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    Summary
    EudraCT Number:2015-001065-76
    Sponsor's Protocol Code Number:P140918
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-09-08
    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 number2015-001065-76
    A.3Full title of the trial
    Blocage du Récepteur de l’Angiotensine II chez des sujets atteints de syndrome d’Ehlers Danlos vasculaire : essai muliticentrique randomisé contrôlé en double insu contre placebo
    A.3.2Name or abbreviated title of the trial where available
    ARCADE
    A.4.1Sponsor's protocol code numberP140918
    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 SponsorASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 IRBESARTAN
    D.2.1.1.2Name of the Marketing Authorisation holderEG LAbo
    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 nameIRBESARTAN
    D.3.4Pharmaceutical form Coated 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 INNirbesartan
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 placeboCoated tablet
    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
    Patients traités et stabilisés sous celiprolol pour un syndrome Dehlers Danlos.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10014316
    E.1.2Term Ehlers-Danlos syndrome
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Déterminer chez des patients atteints de SEDv confirmé par analyse génétique si le blocage des récepteurs de l'angiotensine II par l'IRBESARTAN prescrit à une dose optimale tolérée (150 à 300 mg par jour) administré seule ou en complément du traitement de réference celiprolol,reduit sur 24 mois le taux de survenue des événements cardiovasculaires asymptomatiques et symptomatiques ( critére principal composite ) par rapport au placebo..
    E.2.2Secondary objectives of the trial
    Déterminer chez des patients atteints de SEDv si l IBESARTAN prescrit à une dose optimale,augmente le temps de survenue du premier évenement cardiovasculaire symptômatique,diminue tout évenement à 24 mois notamment les evenements cardio-vasculaires entraînant le DC;les evenements fatals et morbides lié à la SEDv,les dissections artérielles ou ruptures artérielles, les anévrismes artériels,tout évenenment cardiovasculaire non fatal et AVC non mortel.-Diminue les évenements artériels asymptomatiques à 24 mois :lésions artérielles,anévrismes ,dissections des artéres périphériques détectées par angioscanner,diminue tout évenement non cardiovasculaire symptômatique lié à la maladie.Diminue le nombre d'hospitalisations imprévus pour tout évenement cardiovasculaire et/ou evenement non vasculaire lié à la maladie.Diminue tout symptôme lié à la maladie.Augmente la qualité de vie évalué par les questionnaires SF36 et HADS.Modification de la vitesse de l'onde de pouls mesuré par tonométrie d
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Patient confirmé SEDv présence d'une mutation du géne COL3A1.
    -Age compris supériuer ou égal à 18ans et inférieur à 70 ans .
    -Absence de contre-indication à la prise de l'Ibesartan.
    -Sous contraception ou Beta HCG négatif à l'inclusion.
    -Stabilisé sous traitement de Celiprolol depuis plus de douze semaines..
    --Débit de filtration glomérulaire (DFG) ? 30ml/min/1,73m2 (formule MDRD) ;
    -ECG 12 dérivations sans particularité ;
    -Recueil d'un consentement écrit et éclairé
    E.4Principal exclusion criteria
    -Patient ne pouvant se soumettre aux contraintes du protocole (par exemple, non coopérant, incapable de se rendre aux visites de suivi et probablement incapable de finir l'étude), mauvaise observance attendue par l'investigateur ;
    -Participation à une autre étude simultanement ou trois mois avant l'inclusion.
    -Historique de complications symptomatiques viscérales dans les trois mois précedent l'inclusion.
    --Allergie grave aux produits de contraste, non compatible avec les examens préliminaires ;
    -Indication formelle à un traitement antihypertenseur (PA en consultation 140/90 mmHg, avec céliprolol sur au moins 2 visites séparées, confirmées par une MAPA sur 24h , 135/85 mmHg) ;
    -Traitement concomitant avec un agent bloquant du systéme rénine-angiotensine-aldostérone en dehors du traitement de l'étude.Par exemple, IEC, ARAII, un antagoniste de l'aldostérone ou tout inhibiteur de la rénine prescrit dans une indication donnée (insuffisance cardiaque, insuffisance rénale, maladie rénale chronique, protéinurie, infarctus du myocarde, accident vasculaire cérébral) ;
    -Toute atteinte cardiaque qui justifie un traitement médical spécifique .(bloc auriculo-ventriculaire du 2ème ou 3ème degré, arythmie potentiellement mortelle ou arythmie incontrôlée ou persistante, maladie valvulaire cliniquement significative) ;
    -Une sténose de l'artére rénale connue comme une ischémie rénale évidente.(sur échographie Doppler, angioscanner ou un autre examen)
    -tout autre maladie autre que SDeV engageant le pronotic vital du patient (espérance de vie inférieure à 2 ans.)
    -Allergie ou hypersensibilité au traitement à l'étude
    --Patient non affilié à un régime de sécurité social ou bénéficiaire d'un tel régime. .
    E.5 End points
    E.5.1Primary end point(s)
    critéres composites symptomatiques et asymptômatiques:
    La survenue de nouveaux évenements cardio-vasculaires symtômatiques et la survenue de nouvelles lésions artérielles asymptomatiques détectés par Angio-scanner et echo-doppler.
    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 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) 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 No
    E.8.2.3Other No
    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 concerned18
    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 Information not present in EudraCT
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days0
    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) Yes
    F.1.2.1Number of subjects for this age range: 169
    F.1.3Elderly (>=65 years) No
    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 state169
    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 Decision2015-09-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-09-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-02-19
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