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    Summary
    EudraCT Number:2014-000311-13
    Sponsor's Protocol Code Number:RB14.012
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2015-06-22
    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 ConcernedFrance - ANSM
    A.2EudraCT number2014-000311-13
    A.3Full title of the trial
    Prevention of Symptomatic Venous Thromboembolism by Low Molecular Weight Heparin in Hospitalized Medical Patients aged 70 years and older : a Randomized Placebo-Controlled Study
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The SYMPTOMS (SYstematic elderly Medical Patients Thromboprophylaxis : efficacy on symptomatic OutcoMeS) study
    A.3.2Name or abbreviated title of the trial where available
    SYMPTOMS
    A.4.1Sponsor's protocol code numberRB14.012
    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 SponsorCHRU de Brest
    B.1.3.4CountryFrance
    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 supportHealth Ministry
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHRU de Brest
    B.5.2Functional name of contact pointDRCI
    B.5.3 Address:
    B.5.3.1Street Address2 avenue Foch
    B.5.3.2Town/ cityBrest
    B.5.3.3Post code29609
    B.5.3.4CountryFrance
    B.5.4Telephone number0033298223141
    B.5.5Fax number0033298223183
    B.5.6E-mailvalentine.guiton@chu-brest.fr
    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 Lovenox 4000 UI anti-Xa/0,4 ml
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi-Aventis
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameLovenox
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    Subcutaneous use
    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 placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Venous Thromboembolism
    E.1.1.1Medical condition in easily understood language
    Venous Thromboembolism
    E.1.1.2Therapeutic area Not possible to specify
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10049909
    E.1.2Term Venous thromboembolism prophylaxis
    E.1.2System Organ Class 100000004865
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate the efficacy on the risk of symptomatic VTE at one month of low molecular weight heparin enoxaparin 40 mg once daily subcutaneously for 10 ± 4 days as compared with placebo in patients aged 75 years or more who have been hospitalized for an acute medical illness.
    E.2.2Secondary objectives of the trial
    • To evaluate whether the use of prophylactic dose of low molecular weight heparin reduces the risk of symptomatic VTE at 3 months in hospitalized elderly medical patients
    • To assess the risk of bleeding associated with the use of prophylactic low molecular weight heparin at 1month and at 3 months
    • To assess the net clinical benefit (symptomatic VTE and major bleeding events) associated with the use of low molecular weight heparin at 1 month and at 3 months
    • To assess the impact of low molecular weight heparin on atherothrombotic cardiovascular events at 1 month and 3 months
    • To assess the impact of low molecular weight heparin on mortality from any cause at 1 month and at 3 months
    • To assess the risk of cardiovascular death at 1 month and at 3 months
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Patient aged 75 years or older
    • Admitted to hospital for an acute medical illness
    • Anticipated duration of hospitalization of at least 4 days
    • Life expectancy of at least 3 months
    E.4Principal exclusion criteria
    • Admission for one of the following reasons:
    o Planned medical procedure.
    o Routine health assessment requiring admission for baseline/trending of health status (e.g., routine colonoscopy).
    o Admission encountered for another life circumstance that causes no bearing on health status and requires no medical intervention (e.g., lack of housing, economic inadequacy, care-giver respite, family circumstances, administrative).
    • Hypersensitivity to heparin
    • History of Heparin Induced Thrombocytopenia
    • Active bleeding
    • Bacterial endocarditis
    • Platelet count of less than 100,000 per cubic millimeter
    • Patients who require anticoagulant therapy for any indication, and those who received any type of anticoagulant therapy for > 48 hours
    • Active peptic ulcer
    • Concomitant use of aspirin (> 160 mg/day), clopidogrel (> 75 mg/day), or of combined antiplatelet therapy
    • Previous admission to hospital within the last month
    • Creatinine clearance < 15 ml/min
    • Unable or unwilling to consent
    • Ischemic stroke + hemorrhagic transformation
    • Patient requiring admission to Intensive Care Unit
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome is the occurrence of any of the following events through the day 30 visit : symptomatic confirmed deep venous thrombosis (DVT), symptomatic confirmed pulmonary embolism (PE), or fatal PE
    E.5.1.1Timepoint(s) of evaluation of this end point
    day 30 visit
    E.5.2Secondary end point(s)
    The secondary outcomes is the occurrence of any of the following events
    • Symptomatic confirmed VTE (DVT or PE) or fatal PE through the day 90 visit
    • Major bleeding as defined by the criteria of the International Society of Thrombosis and Haemostasis through the day 30 and the day 90 visit
    • Clinically relevant non major bleeding and any bleeding through the day 30 and the day 90 visit
    • Atherothrombotic cardiovascular events through the day 30 and the day 90 visit
    • Cardiovascular death through the day 30 and the day 90 visit
    • Death from any cause through the day 30 and the day 90 visit

    All events are adjudicated by the CEC
    E.5.2.1Timepoint(s) of evaluation of this end point
    day 30 and the day 90 visit
    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 No
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    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 Yes
    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 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 concerned30
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA50
    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
    Belgium
    Canada
    France
    Germany
    Italy
    Spain
    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
    the last visit of the last subject undergoing the trial
    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 months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months3
    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: 5030
    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 state3520
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 4200
    F.4.2.2In the whole clinical trial 5030
    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)
    none
    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 Decision2014-06-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-03-04
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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