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    Summary
    EudraCT Number:2009-017772-25
    Sponsor's Protocol Code Number:CQVA149A2303
    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:2010-07-06
    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 number2009-017772-25
    A.3Full title of the trial
    Estudio multicéntrico, aleatorizado, doble ciego, de grupos paralelos, controlado con placebo y grupo activo (abierto) de 26 semanas de duración, para evaluar la eficacia, seguridad y tolerabilidad de QVA149 (110/50 µg o.d.) en pacientes con enfermedad pulmonar obstructiva crónica (EPOC) de moderada a grave.
    A.4.1Sponsor's protocol code numberCQVA149A2303
    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 SponsorNovartis Farmacéutica S.A
    B.1.3.4CountrySpain
    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 nameIndacaterol maleate/Glycopyrronium bromide
    D.3.2Product code QVA149
    D.3.4Pharmaceutical form Inhalation powder, hard capsule
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGLYCOPYRRONIUM BROMIDE
    D.3.9.1CAS number 596510
    D.3.9.3Other descriptive nameGlycopyrrolate
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNINDACATEROL
    D.3.9.1CAS number 312753-06-3
    D.3.9.3Other descriptive nameIndacaterol Maleate
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number110
    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 SPIRIVA 18 microgramos, polvo para inhalación
    D.2.1.1.2Name of the Marketing Authorisation holderBOEHRINGER INGELHEIM INTERNATIONAL GMBH
    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.3.4Pharmaceutical form Inhalation powder, hard capsule
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTIOTROPIO BROMURO
    D.3.9.3Other descriptive nameTIOTROPIUM BROMIDE
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number18
    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 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 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 nameGlycopyrronium bromide
    D.3.2Product code NVA237
    D.3.4Pharmaceutical form Inhalation powder, hard capsule
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGLYCOPYRRONIUM BROMIDE
    D.3.9.1CAS number 596510
    D.3.9.3Other descriptive nameGlycopyrrolate
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(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: 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.2.1.1.1Trade name Onmbrez Breezhaler
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharma Limited
    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 nameIndacaterol
    D.3.2Product code QAB149
    D.3.4Pharmaceutical form Inhalation powder, hard capsule
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNINDACATEROL
    D.3.9.1CAS number 312753-06-3
    D.3.9.2Current sponsor codeQAB149
    D.3.9.3Other descriptive nameIndacaterol Maleate
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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 placeboInhalation powder, hard capsule
    D.8.4Route of administration of the placeboInhalation use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Enfermedad Pulmonar Obstructiva Crónica (EPOC)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10010952
    E.1.2Term COPD
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Demostrar la superioridad de QVA 110/50 µg en comparación con ambos QAB149 150 µg y NVA237 50 µg en términos de FEV1 valle (media de 23 h 15 min y 23 h 45 min post-dosis) tras 26 semanas de tratamiento en pacientes con EPOC moderada a grave.
    E.2.2Secondary objectives of the trial
    Demostrar la superioridad de QVA149 110/50 µg en comparación con placebo tras 26 semanas de tratamiento en términos de:
    ? El nivel de sensación de falta de aire que presentan los pacientes, evaluado mediante el Índice de Disnea Transicional (TDI)
    ? La calidad de vida relacionada con la salud notificada por los pacientes, mediante el Cuestionario Respiratorio St. Georges (SGRQ)
    ? El uso de medicación de rescate (número de inhalaciones) notificada por los pacientes, evaluado mediante el diario del paciente
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Están previstas evaluaciones exploratorias de farmacogenética como parte de este estudio. El análisis farmacogenético exploratorio se incluye en este estudio con los objetivos de identificar los factores hereditarios que puedan:
    1. estar relacionados con la EPOC o el mecanismo de acción de QVA149/QAB149/NVA237
    2. predecir la respuesta al tratamiento con QVA149, QAB149, o NVA237
    3. predecir la predisposición a efectos secundarios
    4. explicar la variabilidad en el ADME del fármaco
    E.3Principal inclusion criteria
    1. Hombres o mujeres adultos de edad ? 40 años, que hayan firmado un Formulario de Consentimiento Informado antes del inicio de cualquier procedimiento relacionado con el estudio.
    2. Pacientes con EPOC estable moderada a grave (Estadio II o Estadio III) según las Guías GOLD del 2008.
    3. Fumadores o ex-fumadores con antecedentes de consumo de tabaco de al menos 10 paquetes-años. (Diez paquetes-años se define como 20 cigarrillos al día durante 10 años, o 10 cigarrillos al día durante 20 años, etc.)
    4. Pacientes con un FEV1 post-broncodilatación ? 30% y < 80% del valor teórico normal, y FEV1/FVC post-broncodilatación < 0,7 en la Visita 2 (Día -14)
    (Post se refiere a 1 hora después de la inhalación secuencial de 84 µg (o dosis equivalente) de bromuro de ipratropio y 400 µg de salbutamol)
    5. Pacientes sintomáticos de acuerdo con los datos diarios del diario electrónico, entre la Visita 2 (-14) y la Visita 3 (Día 1), con una puntuación total de 1 o más en al menos 4 de los 7 últimos días previos a la Visita 3. (Para ello se utilizará el Diario del estudio principal.)
    E.4Principal exclusion criteria
    1. Mujeres embarazadas o en periodo de lactancia (embarazo confirmado mediante prueba de embarazo en orina positiva).
    2. Mujeres en edad fértil (WOCBP)
    3. Pacientes con contraindicaciones al tratamiento con, o que tengan antecedentes de reacciones/hipersensibilidad a cualquiera de los siguientes fármacos inhalados o fármacos de una clase similar o cualquier otro componente:
    ? agentes anticolinérgicos
    ? beta-2 agonistas de acción prolongada y corta
    ? aminas simpaticomiméticas
    ? lactosa o cualquiera de los otros excipientes
    4. Pacientes con antecedentes de síndrome QT largo o cuyo intervalo QTc determinado en la Visita 2 (Día -14) (método de Fridericia) esté prolongado (> 450 ms para hombres y mujeres) según confirmación del asesor de ECG central.
    5. Pacientes que tengan una anomalía clínicamente significativa en el ECG de la Visita 2 que a criterio del investigador pueda constituir un posible riesgo si se incluye en el estudio. (Estos pacientes no deben ser seleccionados nuevamente).
    6. Pacientes con diabetes Tipo I o Tipo II no controlada.
    Exclusión específica de EPOC
    7. Pacientes que precisen terapia de oxígeno a largo plazo (> 15 h al día) cada día por hipoxemia crónica.
    8. Pacientes que hubieran tenido una exacerbación de EPOC que precisara tratamiento con antibióticos, esteroides sistémicos (orales o intravenosos) u hospitalización, en las 6 semanas previas a la Visita 1 o entre la Visita 1 y Visita 3.
    ? Los pacientes que presenten una exacerbación de EPOC durante el periodo entre las Visitas 1 y 3 no serán elegibles pero podrán ser seleccionados nuevamente tras un mínimo de 6 semanas una vez resuelta la exacerbación de EPOC
    9. Pacientes que hayan presentado una infección del tracto respiratorio durante las 4 semanas previas a la Visita 1. Los pacientes que presenten una infección del tracto respiratorio superior o inferior durante el periodo de selección (hasta la Visita 3) no serán elegibles, pero podrán ser seleccionados nuevamente 4 semanas después de resolverse la infección del tracto respiratorio.
    10. Los pacientes con enfermedad pulmonar concomitante, por ejemplo, tuberculosis pulmonar (a menos que se confirme mediante radiografía de tórax que ya no está activa) o bronquiectasias, sarcoidosis, enfermedad pulmonar intersticial o hipertensión pulmonar clínicamente significativas.
    11. Pacientes con lobectomía pulmonar, o disminución del volumen pulmonar o trasplante pulmonar.
    12. Pacientes que, a criterio del investigador, tengan antecedentes de una alteración de laboratorio importante o una alteración clínicamente significativa como (aunque no limitada a ello):
    ? enfermedad cardiaca isquémica inestable, insuficiencia ventricular izquierda (Clase III y IV NYHA), antecedentes de infarto de miocardio, arritmia (excluyendo FA crónica estable)
    ? antecedentes de cáncer de cualquier órgano (incluyendo cáncer de pulmón), tratado o sin tratar, durante los últimos 5 años, independientemente de si hay o no evidencia de recurrencia o metástasis local, a excepción de carcinoma de células basales localizado de la piel
    ? hipo o hipertiroidismo no controlado, hipopotasemia o estado hiperadrenérgico no controlado
    ? glaucoma de ángulo estrecho
    ? hiperplasia prostática sintomática u obstrucción del cuello de la vejiga o alteración renal moderada a grave o retención urinaria. (Los pacientes con resección transuretral de próstata (TURP) se excluyen del estudio. Los pacientes a quienes se haya realizado una resección total de próstata se pueden considerar para el estudio, así como los pacientes que están asintomáticos y estables con tratamiento farmacológico para dicha alteración)
    ? cualquier condición que pueda comprometer la seguridad del paciente o el cumplimiento, interferir con la evaluación, o impedir la finalización del estudio
    13. Pacientes con algún antecedente de asma indicado mediante (aunque no limitado a ello) un recuento de eosinófilos > 600/mm3 (en la Visita 2), o inicio de síntomas antes de la edad de 40 años.
    14. Pacientes con rinitis alérgica que hayan utilizado un antagonista H1 o corticosteroides intra-nasales de forma intermitente (se permite el tratamiento con una dosis estable).
    15. Pacientes con eczema (atópico), niveles elevados de IgE conocidos, o un prick test cutáneo positivo conocido.
    16. Pacientes con antecedentes conocidos y diagnóstico de deficiencia de ?-1 antitripsina.
    17. Pacientes involucrados en la fase activa de un programa de rehabilitación pulmonar supervisado.
    E.5 End points
    E.5.1Primary end point(s)
    Demostrar la superioridad de QVA 110/50 µg en comparación con ambos QAB149 150 µg y NVA237 50 µg en términos de FEV1 valle (media de 23 h 15 min y 23 h 45 min post-dosis) tras 26 semanas de tratamiento en pacientes con EPOC moderada a grave.
    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 No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    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 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.8.4.1Number of sites anticipated in Member State concerned22
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA194
    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 Yes
    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
    Definido en el protocolo
    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.1.3Elderly (>=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 state150
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 678
    F.4.2.2In the whole clinical trial 2138
    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 Decision2010-09-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-07-30
    P. End of Trial
    P.End of Trial StatusCompleted
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