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    Clinical Trial Results:
    A two part randomized, double-blind, parallel-group, placebo-controlled study to evaluate the renal safety, tolerability and pharmacokinetics of LHW090 in patients with moderately impaired renal function on angiotensin receptor blockers

    Summary
    EudraCT number
    		 2015-004570-15
    Trial protocol
    		 DE  
    Global end of trial date
    11 Oct 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    20 Oct 2019
    First version publication date
    20 Oct 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CLHW090X2102
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02678000
    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, novartis.email@novartis.com
    Scientific contact
    Clinical Disclosure Office, Novartis Pharma, AG, 41 6132411111, Novartis.email@novartis.com
    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
    11 Oct 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Oct 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The Primary Objective for Part 1 was to assess the safety and tolerability of ascending doses of LHW090 in patients with moderate renal impairment to inform design of Part 2. The primary objective for Part 2 was to assess the renal safety of LHW090 in patients with moderate renal impairment.
    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
    10 Mar 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
    Germany: 36
    Country: Number of subjects enrolled
    United States: 48
    Worldwide total number of subjects
    84
    EEA total number of subjects
    36
    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)
    22
    From 65 to 84 years
    62
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 All subjects (N=11) who enrolled in in PART 1 completed the study : LHW090 (N=7) and placebo (N=4). Of all subjects (N=73) in PART 2, a total of 69 subjects completed and 4 subjects discontinued.

    Pre-assignment
    Screening details
    		 All subjects (N=11) who enrolled in in PART 1 completed the study : LHW090 (N=7) and placebo (N=4). Of all subjects (N=73) in PART 2, a total of 69 subjects completed and 4 subjects discontinued.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 LHW090 (PART 1)
    Arm description
    		 For Part 1, patients will receive 3 doses of LHW090 once daily with escalating doses every 4 days for a total 12 days of treatment.
    Arm type
    		 Experimental

    Investigational medicinal product name
    LHW090
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    LHW090 25 mg, LHW090 50 mg, LHW090 100 mg

    Arm title
    		 Placebo (PART 1)
    Arm description
    		 For Part 1, patients will receive matching placebo once daily for 12 days.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo to match LHW090
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo 25 mg, 50 mg, 100 mg

    Arm title
    		 LHW090 100mg (PART 2)
    Arm description
    		 For PART 2, patients will receive LWH090 100 mg for 4 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    LHW090
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    LHW090 100 mg once daily for 4 weeks

    Arm title
    		 LHW090 200mg (PART 2)
    Arm description
    		 For PART 2, patients will receive LWH090 200 mg for 4 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    LHW090
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    LHW090 200 mg once daily for 4 weeks

    Arm title
    		 Placebo (PART 2)
    Arm description
    		 For Part 2, patients will receive matching placebo once daily for 4 weeks.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo once daily for 4 weeks

    Number of subjects in period 1
    		LHW090 (PART 1) Placebo (PART 1) LHW090 100mg (PART 2) LHW090 200mg (PART 2) Placebo (PART 2)
    Started
    7
    4
    28
    27
    18
    Completed
    7
    4
    25
    26
    18
    Not completed
    0
    0
    3
    1
    0
         Consent withdrawn by subject
    -
    -
    1
    -
    -
         Adverse event, non-fatal
    -
    -
    2
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    LHW090 (PART 1)
    Reporting group description
    		 For Part 1, patients will receive 3 doses of LHW090 once daily with escalating doses every 4 days for a total 12 days of treatment.

    Reporting group title
    Placebo (PART 1)
    Reporting group description
    		 For Part 1, patients will receive matching placebo once daily for 12 days.

    Reporting group title
    LHW090 100mg (PART 2)
    Reporting group description
    		 For PART 2, patients will receive LWH090 100 mg for 4 weeks

    Reporting group title
    LHW090 200mg (PART 2)
    Reporting group description
    		 For PART 2, patients will receive LWH090 200 mg for 4 weeks

    Reporting group title
    Placebo (PART 2)
    Reporting group description
    		 For Part 2, patients will receive matching placebo once daily for 4 weeks.

    Reporting group values
    		 LHW090 (PART 1) Placebo (PART 1) LHW090 100mg (PART 2) LHW090 200mg (PART 2) Placebo (PART 2) Total
    Number of subjects
    		 7 4 28 27 18 84
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 1 1 3 10 7 22
        From 65-84 years
    		 6 3 25 17 11 62
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 68.3 ( 3.64 ) 67.5 ( 16.01 ) 71.0 ( 9.18 ) 69.0 ( 8.82 ) 65.3 ( 11.58 ) -
    Sex: Female, Male
    Units: Subjects
        Female
    		 1 3 8 10 9 31
        Male
    		 6 1 20 17 9 53
    Race (NIH/OMB)
    Units: Subjects
        Black or African American
    		 1 1 1 3 0 6
        White
    		 6 3 27 24 18 78

    End points

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    End points reporting groups
    Reporting group title
    LHW090 (PART 1)
    Reporting group description
    		 For Part 1, patients will receive 3 doses of LHW090 once daily with escalating doses every 4 days for a total 12 days of treatment.

    Reporting group title
    Placebo (PART 1)
    Reporting group description
    		 For Part 1, patients will receive matching placebo once daily for 12 days.

    Reporting group title
    LHW090 100mg (PART 2)
    Reporting group description
    		 For PART 2, patients will receive LWH090 100 mg for 4 weeks

    Reporting group title
    LHW090 200mg (PART 2)
    Reporting group description
    		 For PART 2, patients will receive LWH090 200 mg for 4 weeks

    Reporting group title
    Placebo (PART 2)
    Reporting group description
    		 For Part 2, patients will receive matching placebo once daily for 4 weeks.

    Subject analysis set title
    LHW090 25 mg (PART 1)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    For Part 1, patients will receive 3 doses of LHW090 25 mg once daily with escalating doses every 4 days for a total 12 days of treatment.

    Subject analysis set title
    LHW090 50 mg (PART 1)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    For Part 1, patients will receive 3 doses of LHW090 50 mg once daily with escalating doses every 4 days for a total 12 days of treatment.

    Subject analysis set title
    LHW090 100 mg (PART 1)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    For Part 1, patients will receive 3 doses of LHW090 100 mg once daily with escalating doses every 4 days for a total 12 days of treatment.

    Subject analysis set title
    LHW090/LHV527 25 mg (PART 1)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    For Part 1, patients will receive 3 doses of LHW090 25 mg once daily with escalating doses every 4 days for a total 12 days of treatment. (PK draw with active metabolite, LHV527)

    Subject analysis set title
    LHW090/LHV527 50 mg (PART 1)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    For Part 1, patients will receive 3 doses of LHW090 50 mg once daily with escalating doses every 4 days for a total 12 days of treatment. (PK draw with active metabolite, LHV527)

    Subject analysis set title
    LHW090/LHV527 100 mg (PART 1)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    For Part 1, patients will receive 3 doses of LHW090 100 mg once daily with escalating doses every 4 days for a total 12 days of treatment. (PK draw with active metabolite, LHV527)

    Subject analysis set title
    LHW090 100 mg (PART 1)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    For Part 1, patients will receive 3 doses of LHW090 100 mg once daily with escalating doses every 4 days for a total 12 days of treatment

    Subject analysis set title
    LHW090 100 mg (PART 2)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    For PART 2, patients will receive LWH090 100 mg once daily for 4 weeks

    Subject analysis set title
    LHW090/LHV527 100 mg (PART 2)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    For PART 2, patients will receive LWH090 100 mg once daily for 4 weeks. (PK draw with active metabolite, LHV527)

    Subject analysis set title
    LHW090/LHV527 200 mg (PART 2)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    For PART 2, patients will receive LWH090 200 mg once daily for 4 weeks. (PK draw with active metabolite, LHV527)

    Primary: Number of patients with reported adverse events receiving escalating doses of LHW090 (Part 1)

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    End point title
    		 Number of patients with reported adverse events receiving escalating doses of LHW090 (Part 1) [1] [2]
    End point description
    Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. For LHW090, incidence of AEs by primary organ class presented
    End point type
    Primary
    End point timeframe
    Adverse events were collected from first dose of study treatment until end of study treatment, (12 days dosing period + 9 days follow up (PART 1) plus 30 days post treatment, up to maximum duration of approximately 20 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: Statistical Analysis was not planned
    [2] - 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: Statistical Analysis was not planned
    End point values
    		 Placebo (PART 1) LHW090 25 mg (PART 1) LHW090 50 mg (PART 1) LHW090 100 mg (PART 1)
    Number of subjects analysed
    4
    7
    7
    7
    Units: Count of Participants
        Number of patients with at least one AE
    2
    1
    0
    1
        Gastrointestinal disorders
    2
    1
    1
    1
        Skin and subcutaneous tissue disorders
    2
    0
    0
    1
        General disorders & administration site conditions
    1
    0
    0
    0
        Musculoskeletal and connective tissue disorders
    1
    0
    0
    0
        Nervous system disorders
    1
    0
    0
    0
        Psychiatric disorders
    1
    0
    0
    0
    No statistical analyses for this end point

    Primary: Pharmacokinetics of LHW090/LHV527 (active metabolite) in plasma: area under the plasma concentration-time curve from time zero time 't' where t is a defined time point after administration (AUC0-t) (PART 1)

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    End point title
    		 Pharmacokinetics of LHW090/LHV527 (active metabolite) in plasma: area under the plasma concentration-time curve from time zero time 't' where t is a defined time point after administration (AUC0-t) (PART 1) [3]
    End point description
    The area under the plasma concentration-time curve from time zero to 24 hours. Area Under the Curve (AUC0-t) after 4 days dosing will be reported for PART 1. LHW090 and LHV527 (its active metabolite)
    End point type
    Primary
    End point timeframe
    Within 60 minutes prior to dosing, post dose +/- 10 min from greater or equal to 1 hr to 24 hrs.
    Notes
    [3] - 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: Statistical Analysis was not planned
    End point values
    		 LHW090 25 mg (PART 1) LHW090 50 mg (PART 1) LHW090 100 mg (PART 1) LHW090/LHV527 25 mg (PART 1) LHW090/LHV527 50 mg (PART 1) LHW090/LHV527 100 mg (PART 1)
    Number of subjects analysed
    7
    7
    7
    6
    7
    7
    Units: h*ng/mL
        arithmetic mean (standard deviation)
    3750 ( 815 )
    7150 ( 1480 )
    13900 ( 2180 )
    19200 ( 3990 )
    36500 ( 5720 )
    68800 ( 11800 )
    No statistical analyses for this end point

    Primary: Number of patients who developed a renal event (PART 2)

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    End point title
    		 Number of patients who developed a renal event (PART 2) [4] [5]
    End point description
    Patients who developed a renal event will be reported (defined as a ≥0.3 mg/dL increase in serum creatinine from baseline within 24-48 hours post dose )
    End point type
    Primary
    End point timeframe
    Baseline, within 24 to 48 hours of post-dose weekly for up to 8 weeks
    Notes
    [4] - 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: Statistical Analysis was not planned
    [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: Statistical Analysis was not planned
    End point values
    		 LHW090 100mg (PART 2) LHW090 200mg (PART 2) Placebo (PART 2)
    Number of subjects analysed
    26
    26
    18
    Units: Participants
    0
    1
    0
    No statistical analyses for this end point

    Secondary: Cmax : Pharmacokinetics of LHW090/LHV527 (active metabolite) in plasma: observed maximum plasma concentration following administration of LHW090 (PART 1/PART 2)

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    End point title
    		 Cmax : Pharmacokinetics of LHW090/LHV527 (active metabolite) in plasma: observed maximum plasma concentration following administration of LHW090 (PART 1/PART 2) [6]
    End point description
    The observed maximum plasma (or serum or blood) concentration following drug administration for PART 1 and PART 2
    End point type
    Secondary
    End point timeframe
    PART 1: within 60 minutes prior to dosing, post dose +/- 10 min from greater or equal to 1 hr to 24 hrs. PART 2: within 60 min +/- 10 min from greater or equal to 1 hr to 8 hours after 4 weeks dosing.
    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: Statistical Analysis was not planned
    End point values
    		 LHW090 100mg (PART 2) LHW090 200mg (PART 2) LHW090 25 mg (PART 1) LHW090 50 mg (PART 1) LHW090 100 mg (PART 1)
    Number of subjects analysed
    6
    6
    7
    7
    7
    Units: ng / mL
    arithmetic mean (standard deviation)
        PK Value for LHW090
    4470 ( 1690 )
    7530 ( 3750 )
    1160 ( 589 )
    2000 ( 1020 )
    4230 ( 1400 )
        PK Value for LHW090/LHV527(active metabolite)
    6200 ( 1560 )
    10300 ( 1440 )
    1690 ( 338 )
    3070 ( 682 )
    5100 ( 734 )
    No statistical analyses for this end point

    Secondary: AUC0-t: Pharmacokinetics of LHW090/LHV527 (active metabolite)in plasma: area under the plasma concentration-time curve from time zero time 't' where t is a defined time point after administration (PART 2)

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    End point title
    		 AUC0-t: Pharmacokinetics of LHW090/LHV527 (active metabolite)in plasma: area under the plasma concentration-time curve from time zero time 't' where t is a defined time point after administration (PART 2) [7]
    End point description
    The area under the plasma concentration-time curve from time zero to 24 hours
    End point type
    Secondary
    End point timeframe
    PART 2: within60 min +/- 10 min from greater or equal to 1 hr to 8 hours after 4 weeks dosing.
    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: Statistical Analysis was not planned
    End point values
    		 LHW090 100mg (PART 2) LHW090 200mg (PART 2) LHW090/LHV527 100 mg (PART 2) LHW090/LHV527 200 mg (PART 2)
    Number of subjects analysed
    23
    26
    22
    25
    Units: h* ng/mL
        arithmetic mean (standard deviation)
    21500 ( 6810 )
    42900 ( 2700 )
    96700 ( 32800 )
    181000 ( 51100 )
    No statistical analyses for this end point

    Secondary: Tmax: Pharmacokinetics of LHW090/LHV527 in plasma: time to reach the maximum concentration after administration of LHW090 (PART 1/PART 2)

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    End point title
    		 Tmax: Pharmacokinetics of LHW090/LHV527 in plasma: time to reach the maximum concentration after administration of LHW090 (PART 1/PART 2) [8]
    End point description
    The time to reach the maximum concentration after drug administration
    End point type
    Secondary
    End point timeframe
    Part 1: within 60 minutes prior to dosing, post dose +/- 10 min from greater or equal to 1 hr to 24 hrs. Part2: within60 min +/- 10 min from greater or equal to 1 hr to 8 hours after 4 weeks dosing.
    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: Statistical Analysis was not planned
    End point values
    		 LHW090 100mg (PART 2) LHW090 200mg (PART 2) LHW090 25 mg (PART 1) LHW090 50 mg (PART 1) LHW090 100 mg (PART 1)
    Number of subjects analysed
    6
    6
    7
    7
    7
    Units: hour (hr)
    median (full range (min-max))
        PK Value for LHW090
    2.00 (1.00 to 4.00)
    2.50 (1.00 to 12.0)
    2.00 (1.00 to 3.00)
    1.02 (1.00 to 3.00)
    1.00 (1.00 to 4.00)
        PK Value for LHW090/LHV527(active metabolite)
    3.00 (2.00 to 8.00)
    4.00 (3.00 to 12.0)
    3.58 (2.00 to 12.0)
    4.00 (2.00 to 12.0)
    4.00 (2.00 to 8.00)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Treatment-emergent adverse events
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.1
    Reporting groups
    Reporting group title
    PART 1 LHW090 25 mg
    Reporting group description
    		 PART 1 LHW090 25 mg

    Reporting group title
    PART 1 LHW090 50 mg
    Reporting group description
    		 PART 1 LHW090 50 mg

    Reporting group title
    PART 1 LHW090 100 mg
    Reporting group description
    		 PART 1 LHW090 100 mg

    Reporting group title
    PART 1 Placebo
    Reporting group description
    		 PART 1 Placebo

    Reporting group title
    PART 2 LHW090 100 mg
    Reporting group description
    		 PART 2 LHW090 100 mg

    Reporting group title
    PART 2 LHW090 200 mg
    Reporting group description
    		 PART 2 LHW090 200 mg

    Reporting group title
    PART 2 Placebo
    Reporting group description
    		 PART 2 Placebo

    Serious adverse events
    		 PART 1 LHW090 25 mg PART 1 LHW090 50 mg PART 1 LHW090 100 mg PART 1 Placebo PART 2 LHW090 100 mg PART 2 LHW090 200 mg PART 2 Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    3 / 28 (10.71%)
    0 / 27 (0.00%)
    0 / 18 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Radius fracture
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    1 / 28 (3.57%)
    0 / 27 (0.00%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    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
    0 / 0
    Skin laceration
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    1 / 28 (3.57%)
    0 / 27 (0.00%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    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
    0 / 0
    Skin and subcutaneous tissue disorders
    Angioedema
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    1 / 28 (3.57%)
    0 / 27 (0.00%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    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
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 PART 1 LHW090 25 mg PART 1 LHW090 50 mg PART 1 LHW090 100 mg PART 1 Placebo PART 2 LHW090 100 mg PART 2 LHW090 200 mg PART 2 Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    2 / 4 (50.00%)
    13 / 28 (46.43%)
    16 / 27 (59.26%)
    9 / 18 (50.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Lipoma
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 28 (0.00%)
    1 / 27 (3.70%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    Vascular disorders
    Haematoma
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    1 / 28 (3.57%)
    0 / 27 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    1
    Hypotension
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    2 / 28 (7.14%)
    2 / 27 (7.41%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    2
    0
    General disorders and administration site conditions
    Chest discomfort
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 28 (0.00%)
    1 / 27 (3.70%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    Fatigue
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    2 / 28 (7.14%)
    1 / 27 (3.70%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    1
    0
    Infusion site haemorrhage
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 4 (25.00%)
    0 / 28 (0.00%)
    0 / 27 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Oedema peripheral
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    1 / 28 (3.57%)
    0 / 27 (0.00%)
    2 / 18 (11.11%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    2
    Pyrexia
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 28 (0.00%)
    0 / 27 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    Xerosis
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 28 (0.00%)
    0 / 27 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    1 / 28 (3.57%)
    0 / 27 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 28 (0.00%)
    1 / 27 (3.70%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    Epistaxis
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 28 (0.00%)
    0 / 27 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    Nasal dryness
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 28 (0.00%)
    1 / 27 (3.70%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    Nasal pruritus
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 28 (0.00%)
    4 / 27 (14.81%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    5
    0
    Oropharyngeal pain
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 28 (0.00%)
    1 / 27 (3.70%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    Rhinorrhoea
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 28 (0.00%)
    1 / 27 (3.70%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    1
    Psychiatric disorders
    Abnormal dreams
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 4 (25.00%)
    0 / 28 (0.00%)
    0 / 27 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Apathy
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    1 / 28 (3.57%)
    0 / 27 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    Insomnia
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 28 (0.00%)
    1 / 27 (3.70%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    Sleep disorder
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 28 (0.00%)
    2 / 27 (7.41%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    2
    0
    Investigations
    Blood creatinine increased
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 28 (0.00%)
    1 / 27 (3.70%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    2
    Blood pressure decreased
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 28 (0.00%)
    2 / 27 (7.41%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    2
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    1 / 28 (3.57%)
    1 / 27 (3.70%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    0
    Headache
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 4 (25.00%)
    1 / 28 (3.57%)
    0 / 27 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    0
    1
    1
    0
    0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    1 / 28 (3.57%)
    0 / 27 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    Eye disorders
    Eye pruritus
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    1 / 28 (3.57%)
    1 / 27 (3.70%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    0
    Lacrimation increased
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    1 / 28 (3.57%)
    0 / 27 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 28 (0.00%)
    0 / 27 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    Diarrhoea
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    2 / 28 (7.14%)
    4 / 27 (14.81%)
    1 / 18 (5.56%)
         occurrences all number
    1
    0
    0
    0
    2
    5
    1
    Dry mouth
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 4 (25.00%)
    0 / 28 (0.00%)
    0 / 27 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Dyspepsia
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 28 (0.00%)
    1 / 27 (3.70%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    1
    Faeces discoloured
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 4 (25.00%)
    0 / 28 (0.00%)
    0 / 27 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Frequent bowel movements
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 28 (0.00%)
    1 / 27 (3.70%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    3
    0
    Nausea
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    1 / 28 (3.57%)
    0 / 27 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    1 / 28 (3.57%)
    0 / 27 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    Alopecia
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 4 (25.00%)
    0 / 28 (0.00%)
    0 / 27 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Drug eruption
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 28 (0.00%)
    1 / 27 (3.70%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    Ecchymosis
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 4 (25.00%)
    0 / 28 (0.00%)
    0 / 27 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    1
    Pruritus
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 4 (0.00%)
    6 / 28 (21.43%)
    1 / 27 (3.70%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    1
    0
    11
    1
    2
    Pruritus generalised
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 28 (0.00%)
    2 / 27 (7.41%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    2
    0
    Rash macular
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 28 (0.00%)
    1 / 27 (3.70%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    1 / 28 (3.57%)
    0 / 27 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    Haematuria
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 28 (0.00%)
    0 / 27 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    Pollakiuria
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    1 / 28 (3.57%)
    1 / 27 (3.70%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 28 (0.00%)
    0 / 27 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    Back pain
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 28 (0.00%)
    1 / 27 (3.70%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    Muscle spasms
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 4 (25.00%)
    0 / 28 (0.00%)
    0 / 27 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Infections and infestations
    Gastrointestinal infection
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 28 (0.00%)
    1 / 27 (3.70%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 28 (0.00%)
    1 / 27 (3.70%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    1
    Rhinitis
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 28 (0.00%)
    1 / 27 (3.70%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    Urinary tract infection
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 28 (0.00%)
    1 / 27 (3.70%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 28 (0.00%)
    1 / 27 (3.70%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    Metabolism and nutrition disorders
    Gout
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 28 (0.00%)
    1 / 27 (3.70%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    Hyperkalaemia
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    1 / 28 (3.57%)
    1 / 27 (3.70%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    0
    Lactose intolerance
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 28 (0.00%)
    0 / 27 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    07 Aug 2017
    Amendment Version 04

    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
    For support, Contact us.
    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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