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    The EU Clinical Trials Register currently displays   34905   clinical trials with a EudraCT protocol, of which   5686   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2006-004632-69
    Sponsor's Protocol Code Number:P060309
    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:2006-10-25
    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 number2006-004632-69
    A.3Full title of the trial
    Polymorphismes du gène codant pour le cytochrome 2C19 et réponse au clopidogrel chez le sujet sain
    A.3.2Name or abbreviated title of the trial where available
    CLOVIS
    A.4.1Sponsor's protocol code numberP060309
    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 Plavix 75 mg en boite de 50 comprimés
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi Pharma Bristol-Myers Squibb SNC
    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 namePlavix 75 mg en boite de 50 comprimés
    D.3.4Pharmaceutical form Film-coated 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 INNClopidogrel
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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.IMP: 2
    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 Ogast 30 mg en boîte de 7 gélules
    D.2.1.1.2Name of the Marketing Authorisation holderLaboratoires TAKEDA
    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 nameOgast 30 mg en boîte de 7 gélules
    D.3.4Pharmaceutical form Capsule*
    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 INNLansoprazole
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    volontaire sain
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level PT
    E.1.2Classification code 10043414
    E.1.2Term Therapeutic response decreased
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Tester l'impact de l'augmentation de la dose d'entretien de 75 mg à 150 mg/jour chez les sujets sains porteurs d'au moins 1 allèle (*2) codant pour un CYP2C19 déficient.
    La réponse au clopidogrel sera jugée sur l'agrégation plaquettaire ex vivo à l'ADP à la dose de 10 µM.
    E.2.2Secondary objectives of the trial
    Evaluer la possibilité d'une réduction de la réponse anti-agrégante plaquettaire au clopidogrel lors de la co-administration d'un médicament inhibiteur du CYP2C19 (Inhibiteur de pompe à protons : Lansoprazole).
    Evaluer l'influence du variant allélique *2 codant pour un CYP2C19 déficient sur :
    - L'agrégation plaquettaire ex vivo à l'ADP aux doses complémentaires de 5 µM et de 20 µM.
    - la phosphorylation de VASP
    - La pharmacocinétique du clopidogrel et de ses deux métabolites, inactif (2-oxo-clopidogrel) et actif (dérivé thiolé)
    Modéliser la relation pharmacocinétique / pharmacodynamique du clopidogrel
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Les sujets inclus devront remplir les critères suivants :
    - Sexe masculin, non-fumeurs, caucasiens
    - Age compris entre 18 et 35 ans
    - Poids compris entre 60 et 100 kg et indice de masse corporelle compris dans les limites autorisées en fonction de la taille selon l'indice de Quételet - poids (kg)/taille2 (m). L'indice de masse corporelle doit être compris entre 18 et 30 (inclus) kg/m2 (9).
    - Génotype CYP2C19 : *1/*1, *1/*2
    - Génotype P2Y12 : H1/H1, H1/H2
    - Affiliation à la sécurité sociale conformément aux recommandations de la loi française (loi Huriet : n° 88.1138 - 20.12.88) portant sur la recherche biomédicale.
    - Consentement obtenu pour tous les sujets avant l'entrée dans l'étude.
    Les sujets retenus après la visite pour screening génétique devront de plus remplir les critères suivants :
    - Examens biologiques de routine normaux comprenant : glycémie à jeun, ASAT, ALAT, phosphatases alcalines, gamma-GT, bilirubine, créatininémie, ionogramme sanguin, calcémie, albuminémie, protidémie, numération formule sanguine, plaquettes, taux de prothrombine (TP), temps de céphaline plus activateur (TCA), concentration de fibrinogène.
    - Tests d'agrégation plaquettaire normaux (>50%) au collagène 1 µg/mL, à l'acide arachidonique 1 mmol/L et au U46619 1 µmol/L (analogue du thromboxane A2), à l'ADP 10 µM.
    - Sérologies HIV1 et 2, HBV (Ag Hbs) et HCV négatives.
    - Recherche de toxiques urinaires (cannabinacées) négative. Cette recherche ne sera effectuée que sur les sujets qui remplissent tous les autres critères d'inclusion.
    - ECG 12 dérivations, pression artérielle et fréquence cardiaque sans particularité.
    E.4Principal exclusion criteria
    - Sujets porteurs des allèles mutés *3, *4, *5, et *6 du CYP2C19
    - Sujets CYP2C19 *2/*2
    - Génotype P2Y12 : H2/H2
    - Pathologies médicales en évolution traitées ou non dans les 10 jours précédents l'inclusion
    - Antécédent allergique médicamenteux ou autre
    - Antécédent de maladie hémorragique personnelle ou familiale
    - Antécédent d'ulcère gastrique
    - Traitement par Anti-inflammatoires stéroïdiens, aspirine, anticoagulants
    - Examens biologiques situés en dehors des valeurs usuelles du sujet sain
    - Don de sang dans les 3 mois précédant l'étude
    - Personnes en période d'exclusion sur le fichier national des personnes se prêtant à la recherche biomédicale sans bénéfice individuel direct
    - Refus ou incapacité linguistique ou psychique de signer le consentement éclairé
    - Sujet 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).
    - Pratique de sports violents.
    E.5 End points
    E.5.1Primary end point(s)
    La pharmacodynamie du clopidogrel sera évaluée par le test d'agrégation plaquettaire à l'ADP 10 µM, qui représente le critère principal d'évaluation. Cette concentration permet une agrégation à l'ADP indépendante de la voie du thromboxane A2, du moins chez les sujets ne prenant pas d'aspirine. Toutefois, le test sera également réalisé avec les concentrations d'ADP de 5 et 20 µM, qui sont fréquemment utilisées dans les études cliniques évaluant la sensibilité au clopidogrel.
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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 No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    2 phases:1 commune et 1 parall
    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 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 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 years2
    E.8.9.1In the Member State concerned months0
    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) No
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state100
    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 Decision2006-11-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-12-04
    P. End of Trial
    P.End of Trial StatusOngoing
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