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The European Union Clinical Trials Register allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   42564   clinical trials with a EudraCT protocol, of which   7007   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).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .

    Clinical Trials marked as "Trial now transitioned" were transitioned to the Clinical Trial Regulation 536/2014 and can be further followed in the Clinical Trial Information System  
     
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    Summary
    EudraCT Number:2006-003432-30
    Sponsor's Protocol Code Number:P051056
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2007-08-09
    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 number2006-003432-30
    A.3Full title of the trial
    Interaction médicamenteuse entre la warfarine (Coumadine®) et l’association amoxicilline-acide clavulanique (Augmentin®)
    A.4.1Sponsor's protocol code numberP051056
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    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 Augmentin
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmithKline
    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 nameAugmentin
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNAmoxicilline et acide clavulanique
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500/62.50
    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) Information not present in EudraCT
    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 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 Information not present in EudraCT
    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 Information not present in EudraCT
    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
    maladies thromboemboliques
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level PT
    E.1.2Classification code 10043607
    E.1.2Term thrombose
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    montrer que l'Augmentin augmente l'INR des patients traites par warfarine en l'absence de tout syndrome infectieux ou inflammatoire
    E.2.2Secondary objectives of the trial
    Montrer que - Nbre de sujets interrompant leur periode (INR>3.5et / ou chez lesquels,une diminution de dose de warfarine est nécessaire) est > au cours periode Augmentin comparé periode placebo, - que INR moyen au cours de la période Augmentin est > INR moyen au cours de la période placebo, - Montrer que les sujets porteurs de l' allele A du SNP-1639 G/A du gène VKORC1 sont ceux dont l' augmentation de l' INR sous Augmentin est la plus importante, - Déterminer si l 'Augmentin augmente les concentrations residuelles S-et R- warfarine afin de mieux connaitre le mécanisme de l'interaction suspectée (soit d'ordre pharmacocinétique, soit d'ordre pharmacodynamique).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    patients - traités par Warfarine avec INR entre 2 et 3, - INR stable (3 INR entre 2 et 3 separés chacun plus de 5 jours,- ages > 18ans, -avec posologie AVK fixe depuis 1 mois, -normalité bilan biologique (CRP, ALAT),-sans episode infectieux > 3semaines,-consentements approuvés signés, -affiliation à un régime de sécurité sociale.
    E.4Principal exclusion criteria
    Antécédents a) d'allergie médicamenteuse quel que soit le médicament, même autre que les penicillines -b) de maladie psychiatrique tels que dépressifs et attaque de panique.- age supérieur à 80 ans- mauvaise compréhension de la langue Française- maladie néoplasique, d'Alzheimer ou autre trouble cognitif apparenté- thyroïdienne- Affection gastro-entérologique - Patient(e) fréquemment atteint de nausées ou de vomissements- Cirrhose connue ou suspectée- Insuffisance rénale chronique définie par une clairance calculée de la créatinine inférieure à 60 ml/min- prise régulière ou fréquente d'antalgiques ou d'AINS- Intoxication alcoolique - Patient(e)s a) ne pouvant s'abstenir de consommer du jus de pamplemousse ou des tisanes/gélules à base de Millepertuis - b) prenant fréquemment du paracétamol, du tramadol ou des AINS - c)susceptible d'être prochainement traité par amiodarone, ou cimétidine, ou antidépresseur IRS , ou clofibrate, ou fenofibrate, ou diltiazem, ou fluconazole, ou itraconazole, ou isoniazide, ou voriconazole, ou métronidazole, ou miconazole (y compris le gel oral ou vaginal) , ou omeprazole, ou tout glucocorticoide, ou zileuton, ou ritonavir ou inducteur enzymatique (rifampicine, carbamazepine, phenytoine, phenobarbital)- Traitement par un antibiotique dans les 3 semaines précédant l'inclusion- Risque au moment du recrutement de ne pouvoir participer à la totalité de l'étude. Femmes enceintes ou désirant entreprendre une grossesse (les femmes en âge de procréer auront un test de grossesse lors du bilan de pré-iclusion.
    E.5 End points
    E.5.1Primary end point(s)
    Critère principal
    Delta d'INR maximum mesuré au cours de chaque période = différence entre l'INR de base (moyenne du dernier INR avant l'inclusion, l'INR à la visite de screening et l'INR à J1) et l'INR maximum mesuré au cours de chaque période. Si un sujet interrompt sa période en raison d'un INR supérieur 3,5, la valeur d'INR constatée sera conservée comme valeur d'INR maximum de la période. Si un sujet interrompt sa période en raison d'une baisse de la posologie de warfarine, la valeur d'INR motivant la baisse de posologie sera considérée comme son INR maximum de la période.
    Critères secondaires
    - INR moyen mesuré au cours de chaque période : moyenne des INR J1, J3, J5, J6, J7.
    - Nombre de sujets interrompant leur période (INR>3,5 et/ou nécessité de baisser la dose de warfarine).
    - Génotypage VKORC1 1639G>A (analysé en porteur ou non porteur de l'allèle " A ").
    - concentrations plasmatiques de S- et R-warfarine (énantiomères) résiduelles à J1 et J7.
    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 Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    interaction médicamenteuse
    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 Yes
    E.7.1.3.1Other trial type description
    interaction
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 No
    E.8.1.6Cross over Yes
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 years2
    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 Yes
    F.3.2Patients No
    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 2007-08-09. 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 state20
    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 Decision2007-09-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-08-01
    P. End of Trial
    P.End of Trial StatusOngoing
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