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    Summary
    EudraCT Number:2012-004160-22
    Sponsor's Protocol Code Number:LUMC_IEMO80PLUS_1.0
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-03-11
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2012-004160-22
    A.3Full title of the trial
    IEMO 80-plus thyroid trial
    IEMO 80-plus schildklier studie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    IEMO 80-plus thyroid trial
    IEMO 80-plus schildklier studie
    A.3.2Name or abbreviated title of the trial where available
    IEMO 80-plus thyroid trial
    IEMO 80-plus schildklier studie
    A.4.1Sponsor's protocol code numberLUMC_IEMO80PLUS_1.0
    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 SponsorLeiden University Medical Center
    B.1.3.4CountryNetherlands
    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 supportZonMw
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLeiden University Medical Center
    B.5.2Functional name of contact pointIEMO project office
    B.5.3 Address:
    B.5.3.1Street AddressPostzone C7-Q, Albinusdreef 2
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333 AA
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31715266640
    B.5.5Fax number+31715248945
    B.5.6E-mails.p.mooijaart@lumc.nl
    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 Euthyrox
    D.2.1.1.2Name of the Marketing Authorisation holderMerck KGAa
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameLevothyroxine
    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 INNLEVOTHYROXINE SODIUM
    D.3.9.1CAS number 55-03-8
    D.3.9.4EV Substance CodeSUB08495MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLEVOTHYROXINE SODIUM
    D.3.9.1CAS number 55-03-8
    D.3.9.4EV Substance CodeSUB08495MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 placeboTablet
    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
    Subclinical hypothyroidism
    Subklinische hypothyreoidie
    E.1.1.1Medical condition in easily understood language
    Thyroid hormone has multiple actions. In subclinical hypothyroidism the thyroid gland is mildly underactive. This does not cause major symptoms, but may contribute to poor health in old age.
    Schildklier hormoon heeft vele functies. In SCH heeft de schildklier een licht vertraagde werking. Dit leidt niet to hevige symptomen, maar kan bijdragen tot een lagere gezondheid op hoge leeftijd.
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    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
    1. Does Levothyroxine treatment for SCH give multi-modal benefits for the oldest old people with SCH?
    2. Are benefits seen across a wide range of outcomes, including prevention of cardiovascular disease, and improving health-related quality of life, muscle function and cognition?
    3. Are benefits seen in specific subgroups of oldest old people with SCH, including women, and those with mild degrees of SCH (TSH 4.6-10 mU/L)?
    4. Are any benefits offset by adverse effects, such as atrial fibrillation or heart failure?
    1. Leidt behandeling met levothyroxine tot multipele gezondheidsvoordelen in de oudste ouderen met subklinische hypothyreoidie?
    2. Zijn deze voordelen zichtbaar over een breed skala aan eindpunten, includief preventie van cardiovasculaire ziekte en verbetering van kwaliteit van leven, spierfunctie en congnitie?
    3. Worden de voordelen met name gezien binnen subgroepen van oudste ouderen, zoals vrouwen of ouderen met een milde subklinische hypothyreoidie (TSH 4.6-10 mU/L)
    4. Staan er tegenover de voordelen ook bijwerkingen, zoals boezemfibrilleren of hartfalen?
    E.2.2Secondary objectives of the trial
    i. To establish a strong national and interneational network of complementary research expertise in older people, including geriatric medicine, endocrinology and metabolic medicine, primary care, cardiovascular disease and biostatistics.
    ii. To link this research expertise with strong focus on patient perspective and needs.
    iii. To provide the necessary evidence to properly inform best practice for treatment of SCH in the oldest old.
    iv. To disseminate this evidence to health care practitioners and patients
    v. To improve clinical practice in management of SCH in the oldest old
    vi. To improve health and well-being of older people with SCH.
    vii. To establish a blood biobank, to be used in future research into causes and mechanisms of health, disease and disability in later life.
    viii. To establish experience in tailoring an RCT for the oldest old, to be used for future RCTs.
    i. Het opzetten van een sterk nationaal en internationaal netwerk van complementaire research exptertise in ouderen, waaronder geriatrie, endocrinologie en metabolisme, eerstelijnsgeneeskunde, cardiovasculaire ziekte en biostatistiek.
    ii. Het koppelen van deze kennis aan het perspectief en de wensen van ouderen patienten.
    iii. Het verschaffen van het benodigde bewijs voor 'best practice' voor de behandeling van SCH in de oudste ouderen.
    iv. Het dissemineren van dit bewijs naar gezondheidszorg professionals en patienten.
    v. Het verbeteren van de klinische beleid voor de oudste ouderen met SCH
    vi. Het verbeteren van de gezondheid en welzijn van de oudste ouderen.
    vii. Het opzetten van een bloed-biobank, om te gebruiken in toekomstig onderzoen naar de oorzaken en mechanismen van ziekte, gezondheid en afhankelijkeheid op hoge leeftijd.
    viii. Het verkrijgen van expertise in het op maat maken van een RCT voor oudste ouderen, te gebruiken in toekomstige RCT's.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Community-dwelling patients aged >80 years with SCH.

    SCH is defined as persistently elevated TSH levels (>4.6 and ≤19.9 mU/L) and free thyroxine (fT4) in reference range measured on a minimum of two occasions at least 3 months apart.
    Ouderen van 80 jaar en ouder met SCH uit de algemene bevolking.

    SCH is gedefinieerd als een persisterend verhoogd TSH niveau (TSH>4.6 en <19.9 mU/L) gecombineerd met een fT4 waarden binnen de normaalwaarden, gemeten op ten minste 2 gelegenheiden minstens 3 maanden uit elkaar.
    E.4Principal exclusion criteria
    • Subjects currently on Levothyroxine or antithyroid medication (e.g. Carbimazole, methimazole, propylthiouracil, potassium percholate), amiodarone or lithium.
    • Recent thyroid surgery or radio-iodine therapy (within 12 months).
    • Grade IV NYHA heart failure.
    • Prior clinical diagnosis of dementia.
    • Recent hospitalisation for major illness (within 4 weeks).
    • Recent acute coronary syndrome, including myocardial infarction or unstable angina (within 4 weeks).
    • Acute myocarditis ore acute pancarditis
    • Untreated adrenal insufficiency
    • Terminal illness.
    • Patients known to have rare hereditary problem of galactose intolerance.
    • Subjects who are participating in ongoing RCTs of therapeutic interventions (including clinical trials of investigational medicinal products [CTIMPs])
    • Plan to move out of the region in which the trial is being conducted within the next 2 years (proposed minimum follow-up period).
    - Ouderen die levothyroxine gebruiken of middelen met een schildklierhormoon verlagende werking (zoals Carbimazol, methimazol, propylthiouracil, kalium perchloraat), amiodaron of lithium.
    - Recente schildklier-operatie of nuclreaire therapie met Iood (binnen 12 maanden)
    - Graad IV NYHA hartflen
    - Eerdere diagnose van dementie
    - Recente ziekenhuisopname voor belangrijke ziekte (binnen 4 weken)
    - Recent acuut coronair syndrrom, inclusief myocard infarct of instabiele angina pectoris (binnen 4 weken)
    - ACute myocarditis of acute pancarditis
    - Onbehandelde bijnierinsufficientie
    - Terminale ziekte
    - Patienten bekend met zeldzame erfelijke problemen met galactose intolerantie
    - Patienten die deelnemen aan andere RCT's met therapeutische interventie (includief klinische trials met IMP's)
    - Het plan van de deelnemer om binnnen 2 jaar te verhuizen naar buiten het onderzoeksgebied.
    E.5 End points
    E.5.1Primary end point(s)
    Change in disease specific QOL (measured using symtpom and fatigue domains from the Thyroid-specific Quality of Life-reported outcome measure (Thy-PRO) - measured at baseline, at 6-8 weeks; 12 months and close-out.
    Verandering in ziekte-specifieke QOL (gemeten in de domeinen "symptomen" en "vermoeidheid" van de Thyroid-specfic QOL vragenlijst Thy-Pro, gemeten op baseline, op 6-8 weken; 12 maanden en studie-einde)
    E.5.1.1Timepoint(s) of evaluation of this end point
    The ThyPRO will be measured at baseline; 6-8 weeks; 12 months and close-out
    De ThyPRO wordt gemeten op baseline; 6-8 weken; 12 maanden en studie einde
    E.5.2Secondary end point(s)
    - General QOL (Measured using EuroQOL) at baseline; 6-8 weeks; 12 months; final follow-up
    - Handrgrip strength (measured using the JAMAR hand dynamometer) at baseline; 12 months; final follow-up
    - Cognitive function, particularly executive function (measure using Letter Digit Coding Test) at baseline and final follow-up
    - Functional ability (basic Activities of Daily Living measured using Barthell extended activities of daily living measure using the Older American resources and services at baseline and final follow-up.
    - Haemoglobin, measured on a full blood count at baseline and 12 months.
    - Gait speed measured at baseline 12 months and final follow-up
    - Depressive symtpoms, measured using the 15-item Geriatric Depression Scale at baseline an at final follow-up
    - Fatal and non-fatal cardiovascular events (this will include acute myocardial infarction; stroke; amputation for peripheral vascular disease; revascularisation for atherosclerotic vascular disease, including for acute coronary syndrome; heart failure hospitalisation)
    - Treatment satisfaction at final follow-up
    - ALgemene kwaliteit van leven (gemeten mbv EuroQOL op baseline; 6-8 weken; laatste bezoek
    - Handknijpkracht (gemeten met de JAMAR hand dynamometer) op baseline; 12 maanden; laatste studie bezoek
    - Cognitieve functie, meer specifiek executief funcitoneren (gemente met Letter Digit Coding Test) op baseline an bij het laatste bezoek.
    - Functionele capaciteit (basis Activiteiten van het Dagelijke Leven gemeten mbv de Barthel index; uitgebreide activiteiten van het dagelijks leven gemeten met behulp van de Older American Resources and Services (OARS) op baseline en laatste studiebezoek.
    - Hemoglobine, gemeten in een vol-bloed op baseline en na 12 maanden
    - Gangsnelheid gemeten op baseline, na 12 maanden en laatste bezoek
    - Depressieve symptomen gemeten met de 15-item Geriatrics Depression Scale op baseline en bij het laatste bezoek.
    - Fatale en niet-fatale cardiovasculaire events (inclusief acuut myocard infarct; beroerte; amputatie wegens perifere vasculaire ziekte; revascularisatie wegens atheroscleroatische vasculaire ziekte, inclusief voor acuut coronair syndroom; ziekenhuisopname wegens hartfalen)
    - Behandelings tevredenheid tijdens laatste bezoek
    E.5.2.1Timepoint(s) of evaluation of this end point
    Listed above
    Zoals boven beschreven
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    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 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 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.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA1
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Switzerland
    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 visit of last subject
    Laatste bezoek van laatste deelnemer
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months2
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 145
    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 state125
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 125
    F.4.2.2In the whole clinical trial 145
    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 who either complete or withdraw from the study treatment will be referred back to their general practitioner for their ongoing care. Any future treatment would be at the discretion of the patient's general practitioner or treating physician in the hospital. When the research is finished and the database is locked, participants will be informed of whether they were allocated to levothyroxine or placebo and will be advised to discuss this with their GP or treating physician.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-03-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-06-18
    P. End of Trial
    P.End of Trial StatusCompleted
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