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    Summary
    EudraCT Number:2013-003204-40
    Sponsor's Protocol Code Number:PATHBP_2013
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-12-04
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2013-003204-40
    A.3Full title of the trial
    Paracetamol treatment in hypertension: effect on blood pressure
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    PAracetamol Treatment in Hypertension: effect on Blood Pressure (PATH-BP) Study

    A.3.2Name or abbreviated title of the trial where available
    The PATH-BP study
    A.4.1Sponsor's protocol code numberPATHBP_2013
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorUniversity of Edinburgh
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportBritish Heart Foundation
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationQueen’s Medical Research Institute
    B.5.2Functional name of contact pointProfessor Davide Webb
    B.5.3 Address:
    B.5.3.1Street Address47 Little France Crescent
    B.5.3.2Town/ cityEdinburgh
    B.5.3.3Post codeEH16 4TJ
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01312429216
    B.5.6E-maild.j.webb@ed.ac.uk
    B.Sponsor: 2
    B.1.1Name of SponsorNHS Lothian
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportBritish Heart Foundation
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Edinburgh
    B.5.2Functional name of contact pointProf David Webb
    B.5.3 Address:
    B.5.3.1Street AddressCentre for Cardiovascular Science
    B.5.3.2Town/ cityQueen's Medical Research Institute
    B.5.3.3Post codeEH16 4TJ
    B.5.4Telephone number01312429216
    B.5.6E-mailD.J.Webb@ed.ac.uk
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Paracetamol capsules 500mg
    D.2.1.1.2Name of the Marketing Authorisation holderBristol Laboratories Ltd, Unit 3, Canalside, Northbridge Road, Berkhamstead, Hertfordshire, HP4 1EG
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameParacetamol capsules 500mg
    D.3.2Product code Not applicable (Licensed product)
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.4EV Substance CodeAS1
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Hypertension
    E.1.1.1Medical condition in easily understood language
    Blood pressure
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10005729
    E.1.2Term Blood pressure ambulatory
    E.1.2System Organ Class 10022891 - Investigations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10020775
    E.1.2Term Hypertension arterial
    E.1.2System Organ Class 10047065 - Vascular disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10005756
    E.1.2Term Blood pressure systolic
    E.1.2System Organ Class 10022891 - Investigations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10020772
    E.1.2Term Hypertension
    E.1.2System Organ Class 10047065 - Vascular disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10005735
    E.1.2Term Blood pressure diastolic
    E.1.2System Organ Class 10022891 - Investigations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10033762
    E.1.2Term Paracetamol
    E.1.2System Organ Class 10022891 - Investigations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10005727
    E.1.2Term Blood pressure
    E.1.2System Organ Class 10022891 - Investigations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10015488
    E.1.2Term Essential hypertension
    E.1.2System Organ Class 10047065 - Vascular disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the effect of parcetamol on blood pressure in hypertensives adults taking or not taking antihypertensive medications.
    E.2.2Secondary objectives of the trial
    Not applicable.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    1. PATH-BP Urine Prostaglandin study

    The pain relieving effect of paracetamol is thought to be due to the inhibition of the enzyme that controls prostaglandin synthesis. There is some evidence to show that paracetamol can inhibit prostaglandin production in the kidney and reduce urine sodium excretion. This is important because we suspect that through this mechanism of sodium retention, paracetamol may increase blood pressure. Prostaglandins from the kidney can be accurately measured in women from urine, but in men prostaglandins are excreted into urine from both the prostate gland and the kidney. So, for an accurate assessment of the effect of paracetamol on prostaglandin synthesis from the kidney, we will ask only women to participate in this sub-study.

    Female participants will be asked to perform a 24-hour urine collection 4 times throughout the study, before and after each treatment period. This may be inconvenient and they must avoid sexual intercourse on the day before and the day of each collection. They will be given a thorough explanation of how to perform the collection, and they will be provided with a urine container.

    This sub study will not require any additional study visits to the CRC. We will ask patients to drop off the urine collection on the same day they are returning the BP equipment to the CRC. These samples will be analysed at the Vascular Biology Laboratory, Queens Medical Research Institute, Edinburgh.




    2. PATH-BP Biomarker Study

    Paracetamol is very safe in therapeutic doses. However, in overdose, paracetamol can result in acute liver failure and even death. Diagnosis of liver injury following overdose is delayed because current blood tests are slow to detect damage. New blood markers of liver injury has been identified that are increased in concentration earlier in patients following a paracetamol overdose compared to current liver markers. Potentially, these markers may identify patients at risk of liver failure earlier and allow treatment to be initiated sooner.

    There is evidence to suggest that taking paracetamol within the recommended daily amount may cause a very small increase in standard liver tests. Upon stopping paracetamol the liver tests return to normal. Therefore, the objective of this sub-study is to further explore our new markers and determine whether they change in concentration when no liver damage from paracetamol has occurred.

    During the study, participants will be taking paracetamol 1g qid or placebo for 14 days. Participants will be attending the CRC on days 0, 4,7 and 14 for a BP check, renal function check, and paracetamol levels (to ensure compliance). If participants agree to participate in this sub-study, additional blood samples (10mls) will be taken for liver function tests and biomarker analysis.

    In addition, a blood sample (5mls) will be taken on day 1 for DNA analysis. These samples will be stored in the -80 freezer in CRC until the study is complete. The samples will be analysed at Institute of Translational Medicine, University of Liverpool were they have pioneered the technique of liver biomarker analysis through previous collaborative work with Dr J Dear, University of Edinburgh.










    E.3Principal inclusion criteria
    Inclusion criteria: ≥18 years old, men or post-menopausal women. Half of the patients recruited will be women (to allow PG measurement). Treated hypertensive patients with an average daytime ABPM <150/95mmHg on stable doses of one or more antihypertensive medication (at least one of which should be; an ACEi, ARB or diuretic) for 3 months, or untreated hypertensive patients with an average daytime ABPM ≥135/85 but <150/95.
    E.4Principal exclusion criteria
    Exclusion criteria: History of ischaemic heart disease, cardiac failure, cerebrovascular disease, liver impairment (ALT/AST>50IU/L) or stage 3-5 chronic kidney disease. Patients with a history of overdose or suicidal ideation. Patients weighing <55kgs. Patients with chronic pain requiring treatment, with a known allergy to paracetamol, or concomitant use of NSAIDs, oral anticoagulants or corticosteroids.
    E.5 End points
    E.5.1Primary end point(s)
    Difference in mean daytime systolic ambulatory BP between the paracetamol and placebo periods.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Daytime systolic ambulatory BP will be assessed at the start and end of each 14 day period of study drugs.
    E.5.2Secondary end point(s)
    i)Difference in clinic systolic BP between paracetamol and placebo periods
    ii)Difference in daytime diastolic ambulatory BP between paracetamol and placebo periods
    iii)Difference in mean daytime systolic ambulatory BP between the paracetamol and placebo periods in patients taking and not taking antihypertensive medications


    E.5.2.1Timepoint(s) of evaluation of this end point
    Clinic systolic BP will be assessed on day 0, day 4&7, and day 14 of study drugs. Ambulatory BP will be assessed on day 0 and day 14 (ie start and end of study drugs).
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 70
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state110
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    No treatment available after the trial. Participants will be looked after in the usual way by their GP or at the hypertension clinic.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-01-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-09-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-06-04
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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