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    Summary
    EudraCT Number:2016-004236-38
    Sponsor's Protocol Code Number:12250
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2016-12-23
    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 number2016-004236-38
    A.3Full title of the trial
    OPtimising Treatment for MIld Systolic hypertension in the Elderly: a randomised controlled trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Optimising treatment for mild systolic hypertension in the elderly
    A.3.2Name or abbreviated title of the trial where available
    OPTiMISE
    A.4.1Sponsor's protocol code number12250
    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 Oxford
    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 supportNIHR School for Primary Care Research
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportNIHR Oxford Collaborations for leadership in Applied Health Research and Care
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportNIHR Research Professorship
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Oxford
    B.5.2Functional name of contact pointJames Sheppard
    B.5.3 Address:
    B.5.3.1Street AddressNuffield Department of Primary Care Health Sciences
    B.5.3.2Town/ cityUniversity of Oxford
    B.5.3.3Post codeOX2 6GG
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+441865617192
    B.5.6E-mailjames.sheppard@phc.ox.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.2.5The 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 nameMedication withdrawal
    D.3.2Product code Not applicable
    D.3.4Pharmaceutical form
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPRoute of administration not applicable
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot applicable
    D.3.9.3Other descriptive nameNot applicable
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    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
    Hypertension
    E.1.1.1Medical condition in easily understood language
    High blood pressure
    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
    To determine if a reduction in medication can achieve a proportion of patients with clinically safe levels (defined as a systolic blood pressure <150mmHg) which is non-inferior (within 10%) to that achieved by the usual care group.
    E.2.2Secondary objectives of the trial
    Determine the proportion of patients in intervention arm who maintain medication reduction through to follow-up (i.e. are not restarted on therapy)

    Determine the difference in quality of life (according to EQ-5D-5L) between groups at 12 follow-up.

    Determine the difference in frailty (according to the FRAIL scale/frailty index) between the two groups at 12 week follow-up.

    Determine the difference in the change in mean clinic systolic blood pressure (from baseline) between the two groups at 12 week follow-up.

    Determine the difference in reported potential side effects to medication between the two groups at 12 week follow-up (e.g. coughs, dizziness, syncope, ankle swelling, etc.).

    Determine the difference in routinely reported adverse events between the two groups at 12 week follow-up (hospitalisation due to falls, myocardial infarction, stroke or all-cause mortality).

    Determine the characteristics (e.g. age, gender, ethnicity, medical history) of the baseline screening and sample
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion criteria for the main trial:
    • Participant is willing and able to give informed consent for participation in the trial.
    • Male or Female, aged 80 years or above.
    • Clinic systolic blood pressure less than 150 mmHg (according to screening measurement at baseline – clinic blood pressure defined as the mean of the 2nd and 3rd readings taken at 1 minute intervals).
    • Prescribed two or more antihypertensive medications to lower blood pressure for at least 12 months prior to trial entry. Antihypertensive medications defined as any ACE inhibitor, angiotensin II receptor blocker, calcium channel blocker, thiazide and thiazide-like diuretic, potassium-sparing diuretic, alpha-blocker or beta-blocker.
    • Stable dose of current antihypertensive medications for at least four weeks prior to trial entry.
    • In the Investigator’s opinion, could potentially benefit from medication reduction due to existing polypharmacy, co-morbidity, non-adherence or dislike of medicines and/or frailty (i.e. is different from those to which the results of the SPRINT trial are likely to apply).
    • In the Investigator’s opinion, is able and willing to comply with all trial requirements.

    Inclusion criteria for the qualitative study 1:
    • GPs from practices within the Cambridgeshire study region

    or

    • patients aged >80 years.
    • with controlled blood pressure (systolic blood pressure <150mmHg) (according to medical records).
    • receiving ≥2 antihypertensive medications.
    • no compelling indication for medication continuation.
    • GP considers may benefit from medication reduction due to existing polypharmacy, co-morbidity and frailty.

    Inclusion criteria for the qualitative study 2:
    • Patients screened for the main trial
    E.4Principal exclusion criteria
    Exclusion criteria for the main trial:
    • A participant has heart failure due to LVSD and is on only ACE inhibitors/ARBs and/or beta-blockers and/or spironolactone (removing any of which would be contraindicated).
    • A participant has heart failure but has not had an echocardiogram since its onset (might have undiagnosed LVSD and a compelling need for ACEI/ARB and Betablockers).
    • Investigator deems that there is a compelling indication for medication continuation.
    • Suffered a myocardial infarction or stroke within the past 12 months.
    • Blood pressure being managed outside of primary care.
    • A participant with secondary hypertension.
    • A participant with previous accelerated or malignant hypertension.
    • Unable to provide consent unless a consultee is available to provide assent in cases of incapacity.
    • Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant’s ability to participate in the trial (e.g. terminal illness, house bound and unable to attend baseline and follow up clinics).
    • Participants who have participated in another research trial involving antihypertensive medication in the past 4 weeks.

    Exclusion criteria for the qualitative study 1:
    • Capacity to consent and participate in an interview

    Exclusion criteria for the qualitative study 2:
    • None
    E.5 End points
    E.5.1Primary end point(s)
    The proportion of patients with controlled systolic blood pressure levels (systolic blood pressure <150mmHg) at 12 week follow-up.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks (+/-2 weeks)
    E.5.2Secondary end point(s)
    Proportion of patients randomized to the intervention arm who maintain medication reduction throughout 12 week follow-up.

    EQ-5D-5L score at 12 week follow-up.

    FRAIL scale score/frailty index at 12 week follow-up.

    The proportion of patients reporting possible side effects to medication (e.g. coughs, dizziness, syncope, ankle swelling, etc.).

    The proportion of patients reporting adverse events (hospitalisation due to serious falls, myocardial infarction, stroke or all-cause mortality).

    Exploratory analyses examining blood pressure control, change in blood pressure and maintenance of medication reduction at 12 months, by frailty, functional independence, cognitive function, number of antihypertensive medications and co-morbidities at baseline.

    Further quantitative, qualitative and economic analyses will examine:
    • Descriptive statistics of the screening and baseline population
    • Comparison of these characteristics with those eligible/not eligible for the SPRINT trial
    • Thematic analysis of chart-stimulated interviews with GPs
    • Thematic analysis of ‘Brown bag’ medication review interviews with patients.
    • Cardiovascular disease risk, costs and quality-adjusted-life years.
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 weeks (+/-2 weeks)
    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 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 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) Yes
    E.8.2.2Placebo No
    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 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 concerned42
    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 data capture following the last visit of the last participant.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days31
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days31
    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: 540
    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.3.3.6.1Details of subjects incapable of giving consent
    Some older patients lacking capacity (e.g. Dementia) may be included in the trial if an appropriate consultee is available at the point of enrollment.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state540
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 540
    F.4.2.2In the whole clinical trial 540
    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)
    Participants will continue to have their blood pressure managed by their GP after the research has finished, which may include continued medication reduction where appropriate.
    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 Decision2017-01-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-12-06
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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