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    Clinical Trial Results:
    A multi-center, double-blind, randomized, placebo-controlled study to assess the pharmacodynamics, pharmacokinetics, tolerability, and safety of a single subcutaneous injection of ACT-246475 in adults with stable coronary artery disease

    Summary
    EudraCT number
    		 2017-003332-36
    Trial protocol
    		 GB   DK   SE   NL   DE  
    Global end of trial date
    18 Sep 2018

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

    Trial information

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    Trial identification
    Sponsor protocol code
    ID-076A201
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03384966
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Idorsia Pharmaceuticals Ltd.
    Sponsor organisation address
    ​Hegenheimermattweg 91 , Allschwil, Switzerland, 4123
    Public contact
    Clinical Trial Disclosure Desk, Idorsia Pharmaceuticals Ltd., clinical-trials-disclosure@idorsia.com
    Scientific contact
    Clinical Trial Disclosure Desk, Idorsia Pharmaceuticals Ltd., clinical-trials-disclosure@idorsia.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
    26 Oct 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    18 Aug 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Sep 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study was to characterize inhibition of ADP-mediated platelet aggregation relative to placebo after a single subcutaneous injection of selatogrel (ACT-246475) either in the thigh or in the abdomen at 2 different doses in subjects with stable coronary artery disease receiving conventional background oral anti-platelet therapy (e.g., acetylsalicylic acid, P2Y12 receptor antagonists).
    Protection of trial subjects
    Prior to the start of the study, each study site consulted an independent ethics committee (IEC) or institutional review board (IRB), i.e., a review panel that was responsible for ensuring the protection of the rights, safety, and well-being of human subjects involved in a clinical investigation. The protocol and any material provided to the subject (such as a subject information sheet or description of the study used to obtain informed consent) were reviewed and approved by the appropriate Independent ethics committee or institutional review board before the study was started. Written informed consent was obtained from each individual participating in the study after adequate explanation of the aims, methods, objectives, and potential hazards of the study. An Independent Safety Event Committee (ISEC) had overall responsibility for safeguarding the interests of subjects by monitoring study safety data in an unblinded manner, with a specific focus on clinically relevant major bleeding events.
    Background therapy
    		 The subject’s standard of care was not affected by study participation. For this study, subjects received a single administration of study drug on top of their standard of care treatment. Unless medically necessary, subjects continued their standard treatment(s) (including oral P2Y12 receptor antagonists and acetylsalicylic acid) as prescribed (treatments and doses), from Visit 1 (screening) and up to the last PK or PD blood sample collection (whichever was latest) at Visit 3 (Day 2).
    Evidence for comparator
    		 -
    Actual start date of recruitment
    24 Jan 2018
    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
    Netherlands: 66
    Country: Number of subjects enrolled
    Sweden: 30
    Country: Number of subjects enrolled
    United Kingdom: 77
    Country: Number of subjects enrolled
    Denmark: 1
    Country: Number of subjects enrolled
    Germany: 5
    Country: Number of subjects enrolled
    Canada: 6
    Country: Number of subjects enrolled
    Singapore: 8
    Country: Number of subjects enrolled
    United States: 153
    Worldwide total number of subjects
    346
    EEA total number of subjects
    179
    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)
    151
    From 65 to 84 years
    195
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was conducted between 24 Jan and 18 Sep 2018. Of the 362 subjects screened, 346 subjects were randomized and 345 subjects were treated. One subject randomized to the 8 mg selatogrel arm did not receive the treatment allocated by the investigator due to a myocardial infarction on the day of randomization.

    Pre-assignment
    Screening details
    		 The study had a 21 day screening period window before study randomization.

    Period 1
    Period 1 title
    Treatment period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer
    Blinding implementation details
    The double-blind design applied only to the treatment allocation (i.e., Selatogrel [ACT-246475 versus placebo]). The dose was blinded to the subjects only (single blind), and the injection site was not blinded.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Selatogrel 8 mg
    Arm description
    		 A single 8 mg dose of selatogrel (ACT-246475) was administered via a single subcutaneous (s.c.) injection either in the abdomen or the thigh.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Selatogrel
    Investigational medicinal product code
    ACT-246475
    Other name
    Pharmaceutical forms
    Powder for suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Selatogrel (ACT-246475) is a reversible P2Y12 receptor antagonist for s.c. administration. It was supplied in sealed glass vials at a strength of 20 mg. The vials contained 22 mg of lyophilized Selatogrel (ACT-246475A) for reconstitution with water for injection. Selatogrel (ACT-246475) was given as a single s.c. dose of 8 mg administered in a volume of 0.8 mL. Administration was performed at the investigational site by qualified personnel.

    Arm title
    		 Selatogrel 16 mg
    Arm description
    		 A single 16 mg dose of selatogrel (ACT-246475) was administered via a single subcutaneous (s.c.) injection either in the abdomen or the thigh.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Selatogrel
    Investigational medicinal product code
    ACT-246475
    Other name
    Pharmaceutical forms
    Powder for suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Selatogrel (ACT-246475) is a reversible P2Y12 receptor antagonist for s.c. administration. It was supplied in sealed glass vials at a strength of 20 mg. The vials contained 22 mg of lyophilized Selatogrel (ACT-246475A) for reconstitution with water for injection. Selatogrel (ACT-246475) was given as a single s.c. dose of 16 mg administered in a volume of 0.8 mL. Administration was performed at the investigational site by qualified personnel.

    Arm title
    		 Matching Placebo
    Arm description
    		 Matching placebo was administered via single subcutaneous (s.c.) administration either in the thigh or the abdomen.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Matching Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo matching lyophilized Selatogrel (ACT-246475A) for s.c. administration was supplied in sealed glass vials for reconstitution with water for injection. Placebo was given as a single s.c. dose matching 8 or 16 mg ACT-246475 administered in a volume of 0.8 mL. Administration was performed at the investigational site by qualified personnel.

    Number of subjects in period 1
    		Selatogrel 8 mg Selatogrel 16 mg Matching Placebo
    Started
    115
    115
    116
    Completed
    114
    115
    116
    Not completed
    1
    0
    0
         Physician decision
    1
    -
    -
    Period 2
    Period 2 title
    Follow-up period
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    This was a non-treatment period, the blinding of single-dose from the treatment period was maintained.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Selatogrel 8 mg (Follow-up)
    Arm description
    		 During this time the subjects were continued to be observed following the treatment period. No interventions were performed. The follow-up period was planned to last 28 to 35 days. The period started on Day 3 and ended with the safety follow-up telephone call or visit.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Selatogrel 16 mg (Follow-up)
    Arm description
    		 During this time the subjects were continued to be observed following the treatment period. No interventions were performed. The follow-up period was planned to last 28 to 35 days. The period started on Day 3 and ended with the safety follow-up telephone call or visit.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Matching Placebo (Follow-up)
    Arm description
    		 During this time the subjects were continued to be observed following the treatment period. No interventions were performed. The follow-up period was planned to last 28 to 35 days. The period started on Day 3 and ended with the safety follow-up telephone call or visit.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 2
    		Selatogrel 8 mg (Follow-up) Selatogrel 16 mg (Follow-up) Matching Placebo (Follow-up)
    Started
    114
    115
    116
    Completed
    113
    115
    116
    Not completed
    1
    0
    0
         Adverse event, serious fatal
    1
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Selatogrel 8 mg
    Reporting group description
    		 A single 8 mg dose of selatogrel (ACT-246475) was administered via a single subcutaneous (s.c.) injection either in the abdomen or the thigh.

    Reporting group title
    Selatogrel 16 mg
    Reporting group description
    		 A single 16 mg dose of selatogrel (ACT-246475) was administered via a single subcutaneous (s.c.) injection either in the abdomen or the thigh.

    Reporting group title
    Matching Placebo
    Reporting group description
    		 Matching placebo was administered via single subcutaneous (s.c.) administration either in the thigh or the abdomen.

    Reporting group values
    		 Selatogrel 8 mg Selatogrel 16 mg Matching Placebo Total
    Number of subjects
    		 115 115 116 346
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 48 48 55 151
        From 65-84 years
    		 67 67 61 195
    Age continuous
    Units: years
        median (full range (min-max))
    		 67 (41 to 80) 67 (41 to 82) 65 (36 to 83) -
    Gender categorical
    Units: Subjects
        Female
    		 20 26 23 69
        Male
    		 95 89 93 277
    Race
    Units: Subjects
        Black or African American
    		 10 13 9 32
        Asian
    		 7 6 4 17
        White
    		 98 96 103 297
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 1 1 0 2
        Not Hispanic or Latino
    		 114 114 116 344
    Body Mass Index
    Units: kg/m^2
        arithmetic mean (standard deviation)
    		 29.0 ± 5.0 29.4 ± 5.7 30.6 ± 4.9 -

    End points

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    End points reporting groups
    Reporting group title
    Selatogrel 8 mg
    Reporting group description
    		 A single 8 mg dose of selatogrel (ACT-246475) was administered via a single subcutaneous (s.c.) injection either in the abdomen or the thigh.

    Reporting group title
    Selatogrel 16 mg
    Reporting group description
    		 A single 16 mg dose of selatogrel (ACT-246475) was administered via a single subcutaneous (s.c.) injection either in the abdomen or the thigh.

    Reporting group title
    Matching Placebo
    Reporting group description
    		 Matching placebo was administered via single subcutaneous (s.c.) administration either in the thigh or the abdomen.
    Reporting group title
    Selatogrel 8 mg (Follow-up)
    Reporting group description
    		 During this time the subjects were continued to be observed following the treatment period. No interventions were performed. The follow-up period was planned to last 28 to 35 days. The period started on Day 3 and ended with the safety follow-up telephone call or visit.

    Reporting group title
    Selatogrel 16 mg (Follow-up)
    Reporting group description
    		 During this time the subjects were continued to be observed following the treatment period. No interventions were performed. The follow-up period was planned to last 28 to 35 days. The period started on Day 3 and ended with the safety follow-up telephone call or visit.

    Reporting group title
    Matching Placebo (Follow-up)
    Reporting group description
    		 During this time the subjects were continued to be observed following the treatment period. No interventions were performed. The follow-up period was planned to last 28 to 35 days. The period started on Day 3 and ended with the safety follow-up telephone call or visit.

    Subject analysis set title
    Selatogrel 8 mg Pharmacokinetic Analysis Set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The Pharmacokinetic Analysis Set includes all subjects who had at least one plasma concentration measurement after administration of study treatment. One subject did not receive study drug and 3 subjects had no plasma concentration measurement after administration of study treatment.

    Subject analysis set title
    Selatogrel 16 mg Pharmacokinetic Analysis Set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The Pharmacokinetic Analysis Set includes all subjects who had at least one plasma concentration measurement after administration of study treatment.

    Primary: Primary Pharmacodynamic Response

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    End point title
    		 Primary Pharmacodynamic Response
    End point description
    The primary pharmacodynamic endpoint was the pharmacodynamic response, which was defined for each subject as a P2Y12 Reaction Units < 100 starting 30 minutes after injection and lasting for at least 3 hours, as measured via the VerifyNow® assay.
    End point type
    Primary
    End point timeframe
    30 minutes after study drug administration (injection) and lasting for at least 3 h (based on nominal time).
    End point values
    		 Selatogrel 8 mg Selatogrel 16 mg Matching Placebo
    Number of subjects analysed
    114 [1]
    115 [2]
    116 [3]
    Units: subjects
        Responder
    102
    103
    18
    Notes
    [1] - Full Analysis Set
    [2] - Full Analysis Set
    [3] - Full Analysis Set
    Statistical analysis title
    		 Selatogrel 8 mg versus Matching Placebo
    Statistical analysis description
    The primary goal was to determine that the proportion of subjects receiving a dose of selatogrel, who achieved a pharmacodynamic response as measured by VerifyNow® is statistically greater than 70%.
    Comparison groups
    Selatogrel 8 mg v Matching Placebo
    Number of subjects included in analysis
    230
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [4]
    Method
    		 Chi-squared
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    58.9
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 22.4
         upper limit
    		 154.8
    Notes
    [4] - P value significance level was set to 0.025, i.e. type I error (0.05) adjusted for multiplicity (2 comparisons) using a Bonferroni approach.
    Statistical analysis title
    		 Selatogrel 16 mg versus Matching Placebo
    Statistical analysis description
    The primary goal was to determine that the proportion of subjects receiving a dose of selatogrel, who achieved a pharmacodynamic response as measured by VerifyNow® is statistically greater than 70%.
    Comparison groups
    Selatogrel 16 mg v Matching Placebo
    Number of subjects included in analysis
    231
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [5]
    Method
    		 Chi-squared
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    61.2
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 23.1
         upper limit
    		 162.3
    Notes
    [5] - P value significance level was set to 0.025, i.e. type I error (0.05) adjusted for multiplicity (2 comparisons) using a Bonferroni approach.

    Secondary: Maximum plasma concentration - cmax

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    End point title
    		 Maximum plasma concentration - cmax
    End point description
    The plasma pharmacokinetic parameters of selatogrel (ACT-246475) were derived by non-compartmental analyses of the plasma concentration-time profiles.
    End point type
    Secondary
    End point timeframe
    Plasma concentrations at all scheduled sampling time points (pre-dose, 15 minutes, 30 minutes, and 1,2,4,8 and 24 hours post dose).
    End point values
    		 Selatogrel 8 mg Pharmacokinetic Analysis Set Selatogrel 16 mg Pharmacokinetic Analysis Set
    Number of subjects analysed
    111
    115
    Units: ng/mL
        geometric mean (full range (min-max))
    298 (146 to 868)
    484 (161 to 1030)
    No statistical analyses for this end point

    Secondary: Time to reach maximum plasma concentration - Tmax

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    End point title
    		 Time to reach maximum plasma concentration - Tmax
    End point description
    Tmax was derived by non-compartmental analysis of the plasma concentration time.
    End point type
    Secondary
    End point timeframe
    Plasma concentrations at all scheduled sampling time points (pre-dose, 15 minutes, 30 minutes, and 1,2,4,8 and 24 hours post dose).
    End point values
    		 Selatogrel 8 mg Pharmacokinetic Analysis Set Selatogrel 16 mg Pharmacokinetic Analysis Set
    Number of subjects analysed
    111
    115
    Units: hour
        median (full range (min-max))
    0.52 (0.38 to 1.05)
    0.53 (0.23 to 2.02)
    No statistical analyses for this end point

    Secondary: Area under the plasma concentration-time curve from time zero to 24 hour time point - AUC0-24

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    End point title
    		 Area under the plasma concentration-time curve from time zero to 24 hour time point - AUC0-24
    End point description
    The plasma PK parameters of selatogrel (ACT-246475) were derived by non-compartmental analyses of the plasma concentration-time profiles.
    End point type
    Secondary
    End point timeframe
    Plasma concentrations at all scheduled sampling time points (pre-dose, 15 minutes, 30 minutes, and 1,2,4,8 and 24 hours post dose).
    End point values
    		 Selatogrel 8 mg Pharmacokinetic Analysis Set Selatogrel 16 mg Pharmacokinetic Analysis Set
    Number of subjects analysed
    111
    115
    Units: h*ng/mL
        geometric mean (full range (min-max))
    716 (347 to 1425)
    1358 (487 to 2758)
    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 (TEAEs) were those adverse events with onset date/time after the date/time of study drug administration and up to 48 hours after the date/time of study treatment administration.
    Adverse event reporting additional description
    Follow-up period: SAEs were reported (none of them as treatment related) between Day 12 and Day 31 in 5 subjects in selatogrel 8 mg group (atrial fibrillation, ventricular fibrillation and fatal cardiac arrest, syncope, non cardiac chest pain and angina pectoris); 1 in 16 mg group (costochondritis) and 1 in placebo group (myocardial infarction).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.0
    Reporting groups
    Reporting group title
    Selatogrel 8 mg
    Reporting group description
    		 Treatment emergent adverse events (TEAEs) were those adverse events with onset date/time after the date/time of study drug administration and up to 48 hours after the date/time of study treatment administration.

    Reporting group title
    Selatogrel 16 mg
    Reporting group description
    		 Treatment emergent adverse events (TEAEs) were those adverse events with onset date/time after the date/time of study drug administration and up to 48 hours after the date/time of study treatment administration.

    Reporting group title
    Matching Placebo
    Reporting group description
    		 Treatment emergent adverse events (TEAEs) were those adverse events with onset date/time after the date/time of study drug administration and up to 48 hours after the date/time of study treatment administration.

    Serious adverse events
    		 Selatogrel 8 mg Selatogrel 16 mg Matching Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 115 (0.00%)
    0 / 116 (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
    		 Selatogrel 8 mg Selatogrel 16 mg Matching Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    36 / 114 (31.58%)
    26 / 115 (22.61%)
    25 / 116 (21.55%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 115 (0.87%)
    2 / 116 (1.72%)
         occurrences all number
    0
    1
    2
    Hypotension
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 115 (0.87%)
    0 / 116 (0.00%)
         occurrences all number
    0
    1
    0
    General disorders and administration site conditions
    Injection site bruising
         subjects affected / exposed
    3 / 114 (2.63%)
    2 / 115 (1.74%)
    0 / 116 (0.00%)
         occurrences all number
    3
    2
    0
    Injection site erythema
         subjects affected / exposed
    0 / 114 (0.00%)
    2 / 115 (1.74%)
    0 / 116 (0.00%)
         occurrences all number
    0
    2
    0
    Injection site pruritus
         subjects affected / exposed
    0 / 114 (0.00%)
    2 / 115 (1.74%)
    0 / 116 (0.00%)
         occurrences all number
    0
    2
    0
    Injection site reaction
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 115 (0.87%)
    0 / 116 (0.00%)
         occurrences all number
    0
    1
    0
    Medical device site bruise
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 115 (0.00%)
    0 / 116 (0.00%)
         occurrences all number
    1
    0
    0
    Oedema peripheral
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 115 (0.87%)
    0 / 116 (0.00%)
         occurrences all number
    0
    1
    0
    Peripheral swelling
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 115 (0.00%)
    1 / 116 (0.86%)
         occurrences all number
    0
    0
    1
    Pyrexia
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 115 (0.87%)
    0 / 116 (0.00%)
         occurrences all number
    0
    1
    0
    Vessel puncture site bruise
         subjects affected / exposed
    4 / 114 (3.51%)
    0 / 115 (0.00%)
    3 / 116 (2.59%)
         occurrences all number
    6
    0
    4
    Vessel puncture site erythema
         subjects affected / exposed
    2 / 114 (1.75%)
    0 / 115 (0.00%)
    0 / 116 (0.00%)
         occurrences all number
    2
    0
    0
    Vessel puncture site haematoma
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 115 (0.00%)
    0 / 116 (0.00%)
         occurrences all number
    1
    0
    0
    Reproductive system and breast disorders
    Vaginal haemorrhage
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 115 (0.00%)
    1 / 116 (0.86%)
         occurrences all number
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    6 / 114 (5.26%)
    10 / 115 (8.70%)
    0 / 116 (0.00%)
         occurrences all number
    6
    10
    0
    Epistaxis
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 115 (0.00%)
    0 / 116 (0.00%)
         occurrences all number
    1
    0
    0
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 115 (0.00%)
    0 / 116 (0.00%)
         occurrences all number
    1
    0
    0
    Investigations
    Blood creatinine increased
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 115 (0.00%)
    1 / 116 (0.86%)
         occurrences all number
    0
    0
    1
    Blood potassium increased
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 115 (0.00%)
    0 / 116 (0.00%)
         occurrences all number
    1
    0
    0
    ECG P wave inverted
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 115 (0.87%)
    0 / 116 (0.00%)
         occurrences all number
    0
    1
    0
    White blood cell count increased
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 115 (0.00%)
    1 / 116 (0.86%)
         occurrences all number
    0
    0
    1
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    1 / 114 (0.88%)
    1 / 115 (0.87%)
    3 / 116 (2.59%)
         occurrences all number
    1
    1
    3
    Eye contusion
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 115 (0.87%)
    0 / 116 (0.00%)
         occurrences all number
    0
    1
    0
    Procedural dizziness
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 115 (0.87%)
    0 / 116 (0.00%)
         occurrences all number
    0
    1
    0
    Procedural nausea
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 115 (0.87%)
    0 / 116 (0.00%)
         occurrences all number
    0
    1
    0
    Wound haemorrhage
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 115 (0.00%)
    1 / 116 (0.86%)
         occurrences all number
    0
    0
    1
    Cardiac disorders
    Cardiac failure
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 115 (0.00%)
    0 / 116 (0.00%)
         occurrences all number
    1
    0
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    5 / 114 (4.39%)
    4 / 115 (3.48%)
    1 / 116 (0.86%)
         occurrences all number
    5
    4
    1
    Dizziness postural
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 115 (0.00%)
    1 / 116 (0.86%)
         occurrences all number
    1
    0
    1
    Headache
         subjects affected / exposed
    3 / 114 (2.63%)
    3 / 115 (2.61%)
    5 / 116 (4.31%)
         occurrences all number
    3
    3
    5
    Lethargy
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 115 (0.00%)
    1 / 116 (0.86%)
         occurrences all number
    0
    0
    1
    Presyncope
         subjects affected / exposed
    2 / 114 (1.75%)
    0 / 115 (0.00%)
    0 / 116 (0.00%)
         occurrences all number
    2
    0
    0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 115 (0.87%)
    0 / 116 (0.00%)
         occurrences all number
    0
    1
    0
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 115 (0.00%)
    0 / 116 (0.00%)
         occurrences all number
    1
    0
    0
    Diarrhoea
         subjects affected / exposed
    4 / 114 (3.51%)
    1 / 115 (0.87%)
    0 / 116 (0.00%)
         occurrences all number
    4
    1
    0
    Flatulence
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 115 (0.00%)
    1 / 116 (0.86%)
         occurrences all number
    1
    0
    1
    Mouth haemorrhage
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 115 (0.87%)
    0 / 116 (0.00%)
         occurrences all number
    0
    1
    0
    Nausea
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 115 (0.87%)
    1 / 116 (0.86%)
         occurrences all number
    0
    1
    1
    Vomiting
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 115 (0.00%)
    1 / 116 (0.86%)
         occurrences all number
    0
    0
    1
    Skin and subcutaneous tissue disorders
    Dermatitis contact
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 115 (0.00%)
    1 / 116 (0.86%)
         occurrences all number
    1
    0
    1
    Ecchymosis
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 115 (0.87%)
    0 / 116 (0.00%)
         occurrences all number
    0
    1
    0
    Erythema
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 115 (0.00%)
    1 / 116 (0.86%)
         occurrences all number
    0
    0
    1
    Hyperhidrosis
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 115 (0.87%)
    0 / 116 (0.00%)
         occurrences all number
    0
    1
    0
    Petechiae
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 115 (0.00%)
    1 / 116 (0.86%)
         occurrences all number
    0
    0
    1
    Renal and urinary disorders
    Pollakiuria
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 115 (0.00%)
    1 / 116 (0.86%)
         occurrences all number
    0
    0
    1
    Renal impairment
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 115 (0.87%)
    0 / 116 (0.00%)
         occurrences all number
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    Muscle spasms
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 115 (0.87%)
    0 / 116 (0.00%)
         occurrences all number
    0
    1
    0
    Musculoskeletal discomfort
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 115 (0.00%)
    0 / 116 (0.00%)
         occurrences all number
    1
    0
    0
    Metabolism and nutrition disorders
    Gout
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 115 (0.00%)
    0 / 116 (0.00%)
         occurrences all number
    1
    0
    0
    Hypoglycaemia
         subjects affected / exposed
    1 / 114 (0.88%)
    1 / 115 (0.87%)
    0 / 116 (0.00%)
         occurrences all number
    1
    1
    0

    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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