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 are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   35554   clinical trials with a EudraCT protocol, of which   5841   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).
     
    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:2014-000593-19
    Sponsor's Protocol Code Number:D589UC00001
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2014-08-06
    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 number2014-000593-19
    A.3Full title of the trial
    A Phase IIIB, 6-Month, Double-blind, Double-dummy, Randomized, Parallel-group, Multicenter Exacerbation Study of Symbicort® pMDI 160/4.5 µg x 2 Actuations Twice-daily Compared to Formoterol Turbuhaler 4.5 µg x 2 Inhalations Twice-daily in COPD Patients
    The RISE study: Revealing the Impact of Symbicort in reducing Exacerbations in COPD
    Ensayo Fase IIIB, doble ciego, con doble enmascaramiento, aleatorizado, de grupos paralelos, multicéntrico, de 6 meses de tratamiento con Symbicort® pMDI 160/4,5µg x 2 aplicaciones dos veces al día en comparación con Formoterol Turbuhaler 4,5 µg x 2 inhalaciones dos veces al día, sobre las Exacerbaciones en pacientes con EPOC"
    RISE: Revelando el Impacto de Symbicort en la reducción de las exarcebaciones en EPOC
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparing the efficacy of Symbicort® pMDI and Formoterol Turbuhaler in reducing exacerbations in patients suffering from Cronic Obstructive Pulmonary Disease.
    Comparar la eficacia en cuanto a reducción de las exacerbaciones de Symbicort pMDI frente a formoterol Turbuhaler en pacientes con Enfermedad Pulmonar Obstructiva Crónica.
    A.3.2Name or abbreviated title of the trial where available
    The RISE study: Revealing the Impact of Symbicort in reducing Exacerbations in COPD
    RISE: Revelando el Impacto de Symbicort en la reducción de las exarcebaciones en EPOC
    A.4.1Sponsor's protocol code numberD589UC00001
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAstraZeneca AB
    B.1.3.4CountrySweden
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAstraZeneca AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca Farmacéutica Spain, S.A.
    B.5.2Functional name of contact pointUnidad de Investigación Clínica
    B.5.3 Address:
    B.5.3.1Street AddressC/ Serrano Galvache, 56; Parque Norte, Edificio Roble
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28033
    B.5.3.4CountrySpain
    B.5.4Telephone number0034900200444
    B.5.6E-mailinformacionEECC-Spain@astrazeneca.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Vannair
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca AG
    D.2.1.2Country which granted the Marketing AuthorisationSwitzerland
    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 nameSYMBICORT pMDI 160/4.5
    D.3.4Pharmaceutical form Pressurised inhalation, suspension
    D.3.4.1Specific paediatric formulation No
    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 INNBudesonide
    D.3.9.1CAS number 51333-22-3
    D.3.9.3Other descriptive nameBUDESONIDE
    D.3.9.4EV Substance CodeSUB05955MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number160
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFORMOTEROL
    D.3.9.1CAS number 43229-80-7
    D.3.9.3Other descriptive nameFORMOTEROL FUMARATE
    D.3.9.4EV Substance CodeSUB02257MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4.5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP 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 Oxis
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca AB
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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 nameFormoterol Turbuhaler
    D.3.4Pharmaceutical form Inhalation powder
    D.3.4.1Specific paediatric formulation No
    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 INNFORMOTEROL
    D.3.9.1CAS number 43229-80-7
    D.3.9.3Other descriptive nameFORMOTEROL FUMARATE
    D.3.9.4EV Substance CodeSUB02257MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4.5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboPressurised inhalation
    D.8.4Route of administration of the placeboInhalation use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboInhalation powder
    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
    Patients with moderate to very severe chronic obstructive pulmonary disease (COPD)
    Pacientes con enfermedad pulmonar obstructiva crónica (EPOC) de moderada a muy grave
    E.1.1.1Medical condition in easily understood language
    Chronic obstructive pulmonary disease (COPD) is a lung disease characterized by chronic obstruction of lung airflow that interferes with normal breathing and is not fully reversible.
    Enf. pulmonar obstructiva crónica (EPOC) es una enf. pulmonar caracterizada por la obstrucción crónica del flujo de aire al pulmón que interfiere con la respiración normal y no es del todo reversible
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the efficacy in reducing exacerbations with Symbicort pMDI 160/4.5 µg x 2 actuations BID versus formoterol Turbuhaler 4.5 µg x 2 inhalations BID in COPD subjects
    Comparar la eficacia en cuanto a reducción de las exacerbaciones con Symbicort pMDI 160/4,5 µg x 2 aplicaciones BID frente a formoterol Turbuhaler 4,5 µg x 2 inhalaciones BID en pacientes con EPOC
    E.2.2Secondary objectives of the trial
    To compare Symbicort pMDI and formoterol Turbuhaler treatments on the time to the first COPD exacerbation
    To compare Symbicort pMDI and formoterol Turbuhaler treatments on health status/health-related quality of life
    To compare Symbicort pMDI and formoterol Turbuhaler treatments on pulmonary function
    To compare Symbicort pMDI and formoterol Turbuhaler treatments on rescue medication use
    To compare Symbicort pMDI and formoterol Turbuhaler treatments on nocturnal awakenings
    To demonstrate the safety of Symbicort pMDI compared to that of formoterol Turbuhaler in subjects with COPD
    Comparar los tratamientos con Symbicort pMDI y formoterol Turbuhaler respecto al tiempo hasta la primera exacerbación de la EPOC
    Comparar los tratamientos con Symbicort pMDI y formoterol Turbuhaler respecto al estado de salud/la calidad de vida relacionada con la salud
    Comparar los tratamientos con Symbicort pMDI y formoterol Turbuhaler respecto a la función pulmonar
    Comparar los tratamientos con Symbicort pMDI y formoterol Turbuhaler respecto al uso de medicación de rescate
    Comparar los tratamientos con Symbicort pMDI y formoterol Turbuhaler respecto a los despertares nocturnos
    Demostrar la seguridad de Symbicort pMDI en comparación con la de formoterol Turbuhaler en pacientes con EPOC
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signed Informed Consent at Visit 1 obtained prior to conducting any study-related procedures including withdrawal of medications.
    2. Outpatients; men or women ? 40 years of age.
    3. A current clinical diagnosis of COPD with COPD symptoms for more than 1 year, according to the GOLD guidelines.
    4. Current or previous smoker with a smoking history equivalent to 10 or more pack years (1 pack year = 20 cigarettes smoked per day for 1 year).
    5. Post-bronchodilator FEV1/forced vital capacity (FVC) <0.7 (70%) and FEV1 ? 70% of predicted normal (PN) value.
    6. Documented use of a short-acting inhaled bronchodilator (?2-agonists or anticholinergics) as rescue medication within 6 months prior to study start.
    7. A score of ? 2 on the modified medical research council (MMRC) dyspnea scale.
    8. Documented history of ?1 moderate or severe COPD exacerbation(s) that required treatment with systemic (oral, IM, IV) corticosteroids (a minimum 3 day course of an oral corticosteroid treatment or single depot corticosteroid injection), or hospitalization (defined as an inpatient stay or >24 hour stay in an observation area in the emergency department or other equivalent facility depending on the country and healthcare system) within 2-52 weeks before Visit 1 (i.e., not within the 14 days prior to Visit 1). A history of an exacerbation treated exclusively with antibiotics will not be considered adequate.
    1. Firma del consentimiento informado en la visita 1, obtenido antes de realizar ningún procedimiento relacionado con el ensayo, incluida la retirada de medicamentos.
    2. Pacientes ambulatorios; varones o mujeres ? 40 años.
    3. Diagnóstico clínico actual de EPOC con síntomas de EPOC durante más de 1 año, de acuerdo con las directrices GOLD.
    4. Tabaquismo actual o previo con antecedentes de tabaquismo equivalentes a 10 paquetes-año o más (1 paquete-año = 20 cigarrillos fumados al día durante 1 año).
    5. FEV1/capacidad vital forzada (FVC) post-broncodilatador <0,7 (70%) y FEV1 ? 70% del valor normal predictivo (NP) post-broncodilatador.
    6. Uso documentado de un broncodilatador inhalado de acción corta (?2-agonistas o anticolinérgicos) como medicación de rescate dentro de los 6 meses previos al comienzo del ensayo.
    7. Una puntuación ? 2 en la escala de disnea Medical Research Council modificada (MRCm).
    8. Antecedentes documentados de ?1 exacerbación moderada o grave de EPOC que precisó tratamiento con corticosteroides sistémicos (oral, IM, IV) (un ciclo mínimo de 3 días de un tratamiento con corticosteroides orales o una única inyección de corticosteroides depot) u hospitalización (definida como una estancia hospitalaria o una estancia >24 horas en un área de observación en un servicio de urgencias o una instalación equivalente dependiendo del país y del sistema sanitario) en el plazo entre 2 y 52 semanas antes de la visita 1 (esto es, no dentro de los 14 días previos a la visita 1). Los antecedentes de una exacerbación tratada exclusivamente con antibióticos no se considerarán suficientes.
    E.4Principal exclusion criteria
    1. A history of asthma at or after 18 years of age.
    2. Subjects with significant or unstable ischemic heart disease, arrhythmia, cardiomyopathy, heart failure (including significant cor pulmonale), uncontrolled hypertension as defined by the Investigator, or any other relevant cardiovascular disorder as judged by the Investigator.
    3. Known homozygous alpha-1 antitrypsin deficiency.
    4. Any significant disease or disorder (e.g., gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment) which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results of the study, or the subject?s ability to participate in the study.
    5. A history of malignancy (except basal cell carcinoma) within the past 5 years.
    6. Active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, primary pulmonary hypertension, interstitial lung disease, or other active pulmonary diseases.
    7. Subjects who have needed additions or alterations to their usual maintenance or change in formulation of rescue therapy for COPD due to worsening symptoms within the 14 days prior to Visit 1 and up to Visit 3.
    8. CXR (frontal and lateral) with suspicion of pneumonia or other condition/abnormality that will require additional investigation/treatment, or put the subject at risk because of participation in the study.
    9. Risk factors for pneumonia: immune suppression (HIV, lupus) or other risk for pneumonia (e.g. neurological disorders affecting control of the upper airway, such as Parkinson?s disease, myasthenia gravis, etc.).
    10. Pneumonia not resolved within 14 days of Visit 1.
    11. Moderate or severe COPD exacerbation that has not resolved within 14 days prior to Visit 1 or a moderate or severe COPD exacerbation that occurs between Visit 1 and Visit 2.
    12. Long-term oxygen therapy (LTOT) or nocturnal oxygen therapy required for greater than 12 hours a day.
    1. Antecedentes de asma a los 18 años de edad o después.
    2. Pacientes con cardiopatía isquémica significativa o inestable, arritmia, miocardiopatía, insuficiencia cardíaca (incluido cor pulmonale significativo), hipertensión no controlada definida por el investigador o cualquier otro trastorno cardiovascular relevante a criterio del investigador.
    3. Déficit homocigótico conocido de alfa-1 antitripsina.
    4. Cualquier enfermedad o trastorno significativo (p. ej., gastrointestinal, hepático, renal, neurológico, musculoesquelético, endocrino, metabólico, maligno, psiquiátrico, deterioro físico importante) que, en opinión del investigador, podría poner al paciente en riesgo debido a la participación en el ensayo o influir en los resultados del ensayo o la capacidad del paciente para participar en el ensayo.
    5. Antecedentes de tumor maligno (excepto carcinoma basocelular) dentro de los últimos 5 años.
    6. Tuberculosis activa, cáncer de pulmón, bronquiectasias, sarcoidosis, fibrosis pulmonar, hipertensión pulmonar primaria, enfermedad pulmonar intersticial u otra enfermedad pulmonar activa.
    7. Pacientes que hayan necesitado adiciones o modificaciones a su tratamiento habitual de mantenimiento o cambio en la formulación del tratamiento de rescate para la EPOC, debido a empeoramiento de los síntomas dentro de los 14 días previos a la visita 1 y hasta la visita 3.
    8. RxT (frontal y lateral) con sospecha de neumonía u otro problema/anomalía que precisará investigación/tratamiento adicional, o pondrá al paciente en riesgo debido a la participación en el ensayo.
    9. Factores de riesgo de neumonía: inmunosupresión (VIH, lupus) u otro riesgo de neumonía (p. ej., trastornos neurológicos que afectan al control de las vías aéreas superiores, como enfermedad de Parkinson, miastenia grave, etc.).
    10. Neumonía no resuelta en el plazo de 14 días antes de la visita 1.
    11. Exacerbación moderada o grave de la EPOC que no se ha resuelto en el plazo de 14 días antes de la visita 1 o exacerbación moderada o grave de la EPOC que se produce entre la visita 1 y la visita 2.
    12. Oxigenoterapia a largo plazo (OTLP) u oxigenoterapia nocturna, necesarias durante más de 12 horas al día.
    E.5 End points
    E.5.1Primary end point(s)
    The rate of moderate and severe COPD exacerbations defined as:
    Worsening of ?2 major symptoms or worsening of 1 major symptom together with ?1 minor symptom for ?2 consecutive days.
    Moderate exacerbation: treatment of symptoms with systemic corticosteroids (?3 days) and/or antibiotics.
    Severe exacerbation: symptoms that require hospitalization (including >24 hours in ED/urgent care setting).
    Major symptoms:
    - Dyspnea
    - Increase in sputum volume
    - Increase in sputum color/purulence
    Minor symptoms:
    - Sore throat
    - Colds (nasal discharge and/or nasal congestion)
    - Fever without other cause
    - Increased cough
    - Increased wheeze
    Tasa de exacerbación moderada y grave de EPOC definida como:
    Empeoramiento de ? 2 síntomas mayores o empeoramiento de 1 síntoma mayor junto con ? 1 síntoma menor durante ? 2 días consecutivos.
    Exacerbación moderada: tratamiento de síntomas con corticosteroides sistémicos (?3 días) y/o antibióticos.
    Exacerbación grave: síntomas que precisan hospitalización (incluidas >24 horas en un servicio de urgencias).
    Síntomas mayores:
    - Disnea
    - Aumento del volumen de esputo
    - Aumento del color/la purulencia del esputo
    Síntomas menores:
    - Dolor de garganta
    - Resfriados (secreción nasal y/o congestión nasal)
    - Fiebre sin otra causa
    - Aumento de la tos
    - Aumento de las sibilancias
    E.5.1.1Timepoint(s) of evaluation of this end point
    Study Visit:
    Enrolment W -5
    Run-in W -4
    Randomization W 0
    Treatment W 4, 8, 17
    EoT W 26
    Visitas del estudio:
    Reclutamiento: Semana -5
    Preinclusión: Semana -4
    Aleatorización: Semana 0
    Tratamiento: Semana 4, 8, 17
    FdT: Semana 26
    E.5.2Secondary end point(s)
    - Time to first moderate or severe COPD exacerbation
    - St. George´s Respiratory Questionnaire (SGRQ)
    - Pre-dose/pre-bronchodilator FEV1 at the study site
    - Total rescue medication use (average puffs/day)
    - Nights with awakening due to COPD
    - Tiempo hasta la primera exacerbación moderada o grave de la EPOC
    - Cuestionario respiratorio de St. George (SGRQ)
    - Volumen espiratorio forzado en un segundo (FEV1) pre-dosis/pre-broncodilatador en el centro del ensayo
    - Utilización total de medicamentos de rescate (media de inhalaciones/día)
    - Noches con despertares debidos a EPOC
    E.5.2.1Timepoint(s) of evaluation of this end point
    Study Visit:
    Enrolment W -5
    Run-in W -4
    Randomization W 0
    Treatment W 4, 8, 17
    EoT W 26
    Visitas del estudio:
    Reclutamiento: Semana -5
    Preinclusión: Semana -4
    Aleatorización: Semana 0
    Tratamiento: Semana 4, 8, 17
    FdT: Semana 26
    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 No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) 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.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned6
    E.8.5The trial involves multiple Member States No
    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
    Argentina
    Bulgaria
    Chile
    Czech Republic
    European Union
    Mexico
    Poland
    South Africa
    Spain
    United States
    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
    LVLS
    Última visita del último paciente
    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 days8
    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 days8
    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: 1136
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1136
    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 state37
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 353
    F.4.2.2In the whole clinical trial 1136
    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)
    None
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-10-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-10-14
    P. End of Trial
    P.End of Trial StatusOngoing
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2019 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA