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    Summary
    EudraCT Number:2006-002616-96
    Sponsor's Protocol Code Number:D3561C00087
    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:2006-07-13
    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 number2006-002616-96
    A.3Full title of the trial
    Ensayo Fase IIIb de Eficacia y Seguridad de Rosuvastatina en niños y adolescentes de 10 a 17 años de edad con Hipercolesterolemia Familiar Heterocigota (HFHe): aleatorizado, multicéntrico, doble ciego, controlado con placebo durante 12 semanas y con un periodo de seguimiento en abierto de 40 semanas.PLUTO: Pediatric Lipid-redUction Trial of rOsuvastatin
    A.3.2Name or abbreviated title of the trial where available
    PLUTO: Pediatric Lipid-reDuction Trial of rOsuvastatin
    A.4.1Sponsor's protocol code numberD3561C00087
    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 SponsorAstraZeneca AB
    B.1.3.4CountrySweden
    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 Yes
    D.2.1.1.1Trade name Crestor
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca UK Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameCRESTOR 5 mg comprimidos recubiertos con película
    D.3.2Product code AZD4522
    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 INNrosuvastatina de calcio
    D.3.9.2Current sponsor codeAZD4522
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 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 Yes
    D.2.1.1.1Trade name Crestor
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca UK Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameCRESTOR 10 mg comprimidos recubiertos con película
    D.3.2Product code AZD4522
    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 INNrosuvastatina de calcio
    D.3.9.2Current sponsor codeAZD4522
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 Information not present in EudraCT
    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 Yes
    D.2.1.1.1Trade name Crestor 5 mg
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca Pharmaceuticals LP
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameCRESTOR 5 mg comprimidos encapsulados
    D.3.2Product code AZD4522
    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.3.11 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 Information not present in EudraCT
    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 Yes
    D.2.1.1.1Trade name Crestor 10 mg
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca Pharmaceuticals LP
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameCRESTOR 10 mg comprimidos encapsulados
    D.3.2Product code AZD4522
    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.3.11 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: 5
    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 Crestor 20 mg
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca Pharmaceuticals LP
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameCRESTOR 20 mg comprimidos encapsulados (2x10 mg)
    D.3.2Product code AZD4522
    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.3.11 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.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule*
    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
    Hipercolesterolemia familiar heterocigota (HFHe)
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Information not present in EudraCT
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    El objetivo principal de este ensayo es determinar la eficacia de una dosis diaria de rosuvastatina en la reducción de LDL-C en niños y adolescentes entre 10 y 17 años con HFHe desde los valores basales (Día 0) hasta la finalización del periodo de 12 semanas de tratamiento doble ciego.
    E.2.2Secondary objectives of the trial
    1Porcentaje de cambio de LDL-C desde valores basales a semana 6
    2Porcentaje de cambio de HDL-C, CT, TG, no-HDL-C, LDL-C/HDL-C, CT/HDL-C, no-HDL-C/HDL-C, ApoB, ApoB/ApoA-1, y ApoA-1 para cada nivel de dosis asignado desde valores basales (día 0) hasta semana 6, y hasta finalización del periodo de tratamiento doble ciego comparado con placebo
    3Eficacia en alcanzar un objetivo de LDL-C de <110 mg/dL tras 40 semanas de dosificación escalada
    4Seguridad de cada nivel de dosis diario mediante valoración de la incidencia y gravedad de los AA de las anomalías en valores séricos de laboratorio, y de la tasa de discontinuación debido a AA en semana 12 (frente al placebo) y durante las 40 semanas de seguimiento en abierto
    5Efecto en excreción de proteínas por orina y tasa estimada de filtración glomerular
    6Efecto en el crecimiento mediante la valoración de la altura y de las características secundarias de la maduración sexual según los estadíos de Tanner en los valores basales y a 52 semanas
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Firma del consentimiento informado por escrito de uno de los padres o tutor. El investigador debe comunicarse con el paciente y con el padre o tutor a fin de que comprendan y den su conformidad a los requerimientos del ensayo. Podrá requerirse también una declaración de asentimiento del niño o adolescente de acuerdo con los requerimientos locales.
    2. Deben ser niños o adolescentes (entre 10 y 17 años), varones o mujeres (estadíos de Tanner II-V, al menos un año después de la menarquia) con hipercolesterolemia familiar heterocigota (HFHe)* y deben cumplir al menos uno de los siguientes criterios:
    - LDL-C en ayunas ≥190 mg/dL (4,9 mmol/L) en la visita 2
    o
    - LDL-C en ayunas >160 mg/dL (4,1 mmol/L) en la visita 2 y cualquiera de los siguientes:
    - Historia familiar de enfermedades cardiovasculares (ECV) prematuras en parientes de primer grado definido como desarrollo de enfermedades clínicas ateroscleróticas antes de los 55 años en hombres o de los 65 años en mujeres
    o
    - Dos ó más factores de riesgo de ECV (HDL-C <35 mg/dL; hipertensión, fumar tabaco; obesidad severa; diabetes mellitus; inactividad física) presentes tras realizar intentos reiterados para controlar estos factores de riesgo durante las 6 semanas de dieta de la fase de preinclusión.
    *HFHe definido como:
    · Defectos genéticos en el receptor de LDL o ApoB documentados mediante análisis del ADN.
    o
    · Evidencias documentadas de HF en parientes de primer grado (LDL-C >190 mg/dL en adultos; >160 mg/dL en niños <de 18 años).
    3. En mujeres, pruebas séricas de embarazo negativas (análisis de gonadotropina coriónica humana beta [b-HCG]) previas a la aleatorización
    · Las mujeres deben seguir métodos de prevención del embarazo (químicos, mecánicos, o abstinencia) durante el ensayo
    4. Disposición para seguir con todos los procedimientos del ensayo incluyendo la adhesión al régimen dietético, las visitas del ensayo, extracciones de sangre en ayunas y cumplimiento con el tratamiento en ensayo
    E.4Principal exclusion criteria
    1. Historia de miopatía inducida por estatinas o reacciones serias de hipersensibilidad a otros inhibidores de la HMG-CoA reductasa (estatinas), incluyendo rosuvastatina
    2. TG en ayunas ≥250 mg/dL (2,87 mmol/L) en la visita 2
    3. Glucosa sérica en ayunas de 180 mg/dL (9,99 mmol/L) o HbAlc >9% en la visita 1 o pacientes con una historia de cetoacidosis diabética en los últimos 5 años
    4. Hipotiroidismo no controlado indicado por hormona estimulante del tiroides (TSH) > de 1,5 veces sobre el límite normal (LSN) en la visita 1 (semana 6) o pacientes cuya terapia de sustitución para la tiroides se inició o modificó en los últimos 3 meses
    5. Uso de medicaciones concomitantes específicamente prohibidas
    6. Historia de abuso de alcohol o de drogas
    7. Enfermedad de hígado activa en la actualidad o disfunción hepática (excluyendo un diagnóstico confirmado de enfermedad de Gilbert) definido por incrementos de 1,5 veces LSN para cualquier edad en cualquiera de las siguientes pruebas de funcionamiento del hígado: ALT, AST, o bilirrubina en la visita 1
    8. Creatina cinasa (CK) sérica ≥3 veces LSN (a no ser que se explique por el ejercicico) en la visita 1
    9. GFR estimado por la fórmula de Schwartz <50 ml/min en la visita 1
    10. Proteinuria en la orina ≥2+ en la prueba con tira reactiva en la visita 1 o en la 2
    11. Hipertensión en estadio 2 (presión sanguínea sistólica y/o diastólica mayor de 5 mmHg sobre un percentil de 99 para edad, género y altura)
    12. Historia de transplantes de órganos sólidos
    13. Pacientes previamente reclutados para este ensayo y/o pacientes aleatorizados que retiraron posteriormente el consentimiento.
    14. Participación en otro ensayo menos de 4 semanas antes de la inclusión en el periodo de dieta de preinclusión
    15. Condiciones médicas o psicológicas graves o inestables que, en opinión del investigador, puedan comprometer la seguridad del paciente o el éxito de su participación en el ensayo.
    16. Historia de tumor maligno documentada a excepción del carcinoma de células escamosas de la piel
    17. Pacientes que estén en el estadío 1 de Tanner
    18. Chicos > de 12 años con volumen testicular <3 cm3
    19. Los pacientes con una altura <del tercer percentil para edad y sexo o un ratio altura-peso con un percentil > de 97 para edad y sexo
    E.5 End points
    E.5.1Primary end point(s)
    La variable principal de este ensayo es el cambio porcentual del LDL-C desde los valores basales hasta después de 12 semanas de tratamiento.
    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 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 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.8.3 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 final del ensayo se define como la fecha de cierre de la base de datos, que es el momento a partir del cual ningún paciente estará expuesto a actividades relacionadas con el ensayo.
    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 days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    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) Yes
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 2006-07-13. 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    PAcientes entre 10 y 17 años
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 200
    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 Decision2006-09-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-08-02
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-06-04
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