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    Summary
    EudraCT Number:2013-001185-41
    Sponsor's Protocol Code Number:POINT
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-01-24
    Trial results View 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 ConcernedSpain - AEMPS
    A.2EudraCT number2013-001185-41
    A.3Full title of the trial
    Platelet-Oriented Inhibition in New TIA and minor ischemic stroke (POINT) Trial, a randomized, double blind, multicentre clinical trial
    Ensayo sobre inhibición plaquetaria en el AIT y el accidente cerebrovascular isquémico leve reciente aparición (POINT), un ensayo aleatorizado, doble ciego, multicéntrico
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Platelet-Oriented Inhbition in New transient ischemic attack and minor stroke
    Ensayo sobre inhibición plaquetaria en el AIT y el accidente cerebrovascular isquémico leve reciente aparición
    A.3.2Name or abbreviated title of the trial where available
    Platelet-Oriented Inhibition in New TIA and Minor Ischemic stroke
    Inhibición plaquetaria en el AIT y accidente cerebrovascular isquémico leve
    A.4.1Sponsor's protocol code numberPOINT
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00991029
    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 SponsorUniversity of California San Francisco
    B.1.3.4CountryUnited States
    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 supportUS DHHS - National Institute of Neurological Disorders and Stroke
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHarrison Clinical Research Ibérica S.L., A Synteract Company
    B.5.2Functional name of contact pointAriadna Martín
    B.5.3 Address:
    B.5.3.1Street AddressC/Princep Jordi,21-23
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08014
    B.5.3.4CountrySpain
    B.5.4Telephone number0034932266964
    B.5.5Fax number0034932265833
    B.5.6E-mailariadna.martin-balcells@synteractHCR.com
    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
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi Pharma Bristol-Myers Squibb SNC
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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
    D.3.4Pharmaceutical form 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 INNclopidogrel hydrogen sulphate
    D.3.9.3Other descriptive nameClopidogrel Bisulphate
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number75 to 600
    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 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
    Transient Ischemic Attack and Minor Stroke
    Ataque isquémico transitorio y accidente cerebrovascular leve
    E.1.1.1Medical condition in easily understood language
    Mini-Stroke
    accidente cerebrovascular leve
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level PT
    E.1.2Classification code 10068644
    E.1.2Term Brain stem stroke
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level PT
    E.1.2Classification code 10044390
    E.1.2Term Transient ischaemic attack
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine whether clopidogrel 75mg/day by mouth after an initial dose of 600mg, is effective in improving events related to stroke at 90 days, in patients receiving aspirin 50-325mg/day when randomized within 12 hours of time last known free of new stroke symptoms.
    determinar si clopidogrel 75mg/día por vía oral después de una dosis inicial de 600 mg, es eficaz en la mejora de los eventos relacionados con el accidente cerebrovascular a los 90 días, en los pacientes que recibieron aspirina 50-325mg/día cuando los pacientes se aleatorizan en las 12 horas siguientes al último momento en el que se sabe que no presentaban nuevos síntomas isquémicos
    E.2.2Secondary objectives of the trial
    Secondary objectives include the effect of therapy on; (1) ischemic stroke (loss of blood supply to the brain) and hemorrhagic stroke (ruptured blood vessel in the brain), (2)all-cause death (3)new handicap/disability. In addition the impact of therapy on the outcome will be evaluated in specific participant groups (e.g. African Americans and those previously taking aspirin).
    Los objetivos secundarios incluyen el efecto de la terapia en: (1) el accidente cerebrovascular isquémico (pérdida de suministro de sangre al cerebro) y accidente cerebrovascular hemorrágico (vaso sanguíneo roto en el cerebro), (2) todas las causas de muerte (3) nueva de discapacidad / incapacidad. Además, el impacto de la terapia en el resultado se evaluará en grupos específicos de participantes (por ejemplo, los afroamericanos y los que tomaban aspirina con anterioridad).
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    POINT Ancillary Biomarker Study (29/09/2012- 30/09/2015)
    Participants who consent to the main POINT Trial will be invited to consent to an optional ancillary study consisting of a one-time venous blood sample of approximately 10ml, collected at the time of enrollment in the trial.

    The study sample will be prepared to extract Plasma and DNA for genotyping analysis and will be used for testing whether clopidogrel resistant genotyping modify the stroke prevention response in high risk transient ischemic attack.
    Subestudio POINT (29/09/2012- 30/09/2015)
    Se invitará a los participantes que den su consentimiento para el subestudio POINT dar su consentimiento para un subestudio opcional que consta de una sola vez la muestra de sangre venosa de aproximadamente 10 ml, recogida en el momento de la inclusión.

    La muestra del estudio se preparará para extraer plasma y ADN para el análisis de genotipificación y se utilizará para probar si el genotipado resistente a clopidogrel modifica la respuesta de prevención del accidente cerebrovascular en un alto riesgo de ataque isquémico transitorio
    E.3Principal inclusion criteria
    ? Neurologic deficit (based on history or examination) attributed to focal brain ischemia and EITHER:
    o High risk TIA: Complete resolution of the deficit at the time of randomization AND ABCD2 score >4
    Or
    o Minor ischemic stroke: residual deficit with NIHSS <3 at the time of randomization
    ? Ability to randomize within 12 hours of time last known free of new ischemic symptoms.
    ? Head CT or MRI ruling out hemorrhage or other pathology, such as vascular malformation, tumor, or abscess, that could explain symptoms or contraindicate therapy.
    ? Ability to tolerate aspirin at a dose of 50-325 mg/day.
    ? Defecto neurológico (según los antecedentes o el examen) atribuido a isquemia cerebral focalizada y:
    o AIT de alto riesgo: Resolución completa de la deficiencia en el momento de la aleatorización Y una puntuación ABCD2 >4
    O BIEN
    o Accidente cerebrovascular isquémico leve: Deficiencia residual con NIHSS <3 en el momento de la aleatorización.
    ? Posibilidad de ser aleatorizado en las 12 horas siguientes al último momento en el que se sabe que no presentaba nuevos síntomas isquémicos.
    ? TC o RM craneal que excluya una hemorragia u otras patologías, como una malformación vascular, tumor o absceso, que podrían explicar los síntomas o contraindicar el tratamiento.
    ? Capacidad de tolerar dosis de 50 a 325 mg/día de aspirina.
    E.4Principal exclusion criteria
    ? Age <18 years.
    ? TIA symptoms limited to isolated numbness, isolated visual changes, or isolated dizziness/vertigo.
    ? In the judgement of the treating physician, a candidate for thrombolysis, endarterectomy or endovascular intervention, unless the subject declines both endarterectomy and endovascular intervention at the time of evaluation for eligibility.
    ? Receipt of any intravenous or intra-arterial thrombolysis within 1 week prior to index event.
    ? Gastrointestinal bleed or major surgery within 3 months prior to index event.
    ? History of nontraumatic intracranial hemorrhage.
    ? Clear indication for anticoagulation (e.g., warfarin, heparin) anticipated during the study period (atrial fibrillation, mechanical heart valve, deep venous thrombosis, pulmonary embolism, antiphospholipid antibody syndrome, hypercoagulable state).
    ? Qualifying ischemic event induced by angiography or surgery.
    ? Severe non-cardiovascular comorbidity with life expectancy <3 months.
    ? Contraindication to clopidogrel or aspirin:
    ? Known allergy
    ? Severe renal (serum creatinine >2 mg/dL) or hepatic insufficiency (prior or concurrent diagnosis, with INR>1.5, or any resultant complication, such as variceal bleeding, encephalopathy, or icterus)
    ? Haemostatic disorder or systemic bleeding in the past 3 months
    ? Current thrombocytopenia (platelet count <100 x109/l) or neutropenia/granulocytopenia (<1 x109/l)
    ? History of drug-induced haematologic or hepatic abnormalities
    ? Anticipated requirement for long-term (>7 day) non-study antiplatelet drugs (e.g., dipyridamole, clopidogrel, ticlopidine), or NSAIDs affecting platelet function (such as prior vascular stent or arthritis).
    ? Not willing or able to discontinue prohibited concomitant medications.
    ? Inability to swallow medications.
    ? At risk for pregnancy: premenopausal or post menopausal woman within 12 months of last menses without a negative pregnancy test or not committing to adequate birth control (e.g., oral contraceptive, two methods of barrier birth control, or abstinence).
    ? Unavailability for follow-up.
    ? Signed and dated informed consent not obtained from patient.
    ? Other neurological conditions that would complicate assessment of outcomes during follow-up.
    ? Ongoing treatment in another study of an investigational
    therapy, or treatment in such a study within the last 7 days.
    ? Previously enrolled in the POINT study.
    ? Menos de 18 años de edad.
    ? Síntomas de AIT limitados a adormecimientos aislados, cambios visuales aislados o mareos/vértigo aislados.
    ? Según el criterio del médico tratante, debe ser candidato para una trombólisis, endarterectomía o intervención endovascular, salvo que el paciente renuncie tanto a la endarterectomía como a la intervención endovascular en el momento de la evaluación de la idoneidad.
    ? Haber recibido cualquier tratamiento trombolítico por vía intravenosa o intrarterial en la semana anterior al acontecimiento índice.
    ? Haber tenido sangrado gastrointestinal o una operación importante en los 3 meses anteriores al acontecimiento índice.
    ? Tener antecedentes de hemorragia intracraneal no traumática.
    ? Que existan indicaciones claras previstas para anticoagulación (p. ej., warfarina, heparina) durante el período del estudio (fibrilación auricular, válvula cardíaca mecánica, trombosis venosa profunda, embolia pulmonar, síndrome de anticuerpos antifosfolípido, estado de hipercoagulación).
    ? El acontecimiento isquémico calificante fue inducido por una angiografía o una cirugía.
    ? Enfermedad no cardiovascular grave concomitante, con expectativa de vida <3 meses.
    ? Contraindicaciones para el clopidogrel o la aspirina:
    ? Alergia conocida.
    ? Insuficiencia renal grave (creatinina sérica >2 mg/dl o 176,8 µmol/l) o insuficiencia hepática grave (por diagnóstico anterior o simultáneo, con INR>1,5, o cualquier complicación resultante de ella, como sangrado de varices, encefalopatía o ictericia).
    ? Trastornos de la hemostasia o sangrado sistémico en los últimos 3 meses.
    ? Trombocitopenia actual (recuento de plaquetas <100 x109/l) o neutropenia/granulocitopenia (<1 x109/l)
    ? Antecedentes de anomalías hematológicas o hepáticas inducidas por fármacos
    ? Requerimiento previsto de uso prolongado (>7 días) de fármacos antiagregantes plaquetarios distintos a los del estudio (p. ej., dipiridamol, clopidogrel, ticlopidina), o de AINES que afecten la función plaquetaria (como endoprótesis vascular anterior o artritis).
    ? Que no quiera o no pueda interrumpir los medicamentos concomitantes prohibidos.
    ? Imposibilidad de tragar medicamentos.
    ? Que tenga riesgo de quedar embarazada: mujeres premenopáusicas o posmenopáusicas en los 12 meses posteriores a la última menstruación, sin una prueba de embarazo negativa, o que no se comprometan a usar un método anticonceptivo adecuado (p. ej., anticonceptivos orales, dos métodos anticonceptivos de barrera o abstinencia sexual).
    ? No estar disponible para el seguimiento.
    ? No se obtiene el consentimiento informado, firmado y fechado, del paciente.
    ? Otras enfermedades neurológicas que podrían complicar la evaluación de los resultados durante el seguimiento.
    ? Tratamiento en curso en otro estudio con un tratamiento en fase de investigación, o tratamiento en un estudio de ese tipo en los últimos 7 días.
    ? Inscripto previamente en el estudio POINT.
    E.5 End points
    E.5.1Primary end point(s)
    The Primary analysis will be the intention to treat, with inclusion and treatment group defined per randomization assignment. Missing values will remain missing and subjects will be censored at their last follow up assessment (end of study or last visit prior to loss to follow-up). Kaplan-Meier estimates of the cumulative risk of an event will be reported for the maximum 90-day follow up, and the log-rank test will be used to evaluate the statistical significance of the treatment effect. The Type 1 error for the primary analysis will consider two sided alpha=0.05 significant.
    El análisis principal se hará por intención de tratar, con la inclusión y el grupo de tratamiento definidos según la asignación aleatoria. Los valores faltantes quedarán como tales y los pacientes se censurarán según su última evaluación de seguimiento (fin del estudio o última visita antes de perderse para el seguimiento). Se informarán los cálculos de Kaplan-Meier del riesgo acumulativo de un acontecimiento para el seguimiento máximo de 90 días, y se usará la prueba de rangos logarítmicos para evaluar la significancia estadística del efecto del tratamiento. El error tipo I para el análisis principal considerará significativo un alfa bilateral =0,05.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Composite endpoint of new ischemic vascular events: ischemic stroke, myocardial infarction or ischemic vascular death at 90 days.
    Criterio de valoración compuesto de nuevos eventos isquémicos vasculares: accidente cerebrovascular isquémico, infarto de miocardio o muerte vascular isquémica a los 90 días.
    E.5.2Secondary end point(s)
    A number of secondary outcomes will be evaluated separately, including risk of ischemic stroke, intra-cranial haemorrhage,and the composite of the primary outcome and major haemorrhage. The influence of index event type (TIA vs. minor stroke), sex and race/ethnicity will be evaluated in subgroup analysis.
    Una serie de medidas de resultados secundarios se evaluará por separado, incluyendo el riesgo de accidente cerebrovascular isquémico, hemorragia intracraneal, y la combinación de los resultados primarios y la hemorragia grave. La influencia del índice de tipo de evento (AIT vs ictus menor), el sexo y la raza / etnia se evaluará en el análisis de subgrupos.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The time point for the secondary analysis will be 90 days
    El punto en el tiempo para el análisis secundario de 90 días
    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 Yes
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 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 concerned23
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA100
    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
    Canada
    France
    Argentina
    Australia
    Finland
    Germany
    Spain
    Israel
    Mexico
    United Kingdom
    United States
    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
    LVLS and Form 17: End of Study should be completed in the WebDCU? system for every subject once the subject has exited the study.
    LVLS y el Formulario 17: Fin del Estudio debe ser completado en el WebDCU sistema para cada sujeto una vez que el paciente haya salido del estudio.
    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 months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 175
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 55
    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 No
    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 state210
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1000
    F.4.2.2In the whole clinical trial 5840
    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)
    At the end of the study, the treating physician will discuss with the participant the best choice for antiplatelet drugs like those mentioned in the study. Depending on side effects, costs, and the participant's own preferences, clopidogrel, aspirin, or the medication aspirin/dipyridamole (also known as Aggrenox®) may be the best choice.
    Al final del estudio, el médico tratante discutirá con el participante la mejor opción para fármacos antiplaquetarios como los mencionados en el estudio. En función de los efectos secundarios, costes y preferencias de los participantes, el clopidogrel, aspirina o el medicamento aspirina / dipiridamol (también conocido omo Aggrenox ®) pueden ser la mejor opción.
    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 Decision2014-03-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-02-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-03-22
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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