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    Summary
    EudraCT Number:2010-021860-13
    Sponsor's Protocol Code Number:BIA-91067-301
    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:2010-10-27
    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 number2010-021860-13
    A.3Full title of the trial
    EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON'S DISEASE PATIENTS WITH 'WEARING-OFF' PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY.
    EFICACIA Y SEGURIDAD DE BIA 9-1067 EN PACIENTES CON ENFERMEDAD DE PARKINSON IDIOPÁTICA CON FENÓMENO DE 'WEARING OFF' TRATADOS CON LEVODOPA Y UN INHIBIDOR DE DOPA DESCAROBOXILASA (IDDC): ENSAYO CLÍNICO MULTICÉNTRICO, DOBLE CIEGO, ALEATORIZADO, CONTROLADO CON PLACEBO Y ACTIVO, DE GRUPOS PARALELOS
    A.3.2Name or abbreviated title of the trial where available
    BIPARK STUDY I
    A.4.1Sponsor's protocol code numberBIA-91067-301
    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 SponsorBIAL - Portela & Ca, S.A.
    B.1.3.4CountryPortugal
    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 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 nameBIA 9-1067
    D.3.2Product code BIA 9-1067
    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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBIA 9-1067
    D.3.9.1CAS number 923287-50-7
    D.3.9.2Current sponsor codeBIA 9-1067
    D.3.9.3Other descriptive nameBIA 9-1067
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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) 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 No
    D.IMP: 2
    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.2.1.1.1Trade name Comtan®
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Pharmaceuticals
    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 nameOver-encapsulated Entacapone Tablets
    D.3.2Product code Over-encapsulated Entacapone Tablets
    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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNENTACAPONE
    D.3.9.1CAS number 130929-57-6
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 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 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 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 nameBIA 9-1067
    D.3.2Product code BIA 9-1067
    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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBIA 9-1067
    D.3.9.1CAS number 923287-50-7
    D.3.9.2Current sponsor codeBIA 9-1067
    D.3.9.3Other descriptive nameBIA 9-1067
    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 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 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 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 nameBIA 9-1067
    D.3.2Product code BIA 9-1067
    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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBIA 9-1067
    D.3.9.1CAS number 923287-50-7
    D.3.9.2Current sponsor codeBIA 9-1067
    D.3.9.3Other descriptive nameBIA 9-1067
    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 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 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
    Adjunct to levodopa (L-DOPA)/DDCI for use in patients with Parkinson's disease (PD) and end-of-dose motor fluctuations.
    Adjunto a levodopa/inhibidor dopa descarboxilasa para pacientes con enfermedad de Parkinson y fluctuaciones motoras de fin de dosis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10061536
    E.1.2Term Parkinson's disease
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate the efficacy of 3 different doses of BIA 9-1067 (5 mg, 25 mg, and 50 mg) administered once a day, compared with 200 mg of entacapone or placebo, when administered with the existing treatment of L-DOPA plus a DDCI, in patients with PD and end-of-dose motor fluctuations.
    E.2.2Secondary objectives of the trial
    To investigate the safety and tolerability of the combined treatment (L DOPA/DDCI plus BIA 9-1067, entacapone, or placebo).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    V1 (Selección, hasta 14 días antes de la V2)
    1. Ser capaces de comprender y estar dispuesto a firmar el consentimiento informado.
    2. Ser varón o mujer con edades comprendidas entre los 30 y los 83 años de edad, ambas incluidas.
    3. Diagnosis de EP idiopática de acuerdo con los Criterios Diagnósticos Clínicos del Banco de Cerebros de la Sociedad de la Enfermedad de Parkinson del Reino Unido durante al menos 3 años.
    4. Gravedad de la enfermedad en Estadios I-III (escala modificada de Hoehn & Yahr) en ON.
    5. En tratamiento con L-DOPA/IDDC durante al menos 1 año con clara mejoría clínica según el criterio del investigador.
    6. En tratamiento con de 3 a 8 dosis diarias de L-DOPA/IDDC, que puede incluir una formulación de liberación retardada.
    7. En régimen estable de L-DOPA/IDDC y otros fármacos anti-EP durante al menos 4 semanas antes de la selección.
    8. Presentar signos del fenómeno de 'wearing off' (deterioro fin de dosis) durante al menos las 4 semanas antes de la selección, con una media total diaria de periodos OFF de al menos 1.5 horas durante el periodo de vigilia, excluyendo la primera dosis OFF de la mañana, a pesar de recibir una terapia anti-EP óptima (según el criterio del investigador).
    9. Ser capaz de llevar un diario fiable de las fluctuaciones motoras (por sí solo o con ayuda de un familiar/cuidador).
    10. Amenorreica durante al menos 1 año o haber sido esterilizada quirúrgicamente durante al menos 6 meses antes de la selección. Las mujeres en edad fértil deben usar un método eficaz anticonceptivo no hormonal.

    V2 (Aleatorización, Día 0)
    11. Haber rellenado las tablas del diario de auto-puntuación de acuerdo con las instrucciones para ello y con 3 o menos errores al día.
    12. Presentar al menos 1.5 horas al día en estado OFF, excluyendo el primer periodo OFF de la mañana antes de la primera dosis (es decir, el tiempo entre despertar y la respuesta a la primera dosis de L-DOPA/IDDC), registrado en el diario de auto-puntuación durante al menos 2 de los 3 días precedentes a la V2.
    13. El investigador considera aceptables los resultados de las pruebas de laboratorio del periodo de selección (es decir, no son clínicamente relevantes para el bienestar del sujeto o para el objetivo del estudio).
    E.4Principal exclusion criteria
    V1 (Selección, hasta 14 días antes de la V2)
    1. EP no idiopática (parkinsonismo atípico, parkinsonismo secundario [adquirido o sintomático], síndrome de Parkinson Plus).
    2. Puntuación de discapacidad por discinesia >3 en la Escala Unificada de Puntuación de la Enfermedad de Parkinson (UPDRS), subsección IV A, punto 33.
    3. Periodos OFF severo y/o impredecibles.
    4. Tratamiento con medicación prohibida: tolcapona, neurolépticos, venlafaxina, inhibidores de la MAO (a excepción de selegilina hasta 10 mg/día en formulación oral o 1.25 mg/día en formulación por absorción bucal o rasagilina hasta 1 mg/día), o antieméticos con acción antidopaminérgica (a excepción de domperidona) en el mes anterior a la selección.
    5. Uso previo de entacapona.
    6. Tratamiento con apomorfina, alfa-metildopa o reserpina en el mes anterior a la selección o probabilidad de que lo vaya a necesitar en algún momento durante el estudio.
    7. Haber realizado un cambio de dosis en la medicación anti-EP concomitante en las 4 semanas anteriores a la selección.
    8. Estimulación cerebral profunda previa o programada (durante todo el estudio, incluido durante el periodo AB).
    9. Haber sido sometido a una cirugía estereotáctica previa (p. ej., palidotomía, talamotomía) por EP o cirugía estereotáctica planeada durante el periodo del estudio.
    10. Haber recibido cualquier PEI en los 3 meses (o en un plazo de 5 vida medias del PEI, lo que sea más largo) antes de la selección.
    11. Sufrir cualquier afección médica que pudiera aumentar el riesgo del sujeto o interferir con las evaluaciones.
    12. Historia médica actual o antecedentes (durante el último año) de ideas suicidas o de intentos de suicidio.
    13. Diagnóstico actual o previo (en el último año) de trastorno depresivo mayor, manía, trastorno bipolar, psicosis, distimia, trastorno de ansiedad generalizada, alcoholismo o abuso de sustancias, excluidas la cafeína y la nicotina, trastornos de control del impulso (p. ej. ludopatía), demencia o trastornos de la alimentación de acuerdo con el Manual Diagnóstico y Estadístico de los Trastornos Mentales, 4ª Edición, revisión del texto (DSM-IV) de la Asociación Americana de Psiquiatría, criterios del año 2000, a criterio del investigador.
    14. Presentar una anomalía clínicamente relevante en el ECG (en caso necesario, la relevancia será evaluada por un cardiólogo).
    15. Presentar signos actuales de enfermedad cardiovascular inestable, incluidos, entre otros, hipertensión no controlada, infarto de miocardio con disfunción sistólica o diastólica importante, angina inestable, insuficiencia cardíaca congestiva (clase mayor o igual a III de la New York Heart Association) y arritmia cardíaca significativa (bloqueo AV de grado 2 o 3 de Mobitz o cualquier otra arritmia que produzca repercusiones hemodinámicas como bradicardia sintomática o síncope).
    16. Trasplante renal previo o actualmente en diálisis renal.
    17. Feocromocitoma, paraganglioma u otras neoplasias secretoras de catecolaminas.
    18. Hipersensibilidad conocida a los ingredientes del PEI utilizados.
    19. Antecedentes de síndrome neuroléptico maligno (SNM) o síndromes similares al SNM o rabdomiolisis no traumática.
    20. Antecedentes de una enfermedad neoplásica, o presentar un cáncer actualmente, que, en opinión del investigador, excluiría al sujeto del estudio (p. ej., melanoma, cáncer de próstata).
    21. Glaucoma de ángulo estrecho inestable y activo o glaucoma de ángulo ancho inestable.
    22. Antecedentes o signos actuales de una enfermedad relevante en el contexto de este estudio, es decir, con respecto a la seguridad del sujeto o en relación con las afecciones del estudio, que, por ejemplo, podría afectar a la absorción o el metabolismo del PEI (tal como una hepatopatía relevante).
    23. Estar embarazada o en periodo de lactancia.

    V2 (Aleatorización, Día 0)
    24. Cualquier anomalía en las enzimas hepáticas (alanina aminotransferasa y/o aspartato aminotransferasa) > 2 veces el límite superior del intervalo normal en los resultados de las pruebas de laboratorio de la selección.
    25. Niveles de sodio en plasma < 130 mmol/l, recuento de leucocitos < 3000 células/mm3 o cualquier otra anomalía analítica relevante en los resultados de las pruebas de laboratorio de la selección, que, en opinión del investigador, puedan comprometer la seguridad del sujeto.
    26. Cumplimiento inadecuado de la medicación concomitante, L-DOPA/IDDC y otros fármacos anti-EP, durante el periodo de selección.
    E.5 End points
    E.5.1Primary end point(s)
    Criterios de evaluación:
    Eficacia:
    • Las tablas del diario del sujeto para los periodos ON/OFF.
    • Secciones de la UPDRS I (ON), II (ON y OFF) y III (ON)
    • Escala modificada de Hoehn & Yahr (ON) (UPDRS V).
    • Escala de Schwab y England (ON y OFF) (UDPRS VI).
    • Cambios en la dosis de L-DOPA/IDDC.
    • Evaluación de cambio realizada por el investigador y por el sujeto.
    • Escala del sueño para la enfermedad de Parkinson (PDSS).
    • Complicaciones de la terapia (Subsecciones IV A, B y C de la UPDRS).
    • Cuestionario sobre la enfermedad de Parkinson (PDQ-39).
    • Escala de síntomas no motores (NMSS).
    Seguridad:
    • Acontecimientos adversos aparecidos durante el tratamiento (AAAT), incluidos los acontecimientos adversos graves. Los AAAT se definen como todos los AA con inicio o empeoramiento después de la primera administración del PEI hasta 2 semanas (14 días) después de la última dosis del PEI (PSV).
    • Análisis clínicos de seguridad:
    -Bioquímica: sodio, potasio, cloruro, calcio, fosfato, glucosa, creatinina, nitrógeno ureico en sangre, aspartato aminotransferasa, alanina aminotransferasa, gammaglutamil transferasa, fosfatasa alcalina, creatina fosfoquinasa, lactato deshidrogenasa, albúmina, proteínas totales, colesterol total, colesterol de lipoproteínas de alta y baja densidad, triglicéridos, bilirrubina total y bilirrubina directa/indirecta.
    -Hematología: recuento de glóbulos rojos, hematocrito, hemoglobina, recuento de glóbulos blancos (total y con fórmula diferencial), recuento de plaquetas.
    -Coagulación: tiempo de protrombina (índice normalizado internacional y tiempo de tromboplastina parcial activada).
    -Prueba de embarazo en suero y orina: sólo en mujeres en edad fértil.
    -Análisis de orina: pH, densidad, proteínas, sangre, glucosa, cetonas, bilirrubina, urobilinógeno (en tira reactiva, local).
    • Exploraciones físicas y constantes vitales.
    • Exploraciones neurológicas.
    • ECG de 12 derivaciones.
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 Yes
    E.8.1.7.1Other trial design description
    double-blind period followed by open label period
    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.8.4.1Number of sites anticipated in Member State concerned12
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA100
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA 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 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
    provided in the protocol
    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 days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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.1.3Elderly (>=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 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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 400
    F.4.2.2In the whole clinical trial 550
    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 Decision2011-01-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-12-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-12-17
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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