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    Clinical Trial Results:
    A multicenter, double blind, randomized, parallel group, placebo-controlled study to evaluate the effects of intravenous serelaxin infusion on micro- and macro-vascular function in patients with coronary artery disease

    Summary
    EudraCT number
    		 2012-001945-42
    Trial protocol
    		 GB  
    Global end of trial date
    17 Aug 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    31 Aug 2017
    First version publication date
    31 Aug 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CRLX030A2203
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01979614
    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
    12 Jun 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    17 Aug 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Aug 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the effects on the coronary vasculature, as assessed by myocardial perfusion/coronary flow reserve, at the end of the treatment (EoT) of 48hr i.v. administration of 30 μg/kg/24hr serelaxin or placebo; and to evaluate the effects on AIx at the EoT of 48hr i.v. administration of 30 μg/kg/24hr serelaxin or placebo
    Protection of trial subjects
    This study was conducted 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
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    03 Feb 2014
    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
    United Kingdom: 58
    Worldwide total number of subjects
    58
    EEA total number of subjects
    58
    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)
    36
    From 65 to 84 years
    22
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Out of the total 63 participants screened, 62 were randomized. 4 of the randomized participants did not receive study drug, and 58 did receive study drug

    Pre-assignment
    Screening details
    		 Of the 58 participants in the safety analysis set, 56 completed the treatment and follow-up period as planned (i.e. Day 30 and Day 180). Two participants, one in each treatment group, discontinued study prematurely due to AEs (unstable angina)

    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
    		 Investigator, Carer, Assessor, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Serelaxin
    Arm description
    		 Serelaxin was administered at a dose of 30 μg/kg/24h by intravenous infusion for 48 hours
    Arm type
    		 Experimental

    Investigational medicinal product name
    Serelaxin
    Investigational medicinal product code
    RLX030
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Serelaxin was administered at a dose of 30 μg/kg/24h by intravenous infusion for 48 hours

    Arm title
    		 Placebo
    Arm description
    		 Placebo was administered by intravenous infusion for 48 hours
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    RLX030
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo was administered by intravenous infusion for 48 hours

    Number of subjects in period 1
    		Serelaxin Placebo
    Started
    30
    28
    Safety Analysis Set
    30
    28
    PK Analysis Set
    30
    0 [1]
    PD Analysis Set
    25 [2]
    26 [3]
    Completed
    29
    27
    Not completed
    1
    1
         Adverse event, non-fatal
    1
    1
    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: Of the 58 participants in the safety analysis set, 56 completed the treatment and follow-up period as planned (i.e. Day 30 and Day 180). Two participants, one in each treatment group, discontinued study prematurely due to AEs (unstable angina)
    [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: Of the 58 participants in the safety analysis set, 56 completed the treatment and follow-up period as planned (i.e. Day 30 and Day 180). Two participants, one in each treatment group, discontinued study prematurely due to AEs (unstable angina)
    [3] - 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: Of the 58 participants in the safety analysis set, 56 completed the treatment and follow-up period as planned (i.e. Day 30 and Day 180). Two participants, one in each treatment group, discontinued study prematurely due to AEs (unstable angina)

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Serelaxin
    Reporting group description
    		 Serelaxin was administered at a dose of 30 μg/kg/24h by intravenous infusion for 48 hours

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo was administered by intravenous infusion for 48 hours

    Reporting group values
    		 Serelaxin Placebo Total
    Number of subjects
    		 30 28 58
    Age categorical
    Units: Subjects
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 62.6 ( 6.42 ) 60.1 ( 7.05 ) -
    Gender, Male/Female
    Units: Subjects
        Female
    		 3 2 5
        Male
    		 27 26 53

    End points

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    End points reporting groups
    Reporting group title
    Serelaxin
    Reporting group description
    		 Serelaxin was administered at a dose of 30 μg/kg/24h by intravenous infusion for 48 hours

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo was administered by intravenous infusion for 48 hours

    Primary: Statistical analysis of change from baseline to Day 3 in myocardial perfusion endpoints using ANCOVA

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    End point title
    		 Statistical analysis of change from baseline to Day 3 in myocardial perfusion endpoints using ANCOVA
    End point description
    Global MPRI (Myocardial Perfusion Reserve Index) is defined as ratio between mean global myocardial blood flow values at rest and during adenosine stress Participants who did not receive study drug as per study protocol, i.e. a reduced infusion rate, were excluded from this analysis
    End point type
    Primary
    End point timeframe
    baseline to Day 3
    End point values
    		 Serelaxin Placebo
    Number of subjects analysed
    22
    25
    Units: ratio
    arithmetic mean (confidence interval 95%)
        Global Myocardial Perfusion Reserve Index (MPRI)
    -0.244 (-0.454 to -0.035)
    -0.133 (-0.329 to -0.064)
        Mid Perfusion Reserve Index
    -0.264 (-0.519 to -0.01)
    -0.075 (-0.313 to 0.164)
    Statistical analysis title
    		 SAP for Global Myocardial Perfusion Reserve Index
    Statistical analysis description
    SAP for Global Myocardial Perfusion Reserve Index (MPRI)
    Comparison groups
    Serelaxin v Placebo
    Number of subjects included in analysis
    47
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.438
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.399
         upper limit
    		 0.176
    Statistical analysis title
    		 SAP for Mid Perfusion Reserve Index
    Statistical analysis description
    SAP for Mid Perfusion Reserve Index
    Comparison groups
    Serelaxin v Placebo
    Number of subjects included in analysis
    47
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.28
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.54
         upper limit
    		 0.16

    Secondary: Change from baseline in aortic distensibility measured by MRI

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    End point title
    		 Change from baseline in aortic distensibility measured by MRI
    End point description
    Summary table for measurements of arterial stiffness from cardiac MRI – Mean (SD) [n] Aortic distensibility was assessed by MRI and pulse wave velocity using the SphygmoCor device. (mmHg-1)
    End point type
    Secondary
    End point timeframe
    At pre-dose on Day 1 (baseline) until Day 180 after the start of drug infusion
    End point values
    		 Serelaxin Placebo
    Number of subjects analysed
    25
    26
    Units: mmHg-1
    arithmetic mean (standard deviation)
        Ascending Aorta Distensibility, Day 0 (n=24,22)
    0.0017 ( 0.00158 )
    0.0014 ( 0.00192 )
        Ascending Aorta Distensibility, Day 47 (n=23, 22)
    0.0015 ( 0.00124 )
    0.0015 ( 0.00134 )
        Descending Aorta Distensibility, Day 0 (n=24,21)
    0.0023 ( 0.00146 )
    0.0019 ( 0.00221 )
        Descending Aorta Distensibility, Day 47 (n=23,22)
    0.0023 ( 0.00118 )
    0.0023 ( 0.00142 )
        Peak Flow Velocity (cm/s), Day 0 (n=24,24)
    127.994 ( 66.6941 )
    102.699 ( 33.894 )
        Peak Flow Velocity (cm/s), Day 47 (n=23, 25)
    127.981 ( 60.7571 )
    106.557 ( 38.9573 )
    No statistical analyses for this end point

    Secondary: Change from baseline in aortic velocity

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    End point title
    		 Change from baseline in aortic velocity
    End point description
    Summary table for measurements of arterial velocity from cardiac MRI – Mean (SD) [n] Aortic distensibility was assessed by MRI and pulse wave velocity using the SphygmoCor device. (mmHg-1)
    End point type
    Secondary
    End point timeframe
    At pre-dose on Day 1 (baseline) until Day 180 after the start of drug infusion
    End point values
    		 Serelaxin Placebo
    Number of subjects analysed
    25
    26
    Units: mmHg-1
    arithmetic mean (standard deviation)
        Peak Flow Velocity (cm/s), Day 0 (n=24, 24)
    127.981 ( 60.7571 )
    106.557 ( 38.9573 )
        Peak Flow Velocity (cm/s), Day 47 (n=23, 25)
    127.981 ( 60.7571 )
    106.557 ( 38.9573 )
    No statistical analyses for this end point

    Secondary: Change from baseline in augmentation index measured from Sphygmocor device

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    End point title
    		 Change from baseline in augmentation index measured from Sphygmocor device
    End point description
    Summary of values and change from baseline in augmentation index by time and treatment The change from baseline in Augmentation Index was analyzed using a repeated measures analysis of covariance including treatment, time, treatment by time, baseline by time interactions and baseline as fixed factors with an unstructured variance-covariance matrixStatistical analysis of change from baseline in augmentation index using repeated measures Analysis of Covariance For analysis of change from baseline, only subjects with results at both baseline and post-baseline could be included The augmentation index is a ratio calculated from the blood pressure waveform, it is a measure of wave reflection and arterial stiffness. Augmentation index is commonly accepted as a measure of the enhancement (augmentation) of central aortic pressure by a reflected pulse wave
    End point type
    Secondary
    End point timeframe
    At pre-dose on Day 1 (baseline) until Day 180 after the start of drug infusion
    End point values
    		 Serelaxin Placebo
    Number of subjects analysed
    25
    26
    Units: ratio
    arithmetic mean (standard deviation)
        DAY 1, 2h (n=23,25)
    -4.12 ( 11.441 )
    -2.48 ( 11.56 )
        DAY 1, 6h (n=24,26)
    -2.99 ( 9.066 )
    -0.58 ( 9.551 )
        DAY 2, 24h (n=24,25)
    -0.82 ( 8.173 )
    0.22 ( 9.906 )
        DAY 3, 47h (n=23,25)
    3.51 ( 10.608 )
    0.22 ( 12.057 )
        DAY 3, 50h (n=22, 24)
    -0.67 ( 13.034 )
    -3.81 ( 9.397 )
        DAY 3, 54h (n=22,25)
    -1.37 ( 12.253 )
    -0.48 ( 11.748 )
        DAY 30 (n=25, 26)
    -0.83 ( 11.462 )
    0.58 ( 12.124 )
        DAY 180 (n=24,25) end of study
    0.24 ( 6.885 )
    0.54 ( 11.795 )
    No statistical analyses for this end point

    Secondary: Statistical analysis of change from baseline in augmentation index using repeated measures Analysis of Covariance

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    End point title
    		 Statistical analysis of change from baseline in augmentation index using repeated measures Analysis of Covariance
    End point description
    The change from baseline in Augmentation Index was analyzed using a repeated measures analysis of covariance including treatment, time, treatment by time, baseline by time interactions and baseline as fixed factors with an unstructured variance-covariance matrixStatistical analysis of change from baseline in augmentation index using repeated measures Analysis of Covariance For analysis of change from baseline, only subjects with results at both baseline and post-baseline could be included The augmentation index is a ratio calculated from the blood pressure waveform, it is a measure of wave reflection and arterial stiffness. Augmentation index is commonly accepted as a measure of the enhancement (augmentation) of central aortic pressure by a reflected pulse wave
    End point type
    Secondary
    End point timeframe
    At pre-dose on Day 1 (baseline) until Day 180 after the start of drug infusion
    End point values
    		 Serelaxin Placebo
    Number of subjects analysed
    25
    26
    Units: ratio
    arithmetic mean (confidence interval 95%)
        DAY 1, 2h (n=23,25)
    -4.088 (-7.967 to -0.21)
    -1.97 (-5.693 to 1.753)
        DAY 1, 6h (n=24,26)
    -3.277 (-6.129 to -0.425)
    -0.394 (-3.139 to 2.352)
        DAY 2, 24h (n=24,25)
    -0.774 (-4.016 to 2.469)
    0.07 (-3.108 to 3.247)
        DAY 3, 47h (n=23,25)
    3.488 (-0.47 to 7.445)
    0.035 (-3.778 to 3.849)
        DAY 3, 50h (n=22, 24)
    -0.764 (-5.208 to 3.68)
    -4.015 (-8.273 to 0.243)
        DAY 3, 54h (n=22,25)
    -1.737 (-5.915 to 2.44)
    -0.753 (-4.689 to 3.182)
        DAY 30 (n=25, 26)
    -0.979 (-4.912 to 2.954)
    0.776 (-3.081 to 4.633)
        DAY 180 (n=24,25) end of study
    0.234 (-3.066 to 3.535)
    0.284 (-2.95 to 3.518)
    No statistical analyses for this end point

    Secondary: Change from baseline in pulse wave velocity measured from carotid-femoral pulse wave analysis

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    End point title
    		 Change from baseline in pulse wave velocity measured from carotid-femoral pulse wave analysis
    End point description
    Summary of augmentation index for all visits by time and treatment Pulse wave velocity was assessed by the SphygmoCor device at pre-dose on Day1, and at 24, 47h, Day 30, and Day 180 after the start of drug infusion The augmentation index is a ratio calculated from the blood pressure waveform, it is a measure of wave reflection and arterial stiffness. Augmentation index is commonly accepted as a measure of the enhancement (augmentation) of central aortic pressure by a reflected pulse wave
    End point type
    Secondary
    End point timeframe
    At pre-dose on Day1 (baseline) until Day 180 after the start of drug infusion
    End point values
    		 Serelaxin Placebo
    Number of subjects analysed
    25
    26
    Units: meters/second
    arithmetic mean (standard deviation)
        DAY 1, 0hrs (n=25,26)
    7.453 ( 2.0541 )
    8.166 ( 1.9515 )
        DAY 2, 24hrs (n=19,24)
    7.051 ( 1.879 )
    7.677 ( 2.1361 )
        DAY 3, 47hrs (n=22,23)
    7.195 ( 1.9164 )
    8.264 ( 2.4964 )
        DAY 30, 0hrs (n=23, 24)
    7.989 ( 1.8151 )
    8.463 ( 2.4437 )
        DAY 3, 47hrs (n=23,25)
    29.57 ( 9.751 )
    26.04 ( 10.039 )
        EOS (n=23,24)
    8.335 ( 2.1087 )
    8.844 ( 2.1739 )
    No statistical analyses for this end point

    Secondary: Serum concentration of serelaxin

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    End point title
    		 Serum concentration of serelaxin
    End point description
    Summary statistics of serelaxin serum PK concentrations Blood samples were taken to measure serelaxin concentration at Pre-dose on Day 1, and at 24h, 48h, 50h, 54h, and Day 30 after the start of the 48h drug infusion. The steady state concentration was estimated using the serum concentration at the 48h timepoint
    End point type
    Secondary
    End point timeframe
    From pre-dose on Day 1 until Day 30 after the start of drug infusion
    End point values
    		 Serelaxin Placebo
    Number of subjects analysed
    30
    0 [1]
    Units: pg/mL
    arithmetic mean (standard deviation)
        DAY 1, 0hrs (n=30)
    0.637 ( 3.49 )
    ( )
        DAY 2, 24hrs, (n=26)
    27600 ( 79000 )
    ( )
        DAY 3, 48hrs (n=22)
    26300 ( 48000 )
    ( )
        DAY 3, 50 hrs (n=21)
    7940 ( 8450 )
    ( )
        DAY 3, 54hrs, (n=22)
    3960 ( 3140 )
    ( )
        DAY 30 (n=30)
    0 ( 0 )
    ( )
    Notes
    [1] - Summary statistics of serelaxin serum PK concentrations Blood samples were taken to measure serelaxi
    No statistical analyses for this end point

    Secondary: Serum concentration of antibodies to serelaxin

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    End point title
    		 Serum concentration of antibodies to serelaxin
    End point description
    Frequency and percentage of anti-Serelaxin antibodies Blood samples were taken to measure antibodies to serelaxin concentration at Pre-dose on Day 1, and at Day 30 after the start of the 48h drug infusion N: The total number of subjects in the treatment group n: Number of subjects who are at the corresponding category m: Number of subjects with an available response at the visit
    End point type
    Secondary
    End point timeframe
    From pre-dose on Day 1 until Day 30 after the start of drug infusion
    End point values
    		 Serelaxin Placebo
    Number of subjects analysed
    30
    28
    Units: ratio (n/m) expressed as a percentage
        DAY 1 NEGATIVE
    100
    100
        DAY 1 POSITIVE
    0
    0
        DAY 30 NEGATIVE
    100
    100
        DAY 30 POSITIVE
    0
    0
    No statistical analyses for this end point

    Secondary: Systemic clearance of serelaxin

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    End point title
    		 Systemic clearance of serelaxin [2]
    End point description
    Systemic clearance was estimated using the rate of serelaxin infusion and the steady state concentration
    End point type
    Secondary
    End point timeframe
    From pre-dose on Day 1 until 48h after the start of drug infusion
    Notes
    [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: Summary statistics of serelaxin serum PK concentrations Blood samples were taken to measure serelaxin concentration at Pre-dose on Day 1, and at 24h, 48h, 50h, 54h, and Day 30 after the start of the 48h drug infusion. The steady state concentration was estimated using the serum concentration at the 48h timepoint
    End point values
    		 Serelaxin
    Number of subjects analysed
    22
    Units: CL (mL/hr/kg)
        arithmetic mean (standard deviation)
    107 ( 80.6 )
    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
    19.0
    Reporting groups
    Reporting group title
    Serelaxin
    Reporting group description
    		 Serelaxin

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Serious adverse events
    		 Serelaxin Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 30 (16.67%)
    7 / 28 (25.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Cardiac procedure complication
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 28 (3.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular procedure complication
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 28 (3.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    2 / 30 (6.67%)
    1 / 28 (3.57%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina pectoris
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 28 (3.57%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina unstable
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 28 (3.57%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Presyncope
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 28 (3.57%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Type IV hypersensitivity reaction
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 28 (3.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoxia
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 28 (3.57%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 28 (3.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Angioedema
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dermatitis allergic
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 28 (3.57%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Musculoskeletal pain
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neck pain
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 28 (3.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Serelaxin Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    16 / 30 (53.33%)
    18 / 28 (64.29%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Hypotension
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Peripheral coldness
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Fatigue
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Feeling cold
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    1
    Influenza like illness
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    1
    Pyrexia
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Dyspnoea exertional
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Pulmonary mass
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    1
    Pulmonary oedema
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    1
    Throat tightness
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Psychiatric disorders
    Agitation
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    1
    Depressed mood
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    1
    Insomnia
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    1
    Investigations
    Amylase increased
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Blood cholesterol increased
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Blood creatine phosphokinase increased
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Blood creatinine increased
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 28 (3.57%)
         occurrences all number
    1
    1
    Blood sodium decreased
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    1
    Electrocardiogram Q wave abnormal
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Glomerular filtration rate decreased
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Haematocrit decreased
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 28 (3.57%)
         occurrences all number
    1
    1
    Haemoglobin decreased
         subjects affected / exposed
    2 / 30 (6.67%)
    2 / 28 (7.14%)
         occurrences all number
    2
    2
    Lipase increased
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Platelet count increased
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    QRS axis abnormal
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Red blood cell count decreased
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    0 / 30 (0.00%)
    2 / 28 (7.14%)
         occurrences all number
    0
    2
    Extrasystoles
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Tachycardia
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    2 / 30 (6.67%)
    2 / 28 (7.14%)
         occurrences all number
    2
    2
    Headache
         subjects affected / exposed
    2 / 30 (6.67%)
    4 / 28 (14.29%)
         occurrences all number
    2
    4
    Presyncope
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    1
    Sciatica
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    1
    Somnolence
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Dyspepsia
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    1
    Vomiting
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    1
    Skin exfoliation
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Renal and urinary disorders
    Renal impairment
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Muscle spasms
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Muscle tightness
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    1
    Musculoskeletal chest pain
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    1
    Musculoskeletal pain
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Pain in extremity
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    1
    Infections and infestations
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    1
    Urinary tract infection
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    1
    Wound infection
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Metabolism and nutrition disorders
    Hypertriglyceridaemia
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 28 (0.00%)
         occurrences all number
    1
    0
    Hypokalaemia
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    1
    Hypomagnesaemia
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    1
    Type 2 diabetes mellitus
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 28 (3.57%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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