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    Summary
    EudraCT Number:2005-004669-40
    Sponsor's Protocol Code Number:SYR-322-TZD-009
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2006-03-13
    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 number2005-004669-40
    A.3Full title of the trial
    Estudio multicéntrico, aleatorizado, doble ciego, controlado con placebo para determinar la eficacia y la seguridad de SYR110322 (SYR-322) cuando se administra en combinación con pioglitazona en sujetos con diabetes tipo 2

    A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of SYR110322 (SYR-322) When Used in Combination with Pioglitazone in Subjects with Type 2 Diabetes
    A.4.1Sponsor's protocol code numberSYR-322-TZD-009
    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 SponsorTakeda Global Research & Development Center, 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 nameSYR110322
    D.3.2Product code SYR-322
    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.3.9.2Current sponsor codeSYR110322
    D.3.9.3Other descriptive nameSYR-322
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number12.5
    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) 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 Information not present in EudraCT
    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 nameSYR110322
    D.3.2Product code SYR-322
    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.3.9.2Current sponsor codeSYR110322
    D.3.9.3Other descriptive nameSYR-322
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 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 Information not present in EudraCT
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    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.2.1.1.1Trade name Actos
    D.2.1.1.2Name of the Marketing Authorisation holderTakeda Europe R & D Centre Ltd.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameActos
    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 INNPioglitazona
    D.3.9.3Other descriptive nameTiazolidinediona, TZD
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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 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 RoleComparator
    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 nameMetformina
    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 INNMetformina
    D.3.9.2Current sponsor codeN/A
    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 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: 5
    D.1.2 and D.1.3IMP RoleComparator
    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 nameSulfonilurea
    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 INNN/A
    D.3.9.2Current sponsor codeN/A
    D.3.9.3Other descriptive nameSulphonylurea
    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 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 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
    Diabetes mellitus tipo 2

    Type II diabetes mellitus.
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • Evaluar la eficacia de SYR-322 cuando se administra en combinación con pioglitazona comparado con la pioglitazona sola, basándose en el cambio de la hemoglobina glucosilada (HbA1c) basal.
    E.2.2Secondary objectives of the trial
    • Evaluar otras medidas del control glucémico después del tratamiento con SYR-322 en combinación con pioglitazona en comparación con la pioglitazona sola
    • Evaluar los cambios en la función pancreática después del tratamiento con SYR-322 en combinación con pioglitazona en comparación con la pioglitazona sola
    • Evaluar los cambios en el peso corporal después del tratamiento con SYR-322 en combinación con pioglitazona en comparación con la pioglitazona sola.
    • Evaluar la seguridad de SYR-322 en combinación con pioglitazona en comparación con la pioglitazona sola
    • Evaluar las concentraciones de SYR-322 en plasma, a través del acercamiento de muestreo escaso.
    • Evaluar los niveles de respuesta clínicamente significativas de HbA1c después del tratamiento con SYR-322 en combinación con pioglitazona en comparación con pioglitazona sola.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    Para poder ser elegible para el presente estudio, se deben cumplir los siguientes criterios con una respuesta afirmativa (“Si”) (a no ser que no aplique):
    • Mujeres y hombres de 18 a 80 años de edad, inclusive, con un diagnóstico de diabetes mellitus tipo 2 en su historial y que actualmente son tratados con una tiazolidinodiona sola, o en combinación con metmorfina o sulfonilurea, pero que no tienen un contral glicémico adecuado. El sujeto debe haber recibido una terapia con tiazolidinodiona (rosiglitazona o pioglitazona) sóla o en combinación con metmorfina o sulfonilurea por lo menos durante 3 meses previos a la selección; además, deberá tener una dosis estable de todos sus tratamientos antidiabeticos durante al menos un mes antes de al selección.
    • Ningún otro tratamiento antidiabético excepto la tiazolidinodiona sola, o en combinación con metmorfina o sulfonilurea durante los 3 meses previos a la selección, (con excepción de aquellos sujetos que hayan recibido otra terapia antidiabética durante menos de 7 días dentro de los 3 meses previos a la selección).
    • Índice de masa corporal mayor o igual a 23 kg/m2 y menor o igual a 45 kg/m2
    • Concentración del péptido C en ayunas mayor o igual a 0.8 ng/mL. (Si este criterio de selección no se cumple, el sujeto todavía califica si el péptido C es mayor o igual 1.5 ng/mL después de una prueba de esfuerzo. Consultar el Apéndice E).
    • Concentración de HbA1c entre 7.0% y 10.0%, inclusive.
    • Si se toma con regularidad otro medicamento que no esté excluido, deberá hacerse de forma constante durante por lo menos 4 semanas antes de la selección. Sin embargo, cuando se necesite, se permite el uso de medicamentos con o sin prescripción a buen juicio del investigador.
    • Presión sistólica menor o igual a 180 mm Hg y presión diastólica menor o igual a 110 mm Hg.
    • Hemoglobina mayor o igual a 12 g/dL para hombres y mayor o igual a 10 g/dL para mujeres.
    • Alanina aminotransferasa menor o igual a 2.5 x nivel superior normal.
    • Creatinina en suero menor o igual a 2.0 mg/dL
    • El nivel de la hormona estimuladora del tiroides por debajo o igual al límite superior de los niveles normales, y clínicamente el sujeto tiene eutiroidismo.
    • No estar embarazada (confirmado por un test de laboratorio en mujeres con posibilidad de estar embarazadas), ni en lactancia.
    • Los sujetos de sexo femenino con probabilidad de embarazo, es decir, que no estén quirúrgicamente estériles o que no estén en periodo posmenopáusico, deberán estar utilizando métodos anticonceptivos adecuados. Los métodos anticonceptivos adecuados son los siguientes: dispositivo intrauterino, dispositivo de doble barrera tales como diafragma o condón más espermicida; hormonas anticonceptivas,(ya sean inyectables, por implante u orales). Los métodos anticonceptivos deberán usarse todo el tiempo que dure su participación en el estudio.
    • Capaz y con disponibilidad para revisar continuamente la concentración de glucosa en sangre con un glucómetro en casa.
    • No tener una enfermedad mayor o debilitante grave que, de acuerdo a la opinión del investigador, impida que el sujeto termine el estudio.
    • Capaz y con disponibilidad para dar por escrito el consentimiento informado.

    Para poder ser elegible en la aleatorización, se deben satisfacer los siguientes criterios con una respuesta positiva (Si):
    • Concentración de HbA1c entre 7.0% y 10.0%, inclusive, en la visita de la Semana -1. (Nótese que si el sujeto no califica para la aleatorización con base a este criterio, la prueba podrá repetirse de manera semanal por un máximo de 4 semanas adicionales).
    • Haber cumplido con al menos el 75% del régimen de placebo ciego durante el periodo de estabilización, que se evaluará mediante el recuento de comprimidos.
    • No se permite el uso de glucocorticoides orales o inyectados de manera sistémica, ni medicamentos para bajar de peso, dentro de los 3 meses previos a la aleatorización. (Se permite el uso de corticoesteroides inhalados).
    E.4Principal exclusion criteria
    Para poder ser elegible para el presente estudio, se deben cumplir los siguientes criterios con una respuesta negativa (“No”):
    • Proporción albúmina/creatinina >1000 microg/mg al momento de la selección. Si este valor es elevado, el sujeto podrá volver a participar en la selección dentro de una semana.
    • Historia de cáncer, excepto células escamosas o carcinoma de células basales en la piel, que no haya estado en completa remisión por lo menos 5 años antes de la selección. (Se permite una historia de NIC I o NIC II [neoplasia intraepitelial cervical] tratada).
    • Historia de tratamiento láser para retinopatía diabética proliferativa dentro de los 6 meses anteriores a la selección.
    • Historial de paresia gástrica diabética tratada.
    • Insuficiencia Cardiaca tipo III o IV, de acuerdo a la clasificación de la Asociación Cardiológica de Nueva York, a pesar de la terapia. Sujetos que están actualmente bajo tratamiento y que son estables en los tipos I o II son candidatos para el estudio (Consultar Apéndice F).
    • Historial de angioplastía coronaria, colocación de un stent coronario, cirugía de bypass coronario o infarto de miocardio durante los 6 meses previos a la selección.
    • Historial de cualquier tipo de hemoglobinopatía que pudiera afectar la determinación de la HbA1c
    • Historial de hepatitis B, hepatitis C o virus de la inmunodeficiencia humana.
    • Historial de desórdenes psiquiátricos que afectarán la disponibilidad del sujeto para participar en el estudio.
    • Historial de angioedema relacionado con el uso de inhibidores de la enzima transformadora de angiotensina o de inhibidores del receptor de la angiotensina II.
    • Historial de abuso de alcohol o de otras sustancias durante los 2 años previos a la selección.
    • Haber recibido cualquier medicamento en investigación dentro de los 30 días previos a la selección o historial de haber recibido algún medicamento antidiabético en investigación durante los 3 meses previos a la selección.
    • Haber recibido tratamiento previo en un estudio de investigación de SYR-322
    E.5 End points
    E.5.1Primary end point(s)
    La variable primaria de eficacia será el cambio en HbA1c en la semana 26 en comparación con la basal.
    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 Yes
    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) Yes
    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
    Última visita del último paciente
    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 months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months3
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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 2006-03-13. 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 state48
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 330
    F.4.2.2In the whole clinical trial 500
    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 Decision2006-05-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-04-10
    P. End of Trial
    P.End of Trial StatusOngoing
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