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The European Union Clinical Trials Register allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   41499   clinical trials with a EudraCT protocol, of which   6826   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 in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
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    Summary
    EudraCT Number:2017-004004-22
    Sponsor's Protocol Code Number:233928
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2018-01-18
    Trial results View 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 number2017-004004-22
    A.3Full title of the trial
    A Multi-Centred, Open Label, Randomised Study Assessing the Cardiovascular Outcomes Following Treatment of White Coat Hypertension with Established Anti-Hypertensive Drugs versus Standard of Care in the Very Elderly - Feasibility Study
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    HYVET-2: Treatment of white coat HYypertension in the Very Elderly Trial (HYVET 2) - Feasibility of a randomised controlled trial
    A.3.2Name or abbreviated title of the trial where available
    HYVET 2: Treatment of white coat HYpertension in the Very Elderly
    A.4.1Sponsor's protocol code number233928
    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 Sussex
    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 supportDunhill Medical Trust
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBrighton and Sussex Clinical Trials Unit
    B.5.2Functional name of contact pointNicky Perry
    B.5.3 Address:
    B.5.3.1Street AddressUniversity of Brighton, Bevendean House, Room 204
    B.5.3.2Town/ cityBrighton
    B.5.3.3Post codeBN1 9PH
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01273641469
    B.5.6E-mailn.perry@bsms.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 Information not present in EudraCT
    D.2.1.1.1Trade name ALKAPAMID XL 1.5mg prolonged release tablets
    D.2.1.1.2Name of the Marketing Authorisation holderALKALOID-INT d.o.o., Šlandrova ulica 4, 1231 Ljubljana – Črnuče, Slovenia
    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 nameALKAPAMID XL 1.5mg prolonged release tablets
    D.3.4Pharmaceutical form Tablet
    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.3.8INN - Proposed INNIndapamide
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    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.IMP: 2
    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 Information not present in EudraCT
    D.2.1.1.1Trade name Perindopril Erbumine
    D.2.1.1.2Name of the Marketing Authorisation holderACCORD HEALTHCARE LIMITED
    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 namePerindopril Erbumine
    D.3.4Pharmaceutical form Tablet
    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.3.8INN - Proposed INNPerindopril
    D.3.9.4EV Substance CodeAS2
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number2mg to 8mg
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    White Coat Hypertension
    E.1.1.1Medical condition in easily understood language
    White Coat Hypertension
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    This is a feasibility study, which serves as a prelude to a definitive randomised controlled trial to determine whether the treatment of WCH in the very elderly outweighs any adverse events.
    The primary research question is:
    Will it be feasible to conduct a study treating WCH in a cohort of older people?
    To answer the above question, this feasibility study will focus on the following outcomes:
    1. The proportion of eligible patients that can be recruited from initial screening
    2. An exploration of different methods of identifying/recruiting patients including preliminary experience using the National Institute for Health Research/Clinical Research Network recruitment methods
    3. The willingness of GPs to recruit and randomise patients
    4. The willingness of patients to be randomised
    5. Recruitment rate
    6. Adherence to the treatment protocol
    7. Withdrawal from the clinical trial
    8. Expanding the opportunities for PPI (patient and public involvement) in the research design and its subseque
    E.2.2Secondary objectives of the trial
    As this is a feasibility trial there are no secondary objectives
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Patients ≥75 years of age
    • Clinic sitting systolic BP ≥150mmHg but <200mmHg and diastolic BP <110mmHg
    • Diagnosis of white coat hypertension at baseline if the mean ambulatory day time average systolic BP is <135 mmHg and diastolic BP is <85mmHg (from at least 14 measurements) or for HBPM from BP readings twice a day for at least 5 days (ideally 7 days)at baseline
    • Not taken antihypertensive drug therapy within the last 6 months
    • Capacity to consent
    • Provision of documented informed consent
    • Ability to comply with the protocol and additional study visits & assessments
    E.4Principal exclusion criteria
    • Contraindication to the use of indapamide MR and perindopril in accordance with the summary of product characteristics
    • Regular non-steroidal anti-inflammatory drug (NSAID) use. Regular use being defined by the local GP with consideration to cardiovascular risk and blood pressure
    • Hypertensive emergency
    • Secondary hypertension
    • Postural hypotension (postural drop in systolic BP≥20mmHg or postural symptoms at screening)
    • Any stroke or myocardial infarction in the previous 6 months
    • Heart failure requiring treatment with drugs having an antihypertensive effect
    • Previous documented evidence of gout
    • eGFR less than 30ml/min
    • Montreal cognitive assessment score (MoCA) < 22
    • Life expectancy <1year due to malignancy or chronic disease
    E.5 End points
    E.5.1Primary end point(s)
    This is a feasibility study, which serves as a prelude to a definitive randomised controlled trial, in order to determine whether the treatment of WCH in the very elderly is feasible and outweighs any adverse events.
    This feasibility study will focus on the following outcomes:
    1. The proportion of eligible patients that can be recruited from initial screening
    2. An exploration of different methods of identifying/recruiting patients including preliminary experience using the National Institute for Health Research/Clinical Research Network recruitment methods
    3. The willingness of GPs to recruit and randomise patients
    4. The willingness of patients to be randomised
    5. Recruitment rate
    6. Adherence to the treatment protocol
    7. Withdrawal from the clinical trial
    8. Expanding the opportunities for PPI (patient and public involvement) in the research design and its subsequent conduct and dissemination
    9. Estimate the incidence of Cardiovascular Events
    10. measure ambulatory and home blood pressure
    E.5.1.1Timepoint(s) of evaluation of this end point
    By the end of the study, its feasibility will be ascertained through answering the above questions.
    E.5.2Secondary end point(s)
    As this is a feasibility study there are no secondary end points
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not applicable.
    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 Yes
    E.6.4Safety No
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    No treatment
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned36
    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 Yes
    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
    Last Post Treatment Follow Up contact with participants GP
    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 months6
    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 months6
    E.8.9.2In all countries concerned by the trial days1
    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) No
    F.1.2.1Number of subjects for this age range: 0
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 100
    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 arrangements have been made. However, if this feasibility trial proves successful and progresses to a full trial then participants may be eligible to participate in this.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Kent Surrey Sussex Clinical Research Network
    G.4.3.4Network Country United Kingdom
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-02-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-03-16
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2020-02-17
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