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    The EU Clinical Trials Register currently displays   33764   clinical trials with a EudraCT protocol, of which   5467   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).
     
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    Summary
    EudraCT Number:2012-000232-25
    Sponsor's Protocol Code Number:P110138
    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:2012-08-27
    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 number2012-000232-25
    A.3Full title of the trial
    Efficacité du prétraitement par levosimendan avant pontage aorto-coronaire sous circulation extra-corporelle chez des patients à haut risque (FE < 40%): essai randomisé, multicentrique, en double insu versus placebo. LICORN: Levosimendan In COronary RevascularisatioN
    A.3.2Name or abbreviated title of the trial where available
    LICORN
    A.4.1Sponsor's protocol code numberP110138
    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 simdax
    D.2.1.2Country which granted the Marketing AuthorisationFinland
    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 nameSimdax
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNlevosimendan
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    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 placeboConcentrate for solution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    patients avec FEVG 40% et devant bénéficier d'une chirurgie coronaire avec CEC, seule ou combinée à une chirurgie valvulaire
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level LLT
    E.1.2Classification code 10068176
    E.1.2Term Coronary artery bypass graft
    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
    L'objectif principal est d'évaluer l'efficacité du prétraitement par levosimendan au moment de l'induction anesthésique chez des patients dont la FEVG est 40% et devant bénéficier d'une chirurgie cardiaque sous CEC de type PAC (avec ou sans chirurgie valvulaire) pour réduire l'incidence et la sévérité du SBDC postopératoire.
    E.2.2Secondary objectives of the trial
    - comparer le taux de mortalité à J 28 et J 180 pour les patients des 2 groupes.
    - évaluer l'impact économique de l'injection du levosimendan selon une étude de type " coût-efficacité " pendant le séjour hospitalier
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - patient d'âge 18 ans
    - patient bénéficiant d'un régime de sécurité sociale
    - patient ayant reçu et compris l'information et, ayant signé le consentement éclairé
    - patients devant subir un PAC seul ou associé à une chirurgie valvulaire avec CEC
    - FEVG préopératoire 40% (documentée par un examen de moins de 6 mois)
    - Les patients présentant une insuffisance circulatoire aiguë préopératoire sous traitement inotrope positif et/ou assistance mécanique (BCPIA ou ECLS) peuvent être inclus dans l'étude. Le traitement par levosimendan ou placebo se surajoutant au traitement existant. La technique de minimisation est prévue pour équilibrer la distribution de tels patients entre les 2 groupes.
    E.4Principal exclusion criteria
    - patient ayant refusé de donner son consentement
    - PAC sans CEC
    - chirurgie valvulaire sans geste de revascularisation coronaire sous CEC associé
    - femme enceinte ou en cours d'allaitement
    - participation du patient à un autre protocole de recherche clinique.
    - Contre-indications au levosimendan (celles de la monographie) : (allergie connue au levosimendan ou à l'un de ses excipients , insuffisance rénale sévère préopératoire (clairance de la créatinine <30 mL/min) , patient nécessitant des séances de dialyse en préopératoire , insuffisance hépatique sévère (TP < 50% hors prise d'AVK) , sévère hypotension et tachycardie , antécédent de torsade de pointe , obstruction dynamique de la chambre de chasse du VG).
    E.5 End points
    E.5.1Primary end point(s)
    Le critère de jugement principal est un critère composite qui reflète la présence d'un SBDC avéré. Ce critère regroupe :
    (1) l'utilisation d'agent inotrope positif au-delà de la 24ème heure après la fin de la perfusion du médicament à l'étude (soit 48 heures après l'induction anesthésique) ; ou
    (2) le recours à des techniques d'assistance circulatoire mécanique (BCPIA, ECLS) ou l'absence d'arrêt de celles-ci si elles existent en préopératoire au-delà de la 96ème heure ; ou
    (3) le recours à une technique d'épuration extra-rénale (hémodialyse conventionnelle intermittente ou hémofiltration continue) pendant le séjour en réanimation.

    Les critères retenus pour évaluer la mortalité sont :
    - la mortalité pendant le séjour hospitalier
    - la mortalité à J 28
    - la mortalité à J 180.

    Les critères retenus pour étudier l'impact économique sont :
    - le nombre total de jours hors-hôpital à J28.
    - le nombre de jours d'hospitalisation en unité de réanimation et en service conventionnel
    - le nombre total de jours hors-ventilateur pendant le séjour hospitalier
    - la quantité totale d'inotropes positifs injectés et la durée de leurs perfusions
    - le nombre de jours sous assistance circulatoire mécanique
    - le nombre d'heures d'épuration extra-rénale et le nombre de circuits et de cathéters utilisés.
    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 No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Information not present in EudraCT
    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.8.3 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 concerned15
    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 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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    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.1.3Elderly (>=65 years) Yes
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2012-08-27. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state340
    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 Decision2012-06-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-06-27
    P. End of Trial
    P.End of Trial StatusCompleted
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