Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    Paracetamol Treatment in Hypertension: effect on Blood Pressure Study.

    Summary
    EudraCT number
    		 2013-003204-40
    Trial protocol
    		 GB  
    Global end of trial date
    01 Feb 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    05 Oct 2023
    First version publication date
    05 Oct 2023
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    PATHBP_2013
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01997112
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    ACCORD (University of Edinburgh and NHS Lothian)
    Sponsor organisation address
    47 Little France Crescent, Edinburgh, United Kingdom, EH16 4TJ
    Public contact
    Prof David Webb, University of Edinburgh, +44 01312429216, D.J.Webb@ed.ac.uk
    Scientific contact
    Prof David Webb, University of Edinburgh, +44 01312429216, D.J.Webb@ed.ac.uk
    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
    01 Feb 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Feb 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Feb 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine the effect of parcetamol on blood pressure in hypertensives adults taking or not taking antihypertensive medications.
    Protection of trial subjects
    The trial was conducted in accordance with all relevant data protection, ethical and regulatory requirements to ensure the privacy and security of patient information and to ensure the rights, safety and well-being of the patients and the quality of the research data.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    13 Jan 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: 110
    Worldwide total number of subjects
    110
    EEA total number of subjects
    110
    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)
    66
    From 65 to 84 years
    44
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Between September 2014 and June 2019 204 patients were identified through: the hypertension service in Edinburgh; NHS Lothian GP Practices; GP ABPM service; SHARE (NHS Research Scotland initiative - to search for willing participants in the SE Scotland). 110 of these were randomised into the trial.

    Pre-assignment
    Screening details
    		 Participant’s medical history & medication use will be reviewed. Complete physical examination: height, weight, vital signs. Blood taken for full blood count, paracetamol level, coagulation screen, INR, liver, renal function. Participants asked to wear a 24-hour ambulatory blood pressure monitor, if ABPM has not been performed in previous 3 months.

    Period 1
    Period 1 title
    Baseline (overall trial) (Studies 1 + 2)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Paracetamol
    Arm description
    		 Paracetamol 1g (500mg x2) four times daily, given for 14 days, with a 14-day washout period. (Cross-over trial.)
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Paracetamol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    1g (500mg x 2) four times daily.

    Arm title
    		 Placebo
    Arm description
    		 Placebo: hard gelatin capsules containing Maize Starch Ph. Eur.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Two capsules, four times per day. There is a washout phase of 14(+7) days between treatment phases.

    Number of subjects in period 1
    		Paracetamol Placebo
    Started
    55
    55
    Completed
    53
    50
    Not completed
    2
    5
         Consent withdrawn by subject
    2
    -
         Physician decision
    -
    5
    Period 2
    Period 2 title
    Sub-study: biomarker study
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Sub-study: biomarker study
    Arm description
    		 All participants will be asked to participate in this sub-study. One extra blood sample will be taken at each study visit (10mls) for liver function tests and biomarker analyses. In addition, a blood sample (5mls) will be taken on day 1 for DNA analysis.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 2
    		Sub-study: biomarker study
    Started
    103
    Completed
    103
    Period 3
    Period 3 title
    Sub-study: urinary prostaglandins study
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Sub-study: urinary prostaglandins study
    Arm description
    		 All females taking part in the baseline studies 1 and 2 will be asked to provide a 24-hour urine collection for PGE₂ and 6-keto-PGF₁α estimation. A 24-hour urine collection will be performed on four occasions throughout the study, at the start and end of each study drug period.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 3 [1]
    		Sub-study: urinary prostaglandins study
    Started
    17
    Completed
    17
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Of the 17 subjects actually enrolled into the sub-study - 17 started this sub-study and 17 completed the sub-study

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Baseline (overall trial) (Studies 1 + 2)
    Reporting group description
    		 -

    Reporting group values
    		 Baseline (overall trial) (Studies 1 + 2) Total
    Number of subjects
    		 110 110
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 66 66
        From 65-84 years
    		 44 44
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 26 26
        Male
    		 84 84

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Paracetamol
    Reporting group description
    		 Paracetamol 1g (500mg x2) four times daily, given for 14 days, with a 14-day washout period. (Cross-over trial.)

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo: hard gelatin capsules containing Maize Starch Ph. Eur.
    Reporting group title
    Sub-study: biomarker study
    Reporting group description
    		 All participants will be asked to participate in this sub-study. One extra blood sample will be taken at each study visit (10mls) for liver function tests and biomarker analyses. In addition, a blood sample (5mls) will be taken on day 1 for DNA analysis.
    Reporting group title
    Sub-study: urinary prostaglandins study
    Reporting group description
    		 All females taking part in the baseline studies 1 and 2 will be asked to provide a 24-hour urine collection for PGE₂ and 6-keto-PGF₁α estimation. A 24-hour urine collection will be performed on four occasions throughout the study, at the start and end of each study drug period.

    Primary: Difference in mean daytime systolic ambulatory BP

    		 Close Top of page
    End point title
    		 Difference in mean daytime systolic ambulatory BP [1]
    End point description
    End point type
    Primary
    End point timeframe
    Study: day 1 (visit -1), day 5 (visit 4), day 8 (visit 7) and day 15 (visit 14). Cross-over: day 29 (visit -1), day 33 (visit 4), day 36 (visit 7) and day 43 (visit 14).
    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: Arithmetic mean Precision/Dispersion Type: Standard deviation Difference in least square mean: 4.7 Confidence interval: 2.9-6.6
    End point values
    		 Paracetamol Placebo
    Number of subjects analysed
    53
    50
    Units: mmHg
        arithmetic mean (standard deviation)
    4.7 ( 2.9 )
    4.7 ( 2.9 )
    No statistical analyses for this end point

    Secondary: Difference in clinic systolic BP

    		 Close Top of page
    End point title
    		 Difference in clinic systolic BP
    End point description
    End point type
    Secondary
    End point timeframe
    Study: day 1 (visit -1), day 5 (visit 4), day 8 (visit 7) and day 15 (visit 14). Cross-over: day 29 (visit -1), day 33 (visit 4), day 36 (visit 7) and day 43 (visit 14).
    End point values
    		 Paracetamol Placebo
    Number of subjects analysed
    55
    55
    Units: mmHg
        arithmetic mean (standard deviation)
    4.6 ( 6.7 )
    4.6 ( 6.7 )
    No statistical analyses for this end point

    Secondary: Difference in daytime diastolic ambulatory BP

    		 Close Top of page
    End point title
    		 Difference in daytime diastolic ambulatory BP
    End point description
    End point type
    Secondary
    End point timeframe
    Study: day 1 (visit -1), day 5 (visit 4), day 8 (visit 7) and day 15 (visit 14). Cross-over: day 29 (visit -1), day 33 (visit 4), day 36 (visit 7) and day 43 (visit 14).
    End point values
    		 Paracetamol Placebo
    Number of subjects analysed
    55
    55
    Units: mmHg
        arithmetic mean (standard deviation)
    1.6 ( 2.7 )
    1.6 ( 2.7 )
    No statistical analyses for this end point

    Secondary: Difference in mean daytime systolic ambulatory BP in patients taking and not taking antihypertensive medications

    		 Close Top of page
    End point title
    		 Difference in mean daytime systolic ambulatory BP in patients taking and not taking antihypertensive medications
    End point description
    End point type
    Secondary
    End point timeframe
    Study: day 1 (visit -1), day 5 (visit 4), day 8 (visit 7) and day 15 (visit 14). Cross-over: day 29 (visit -1), day 33 (visit 4), day 36 (visit 7) and day 43 (visit 14).
    End point values
    		 Paracetamol Placebo
    Number of subjects analysed
    55
    55
    Units: mmHg
        arithmetic mean (standard deviation)
    3.6 ( 11.3 )
    3.6 ( 11.3 )
    No statistical analyses for this end point

    Other pre-specified: Difference in urinary prostaglandins

    		 Close Top of page
    End point title
    		 Difference in urinary prostaglandins
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Study: start 24hr urine collection (UC) study day 1, finish study day 2; start 24hr UC study day 15, finish study day 16. Crossover: start 24hr UC study day 29, finish study day 2; start 24hr UC study day 43, study day 44.
    End point values
    Number of subjects analysed
    Units: ng/g
        arithmetic mean (standard deviation)
    No statistical analyses for this end point

    Other pre-specified: Difference in liver biomarkers

    		 Close Top of page
    End point title
    		 Difference in liver biomarkers
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Study: day 1 (visit -1), day 5 (visit 4), day 8 (visit 7) and day 15 (visit 14). Cross-over: day 29 (visit -1), day 33 (visit 4), day 36 (visit 7) and day 43 (visit 14).
    End point values
    		 Sub-study: biomarker study
    Number of subjects analysed
    0 [2]
    Units: U/L
        arithmetic mean (standard deviation)
    ( )
    Notes
    [2] - Not analysed.
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Investigators must report all SAEs to the Sponsor within 24 hours of becoming aware of event.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.1
    Reporting groups
    Reporting group title
    Baseline (overall trial) (Studies 1 + 2)
    Reporting group description
    		 -

    Serious adverse events
    		 Baseline (overall trial) (Studies 1 + 2)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 110 (1.82%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    1 / 110 (0.91%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Acute myocardial infarction
         subjects affected / exposed
    1 / 110 (0.91%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Baseline (overall trial) (Studies 1 + 2)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    66 / 110 (60.00%)
    Injury, poisoning and procedural complications
    Accidental injury to right thumb, requiring sutures.
         subjects affected / exposed
    1 / 110 (0.91%)
         occurrences all number
    1
    Broken tooth.
         subjects affected / exposed
    1 / 110 (0.91%)
         occurrences all number
    1
    Bruised ribs (left sided) post accidental injury.
         subjects affected / exposed
    1 / 110 (0.91%)
         occurrences all number
    1
    Bruised ribs - sporting accident
         subjects affected / exposed
    1 / 110 (0.91%)
         occurrences all number
    1
    Left knee injury
    Additional description: Left knee injury- attending Osteopath regularly
         subjects affected / exposed
    1 / 110 (0.91%)
         occurrences all number
    1
    Minor knee injury
         subjects affected / exposed
    1 / 110 (0.91%)
         occurrences all number
    1
    Pulled muscle (strain) right side below rib
         subjects affected / exposed
    1 / 110 (0.91%)
         occurrences all number
    1
    Left leg muscle tear
         subjects affected / exposed
    1 / 110 (0.91%)
         occurrences all number
    1
    Vascular disorders
    Patchy facial flushing
         subjects affected / exposed
    1 / 110 (0.91%)
         occurrences all number
    1
    Cardiac disorders
    Atrial Fibrillation
         subjects affected / exposed
    1 / 110 (0.91%)
         occurrences all number
    1
    Atrial Flutter
         subjects affected / exposed
    1 / 110 (0.91%)
         occurrences all number
    1
    fluttering in his upper left chest
    Additional description: Patient noted both yesterday x 3 episodes and today x 4 episodes over a six hour period - fluttering in his upper left chest. No other symptoms to note. Arrhythmia PMH 2011. Manual pulse taken - regular, strong and around 60 BPM. ECG performed today
         subjects affected / exposed
    1 / 110 (0.91%)
         occurrences all number
    1
    Nervous system disorders
    Dizziness/lightheaded
         subjects affected / exposed
    1 / 110 (0.91%)
         occurrences all number
    1
    Headaches
         subjects affected / exposed
    1 / 110 (0.91%)
         occurrences all number
    1
    Occasional headaches
         subjects affected / exposed
    1 / 110 (0.91%)
         occurrences all number
    1
    Right sided sciatica
         subjects affected / exposed
    2 / 110 (1.82%)
         occurrences all number
    2
    Sporadic nerve pain in left forefinger (distal joint). Possible gym injury.
         subjects affected / exposed
    1 / 110 (0.91%)
         occurrences all number
    1
    light headed
         subjects affected / exposed
    1 / 110 (0.91%)
         occurrences all number
    1
    poor quality sleep
         subjects affected / exposed
    1 / 110 (0.91%)
         occurrences all number
    1
    sciatic pain
         subjects affected / exposed
    1 / 110 (0.91%)
         occurrences all number
    1
    Left sided sciatica
         subjects affected / exposed
    1 / 110 (0.91%)
         occurrences all number
    1
    Migraine
         subjects affected / exposed
    1 / 110 (0.91%)
         occurrences all number
    1
    General disorders and administration site conditions
    Lump at left lymph removal site.
    Additional description: Lump at left lymph removal site. Assessed. NAD.
         subjects affected / exposed
    1 / 110 (0.91%)
         occurrences all number
    1
    Tiredness
         subjects affected / exposed
    1 / 110 (0.91%)
         occurrences all number
    1
    Immune system disorders
    Hayfever symptoms
         subjects affected / exposed
    1 / 110 (0.91%)
         occurrences all number
    1
    Mild hayfever symptoms of sneezing
         subjects affected / exposed
    1 / 110 (0.91%)
         occurrences all number
    1
    Seasonal hayfever.
         subjects affected / exposed
    1 / 110 (0.91%)
         occurrences all number
    1
    Eye disorders
    Dry eyes
         subjects affected / exposed
    2 / 110 (1.82%)
         occurrences all number
    2
    Red and Itchy eyes
         subjects affected / exposed
    1 / 110 (0.91%)
         occurrences all number
    1
    Gastrointestinal disorders
    Gastric upset. Diarrhoea + vomiting x single episode
         subjects affected / exposed
    1 / 110 (0.91%)
         occurrences all number
    1
    Heartburn
         subjects affected / exposed
    1 / 110 (0.91%)
         occurrences all number
    1
    Indigestion
         subjects affected / exposed
    4 / 110 (3.64%)
         occurrences all number
    4
    Mild Nausea
         subjects affected / exposed
    3 / 110 (2.73%)
         occurrences all number
    3
    Mild stomach ache on occasions
         subjects affected / exposed
    1 / 110 (0.91%)
         occurrences all number
    1
    Mouth ulcers
         subjects affected / exposed
    1 / 110 (0.91%)
         occurrences all number
    1
    Sporadic toothache
         subjects affected / exposed
    1 / 110 (0.91%)
         occurrences all number
    1
    tooth pain following extraction and abscess
         subjects affected / exposed
    1 / 110 (0.91%)
         occurrences all number
    1
    Gastric upset.
         subjects affected / exposed
    1 / 110 (0.91%)
         occurrences all number
    1
    Nauseous when taking IMP
         subjects affected / exposed
    1 / 110 (0.91%)
         occurrences all number
    1
    Constipation
         subjects affected / exposed
    1 / 110 (0.91%)
         occurrences all number
    1
    Increased bowel movement to twice daily.
         subjects affected / exposed
    1 / 110 (0.91%)
         occurrences all number
    1
    Nausea and vomiting
         subjects affected / exposed
    1 / 110 (0.91%)
         occurrences all number
    1
    Nausea
         subjects affected / exposed
    1 / 110 (0.91%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Chesty wheeze
         subjects affected / exposed
    1 / 110 (0.91%)
         occurrences all number
    1
    Nasal congestion
         subjects affected / exposed
    1 / 110 (0.91%)
         occurrences all number
    1
    Patient aware of clearing throat more often.
         subjects affected / exposed
    1 / 110 (0.91%)
         occurrences all number
    1
    Sore throat
         subjects affected / exposed
    2 / 110 (1.82%)
         occurrences all number
    2
    Tickly cough
         subjects affected / exposed
    2 / 110 (1.82%)
         occurrences all number
    2
    Throat pain
         subjects affected / exposed
    1 / 110 (0.91%)
         occurrences all number
    1
    exacerbation of asthma
         subjects affected / exposed
    1 / 110 (0.91%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Left forearm lesion
    Additional description: Left forearm lesion under review - GP referral to dermatology 21/01/2019 Discharged from appointment with no follow-up except pre arranged 6 monthly visits for monitoring re PMH.
         subjects affected / exposed
    1 / 110 (0.91%)
         occurrences all number
    1
    Night sweats
         subjects affected / exposed
    1 / 110 (0.91%)
         occurrences all number
    1
    Rash over right forearm
         subjects affected / exposed
    1 / 110 (0.91%)
         occurrences all number
    1
    dry skin on legs and armpits
         subjects affected / exposed
    1 / 110 (0.91%)
         occurrences all number
    1
    Cellulitis/Allergic reaction/Photosensitivity
         subjects affected / exposed
    1 / 110 (0.91%)
         occurrences all number
    1
    Itching round ankles
         subjects affected / exposed
    1 / 110 (0.91%)
         occurrences all number
    1
    Rash on right forearm
         subjects affected / exposed
    1 / 110 (0.91%)
         occurrences all number
    1
    Urticaria
         subjects affected / exposed
    1 / 110 (0.91%)
         occurrences all number
    1
    Itchy rash on forehead & neck
         subjects affected / exposed
    1 / 110 (0.91%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Backache
         subjects affected / exposed
    1 / 110 (0.91%)
         occurrences all number
    1
    Lower back ache
         subjects affected / exposed
    1 / 110 (0.91%)
         occurrences all number
    1
    Painful left ankle
         subjects affected / exposed
    1 / 110 (0.91%)
         occurrences all number
    1
    Right Achilles tendon pain
         subjects affected / exposed
    1 / 110 (0.91%)
         occurrences all number
    1
    Right sided ache under ribs
         subjects affected / exposed
    1 / 110 (0.91%)
         occurrences all number
    1
    right knee pain
         subjects affected / exposed
    1 / 110 (0.91%)
         occurrences all number
    1
    Lower back pain
         subjects affected / exposed
    1 / 110 (0.91%)
         occurrences all number
    1
    Slight swelling both ankles
         subjects affected / exposed
    1 / 110 (0.91%)
         occurrences all number
    1
    Stiffness left shoulder and neck.
         subjects affected / exposed
    1 / 110 (0.91%)
         occurrences all number
    1
    left knee pain
         subjects affected / exposed
    1 / 110 (0.91%)
         occurrences all number
    1
    Right ankle Achilles tendon tenderness
         subjects affected / exposed
    1 / 110 (0.91%)
         occurrences all number
    1
    Infections and infestations
    Cold symptoms
         subjects affected / exposed
    9 / 110 (8.18%)
         occurrences all number
    9
    Cold symptoms - upper respiratory tract infection
         subjects affected / exposed
    2 / 110 (1.82%)
         occurrences all number
    2
    Gum infection followed by a tooth extraction
         subjects affected / exposed
    1 / 110 (0.91%)
         occurrences all number
    1
    Mild infection of left eye.
    Additional description: Mild infection of left eye. Over the counter eye drops used and symptoms improving.
         subjects affected / exposed
    1 / 110 (0.91%)
         occurrences all number
    1
    Right eye conjunctivitis
         subjects affected / exposed
    1 / 110 (0.91%)
         occurrences all number
    1
    Sore throat and cold symptoms
         subjects affected / exposed
    1 / 110 (0.91%)
         occurrences all number
    1
    Viral illness.
         subjects affected / exposed
    1 / 110 (0.91%)
         occurrences all number
    1
    upper respiratory tract infection
         subjects affected / exposed
    1 / 110 (0.91%)
         occurrences all number
    1
    flu like symptoms
         subjects affected / exposed
    1 / 110 (0.91%)
         occurrences all number
    1

    More information

    		 Close Top of page

    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
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sun Apr 28 08:14:20 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA