exposed
    0 / 264 (0.00%)
    0 / 263 (0.00%)
    1 / 267 (0.37%)
    0 / 268 (0.00%)
         occurrences all number
    0
    0
    1
    0
    FB56.4: Pain in limb
         subjects affected / exposed
    2 / 264 (0.76%)
    0 / 263 (0.00%)
    0 / 267 (0.00%)
    1 / 268 (0.37%)
         occurrences all number
    2
    0
    0
    1
    FB56.6: Other specified soft tissue disorders
         subjects affected / exposed
    1 / 264 (0.38%)
    0 / 263 (0.00%)
    0 / 267 (0.00%)
    1 / 268 (0.37%)
         occurrences all number
    1
    0
    0
    1
    ME82: Pain in joint
         subjects affected / exposed
    0 / 264 (0.00%)
    0 / 263 (0.00%)
    1 / 267 (0.37%)
    1 / 268 (0.37%)
         occurrences all number
    0
    0
    1
    1
    ME84.Z: Spinal pain, unspecified
         subjects affected / exposed
    0 / 264 (0.00%)
    1 / 263 (0.38%)
    1 / 267 (0.37%)
    0 / 268 (0.00%)
         occurrences all number
    0
    1
    1
    0
    ME85: Stiffness of joint
         subjects affected / exposed
    1 / 264 (0.38%)
    0 / 263 (0.00%)
    0 / 267 (0.00%)
    0 / 268 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Infections and infestations
    1A40.Z: Infectious gastroenteritis or colitis without specification of infectious agent
         subjects affected / exposed
    1 / 264 (0.38%)
    0 / 263 (0.00%)
    0 / 267 (0.00%)
    0 / 268 (0.00%)
         occurrences all number
    1
    0
    0
    0
    1B72.Z: Impetigo, unspecified
         subjects affected / exposed
    0 / 264 (0.00%)
    1 / 263 (0.38%)
    0 / 267 (0.00%)
    0 / 268 (0.00%)
         occurrences all number
    0
    1
    0
    0
    1C1G.0: Early cutaneous Lyme borreliosis
         subjects affected / exposed
    1 / 264 (0.38%)
    1 / 263 (0.38%)
    0 / 267 (0.00%)
    1 / 268 (0.37%)
         occurrences all number
    1
    1
    0
    1
    1C1G: Lyme borreliosis
         subjects affected / exposed
    1 / 264 (0.38%)
    0 / 263 (0.00%)
    0 / 267 (0.00%)
    1 / 268 (0.37%)
         occurrences all number
    1
    0
    0
    1
    1D9Z: Unspecified viral infection of unspecified site
         subjects affected / exposed
    0 / 264 (0.00%)
    1 / 263 (0.38%)
    0 / 267 (0.00%)
    0 / 268 (0.00%)
         occurrences all number
    0
    1
    0
    0
    1E32: Influenza, virus not identified
         subjects affected / exposed
    0 / 264 (0.00%)
    0 / 263 (0.00%)
    0 / 267 (0.00%)
    1 / 268 (0.37%)
         occurrences all number
    0
    0
    0
    1
    1E91.0: Zoster without complications
         subjects affected / exposed
    1 / 264 (0.38%)
    0 / 263 (0.00%)
    0 / 267 (0.00%)
    1 / 268 (0.37%)
         occurrences all number
    1
    0
    0
    1
    1E91.Z: Zoster, unspecified
         subjects affected / exposed
    0 / 264 (0.00%)
    3 / 263 (1.14%)
    0 / 267 (0.00%)
    1 / 268 (0.37%)
         occurrences all number
    0
    3
    0
    1
    1F00.Z: Herpes simplex infections, unspecified
         subjects affected / exposed
    0 / 264 (0.00%)
    1 / 263 (0.38%)
    0 / 267 (0.00%)
    0 / 268 (0.00%)
         occurrences all number
    0
    1
    0
    0
    1F23.Z: Candidosis, unspecified
         subjects affected / exposed
    0 / 264 (0.00%)
    0 / 263 (0.00%)
    1 / 267 (0.37%)
    0 / 268 (0.00%)
         occurrences all number
    0
    0
    1
    0
    1F28.Y: Other specified dermatophytosis
         subjects affected / exposed
    1 / 264 (0.38%)
    0 / 263 (0.00%)
    0 / 267 (0.00%)
    0 / 268 (0.00%)
         occurrences all number
    1
    0
    0
    0
    1H0Z: Infection, unspecified
         subjects affected / exposed
    0 / 264 (0.00%)
    0 / 263 (0.00%)
    0 / 267 (0.00%)
    1 / 268 (0.37%)
         occurrences all number
    0
    0
    0
    1
    RA01.0: COVID-19, virus identified
         subjects affected / exposed
    1 / 264 (0.38%)
    1 / 263 (0.38%)
    3 / 267 (1.12%)
    1 / 268 (0.37%)
         occurrences all number
    1
    1
    3
    1
    Metabolism and nutrition disorders
    5C72: Hypo-osmolality or hyponatraemia
         subjects affected / exposed
    0 / 264 (0.00%)
    0 / 263 (0.00%)
    0 / 267 (0.00%)
    1 / 268 (0.37%)
         occurrences all number
    0
    0
    0
    1
    5C77: Hypokalaemia
         subjects affected / exposed
    0 / 264 (0.00%)
    0 / 263 (0.00%)
    1 / 267 (0.37%)
    1 / 268 (0.37%)
         occurrences all number
    0
    0
    1
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    20 May 2016
    Medical Products Agency requested updates: (1) Analysis of the primary variable was changed to include randomised, instead of treated, patients. (2) A pregnancy test was included in the screening visit. (3) Any contraindications to the investigational products, atrial fibrillation in need of rate control, and heart failure due to left ventricular systolic dysfunction were added to the exclusion criteria.
    08 May 2017
    (1) Body weight measurement was added to visit 3. (2) Fasting was not required prior to collection of whole blood samples at visit 1.
    15 Dec 2017
    (1) Exclusion criteria were clarified: o Gout -> active gout. o Use of concomitant medication -> continuous use of… o Any history of drug reaction -> any history of drug reaction to active or inactive compounds in the investigational product (IP). o Previous enrolment in present study -> Previous randomization… (2) Introduction to reporting symptoms and QoL in an electronic diary was moved from the placebo run-in period to visit 2. (3) At visit 3, the patient was not allowed to keep one capsule of the IP, but had to return all unused IPs. (4) If the patient discontinued the study, he/she was asked to carry out visit 3 and 4.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/30265168
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