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    Summary
    EudraCT Number:2006-005022-23
    Sponsor's Protocol Code Number:D4200C00047
    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:2012-03-29
    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 number2006-005022-23
    A.3Full title of the trial
    A Phase II, Double-Blind, Placebo Controlled, Randomised Study To Assess The Efficacy And Safety Of 2 Doses Of ZACTIMA (ZD6474) In Combination With FOLFOX vs FOLFOX Alone For The Treatment Of Colorectal Cancer In Patients Who Have Failed Therapy With An Irinotecan And Fluoropyrimidine Containing Regimen.
    Ensayo de fase II, aleatorizado, doble ciego, controlado con placebo, para evaluar la eficacia y seguridad de dos dosis de ZACTIMA (ZD6474) en combinación con FOLFOX versus FOLFOX solo, para el tratamiento del cáncer colorrectal en pacientes que han fracasado a un régimen con irinotecan y fluoropirimidinas.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase II, Double-Blind, Placebo Controlled, Randomised Study To Assess The Efficacy And Safety Of 2 Doses Of ZACTIMA (ZD6474) In Combination With FOLFOX vs FOLFOX Alone For The Treatment Of Colorectal Cancer In Patients Who Have Failed Therapy With An Irinotecan And Fluoropyrimidine Containing Regimen
    Ensayo de fase II, aleatorizado, doble ciego, controlado con placebo, para evaluar la eficacia y seguridad de dos dosis de ZACTIMA (ZD6474) en combinación con FOLFOX versus FOLFOX solo, para el tratamiento del cáncer colorrectal en pacientes que han fracasado a un régimen con irinotecan y fluoropirimidinas.
    A.4.1Sponsor's protocol code numberD4200C00047
    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 SponsorAstraZeneca AB
    B.1.3.4CountrySweden
    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 supportAstraZeneca AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca
    B.5.2Functional name of contact pointInformation Centre
    B.5.3 Address:
    B.5.3.1Street Addressn/a
    B.5.3.2Town/ cityn/a
    B.5.3.3Post coden/a
    B.5.3.4CountrySweden
    B.5.4Telephone numbern/a
    B.5.5Fax numbern/a
    B.5.6E-mailinformation.centre@astrazeneca.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 No
    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 nameZACTIMA
    D.3.2Product code ZD6474
    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 INNvandetanib
    D.3.9.1CAS number 443913-73-3
    D.3.9.2Current sponsor codeZD6474
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 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.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 No
    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 nameZACTIMA
    D.3.2Product code ZD6474
    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 INNvandetanib
    D.3.9.1CAS number 443913-73-3
    D.3.9.2Current sponsor codeZD6474
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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.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 Yes
    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 nameoxaliplatino
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNoxaliplatino
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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) 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.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 Yes
    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 nameleucovorin
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNfolinato cálcico
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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) 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.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 Yes
    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 nameFluorouracilo
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNfluorouracilo
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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
    D.8 Placebo: 2
    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
    Colorectal Cancer
    Cáncer colorrectal
    E.1.1.1Medical condition in easily understood language
    Colorectal Cancer
    Cáncer colorrectal
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10052362
    E.1.2Term Metastatic colorectal cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to assess the efficacy of ZD6474 (100 mg and 300 mg) in combination with mFOLFOX6 versus mFOLFOX6 alone for the treatment of patients with colorectal cancer that have failed prior treatment with irinotecan and a fluoropyrimidine by assessment of disease progression.
    El objetivo principal de este ensayo es valorar la eficacia de ZD6474 (100 mg y 300 mg) en combinación con mFOLFOX6 frente a mFOLFOX6 solo, en el tratamiento de pacientes con cáncer colorrectal en quienes ha fracasado un tratamiento previo con irinotecán y una fluoropirimidina, mediante la evaluación de los episodios de progresión de la enfermedad.
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study are to assess the safety and tolerability of ZD6474 (100 mg and 300 mg) in combination with mFOLFOX6 in the treatment of colorectal cancer by review of AEs and laboratory parameters.
    Los objetivos secundarios del ensayo son valorar la seguridad y la tolerabilidad de ZD6474 (100 mg y 300 mg) en combinación con mFOLFOX6 en el tratamiento del cáncer colorrectal mediante la revisión de los AA y los parámetros de laboratorio.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Firma del consentimiento informado.
    2. Tener cáncer colorrectal confirmado histológicamente.
    3. Fracaso de un tratamiento con un régimen formado por irinotecán y fluoropirimidina definido como:
    - Progresión durante o tras el tratamiento del cáncer colorrectal metastático.
    - Progresión en los 12 meses siguientes a la quimioterapia adyuvante del cáncer colorrectal.
    4. Un estado funcional de la OMS de 0-2 y una esperanza de vida > 12 semanas.
    5. Ser aptos para el tratamiento con oxaliplatino, 5-FU y leucovorina (FOLFOX) (apéndice E).
    6. Tener al menos 18 años.
    E.4Principal exclusion criteria
    1. Tratamiento previo con inhibidores de molécula pequeña de la tirosina cinasa del VEGFR o el EGFR, como erlotinib o gefitinib. Se permite el uso previo de anticuerpos monoclonales como cetuximab o bevacizumab.
    2. Tratamiento adyuvante previo con oxaliplatino en los 12 meses anteriores a la aleatorización.
    3. Más de un régimen previo de quimioterapia para tratamiento del cáncer colorrectal metastático.
    4. Intervención quirúrgica reciente, incisión quirúrgica no cicatrizada o proceso concomitante grave que, en opinión del investigador, desaconseje la participación del paciente en el ensayo o pueda poner en peligro el cumplimiento del protocolo del ensayo.
    5. Proceso maligno actual o previo en los últimos 3 años (distinto de cáncer colorrectal o de carcinoma basocelular o escamocelular de la piel o carcinoma in situ del cuello uterino adecuadamente tratados).
    6. Metástasis cerebrales o compresión medular, a menos que se hayan tratado y lleven un mes estables sin uso de esteroides.
    7. A excepción de alopecia, cualquier toxicidad ? grado 2 de los CTCAE por un tratamiento anticanceroso previo (salvo indicación en contrario en estos criterios de selección).
    8. Neuropatía persistente tras tratamiento previo con oxaliplatino.
    9. En el momento de la aleatorización, menos de 4 semanas desde que se completó una radioterapia previa al tumor primario o persistencia de cualquier toxicidad aguda por la radioterapia.
    10. Enfermedad intestinal inflamatoria crónica, obstrucción intestinal u otra enfermedad digestiva activa en curso.
    11. Episodio cardiovascular importante (p. ej., infarto de miocardio, clasificación de cardiopatía ?2 según la New York Heart Association [NYHA] en los 3 meses anteriores a la aleatorización, o presencia de cardiopatía que, en opinión del investigador, aumenta el riesgo de arritmia ventricular.
    12. Antecedentes de arritmia (extrasístoles ventriculares multifocales, bigeminismo, trigeminismo, taquicardia ventricular, fibrilación auricular sintomática o incontrolada) sintomática o que precise tratamiento (grado 3 de los CTCAE) o de taquicardia ventricular sostenida asintomática. No se excluye la fibrilación auricular controlada con medicación.
    13. Bloqueo de rama izquierda.
    14. Hipertensión no controlada por el tratamiento médico (presión arterial sistólica >160 mmHg o presión arterial diastólica >110 mmHg).
    15. QTc medio basal ? 480 ms, determinado mediante la fórmula de Bazett. Los pacientes que reciban un medicamento que implique el riesgo de prolongar el QTc (ver el Apéndice C, Tabla 2) serán excluidos si QTc es ? 460 ms.
    16. Pacientes con factores que aumentan el riesgo de prolongación del QTc o de episodios arrítmicos como insuficiencia cardíaca, hipopotasemia, síndrome de QT largo congénito, antecedentes familiares de muerte súbita explicada a edad inferior a los 40 años o cualquier medicamentos concomitante que se sabe que prolonga el QTc.
    17. Cualquiera de los siguientes valores de laboratorio:
    - Potasio < 4,0 mmol/l a pesar de suplementación
    - Calcio (o calcio ajustado por albúmina) o magnesio fuera por debajo de los límites normales a pesar del uso de suplementos.
    18. Cualquiera de los siguientes valores de laboratorio:
    - Bilirrubina total >1,5 x LSN (límite superior normal)
    - Alanina aminotransferasa (ALT) o aspartato aminotransferasa (AST) >2,5 x LSN si no hay metástasis hepáticas demostrables o > 5 x LSN en presencia de metástasis hepáticas.
    19. Cualquiera de los siguientes valores de laboratorio:
    - Plaquetas < 100 x 109/l.
    - Hemoglobina < 9 g/dl a pesar del uso de transfusiones
    - Recuento absoluto de neutrófilos < 2,0 x 109/l.
    20. Aclaramiento de creatinina < 50 ml/min, creatinina sérica elevada > 1,5 LSN o ambas cosas
    21. Presencia de cantidades clínicamente significativas de sangre o proteínas en el análisis de orina repetido.
    22. No se permite el uso concomitante de los inductores de la CYP3A4 (p. ej., fenitoína, rifampicina, carbamazepina, barbitúricos e hipérico) en las 2 semanas previas a la aleatorización ni durante ningún tratamiento del ensayo.
    23. Antecedentes de hipersensibilidad al principio activo o a los excipientes inactivos de cualquier medicamento del ensayo (ZD6474/placebo, oxaliplatino, fluorouracilo, leucovorina).
    24. Mujeres embarazadas o en periodo de lactancia o mujeres en edad fértil que no utilicen un método anticonceptivo eficaz.
    25. Reclutamiento y aleatorización previos en este ensayo
    26. Participación en la planificación y la realización del ensayo (se aplica al personal tanto de AstraZeneca como del centro de ensayo)
    E.5 End points
    E.5.1Primary end point(s)
    to assess the efficacy of ZD6474 (100 mg and 300 mg) in combination with mFOLFOX6 versus mFOLFOX6 alone for the treatment of patients with colorectal cancer.
    Evaluar la eficacia de ZD6474 (100mg y 300mg) en combinación con mFOLFOX6 frente a mFOLFOX6 sólo en el tratamiento de cáncer colorrectal.
    E.5.1.1Timepoint(s) of evaluation of this end point
    NA
    NA
    E.5.2Secondary end point(s)
    The secondary objectives of the study are to assess the safety and tolerability of ZD6474 (100 mg and 300 mg) in combination with mFOLFOX6 in the treatment of colorectal cancer by review of AEs and laboratory parameters.
    Los objetivos secundarios del ensayo son valorar la seguridad y la tolerabilidad de ZD6474 (100 mg y 300 mg) en combinación con mFOLFOX6 en el tratamiento del cáncer colorrectal mediante la revisión de los AA y los parámetros de laboratorio.
    E.5.2.1Timepoint(s) of evaluation of this end point
    NA
    NA
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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.8.2.4Number 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    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
    France
    Hungary
    Korea, Republic of
    Slovakia
    Spain
    Taiwan
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end of the study will be data cut-off, following which no further data are expected on the clinical database.
    El final del ensayo se define como la fecha de bloqueo de la base de datos, que es el punto cronológico más allá del cual ningún paciente quedará 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 years1
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months5
    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.1.1.1In 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.1.2.1Number of subjects for this age range: 9999
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 9999
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 105
    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)
    NA
    NA
    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 Decision2007-03-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-02-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-11-11
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