Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43845   clinical trials with a EudraCT protocol, of which   7282   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2010-018414-69
    Sponsor's Protocol Code Number:4305-029
    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:2010-03-22
    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 number2010-018414-69
    A.3Full title of the trial
    "Estudio de fase III, multicéntrico, aleatorizado, doble ciego, controlado con placebo, de grupos paralelos para evaluar la seguridad y la eficacia de MK-4305 en pacientes con insomnio primario -Estudio B" ;A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of MK-4305 in Patients with Primary Insomnia- Study B
    A.4.1Sponsor's protocol code number4305-029
    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 SponsorMerck & Co., Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation 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.3.2Product code MK-4305
    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.3.9.2Current sponsor codeMK-4305
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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 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.3.2Product code MK-4350
    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.3.9.2Current sponsor codeMK-4305
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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.3.2Product code MK-4305
    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.3.9.2Current sponsor codeMK-4305
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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.3.2Product code MK-4305
    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.3.9.2Current sponsor codeMK-4305
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product 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 placeboFilm-coated tablet
    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 placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 3
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 4
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    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
    Insomnio Primario /Primary Insomnia
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 11
    E.1.2Level LLT
    E.1.2Classification code 10036701
    E.1.2Term Insomnio primario
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1.Evaluar la eficacia de la dosis alta de MK 4305 en comparación con placebo en cuanto a la mejora del insomnio, medida por la variación con respecto al valor basal del tiempo subjetivo total de sueño medio (sTTSm) en el diario-e de sueño diario en el mes 1.
    2. Evaluar la eficacia de la dosis alta de MK 4305 en comparación con placebo en cuanto a la mejora del insomnio, medida por la variación con respecto al valor basal del desvelamiento posterior al inicio del sueño persistente (DPIS) en el mes 1.
    3.Evaluar la eficacia de la dosis alta de MK 4305 en comparación con placebo en cuanto a la mejora del insomnio, medida por la variación con respecto al valor basal del tiempo subjetivo total de sueño medio (sTTSm) en el diario-e de sueño diario en el mes 3.
    (Para ver más detalles, ver el protocolo)
    E.2.2Secondary objectives of the trial
    Mantenimiento
    1.Evaluar la eficacia de la dosis alta de MK 4305 en comparación con placebo en cuanto a la mejora del insomnio, medida por la variación con respecto al valor basal del tiempo subjetivo total de sueño medio (sTTSm) en el diario-e de sueño diario en la semana 1.
    2.Evaluar la eficacia de la dosis alta de MK 4305 en comparación con placebo en cuanto a la mejora del insomnio, medida por la variación con respecto al valor basal del desvelamiento posterior al inicio del sueño persistente (DPIS) en la noche 1.
    Inicio
    3. Evaluar la eficacia de dosis altas de MK 4305 en comparación con placebo en cuanto a la mejora del insomnio, medida por la variación con respecto al valor basal del tiempo subjetivo medio hasta el inicio del sueño (sTISm) en el diario-e de sueño diario en la semana 1.
    (Para ver más detalles, ver el protocolo)
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Tipo de consentimiento: Obtención opcional de muestras para estudios genéticos y otras investigaciones biomédicas (Versión 00 Genético y Muestras Futuras del 2 de Marzo de 2010)El objetivo para la investigación futura consiste en explorar e identificar marcadores biológicos que contribuyen a la comprensión científica de enfermedades y / o sus tratamientos terapéuticos. Objetivo último garantizar que los sujetos / pacientes reciben la dosis correcta del medicamento en el momento correcto.
    E.3Principal inclusion criteria
    1.a Pacientes de ambos sexos y de 18 años o más de edad el día de la firma del consentimiento informado.
    1.b El paciente presenta un diagnóstico de insomnio primario según el DSM-IV-TR (apéndice 6.1) a criterio del investigador y de los antecedentes de sueño del paciente, evaluados en la entrevista diagnóstica y los antecedentes del sueño.
    1.c En los pacientes > ó = 65 años de edad: puntuación > ó =25 en el miniexamen cognoscitivo (MMSE).
    1.d El paciente goza de buena salud física y mental en opinión del investigador.
    1.e Las pacientes en edad fértil tienen una concentración sérica de Beta-hCG compatible con una ausencia de embarazo y acepta utilizar un método anticonceptivo aceptable.
    - La anticoncepción aceptable se define como la abstinencia (allá donde la abstinencia sea una forma localmente aceptada de anticoncepción) o el uso de dos métodos anticonceptivos eficaces regionalmente aceptados, entre ellos: la pareja emplea preservativo con espermicida o situación posterior a una vasectomía y la paciente emplea anticonceptivos hormonales, dispositivo intrauterino (DIU), diafragma con espermicida o esponja anticonceptiva. Tenga en cuenta que si la pareja no utiliza un método anticonceptivo eficaz, una paciente DEBERÁ utilizar dos métodos anticonceptivos aceptables para cumplir los requisitos del estudio.
    Nota: si el método anticonceptivo elegido es hormonal, deberá haberse utilizado durante al menos 2 meses antes de la aleatorización para que la paciente sea apta para participar en este estudio.
    Nota: las mujeres que no están en edad fértil son: mujeres posmenopáusicas o que se han sometido a una histerectomía, ligadura de trompas bilateral u ovariectomía bilateral. La situación posmenopáusica se define como una edad > ó = 43 años y (1) ausencia de menstruación durante > 1 año pero < 3 años confirmada por unas cifras elevadas de FSH en el intervalo posmenopáusico, según la definición del laboratorio designado, o bien (2) ausencia de menstruación durante 3 años como mínimo.
    1.f El paciente comunica un tiempo total de sueño < 6,5 horas en al menos 3 de 7 noches por semana durante las 4 semanas previas a la visita 1*.
    1.g El paciente comunica una latencia del sueño > ó = 30 minutos en al menos 3 de 7 noches por semana durante las 4 semanas previas a la visita 1*.
    1.h El paciente comunica > ó = 1 hora de desvelamiento después del inicio del sueño en al menos 3 de 7 noches por semana durante las 4 semanas previas a la visita 1*.
    *Se aplica a 1.f a 1.h: en los pacientes con uso crónico de un hipnótico o ansiolítico para el tratamiento del insomnio (definido como un uso > ó = 4 veces/semana), se exige un período de depuración de 4 semanas (o 5 semividas, t½, lo que sea mayor) antes de la evaluación de estos criterios de la visita 1. Véase la tabla 2-1 y la sección 3.2.1 para obtener más información.
    (Ver en el protocolo el resto de los criterios)
    E.4Principal exclusion criteria
    1.a En el caso de las mujeres, la paciente está embarazada (prueba de embarazo en suero positiva en la visita previa al estudio) o en período de lactancia, o espera concebir durante el período previsto del estudio. NOTA: si es varón, responda “NO”.
    1.b El paciente tiene previsto donar óvulos o espermatozoides durante el estudio.
    1.c En opinión del investigador, el paciente tiene antecedentes o está diagnosticado de alguno de los siguientes trastornos:
    Narcolepsia
    Cataplejía (familiar o idiopática)
    Trastornos del ritmo circadiano del sueño
    Parasomnias, entre ellas, trastorno de pesadillas, terrores nocturnos, sonambulismo y trastorno de la conducta en el sueño REM
    Trastorno respiratorio relacionado con el sueño (es decir, síndrome de apnea del sueño obstructiva o central, síndrome de hipoventilación alveolar central)
    Trastorno de movimientos periódicos de las extremidades
    Síndrome de las piernas inquietas
    Hipersomnia primaria
    Somnolencia diurna excesiva (SDE), no atribuible a insomnio primario.
    1.d En opinión del investigador, el paciente tiene problemas para dormirse debido a un trastorno médico que puede crear confusión. NOTA: entre los “trastornos médicos” figuran síndromes de dolor crónico, migraña crónica, cardiopatías, nicturia (> 3 veces/noche), asma, enfermedad por reflujo gastroesofágico (ERGE) o sofocos.
    1.e El paciente tiene antecedentes de viajes transmeridianos (a través de > 3 husos horarios o > 3 horas de diferencia horaria) en las 2 semanas precedentes o prevé viajar (a través de > 3 husos horarios o > 3 horas de diferencia horaria) durante el estudio. (Sólo en la cohorte-PC: los viajes transmeridianos están prohibidos 1 semana antes de las visitas con PSG.) (Véanse más detalles en la sección 3.2.2.5.)
    1.f El paciente tiene antecedentes de trabajo por turnos (definido como turno nocturno permanente o trabajo rotatorio con turnos de día y noche) en las 2 últimas semanas, o prevé la necesidad de realizar trabajo por turnos durante el estudio.
    1.g El paciente tiene antecedentes de un trastorno neurológico, como por ejemplo un trastorno convulsivo (aparte de episodios aislados de convulsiones febriles de la infancia), ictus, accidente isquémico transitorio, esclerosis múltiple, deterioro cognitivo o traumatismo craneoencefálico importante con pérdida sostenida del conocimiento en los últimos 10 años.
    (Ver en el protocolo el resto de los criterios)
    E.5 End points
    E.5.1Primary end point(s)
    (Mantenimiento)
    - Variación con respecto al valor basal del tiempo subjetivo total de sueño medio (sTTSm) en el diario-e en los meses 1 y 3
    - Variación con respecto al valor basal del desvelamiento posterior al inicio del sueño persistente (DPIS) según la PSG en los meses 1 y 3
    (Inicio)
    - Variación con respecto al valor basal del tiempo hasta el inicio del sueño subjetivo medio (sTISm) en el diario-e en los meses 1 y 3
    -Variación con respecto al valor basal de la latencia hasta el inicio del sueño persistente (LSP) según la PSG en los meses 1 y 3
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    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 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.8.4.1Number of sites anticipated in Member State concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA70
    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
    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 months1
    E.8.9.1In the Member State concerned days4
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days4
    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 state35
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 735
    F.4.2.2In the whole clinical trial 945
    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 Decision2010-05-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-05-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-11-08
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Fri Apr 19 02:54:27 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA