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    Summary
    EudraCT Number:2011-004590-90
    Sponsor's Protocol Code Number:3415A-001
    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:2011-11-28
    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 number2011-004590-90
    A.3Full title of the trial
    A Phase III, Randomized, Double-Blind, Placebo-Controlled, Adaptive Design Study of the Efficacy, Safety, and Tolerability of a Single Infusion of MK-3415 (Human Monoclonal Antibody to Clostridium difficile toxin A), MK-6072 (Human Monoclonal Antibody to Clostridium difficile toxin B), and MK-3415A (Human Monoclonal Antibodies to Clostridium difficile toxin A and toxin B) in Patients Receiving Antibiotic Therapy for Clostridium difficile Infection(MODIFY I)
    Estudio de fase III aleatorizado, doble ciego y controlado con placebo, de diseño adaptativo, de la eficacia, la seguridad y la tolerabilidad de una sola infusión de MK 3415 (anticuerpo monoclonal humano frente a la toxina A de Clostridium difficile), MK 6072 (anticuerpo monoclonal humano frente a la toxina B de Clostridium difficile) y MK 3415A (anticuerpos monoclonales humanos contra las toxinas A y B de Clostridium difficile) en pacientes sometidos a tratamiento antibiótico por infección por Clostridium difficile (MODIFY I)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase III, Randomized, Double-Blind, Placebo-Controlled, Adaptive Design Study of the Efficacy, Safety, and Tolerability of a Single Infusion of MK-3415, MK-6072, and MK-3415A in Patients Receiving Antibiotic Therapy for Clostridium difficile Infection(MODIFY I)
    Estudio de fase III aleatorizado, doble ciego y controlado con placebo, de diseño adaptativo, de la eficacia, la seguridad y la tolerabilidad de una sola infusión de MK 3415, MK 6072 y MK 3415A en pacientes sometidos a tratamiento antibiótico por infección por Clostridium difficile (MODIFY I)
    A.3.2Name or abbreviated title of the trial where available
    MODIFY I
    MODIFY I
    A.4.1Sponsor's protocol code number3415A-001
    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 SponsorMerck Sharp & Dohme Corp.
    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 supportMerck Sharp & Dohme Corp.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMerck Sharp & Dohme Corp.
    B.5.2Functional name of contact pointMerck Sharp & Dohme Corp.
    B.5.3 Address:
    B.5.3.1Street AddressOne Merck Drive, PO Box 100
    B.5.3.2Town/ cityWhitehouse Station, NJ
    B.5.3.3Post code08889-0100
    B.5.3.4CountryUnited States
    B.5.4Telephone number2673057019
    B.5.5Fax numberN/AN/AN/A
    B.5.6E-mailmary.beth.dorr@merck.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 nameMK-3415
    D.3.2Product code MK-3415
    D.3.4Pharmaceutical form 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.3.9.2Current sponsor codeMK 3415
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    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 No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 nameMK-6072, MDX-1388, CDB1
    D.3.2Product code MK-6072
    D.3.4Pharmaceutical form 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.3.9.2Current sponsor codeMK 6072
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    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 No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 nameMK-3415A (MK-3415/MK-6072)
    D.3.2Product code MK-3415 A
    D.3.4Pharmaceutical form 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.3.9.2Current sponsor codeMK 3415
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeMK-6072
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    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 No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 placeboInjection
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    recurrence of Clostridium difficile infection (CDI)
    recurrencia de la infección por C. difficile (ICD).
    E.1.1.1Medical condition in easily understood language
    recurrence of Clostridium difficile infection (CDI)
    recurrencia de la infección por C. difficile (ICD).
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level LLT
    E.1.2Classification code 10054236
    E.1.2Term Clostridium difficile infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary Objective 1: To determine if treatment with a single infusion of combined monoclonal antibody therapy (MK-3415A) with SOC therapy decreases the proportion of patients with CDI recurrence over a period of 12 weeks as compared to treatment with a single infusion of individual monoclonal antibody therapy (MK-3415 or MK-6072) with SOC therapy. (Read the rest of the Primary Objectives in the protocol)
    Objetivo principal 1: Determinar si el tratamiento con una sola infusión de tratamiento con anticuerpos monoclonales combinados (MK 3415A) junto con el TH reduce la proporción de pacientes con recurrencia de la ICD durante un período de 12 semanas en comparación con el tratamiento con una sola infusión de tratamiento con anticuerpos monoclonales individuales (MK 3415 o MK 6072) junto con el TH. (Leer el resto de objetivos principales en el protocolo)
    E.2.2Secondary objectives of the trial
    Secondary Objective 1: To evaluate, in the subset of patients who achieve a clinical cure for the initial CDI episode, if treatment with a single infusion of MK-3415A with SOC therapy decreases the proportion of patients with CDI recurrence over a period of 12 weeks as compared to treatment with a single infusion of placebo and SOC therapy.(Read the rest of the Secondary Objectives in the protocol)
    Objetivo secundario 1:Evaluar, en el subgrupo de pacientes que logren curación clínica del episodio de ICD inicial, si el tratamiento con una sola infusión de MK 3415A con TH reduce la proporción de pacientes con recurrencia de la ICD durante un período de 12 semanas en comparación con el tratamiento con una sola infusión de placebo y el TH.(Leer el resto de objetivos secundarios en 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
    ICF( version 00 extensión 9 months 3-nov-2011)
    ICF( Versión 00 Genetic and further samples version 00 date 9-11-11)
    HIP y CI (versión 00 extensión 9 meses 3-nov-2011)
    HIP y CI (Versión 00 Genético y Muestras Futuras del 9 de Noviembre de 2011)
    E.3Principal inclusion criteria
    1. Participant must be 18 years of age or older.
    2. Participant has a diagnosis of CDI as defined by:
    a. Presence of diarrhea, as defined by passage of 3 or more loose stools in 24 or fewer hours, AND
    b. A positive stool test for toxigenic C. difficile.
    3. Participant must be receiving SOC therapy for CDI. SOC therapy is defined as the receipt of oral metronidazole, oral vancomycin, IV metronidazole concurrent with oral vancomycin, oral fidaxomicin, or oral fidaxomicin concurrent with IV metronidazole.
    4. Participant is highly unlikely to become pregnant or to impregnate a partner since they meet at least one of the following criteria: a. A female participant who is not of reproductive potential is eligible without requiring the use of contraception.
    A female participant who is not of reproductive potential is defined as: one who has either (1) reached natural menopause (defined as 6 months of spontaneous amenorrhea with serum follicle stimulating hormone (FSH) levels in the postmenopausal range as determined by the local laboratory, or 12 months of spontaneous amenorrhea); (2) 6 weeks post surgical bilateral oophorectomy with or without hysterectomy; or (3) bilateral tubal ligation. Spontaneous amenorrhea does not include cases for which there is an underlying disease that causes amenorrhea (e.g. anorexia nervosa). b. A participant who is of reproductive potential agrees to remain abstinent or use (or have their partner use) 2 acceptable methods of birth control starting at enrollment and through the 12 Week study period. Acceptable methods of birth control are: intrauterine device (IUD), diaphragm with spermicide, contraceptive sponge, condom, vasectomy and any registered and marketed hormonal contraceptives that contain an estrogen and/or a progestational agent (including oral, subcutaneous, intrauterine, or intramuscular agents)
    5. Participant or legal representative must have voluntarily agreed to participate by providing written informed consent after the nature of the study has been fully explained.
    1.Pacientes de 18 o más años de edad.
    2.Pacientes con diagnóstico de infección por C. difficile (ICD), definido por:
    a.Presencia de diarrea, definida como la evacuación de 3 o más deposiciones sueltas en 24 horas o menos [16]
    Y
    b.Prueba de heces positiva para la toxina de C. difficile.
    3.Los pacientes deberán estar recibiendo, o deberá estar previsto que reciban, un ciclo de 10 a 14 días del TH para la ICD. Se entiende por TH la recepción de metronidazol oral, vancomicina oral, metronidazol intravenoso junto con vancomicina oral, fidaxomicina oral o fidaxomicina oral junto con metronidazol intravenoso.
    4.Pacientes con muy escasa probabilidad de quedarse embarazadas o de dejar embarazada a su pareja porque cumplen al menos uno de los criterios siguientes:
    a.Las pacientes en edad no fértil podrán participar sin tener que utilizar anticonceptivos. Una mujer que no está en edad fértil se define como la que: (1) ha alcanzado la menopausia natural (definida como 6 meses de amenorrea espontánea con concentraciones séricas de FSH dentro del intervalo posmenopáusico según lo determinado por el laboratorio local, o 12 meses de amenorrea espontánea); (2) se ha sometido a una ovariectomía bilateral con o sin histerectomía 6 semanas antes, o (3) se ha sometido a una ligadura de trompas bilateral. La amenorrea espontánea no incluye los casos en los que existe una enfermedad subyacente que causa amenorrea (p. ej., anorexia nerviosa).
    b.Un paciente de cualquier sexo que está en edad fértil se compromete a mantener abstinencia sexual o a utilizar (o hacer que su pareja utilice) 2 métodos anticonceptivos aceptables desde el reclutamiento y durante todo el período de 12 semanas del estudio. Son métodos anticonceptivos aceptables: el dispositivo intrauterino (DIU), el diafragma con espermicida, la esponja anticonceptiva, el preservativo, la vasectomía y los anticonceptivos hormonales registrados y comercializados que contienen un estrógeno, un progestágeno o ambos (incluidos los orales, subcutáneos, intrauterinos o intramusculares).
    5.El paciente o su representante legal deberán haber aceptado participar voluntariamente dando su consentimiento informado por escrito después de haber recibido una explicación completa de la naturaleza del estudio.
    E.4Principal exclusion criteria
    1. participant with an active chronic diarrheal illness such as, but not limited to, ulcerative colitis or Crohn's disease or with a condition that causes routine passage of loose stool (e.g., an ostomy).
    2. Participant with a planned surgery for CDI within 24 hours.
    3. Participant has a positive pregnancy test in the 48 hours before the infusion or is unwilling to undergo pregnancy testing if a pre-menopausal female who is not sterilized and therefore has the potential to bear a child.
    4. Participant is breast-feeding or plans to breastfeed prior to the completion of the 12-week study period.
    5. A female participant who plans to donate ova prior to the completion of the 12-week study period, or a male participant who is planning to impregnate or provide sperm donation prior to the completion of the 12-Week study period.
    6. Participant has previously participated in this study or has previously received MK-3415 or MK-6072 (either alone or in combination).
    7. Participant plans to donate blood and/or blood products within 6 months following the infusion.
    8. Participant has received immune globulin within 6 months prior to receipt of the infusion or is planning to receive immune globulin prior to the completion of the 12-week study period.
    9. Treatment with SOC therapy is planned for longer than 14 days
    10. Participant has received cholestyramine, rifaximin, or nitazoxanide within 14 days prior to receipt of the infusion or is planning to receive these medications prior to the completion of the 12-week study period.
    11. Participant plans to take antiperistaltic agents, such as loperamide (Imodium?) or diphenoxylate
    hydrochloride/atropine sulfate (LOMOTIL?), at any time during the 14 days following infusion. Participants receiving opioid medications at the onset of diarrhea may be included if they are on a stable dose or if there is anticipation of a dose decrease or cessation of use.
    12. Participant plans to take the probiotic Saccharomyces boulardii at any time following infusion (Day 1) and through the completion of the 12-week study period.
    13. Participant has received another investigational study agent within the previous 30 days, or is currently participating in or scheduled to participate in any other clinical trial during the 12- week study period.
    14. Participant is not expected to survive for 72 hours.
    15. participant has any other condition that, in the opinion of the investigator, would jeopardize the safety or rights of the participant participating in the study, would make it unlikely for the participant to complete the study, or would confound the results of the study.
    1.Pacientes con una enfermedad diarreica crónica activa como, entre otras, la colitis ulcerosa o la enfermedad de Crohn, o con una situación en la que evacuan sistemáticamente deposiciones sueltas (p. ej., pacientes con una ostomía).
    2.Pacientes en quienes esté prevista una intervención quirúrgica para la ICD en el plazo de 24 horas.
    3.Paciente con una prueba de embarazo positiva en las 48 horas previas a la infusión o no dispuesta a someterse a una prueba de embarazo si es una mujer premenopáusica que no está esterilizada y puede, en consecuencia, engendrar un niño.
    4.Pacientes que alimentan al pecho a su hijo o tienen previsto hacerlo antes de completar el período del estudio de 12 semanas.
    5.Una paciente que tenga previsto donar óvulos antes de completar el período del estudio de 12 semanas o un paciente varón que tenga previsto fecundar o donar semen antes de completar el período del estudio de 12 semanas.
    6.Pacientes que hayan participado previamente en este estudio o recibido previamente MK 3415 o MK 6072 (solos o en combinación).
    7.Pacientes que prevean donar sangre o hemoderivados en los 6 meses siguientes a la infusión.
    8.Pacientes que hayan recibido inmunoglobulinas en los 6 meses previos a la recepción de la infusión o que esté previsto que las reciban antes de completar el período del estudio de 12 semanas.
    9.Pacientes en quienes esté prevista la administración del TH durante más de 14 días (p. ej., previsión de una pauta de vancomicina gradual o en pulsos).
    10.Pacientes que hayan recibido colestiramina, rifaximina o nitazoxanida en los 14 días previos a la recepción de la infusión o que se prevea que las recibirán antes de completar el período del estudio de 12 semanas.
    11.Pacientes que planeen tomar medicación para controlar la diarrea o disminuir el peristaltismo, como loperamida (Immodium ?) o clorhidrato de difenoxilato/sulfato de atropina (Lomotil ?), en cualquier momento durante los 14 días siguientes a la infusión. Los pacientes que reciban medicación opiácea al comienzo de la diarrea pueden participar si se espera que permanezcan con dosis estables de estos medicamentos o se prevén una reducción de sus dosis o la suspensión de su uso.
    12.Pacientes que planeen tomar el probiótico Saccharomyces boulardii en cualquier momento después de la infusión (día 1) y hasta que se complete el período del estudio de 12 semanas.
    13.Pacientes que hayan recibido otro fármaco en investigación en los 30 días previos o que estén participando o tengan previsto participar en cualquier otro ensayo clínico durante el período del estudio de 12 semanas.
    14.Pacientes que no se espere que sobrevivan durante 72 horas.
    15.Pacientes con cualquier otro proceso que, en opinión del investigador, pondría en peligro la seguridad o los derechos del paciente participante en el estudio, haría improbable que el paciente completara el estudio o confundiría los resultados del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of patients with CDI recurrence.
    Proporción de pacientes con Recurrencia de la ICD.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12 (Day 85±5 days)
    Semana 12 (Día 85 más o menos 5 días)
    E.5.2Secondary end point(s)
    Proportion of patients with global cure.
    Proporción de pacientes con cura global
    E.5.2.1Timepoint(s) of evaluation of this end point
    número de pacientes de la población FAS que logren curación clínica del episodio de ICD inicial Y no sufran recurrencia de la ICD hasta la semana 12
    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 No
    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 No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    adaptive design allows for discontinuation of suboptimal treatment arm(s)
    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 trial4
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA52
    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
    Australia
    Austria
    Belgium
    Brazil
    Canada
    Chile
    Colombia
    Czech Republic
    Denmark
    Germany
    India
    Israel
    Italy
    Mexico
    New Zealand
    Portugal
    Puerto Rico
    South Africa
    Spain
    United Kingdom
    United States
    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
    LPLV
    LPLV
    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 months4
    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 months4
    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 No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 800
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 800
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    patient or legal representative can provide written informed consent
    Pacientes o representante legal que pueda firmar el consentimiento informado.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state80
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 581
    F.4.2.2In the whole clinical trial 1600
    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)
    Not applicable
    No aplica
    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 Decision2012-01-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-01-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-12-09
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