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    Clinical Trial Results:
    A Randomized, Double-Blind, 12-Week, Placebo-Controlled Study Followed by a 12-Week Extension Phase Without Placebo to Evaluate the Efficacy and Safety of Oral VB-201 in Subjects with Mild to Moderate Ulcerative Colitis.

    Summary
    EudraCT number
    2012-003974-18
    Trial protocol
    HU   BG  
    Global end of trial date
    28 Nov 2014

    Results information
    Results version number
    v1(current)
    This version publication date
    29 Jul 2016
    First version publication date
    29 Jul 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    VB-201-064
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Vascular Biogenics Ltd.
    Sponsor organisation address
    6 Jonathan Netanyahu St., Or Yehuda, Israel, 60376
    Public contact
    VBL, Vascular Biogenics Ltd., 972 36346450,
    Scientific contact
    VBL, Vascular Biogenics Ltd., 972 36346450,
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    02 Feb 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    28 Nov 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Nov 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    - Safety Objective • To examine the safety and tolerability of up to 24 weeks’ treatment with VB-201 or placebo in subjects with Ulcerative Colitis - Efficacy Objective • Base Phase: To examine the effect of treatment with VB-201 80 mg twice daily, compared to placebo (initial 12 weeks) on measures of disease activity in subjects with Ulcerative Colitis. • Extension Phase: To examine the effect of longer-term treatment with VB-201 (24 weeks) on measures of disease activity in subjects with Ulcerative Colitis.
    Protection of trial subjects
    The trial was conducted in accordance with applicable national and international laws and regulations, the ICH-GCP guideline and the ethics principles that have their origins in the Declaration of Helsinki
    Background therapy
    Not applicable
    Evidence for comparator
    Not applicable
    Actual start date of recruitment
    30 Nov 2012
    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
    Bulgaria: 23
    Country: Number of subjects enrolled
    Hungary: 1
    Country: Number of subjects enrolled
    Poland: 88
    Worldwide total number of subjects
    112
    EEA total number of subjects
    112
    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)
    107
    From 65 to 84 years
    5
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    The first informed consent was given on 22 January 2013 and last patient last visit was on 28 November 2014.

    Pre-assignment
    Screening details
    Male or female sujects, ≥18 years of age, who had a diagnosis of active Ulcerative Colitis for at least 6 months prior to screening were selected according to the protocol inclusion and exclusion criteria.

    Period 1
    Period 1 title
    Period 1 (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Data analyst
    Blinding implementation details
    The identity of the treatments was concealed by the use of trial medications that were all identical in packaging, labelling and schedule of administration. A combined batch number was generated. The IMP and the respective vehicle were indistinguishable in appearance, consistency and odor.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    VB-201 (Arm A)
    Arm description
    The VB-201 dose was 80 mg/day for the initial 2 weeks followed by 80 mg BID (160 mg/day) for 10 weeks. After the initial 12 weeks, subjects entered the Extension Phase. During this phase, subjects continued dosing VB-201 at 80 mg BID.
    Arm type
    Experimental

    Investigational medicinal product name
    VB-201
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    All doses of trial medication were taken approximately 12 hours apart with food.

    Arm title
    Placebo & VB-201 (Arm B)
    Arm description
    Subjects received placebo for weeks 1-12, followed by extension phase where subjects switched to dosing with VB-201 dosed at 80 mg/day for the initial 2 weeks followed by 80 mg BID during the final 10 weeks of the trial.
    Arm type
    Experimental

    Investigational medicinal product name
    VB-201
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    All doses of trial medication (placebo or VB-201) were taken approximately 12 hours apart with food.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    All doses of trial medication (placebo or VB-201) were taken approximately 12 hours apart with food..

    Number of subjects in period 1
    VB-201 (Arm A) Placebo & VB-201 (Arm B)
    Started
    58
    54
    Completed
    42
    46
    Not completed
    16
    8
         Protocol deviation
    -
    1
         Lack of cooperation
    -
    1
         Lack of efficacy
    5
    1
         Lack of motivation
    3
    1
         Adverse event, non-fatal
    6
    3
         Medical monitor decision
    -
    1
         Disease progression
    1
    -
         Lost to follow-up
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    VB-201 (Arm A)
    Reporting group description
    The VB-201 dose was 80 mg/day for the initial 2 weeks followed by 80 mg BID (160 mg/day) for 10 weeks. After the initial 12 weeks, subjects entered the Extension Phase. During this phase, subjects continued dosing VB-201 at 80 mg BID.

    Reporting group title
    Placebo & VB-201 (Arm B)
    Reporting group description
    Subjects received placebo for weeks 1-12, followed by extension phase where subjects switched to dosing with VB-201 dosed at 80 mg/day for the initial 2 weeks followed by 80 mg BID during the final 10 weeks of the trial.

    Reporting group values
    VB-201 (Arm A) Placebo & VB-201 (Arm B) Total
    Number of subjects
    58 54 112
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    39.57 ± 15.15 40.54 ± 13.05 -
    Gender categorical
    Units: Subjects
        Female
    23 21 44
        Male
    35 33 68
    Full modified Mayo Score
    Units: not applicable
        arithmetic mean (standard deviation)
    8 ± 1.4 7.83 ± 1.58 -

    End points

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    End points reporting groups
    Reporting group title
    VB-201 (Arm A)
    Reporting group description
    The VB-201 dose was 80 mg/day for the initial 2 weeks followed by 80 mg BID (160 mg/day) for 10 weeks. After the initial 12 weeks, subjects entered the Extension Phase. During this phase, subjects continued dosing VB-201 at 80 mg BID.

    Reporting group title
    Placebo & VB-201 (Arm B)
    Reporting group description
    Subjects received placebo for weeks 1-12, followed by extension phase where subjects switched to dosing with VB-201 dosed at 80 mg/day for the initial 2 weeks followed by 80 mg BID during the final 10 weeks of the trial.

    Primary: Remission Rates

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    End point title
    Remission Rates
    End point description
    End point type
    Primary
    End point timeframe
    Summary of remission rates by visit and treatment group, base and extension phase
    End point values
    VB-201 (Arm A) Placebo & VB-201 (Arm B)
    Number of subjects analysed
    57
    53
    Units: number of subjects
        remission at week 12
    6
    8
        no remission at week 12
    51
    45
        remission at week 24
    13
    10
        no remission at week 24
    44
    43
    Statistical analysis title
    Remission at week 12 base phase
    Statistical analysis description
    P-value chi-square test
    Comparison groups
    VB-201 (Arm A) v Placebo & VB-201 (Arm B)
    Number of subjects included in analysis
    110
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.4726
    Method
    Chi-squared
    Confidence interval
    Statistical analysis title
    Remission at week 24
    Statistical analysis description
    Between group comparison week 12 Placebo (weeks 0-12) vs week 24 VB-201 80mg twice daily (weeks 0-24)
    Comparison groups
    VB-201 (Arm A) v Placebo & VB-201 (Arm B)
    Number of subjects included in analysis
    110
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.3038
    Method
    Chi-squared
    Confidence interval

    Primary: Safety

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    End point title
    Safety [1]
    End point description
    Summary of incidence of treatment emergent adverse events (TEAEs) for the study, for subjects in treatment Arms A& B. A full breakdown of adverse events (AEs) by study group and treatment administered (VB-201, placebo) is presented in the 'adverse events' section.
    End point type
    Primary
    End point timeframe
    Entire duration of the study
    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: As safety is specified as a primary endpoint, descriptive statistics only are reported.
    End point values
    VB-201 (Arm A) Placebo & VB-201 (Arm B)
    Number of subjects analysed
    58
    54
    Units: number of subjects
        Subjects with any AEs
    35
    27
        Subjects with any Serious Adverse Events (SAEs)
    5
    6
        Subjects with any AEs leading to withdrawal
    7
    4
        Subjects with at least one Mild TEAE
    29
    13
        Subjects with at least one Moderate TEAE
    11
    17
        Subjects with at least one Severe TEAE
    4
    3
    No statistical analyses for this end point

    Secondary: Secondary Efficacy

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    End point title
    Secondary Efficacy
    End point description
    End point type
    Secondary
    End point timeframe
    weeks 0-24 Arm A & weeks 12-24 Arm B.
    End point values
    VB-201 (Arm A) Placebo & VB-201 (Arm B)
    Number of subjects analysed
    57
    53
    Units: Total Modified Mayo score
    arithmetic mean (standard deviation)
        Week 12
    6.33 ± 2.61
    5.64 ± 2.78
        Week 24
    5.58 ± 3.17
    4.57 ± 2.71
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Throughout the duration of the study (from screening visit to follow-up visit)
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    15.1
    Reporting groups
    Reporting group title
    VB-201 (Arm A)
    Reporting group description
    The VB-201 dose was 80 mg/day for the initial 2 weeks followed by 80 mg BID (160 mg/day) for 10 weeks. After the initial 12 weeks, subjects entered the Extension Phase. During this phase, subjects continued dosing VB-201 at 80 mg twice daily..

    Reporting group title
    placebo & VB-201 (Arm B)
    Reporting group description
    Subjects received placebo for weeks 1-12, followed by extension phase where subjects switched to dosing with VB-201 dosed at 80 mg/day for the initial 2 weeks followed by 80 mg twice daily during the final 10 weeks of the trial.

    Serious adverse events
    VB-201 (Arm A) placebo & VB-201 (Arm B)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 58 (8.62%)
    6 / 54 (11.11%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Surgical and medical procedures
    Ovarian cystectomy
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal cell carcinoma
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis ulcerative
         subjects affected / exposed
    4 / 58 (6.90%)
    3 / 54 (5.56%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Bronchopneumonia
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 54 (1.85%)
         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
    VB-201 (Arm A) placebo & VB-201 (Arm B)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    33 / 58 (56.90%)
    24 / 54 (44.44%)
    Surgical and medical procedures
    Tooth extraction
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 54 (0.00%)
         occurrences all number
    3
    0
    Mucosal haemorrhage
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 54 (0.00%)
         occurrences all number
    1
    0
    Pyrexia
         subjects affected / exposed
    2 / 58 (3.45%)
    1 / 54 (1.85%)
         occurrences all number
    2
    1
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 54 (0.00%)
         occurrences all number
    1
    0
    Reproductive system and breast disorders
    Breast pain
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    0
    1
    Ovarian cyst
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    0
    1
    Vaginal haemorrhage
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    0
    1
    Injury, poisoning and procedural complications
    Injury
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 54 (0.00%)
         occurrences all number
    1
    0
    Limb injury
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 54 (0.00%)
         occurrences all number
    1
    0
    Soft tissue injury
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    0
    1
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 58 (1.72%)
    1 / 54 (1.85%)
         occurrences all number
    1
    1
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 58 (1.72%)
    1 / 54 (1.85%)
         occurrences all number
    1
    1
    Blood creatine phosphokinase increased
         subjects affected / exposed
    2 / 58 (3.45%)
    3 / 54 (5.56%)
         occurrences all number
    2
    3
    Body temperature increased
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    0
    1
    C-reactive protein increased
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 54 (0.00%)
         occurrences all number
    1
    0
    Eosinophil count increased
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 54 (0.00%)
         occurrences all number
    1
    0
    Eosinophil percentage increased
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 54 (0.00%)
         occurrences all number
    1
    0
    Haemoglobin abnormal
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 54 (0.00%)
         occurrences all number
    1
    0
    Haemoglobin decreased
         subjects affected / exposed
    1 / 58 (1.72%)
    1 / 54 (1.85%)
         occurrences all number
    1
    1
    Hepatic enzyme increased
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 54 (0.00%)
         occurrences all number
    2
    0
    Lymphocyte count abnormal
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 54 (0.00%)
         occurrences all number
    1
    0
    Lymphocyte percentage abnormal
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 54 (0.00%)
         occurrences all number
    1
    0
    Mean cell haemoglobin concentration decreased
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 54 (0.00%)
         occurrences all number
    1
    0
    Neutrophil count decreased
         subjects affected / exposed
    3 / 58 (5.17%)
    2 / 54 (3.70%)
         occurrences all number
    5
    3
    Platelet count increased
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 54 (0.00%)
         occurrences all number
    1
    0
    Protein urine
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 54 (0.00%)
         occurrences all number
    1
    0
    White blood cell count decreased
         subjects affected / exposed
    2 / 58 (3.45%)
    1 / 54 (1.85%)
         occurrences all number
    2
    1
    White blood cell count increased
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 54 (0.00%)
         occurrences all number
    1
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    4 / 58 (6.90%)
    2 / 54 (3.70%)
         occurrences all number
    4
    2
    Iron deficiency anaemia
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 54 (0.00%)
         occurrences all number
    1
    0
    Leukopenia
         subjects affected / exposed
    3 / 58 (5.17%)
    2 / 54 (3.70%)
         occurrences all number
    3
    3
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    2 / 58 (3.45%)
    0 / 54 (0.00%)
         occurrences all number
    8
    0
    Headache
         subjects affected / exposed
    6 / 58 (10.34%)
    4 / 54 (7.41%)
         occurrences all number
    8
    8
    Loss of consciousness
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    0
    1
    Syncope
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 54 (0.00%)
         occurrences all number
    3
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    2 / 58 (3.45%)
    4 / 54 (7.41%)
         occurrences all number
    9
    4
    Abdominal pain upper
         subjects affected / exposed
    1 / 58 (1.72%)
    3 / 54 (5.56%)
         occurrences all number
    1
    3
    Anal fissure
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    0
    1
    Diarrhoea
         subjects affected / exposed
    0 / 58 (0.00%)
    2 / 54 (3.70%)
         occurrences all number
    0
    2
    Diarrhoea haemorrhagic
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    0
    1
    Dyspepsia
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    0
    1
    Frequent bowel movements
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    0
    1
    Haemorrhoids
         subjects affected / exposed
    0 / 58 (0.00%)
    2 / 54 (3.70%)
         occurrences all number
    0
    2
    Nausea
         subjects affected / exposed
    8 / 58 (13.79%)
    1 / 54 (1.85%)
         occurrences all number
    20
    2
    Proctalgia
         subjects affected / exposed
    1 / 58 (1.72%)
    1 / 54 (1.85%)
         occurrences all number
    1
    1
    Rectal prolapse
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    0
    1
    Vomiting
         subjects affected / exposed
    5 / 58 (8.62%)
    1 / 54 (1.85%)
         occurrences all number
    17
    2
    Hepatobiliary disorders
    Hyperbilirubinaemia
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 54 (0.00%)
         occurrences all number
    1
    0
    Renal and urinary disorders
    Leukocyturia
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 54 (0.00%)
         occurrences all number
    1
    0
    Pollakiuria
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 54 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    2 / 58 (3.45%)
    0 / 54 (0.00%)
         occurrences all number
    2
    0
    Hyperhidrosis
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 54 (0.00%)
         occurrences all number
    1
    0
    Onychoclasis
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 54 (0.00%)
         occurrences all number
    1
    0
    Rash
         subjects affected / exposed
    1 / 58 (1.72%)
    1 / 54 (1.85%)
         occurrences all number
    1
    3
    Rash pruritic
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 54 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 58 (3.45%)
    2 / 54 (3.70%)
         occurrences all number
    9
    2
    Osteoporosis
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 54 (0.00%)
         occurrences all number
    2
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 54 (0.00%)
         occurrences all number
    1
    0
    Hypercholesterolaemia
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 54 (0.00%)
         occurrences all number
    1
    0
    Hyperkalaemia
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 54 (0.00%)
         occurrences all number
    1
    0
    Impaired fasting glucose
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 54 (0.00%)
         occurrences all number
    1
    0
    Vitamin D deficiency
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    0
    1
    Infections and infestations
    Bacteriuria
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    0
    1
    Bronchitis
         subjects affected / exposed
    2 / 58 (3.45%)
    0 / 54 (0.00%)
         occurrences all number
    2
    0
    Clostridium difficile infection
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    0
    1
    Enterocolitis viral
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    0
    1
    Influenza
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    0
    1
    Lyme disease
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 54 (0.00%)
         occurrences all number
    1
    0
    Pharyngitis
         subjects affected / exposed
    1 / 58 (1.72%)
    1 / 54 (1.85%)
         occurrences all number
    1
    1
    Pneumonia
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    0
    1
    Respiratory tract infection
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 54 (0.00%)
         occurrences all number
    1
    0
    Sinusitis
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    0
    1
    Upper respiratory tract infection
         subjects affected / exposed
    3 / 58 (5.17%)
    1 / 54 (1.85%)
         occurrences all number
    3
    1
    Urinary tract infection
         subjects affected / exposed
    1 / 58 (1.72%)
    1 / 54 (1.85%)
         occurrences all number
    1
    1
    Viral infection
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    0
    2

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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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