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The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
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    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43845   clinical trials with a EudraCT protocol, of which   7282   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 on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    Summary
    EudraCT Number:2005-005278-59
    Sponsor's Protocol Code Number:20050222
    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:2006-06-08
    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 number2005-005278-59
    A.3Full title of the trial
    Estudio doble ciego, aleatorizado, comparativo con placebo y multicéntrico para valorar la eficacia y seguridad del tratamiento con darbepoetina alfa sobre la mortalidad y morbilidad en sujetos con insuficiencia cardíaca (IC) con disfunción sistólica ventricular izquierda sintomática y anemia.
    A.3.2Name or abbreviated title of the trial where available
    RED-HF Trial – Reduction of Events with Darbepoetin alfa in Heart Failure Trial
    A.4.1Sponsor's protocol code number20050222
    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 SponsorAmgen Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    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 Information not present in EudraCT
    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 nameDarbepoetina alfa 100 microgramos solución
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDarbepoetina alfa
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 Information not present in EudraCT
    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 nameDarbepoetina alfa 200 microgramos solución
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDarbepoetina alfa
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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: 3
    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 Information not present in EudraCT
    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 nameDarbepoetina alfa 500 microgramos solución
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDarbepoetina alfa
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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: 4
    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 Information not present in EudraCT
    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 nameDarbepoetina alfa 1000 microgramos solución
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDarbepoetina alfa
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Sujetos con insuficiencia cardiaca (IC) con disfunción sistólica ventricular izquierda sintomática y anemia.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level PT
    E.1.2Classification code 10007559
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Determinar la eficacia de darbepoetina alfa comparado con placebo sobre la variable de valoración compuesta de tiempo hasta la muerte por cualquier causa o primer ingreso hospitalario por empeoramiento de la IC en sujetos con disfunción sistólica ventricular izquierda sintomática y anemia.
    E.2.2Secondary objectives of the trial
    Evaluar los efectos del tratamiento con darbepoetina alfa sobre:
    • Tiempo hasta la muerte por cualquier causa
    • Tiempo hasta muerte cardiovascular o primer ingreso hospitalario por empeoramiento de la IC, lo que ocurra primero.
    • Cambio en Overall Summary Score Kansas City Cardiomyopathy Questionnaire (KCCQ) desde el periodo basal hasta el mes 6.
    • Cambio en la KCCQ Symptom Frequency Score desde el periodo basal hasta el mes 6.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    - Antes de llevar a cabo cualquier procedimiento específico del estudio, se obtendrá el correspondiente consentimiento informado por escrito.

    - Edad ≥18 años en el momento de la aleatorización.

    - Insuficiencia cardíaca durante ≥3 meses, y clase II, III ó IV de la NYHA en el momento de la aleatorización. Los sujetos que tengan clase II de la NYHA deberán haber tenido un ingreso hospitalario no previsto o visita a un departamento de urgencias por un motivo cardiovascular en los 12 meses previos a la aleatorización.

    - Fracción de eyección ventricular izquierda ≤ 35% por ecocardiograma, ventriculografía por radionúclidos, imagen de resonancia magnética cardíaca o ventriculografía de contraste de rayos X en los 6 meses anteriores a la aleatorización (el resultado de FEVI más reciente disponible determina la idoneidad). En los sujetos con TRC, las valoraciones FEVI para determinar la idoneidad deberán realizarse 6 meses después de la implantación del dispositivo.

    - La concentración de hemoglobina deberá ser ≥9,0 g/dl y ≤12,0 g/dl (promedio de dos concentraciones de hemoglobina, determinadas mediante analizador HemoCue® en condiciones ciegas [codificado].

    - En tratamiento farmacológico óptimo estable para la IC. En general, el tratamiento óptimo incluirá un betabloqueante y un IECA y/o un BRA en dosis que hayan demostrado eficacia en los estudios IC, a menos que no se toleren. El tratamiento médico estable se define como aquel en que no se ha introducido una clase de fármacos nueva para la IC 4 semanas antes de la aleatorización, aunque pueden ajustarse las dosis de todos los fármacos administrados a lo largo del estudio.

    E.4Principal exclusion criteria
    - Hipertensión mal controlada, definida como tensión arterial >160/100 mm Hg valorada en dos ocasiones independientes antes de la aleatorización.
    - Creatinina sérica > 3,5 mg/dl (>310 µmol/L).
    - Insuficiencia cardíaca debida principalmente a cardiopatía vascular o cardiopatía vascular clínicamente significativa que pueda conducir a corrección quirúrgica en los 12 meses siguientes a la aleatorización.
    - Desfibrilador cardíaco implantable (DCI) en los 30 días previos a la aleatorización o inicio del tratamiento de resincronización cardíaca (TRC con o sin DCI) en los 6 meses previos a la aleatorización.
    - Infusiones i.v. programadas de forma sistemática para la IC (por ejemplo, inotropos, vasodilatadores [por ejemplo, nesiritida], diuréticos).

    - Infarto agudo de miocardio o accidente cerebrovascular en los 3 meses previos a la aleatorización.
    - Intervención percutánea (cardíaca, cerebrovascular, aórtica) en las 8 semanas previas a la aleatorización. Cirugía mayor, especialmente torácica o cardíaca, en los tres meses previos a la aleatorización.
    - Taquiarritmia sintomática con respuesta ventricular no controlada (>100 lpm en reposo) o una bradiarritmia sintomática no tratada en el mes previo a la aleatorización.
    - Miocardiopatía hipertrófica obstructiva, miocarditis activa o pericarditis constrictiva.
    -Probabilidad de recibir trasplante cardíaco en los 12 meses siguientes a la aleatorización.
    -Receptor del trasplante de un órgano importante (por ejemplo, pulmón, hígado, corazón, médula ósea) o administración de tratamiento de reemplazamiento renal.
    - Anemia que se considera debida a hemorragia aguda o crónica .
    - Saturación de transferrina (Tsat) < 15% en el momento de la selección (valor redondeado al porcentaje completo más próximo).
    - Nivel de Vitamina B12 sérica o ácido fólico (folato) por debajo del límite de la normalidad.
    - Transfusión de sangre completa o concentrado de eritrocitos (RBC) en las 8 semanas previas a la aleatorización.
    - Enfermedad no cardiovascular concomitante severa que se espera que reduzca la esperanza de vida a menos de 3 años.
    - Está recibiendo o ha recibido quimioterapia, radioterapia o ambas para el tratamiento de una neoplasia maligna en los 6 meses previos a la aleatorización o pruebas clínicas de neoplasia en curso, con las siguientes excepciones: Carcinoma basocelular o epidermoide de la piel, neoplasia intraepitelial cervical y cáncer de próstata (si es una enfermedad estable localizada, con una esperanza de vida superior a 3 años).
    - Enfermedad hematológica sistémica activa conocida (por ejemplo, anemia drepanocítica, síndromes mielodisplásicos, neoplasias hematológicas, mieloma, anemia hemolítica), hemólisis debida a cualquier causa, talasemia.
    - Hiper o hipotiroidismo no tratado, insuficiencia adrenal, vasculitis activa debida a enfermedad vascular del colágeno.
    - Utilización de cualquier proteína eritropoyética (por ejemplo, rHuEPO) en las 12 semanas previas a la aleatorización.
    - Hipersensibilidad conocida a cualquiera de los productos que se administran durante el estudio, incluso hierro por vía i.v. u oral.
    - La paciente está embarazada (por ejemplo, prueba de gonadotropina coriónica humana [HCG] positiva), está en periodo de lactancia, o está en edad fértil y no utiliza un método anticonceptivo adecuado.
    - El sujeto está incluido o lo ha estado en los últimos 30 días en un estudio de un fármaco o dispositivo en investigación, o está utilizando otro procedimiento o agente en investigación.
    - El sujeto sufre un trastorno que compromete su capacidad para otorgar el consentimiento informado por escrito o para cumplir los procedimientos del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    - Tiempo hasta la muerte por cualquier causa o primer ingreso hospitalario por empeoramiento de la IC, lo que ocurra primero.
    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 Information not present in EudraCT
    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.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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
    El estudio está dirigido por los acontecimientos y concluirá cuando aproximadamente 1450 sujetos hayan experimentado un acontecimiento índice de una variable principal de valoración (después de su evaluación).
    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 months10
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months10
    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 Information not present in EudraCT
    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 2006-06-08. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state160
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1600
    F.4.2.2In the whole clinical trial 3400
    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 Decision2006-08-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-07-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-10-11
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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
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