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    Clinical Trial Results:
    A randomized, sponsor open, site and subject double blind, parallel group, placebo-controlled study to evaluate the safety and efficacy of LHW090 after 4 weeks treatment in patients with resistant hypertension

    Summary
    EudraCT number
    		 2015-001890-42
    Trial protocol
    		 DE   FR   DK   NL  
    Global end of trial date
    17 Aug 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    22 Jun 2018
    First version publication date
    22 Jun 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CLWH090X2202
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharma AG
    Sponsor organisation address
    CH-4002, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111,
    Scientific contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111,
    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
    17 Aug 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Aug 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the safety and tolerability of LHW090 for 4 weeks on a background of conventional anti-hypertensive medications in patients with resistant hypertension. To evaluate the effect of LHW090 on placebo-adjusted mean daytime systolic blood pressure (SBP) after 4 weeks in patients with resistant hypertension.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    04 Nov 2015
    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
    Denmark: 1
    Country: Number of subjects enrolled
    France: 2
    Country: Number of subjects enrolled
    Germany: 16
    Country: Number of subjects enrolled
    Switzerland: 1
    Country: Number of subjects enrolled
    United States: 36
    Country: Number of subjects enrolled
    Netherlands: 8
    Worldwide total number of subjects
    64
    EEA total number of subjects
    27
    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)
    33
    From 65 to 84 years
    31
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Participants were randomized in a 1:1:2 ratio to LHW090 100 mg, LHW090 200 mg and placebo, respectively.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 LHW090 100 mg
    Arm description
    		 LHW090 100 mg once daily for 28 days
    Arm type
    		 Experimental

    Investigational medicinal product name
    LHW090
    Investigational medicinal product code
    LHW090
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    LHW090 100 mg once daily for 28 days

    Arm title
    		 LHW090 200 mg
    Arm description
    		 LHW090 200 mg once daily for 28 days
    Arm type
    		 Experimental

    Investigational medicinal product name
    LHW090
    Investigational medicinal product code
    LHW090
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    LHW090 200 mg once daily for 28 days

    Arm title
    		 Placebo
    Arm description
    		 Matching placebo to LHW090 oral dose for 28 days
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Matching placebo to LHW090 oral dose for 28 days

    Number of subjects in period 1
    		LHW090 100 mg LHW090 200 mg Placebo
    Started
    17
    15
    32
    Primary Pharmacodynamic Analysis Set
    15
    14 [1]
    29
    Pharmacokinetic (PK) analysis set
    17
    15
    0 [2]
    Completed
    15
    15
    28
    Not completed
    2
    0
    4
         Consent withdrawn by subject
    -
    -
    1
         Adverse event, non-fatal
    2
    -
    -
         Protocol deviation
    -
    -
    3
    Notes
    [1] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: The number is correct as is
    [2] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: The number is correct as is

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    LHW090 100 mg
    Reporting group description
    		 LHW090 100 mg once daily for 28 days

    Reporting group title
    LHW090 200 mg
    Reporting group description
    		 LHW090 200 mg once daily for 28 days

    Reporting group title
    Placebo
    Reporting group description
    		 Matching placebo to LHW090 oral dose for 28 days

    Reporting group values
    		 LHW090 100 mg LHW090 200 mg Placebo Total
    Number of subjects
    		 17 15 32 64
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 9 10 14 33
        From 65-84 years
    		 8 5 18 31
        85 years and over
    		 0 0 0 0
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 64.2 ( 8.42 ) 61.8 ( 5.16 ) 64.4 ( 9.56 ) -
    Sex: Female, Male
    Units: Subjects
        Female
    		 4 9 13 26
        Male
    		 13 6 19 38
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0 0
        Asian
    		 1 0 0 1
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0
        Black or African American
    		 4 7 14 25
        White
    		 11 7 18 36
        More than one race
    		 0 0 0 0
        Unknown or Not Reported
    		 1 1 0 2

    End points

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    End points reporting groups
    Reporting group title
    LHW090 100 mg
    Reporting group description
    		 LHW090 100 mg once daily for 28 days

    Reporting group title
    LHW090 200 mg
    Reporting group description
    		 LHW090 200 mg once daily for 28 days

    Reporting group title
    Placebo
    Reporting group description
    		 Matching placebo to LHW090 oral dose for 28 days

    Primary: Number of participants with reported adverse events (AEs), serious adverse events (SAEs) and deaths

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    End point title
    		 Number of participants with reported adverse events (AEs), serious adverse events (SAEs) and deaths [1]
    End point description
    Number of participants with AEs, SAEs and deaths were assessed.
    End point type
    Primary
    End point timeframe
    6 months
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis analyzed for this outcome measure
    End point values
    		 LHW090 100 mg LHW090 200 mg Placebo
    Number of subjects analysed
    17
    15
    32
    Units: Participants
        AEs|
    12
    3
    14
        SAEs|
    0
    0
    0
        Deaths|
    0
    0
    0
    No statistical analyses for this end point

    Primary: Change from baseline in mean daytime blood pressure

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    End point title
    		 Change from baseline in mean daytime blood pressure
    End point description
    Change in the 12 hour average of systolic blood pressure (SBP) measured by ambulatory blood pressure was defined as the 12 hour daytime average SBP on Day 28 minus the 12 hour daytime average SBP on Day -1. monitoring (ABPM). A negative change from baseline indicates improvement.
    End point type
    Primary
    End point timeframe
    Baseline, day 27
    End point values
    		 LHW090 100 mg LHW090 200 mg Placebo
    Number of subjects analysed
    15
    13
    28
    Units: mmHg
        arithmetic mean (standard deviation)
    -9.41 ( 8.379 )
    -16.84 ( 7.678 )
    -0.79 ( 10.555 )
    Statistical analysis title
    		 Change from baseline in mean daytime BP
    Comparison groups
    LHW090 100 mg v Placebo
    Number of subjects included in analysis
    43
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.002 [2]
    Method
    		 Longitudinal repeated measures mixed eff
    Parameter type
    		 Mean difference (net)
    Point estimate
    -8.555
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -14.388
         upper limit
    		 -2.722
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.9077
    Notes
    [2] - 1-sided p-value
    Statistical analysis title
    		 Change from baseline in mean daytime BP
    Comparison groups
    LHW090 200 mg v Placebo
    Number of subjects included in analysis
    41
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.001 [3]
    Method
    		 Longitudinal repeated measures mixed eff
    Parameter type
    		 Mean difference (net)
    Point estimate
    -14.727
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -20.852
         upper limit
    		 -8.602
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.0548
    Notes
    [3] - 1-sided p-value

    Secondary: Pharmacokinetics of LHW090/LHV527 in plasma: observe maximum plasma concentration following LHW090 at steady state in patients (Cmax)

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    End point title
    		 Pharmacokinetics of LHW090/LHV527 in plasma: observe maximum plasma concentration following LHW090 at steady state in patients (Cmax) [4]
    End point description
    Blood samples were collected to assess Cmax.
    End point type
    Secondary
    End point timeframe
    Within 60 min prior to dosing, post dose: +/- 5 min up to 3 hrs, +/- 10 min from ≥3 hrs up to 12 hrs on Day 1 and Day 28
    Notes
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analysis analyzed for this outcome measure
    End point values
    		 LHW090 100 mg LHW090 200 mg
    Number of subjects analysed
    17
    15
    Units: ng/mL
    arithmetic mean (standard deviation)
        LHW090, day 1|
    3620 ( 1220 )
    6340 ( 3440 )
        LHW090, day 28|
    4190 ( 1740 )
    7340 ( 4300 )
        LHV527, day 1|
    5040 ( 1770 )
    6330 ( 3700 )
        LHV527, day 28|
    5240 ( 1960 )
    9870 ( 1810 )
    No statistical analyses for this end point

    Secondary: Pharmacokinetics of LHW090/LHV527 in plasma: time to reach the maximum concentration after administration of LHW090 (Tmax)

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    End point title
    		 Pharmacokinetics of LHW090/LHV527 in plasma: time to reach the maximum concentration after administration of LHW090 (Tmax) [5]
    End point description
    Blood samples were collected to assess Tmax.
    End point type
    Secondary
    End point timeframe
    Within 60 min prior to dosing, post dose: +/- 5 min up to 3 hrs, +/- 10 min from ≥3 hrs up to 12 hrs on Day 1 and Day 28
    Notes
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analysis analyzed for this outcome measure
    End point values
    		 LHW090 100 mg LHW090 200 mg
    Number of subjects analysed
    17
    15
    Units: hour
    median (full range (min-max))
        LHW090, day 1|
    2.08 (1.00 to 7.95)
    3.00 (2.00 to 8.08)
        LHW090, day 28|
    2.00 (1.00 to 3.00)
    2.92 (0.383 to 8.08)
        LHV527, day 1|
    3.07 (2.08 to 8.03)
    4.08 (1.00 to 8.50)
        LHV527, day 28|
    3.92 (1.17 to 8.00)
    4.00 (2.38 to 8.08)
    No statistical analyses for this end point

    Secondary: Pharmacokinetics of LHW090/LHV527 in plasma: area under the plasma concentration-time curve from time zero to the time of last quantifiable concentration (AUClast)

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    End point title
    		 Pharmacokinetics of LHW090/LHV527 in plasma: area under the plasma concentration-time curve from time zero to the time of last quantifiable concentration (AUClast) [6]
    End point description
    Blood samples were collected to assess AUClast.
    End point type
    Secondary
    End point timeframe
    Within 60 min prior to dosing, post dose: +/- 5 min up to 3 hrs, +/- 10 min from ≥3 hrs up to 12 hrs on Day 1 and Day 28
    Notes
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analysis analyzed for this outcome measure
    End point values
    		 LHW090 100 mg LHW090 200 mg
    Number of subjects analysed
    17
    15
    Units: Hr*ng/mL
    arithmetic mean (standard deviation)
        LHW090, day 1|
    12300 ( 3870 )
    24500 ( 16000 )
        LHW090, day 28|
    13700 ( 4370 )
    24400 ( 11400 )
        LHV527, day 1|
    25300 ( 11800 )
    28700 ( 17900 )
        LHV527, day 28|
    27700 ( 11600 )
    52300 ( 14400 )
    No statistical analyses for this end point

    Secondary: Pharmacokinetics of LHW090/LHV527 in plasma: Last measurable plasma concentration (Clast)

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    End point title
    		 Pharmacokinetics of LHW090/LHV527 in plasma: Last measurable plasma concentration (Clast) [7]
    End point description
    Blood samples were collected to assess Clast.
    End point type
    Secondary
    End point timeframe
    Within 60 min prior to dosing, post dose: +/- 5 min up to 3 hrs, +/- 10 min from ≥3 hrs up to 12 hrs on Day 1 and Day 28
    Notes
    [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analysis analyzed for this outcome measure
    End point values
    		 LHW090 100 mg LHW090 200 mg
    Number of subjects analysed
    17
    15
    Units: ng/mL
    arithmetic mean (standard deviation)
        LHW090, day 1|
    404 ( 358 )
    1710 ( 1600 )
        LHW090, day 28|
    682 ( 752 )
    1790 ( 1740 )
        LHV527, day 1|
    3490 ( 1700 )
    4670 ( 3050 )
        LHV527, day 28|
    3430 ( 1340 )
    7840 ( 3130 )
    No statistical analyses for this end point

    Secondary: Pharmacokinetics of LHW090/LHV527 in plasma:Tlast

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    End point title
    		 Pharmacokinetics of LHW090/LHV527 in plasma:Tlast [8]
    End point description
    Blood samples were collected to assess Tlast.
    End point type
    Secondary
    End point timeframe
    Within 60 min prior to dosing, post dose: +/- 5 min up to 3 hrs, +/- 10 min from ≥3 hrs up to 12 hrs on Day 1 and Day 28
    Notes
    [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analysis analyzed for this outcome measure
    End point values
    		 LHW090 100 mg LHW090 200 mg
    Number of subjects analysed
    17
    15
    Units: hour
    median (full range (min-max))
        LHW090, day 1|
    8.00 (7.07 to 8.08)
    8.00 (7.83 to 8.50)
        LHW090, day 28|
    8.00 (4.00 to 8.50)
    8.00 (7.83 to 8.50)
        LHV527, day 1|
    8.00 (7.07 to 8.08)
    8.00 (7.83 to 8.50)
        LHV527, day 28|
    8.00 (4.00 to 8.50)
    8.00 (7.38 to 8.08)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Serious Adverse Events are monitored from date of First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All other adverse events are monitored from First Patient First Treatment until Last Patient Last Visit.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    LHW090 100mg
    Reporting group description
    		 LHW090 100mg

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Reporting group title
    LHW090 200mg
    Reporting group description
    		 LHW090 200mg

    Serious adverse events
    		 LHW090 100mg Placebo LHW090 200mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 15 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 LHW090 100mg Placebo LHW090 200mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    12 / 17 (70.59%)
    14 / 32 (43.75%)
    3 / 15 (20.00%)
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 32 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    2
    0
    0
    Feeling hot
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 32 (3.13%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    Oedema peripheral
         subjects affected / exposed
    2 / 17 (11.76%)
    3 / 32 (9.38%)
    0 / 15 (0.00%)
         occurrences all number
    2
    3
    0
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 32 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Reproductive system and breast disorders
    Breast discomfort
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 32 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea exertional
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    Investigations
    Blood cholesterol increased
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 32 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Blood potassium increased
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 32 (3.13%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Cardiac murmur
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 32 (3.13%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Haematocrit increased
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 32 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Haemoglobin increased
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 32 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Weight increased
         subjects affected / exposed
    1 / 17 (5.88%)
    1 / 32 (3.13%)
    0 / 15 (0.00%)
         occurrences all number
    1
    1
    0
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    1 / 17 (5.88%)
    1 / 32 (3.13%)
    0 / 15 (0.00%)
         occurrences all number
    1
    1
    0
    Fall
         subjects affected / exposed
    1 / 17 (5.88%)
    1 / 32 (3.13%)
    0 / 15 (0.00%)
         occurrences all number
    1
    1
    0
    Cardiac disorders
    Sinus tachycardia
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 32 (3.13%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Syncope
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 32 (3.13%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Blood and lymphatic system disorders
    Iron deficiency anaemia
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 32 (3.13%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Lymphadenopathy
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 32 (3.13%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Thrombocytopenia
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 32 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Eye disorders
    Eyelid oedema
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 32 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Photopsia
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 32 (3.13%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 32 (3.13%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Constipation
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 32 (3.13%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Diarrhoea
         subjects affected / exposed
    1 / 17 (5.88%)
    1 / 32 (3.13%)
    1 / 15 (6.67%)
         occurrences all number
    2
    1
    1
    Gastrointestinal motility disorder
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 32 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 32 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Haematochezia
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 32 (3.13%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Haemorrhoids
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 32 (3.13%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Nausea
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 32 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Skin and subcutaneous tissue disorders
    Dermatosis
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 32 (3.13%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Erythema
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 32 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Pruritus
         subjects affected / exposed
    3 / 17 (17.65%)
    0 / 32 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    4
    0
    0
    Pruritus generalised
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 32 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Rash
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 32 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Skin discolouration
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 32 (3.13%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Skin irritation
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 32 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Renal and urinary disorders
    Pollakiuria
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 32 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Renal failure
         subjects affected / exposed
    1 / 17 (5.88%)
    1 / 32 (3.13%)
    1 / 15 (6.67%)
         occurrences all number
    1
    1
    1
    Urethral pain
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 32 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 32 (3.13%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Arthritis
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 32 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Back pain
         subjects affected / exposed
    0 / 17 (0.00%)
    2 / 32 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    0
    2
    0
    Muscular weakness
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    Neck pain
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 32 (3.13%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Pain in extremity
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 32 (3.13%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Infections and infestations
    Eye infection
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 32 (3.13%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 17 (0.00%)
    2 / 32 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    0
    2
    0
    Metabolism and nutrition disorders
    Gout
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 32 (3.13%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Hypercholesterolaemia
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 32 (3.13%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Hypokalaemia
         subjects affected / exposed
    0 / 17 (0.00%)
    2 / 32 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    0
    2
    0

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    13 Oct 2015
    Amendment 1 issued before study start provided pharmacokinetic based guidance for the initiation of an ACE inhibitor following discontinuation of study medication.
    06 Jan 2016
    Amendment 2, issued after inclusion of 1 patient, was generated in response to the following: • to include withdrawal criteria based on an upper limit blood pressure measurement • to add creatine kinase (CK) assessments to safety laboratory evaluations in order to satisfy requirements for CK monitoring • Request from the Health Authority in Germany (BfArM) to clarify extent of ophthalmologic screening for study patients
    28 Jan 2016
    Amendment 3 was done to update the eligibility criteria and clarified to exclude women of childbearing potential. Language was also updated throughout the protocol to clarify the allowed anti-hypertensive medications for inclusion in the study.
    08 Mar 2016
    Amendment 4 was generated to fulfill request of German Health Authority to add clarification in the protocol to highlight that all patients will be diagnostically evaluated for secondary hypertension according to clinical guidelines as part of screening assessments.
    22 Aug 2016
    Amendment 5 was proposed to eliminate the pharmacokinetic monitoring on Day 1. Based on the modeling of PK data obtained in a previous study, the expectation is that the Day 1 profile of LHW090/LHV527 in resistant hypertension patients in the study could be adequately characterized based on prior data and the data obtained to date in the patients that were already enrolled in this study. The protocol was thus amended to eliminate the 8 hours of pharmacokinetic monitoring on Day 1 so that on Day 1 patients could be released from the site after dosing at the Investigator’s discretion. Reducing the frequency of blood sampling also had the effect of reducing patient burden and adding scheduling flexibility which was expected to enhance patient recruitment.

    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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