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    Summary
    EudraCT Number:2015-002676-24
    Sponsor's Protocol Code Number:D1690C00023
    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:2015-10-05
    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 number2015-002676-24
    A.3Full title of the trial
    An exploratory Phase II/III, randomized, double-blind, placebo controlled,
    parallel design study to evaluate the efficacy, safety and
    pharmacodynamics of dapagliflozin and dapagliflozin in combination with
    saxagliptin in CKD3 patients with type 2 diabetes mellitus and albuminuria
    treated with ACEi or ARB.
    Ensayo clínico exploratorio de fase II/III, aleatorizado, doble ciego, controlado con placebo, de grupos paralelos para evaluar la eficacia, seguridad y farmacodinamia de dapagliflozina y de la combinación de dapagliflozina con saxagliptina en pacientes con enfermedad renal crónica en estadio 3 (ERC3), diabetes mellitus tipo 2 y albuminuria tratados con inhibidores de la enzima convertidora de la angiotensina (iECA) o bloqueantes de los receptores de la angiotensina II (BRA)- DELIGHT
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate the efficacy and safety of dapagliflozin and dapagliflozin
    in combination with saxagliptin in type 2 diabetes with kidney disease.
    Ensayo para evaluar el efecto y la seguridad de dapaglifozina y dapaglifozina en combinación con saxagiptina en pacientes con diabetes tipo 2 con enfermedad renal crónica.
    A.3.2Name or abbreviated title of the trial where available
    DELIGHT
    DELIGHT
    A.4.1Sponsor's protocol code numberD1690C00023
    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
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28033
    B.5.3.4CountrySpain
    B.5.4Telephone number+34900200444
    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 Forxiga
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca AB
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameDapagliflozin
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDapagliflozin propanediol
    D.3.9.1CAS number 960404-48-2
    D.3.9.3Other descriptive nameDAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE
    D.3.9.4EV Substance CodeSUB90205
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 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 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 Onglyza
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca AB
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameSaxagliptin
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSaxagliptin
    D.3.9.1CAS number 361442-04-8
    D.3.9.3Other descriptive nameSAXAGLIPTIN
    D.3.9.4EV Substance CodeSUB25220
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    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 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    CKD3 patients with type 2 diabetes mellitus and albuminuria.
    ERC 3A pacientes con diabetes mellitus tipo 2 y albuminuria.
    E.1.1.1Medical condition in easily understood language
    Diabetes
    Diabetes
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10045250
    E.1.2Term Type II diabetes mellitus with renal manifestations
    E.1.2System Organ Class 100000004857
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary objectives for the Saxagliptin/Dapagliflozin treatment arm
    - To compare the mean change from baseline in HbA1c between dapagliflozin 10 mg plus saxagliptin 2.5 mg and placebo, after 24 weeks of oral administration of double-blind treatment in patients with type 2 diabetes and CKD stage 3.- To compare the mean percent change from baseline in urine albumin-to creatinine ratio (UACR) between dapagliflozin 10 mg plus saxagliptin 2.5 mg and placebo, after 24 weeks of oral administration of double-blind treatment in patients with type 2 diabetes and CKD stage 3. Primary objective for the Dapagliflozin treatment arm. - To compare the mean percent change from baseline in urine albumin-to creatinine ratio
    (UACR) between dapagliflozin 10 mg and placebo, after 24 weeks of oral administration of double-blind treatment in patients with type 2 diabetes and CKD stage 3.
    Objetivos principales para el grupo de tratamiento con saxagliptina/dapagliflozina
    - Comparar el cambio medio respecto al momento basal de la HbA1c entre 10 mg de dapagliflozina más 2,5 mg de saxagliptina y placebo, tras 24 semanas de admón. oral de tto. doble ciego en pacientes con diabetes tipo 2 y ERC en estadio 3.
    - Comparar el cambio medio porcentual respecto al momento basal en el cociente albúmina/creatinina en orina (CACo) entre 10 mg de dapagliflozina más 2,5 mg de saxagliptina y placebo, tras 24 semanas de admón. oral de tto. doble ciego en pacientes con diabetes tipo 2 y ERC en estadio 3.
    Objetivo ppal. para el grupo de tto. con dapagliflozina
    - Comparar el cambio medio porcentual respecto al momento basal en el cociente albúmina/creatinina en orina (CACo) entre 10 mg de dapagliflozina y placebo, tras 24 semanas de admón. oral de tto. doble ciego en pacientes con diabetes tipo 2 y ERC en estadio 3.
    E.2.2Secondary objectives of the trial
    ·To compare the mean percent change from baseline in total body weight, and to compare the mean change from baseline in fasting plasma glucose or seated systolic blood pressure between dapagliflozin 10 mg plus saxagliptin 2.5 mg and placebo. ·To compare the proportion of patients achieving a 30% reduction in Urine albumin-to-creatinine ratio or a reduction in HbA1c <7.0% between dapagliflozin 10 mg plus saxagliptin 2.5 mg and placebo. ·To compare the mean percent change from baseline in total body weight and to compare the mean change from basleine in seated systolic blood pressure, HbA1c, or fasting plasma glucose between dapagliflozin 10 mg and placebo. ·To compare the proportion of patients achieving a 30% reduction in Urine albumin-to-creatinine ratio or a reduction in HbA1c <7.0% between dapagliflozin 10 mg and placebo.
    - Comparar el cambio medio porcentual respecto al momento basal en el peso corporal total, comparar el cambio medio respecto al mto. basal en la glucosa plasmática en ayunas (GPA) o comparar el cambio medio respecto al mto. basal en la presión arterial sistólica (PAS) en sedest. entre 10 mg de dapagliflozina más 2,5 mg de saxagliptina y placebo
    - Comparar la proporción de pac. que logran una reduc. del 30 % del CACo o comparar la de pac. que logran una reduc. de HbA1c <7,0 % entre 10 mg de dapag. más 2,5 mg de saxag. y placebo.
    - Comparar el cambio medio porcentual respecto al mto. basal en el peso corporal total y comparar el cambio medio respecto al mto. basal en la presión art. sist.(PAS) en sedest., HbA1c, o en la gluc. plasmát. en ayunas (GPA) entre 10 mg de dapag. y placebo.
    - Comparar la prop. de pac. que logran una reduc. del 30 % del CACo entre 10 mg de dapag. y placebo o comparar la prop. de pac. que logran una reduc. de la HbA1c <7,0 % entre 10 mg de dapag. y placebo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Provision of informed consent prior to any study specific procedures 2. Female or male aged > o = 18 years and < 75 years. 3. History of type 2 diabetes mellitus for more than 12 months 4. Inadequate glycemic control, defined as HbA1c > o = 7.5% and < o = 10.5%. 5. Stable antidiabetic treatment during the last 12 weeks up to randomization.Stable antidiabetic treatment regimen, defined as: Stable diet and exercise therapy alone or in combination with any or both of the two following alternatives a.A regimen of any approved oral anti-diabetic medication (except SGLT2 inhibitors, GLP-1 receptor agonists and DPP4 inhibitors) where no dosechanges have occurred during the last 12 weeks up to randomization. b.Long acting or intermediate acting insulin and mixed insulin permitted as long as the dose is stable 12 weeks before randomization, changes ± 10% are allowed (in relation to number of units at randomization). 6. Renal impairment defined as eGFR 30 - 59 mL/minute/1.73 m^2, inclusive. 7. Micro or macroalbuminuria (UACR 30 - 3500 mg/g, inclusive). 8. Patient must be receiving an angiotensin converting enzyme (ACE) inhibitor or an angiotensin II receptor blocker (ARB) for at least 3 months prior to screening, where the dose of the ACE inhibitor or the ARB is considered appropriate for that patient, and has been stable and maintained on that dose for at least 4 weeks prior to study randomization.
    9. Body mass index between 20 and 40 kg/m^2, inclusive.
    1. Firma del consentimiento informado con anterioridad a la realización de cualquiera de los procedimientos específicos del ensayo.
    2. Mujer o varón de > o = 18 años y <75 años en la visita 1.
    3. Antecedentes de DMT2 durante más de 12 meses.
    4. Control glucémico inadecuado, definido como HbA1c > o = 7,5 % y < o = 10,5 % medida en la visita 1.
    5. Tratamiento antidiabético estable durante las últimas 12 semanas previas a la aleatorización
    La pauta de tratamiento antidiabético estable se define como: tratamiento con dieta estable y ejercicio solo o en combinación con cualquiera de las dos siguientes alternativas o con ambas:
    a. Un régimen de cualquier medicación antidiabética oral aprobada (salvo inhibidores de SGLT2, agonistas del receptor de GLP-1 e inhibidores de DPP4) en la que no se hayan producido cambios en la dosis durante las 12 semanas anteriores a la aleatorización.
    b. Se permite el uso de insulina de acción larga o intermedia e insulina mixta siempre que la dosis sea estable durante las 12 últimas semanas antes de la aleatorización, se permiten cambios de ±10 % (en relación con el número de unidades en la aleatorización).
    6. La insuficiencia renal se define como una TFGe de 25-64 ml/minuto/1,73 m2, ambos inclusive, en la visita 1 y 30-59 ml/minuto/1,73 m2, ambos inclusive, en la visita 2 (para el cálculo de la TFGe, véase la sección 5.2.1).
    7. Micro- o macroalbuminuria (CACo 30-3500 mg/g, ambos inclusive) en la visita 1.
    8. El paciente debe recibir tratamiento con inhibidores de la enzima convertidora de la angiotensina (iECA) o bloqueantes del receptor de la angiotensina II (BRA) durante al menos 3 meses antes de la selección, en el que la dosis del inhibidor ECA o del BRA se considere apropiada para dicho paciente y el paciente se haya mantenido estable en esa dosis durante al menos 4 semanas antes de la aleatorización para el ensayo.
    9. Índice de masa corporal entre 20 y 40 kg/m2, ambos inclusive.
    E.4Principal exclusion criteria
    Main exclusion criteria are:- History of ?2 major hypoglycaemic events in the 3 months prior to enrolment visit, defined as symptomatic events
    requiring external assistance due to severe impairment in consciousness or behaviour, with blood glucose level <3.0 mmol/L, <54 mg/dL (plasma glucose level <3.5 mmol/L, <63 mg/dL) and prompt recovery after glucose or glucagon administration.- Patients with Type 1 DM, history of diabetes insipidus, diabetic ketoacidosis, hyperosmolar nonketotic coma- Severe uncontrolled hypertension or any CV/Vascular Diseases within 3 month prior to signing the following: - Myocardial infarction. - Cardiac surgery or revascularization.- Unstable angina.- Unstable heart failure.- HF
    New York Heart Association Class III-IV.- Transient ischemic attack or
    significant cerebrovascular disease.- Unstable or previously undiagnosed arrhythmia.-Significant hepatic disease, severe hepatobiliary disease or hepatotoxicity with any medication- History of haemoglobinopathy or acute kidney injury requiring renal replacement therapy or any biopsy or imaging verifying intercurrent kidney disease other than diabetic nephropathy or diabetic nephropathy with nephrosclerosis.- History of unexplained microscopic or gross haematuria, or microscopic haematuria, confirmed by a follow-up sample at next scheduled visit- Treatment with a SGLT2 inhibitor, GLP-1 agonist or DPP4 inhibitors.- Simultaneous treatment with both an ACEi and an ARB- A metformin dose which is outside the specified dose range for moderate renal impairment (eGFR 30-59 mL/minute/1.73 m^2,) according to local guidelines and investigators judgement.- Any condition which, in the ju gment of the Investigator, may render the patient unable to complete the study or which may pose a significant risk or suspected risk to the patient or with confirmed poor protocol or medication compliance - Patients at risk for volume depletion as judged by the investigator.
    1. Antecedentes de ?2 acontecimientos hipoglucémicos importantes en los 3 meses previos a la visita de inclusión (visita 1), definidos como acontecimientos sintomáticos que requieren asistencia externa debido a una afectación grave de la consciencia o el comportamiento, con un nivel de glucosa en sangre <3,0 mmol/l, <54 mg/dl (nivel de glucosa plasmática <3,5 mmol/l, <63 mg/dl) y una pronta recuperación tras la administración de glucosa o glucagón.
    2. Pacientes con DM tipo 1
    3. Antecedentes de diabetes insípida, cetoacidosis diabética o coma hiperosmolar no cetósico.
    4. Hipertensión no controlada grave
    5. Cualquiera de las siguientes enfermedades CV/vasculares en el plazo de 3 meses antes de la firma del consentimiento en la visita 1:
    -Infarto de miocardio.
    -Cirugía cardíaca o revascularización (IDAC/ACTP).
    -Angina inestable.
    -Insuficiencia cardíaca (IC) inestable.
    -IC de clase III-IV según la New York Heart Association (NYHA).
    -Accidente isquémico transitorio (AIT) o enfermedad cerebrovascular importante.
    - Arritmia inestable o sin diagnosticar previamente.
    6. Enfermedad hepática significativa, incluidas, entre otras, hepatitis activa crónica y/o insuficiencia hepática grave.
    7. Antecedentes documentados de hepatotoxicidad con cualquier medicación.
    8. Antecedentes de hemoglobinopatía o hemólisis crónica o recurrente.
    9. Antecedentes de lesión renal aguda que requiera terapia de sustitución renal (diálisis o ultrafiltración) o cualquier biopsia o estudio de imagen que confirme una enfermedad renal intercurrente distinta de la nefropatía diabética o la nefropatía diabética con nefroesclerosis.
    10. Antecedentes de hematuria microscópica o macroscópica inexplicada o hematuria microscópica en la visita 1, confirmada por una muestra de seguimiento en la siguiente visita programada.
    11. Tratamiento con un inhibidor de SGLT2, agonista de GLP-1 o inhibidores de DPP4
    12. Tratamiento simultáneo con iECA y un BRA.
    13. Una dosis de metformina que esté fuera del intervalo de dosis especificado para la insuficiencia renal moderada (TFGe 30?59 ml/minuto/1,73 m2,) según las directrices locales y el juicio del investigador.
    14. Cualquier enfermedad que, a juicio del investigador, podría hacer que el paciente fuese incapaz de finalizar el ensayo o que pudiera suponer un riesgo significativo para el paciente o si se sospecha o se confirma que el paciente no cumple adecuadamente con el protocolo o la medicación.
    15. Pacientes con riesgo de hipovolemia a juicio del investigador.
    E.5 End points
    E.5.1Primary end point(s)
    Outcome Measure for the Saxagliptin/Dapagliflozin treatment
    arm?Change from baseline in HbA1c at Week 24.- Percent change from
    baseline in UACR at Week 24 Outcome Measure for the Dapagliflozin
    treatment arm.- Percent change from baseline in UACR at Week 24
    Cambio en la HbA1c respecto al momento basal en la semana 24.
    Cambio porcentual en el CACo respecto al momento basal en la semana 24, en el brazo de combinación Saxagliptina/ Dapagliflozina.
    Cambio porcentual en el CACo respecto al momento basal en la semana 24, en el brazo de tratamiento de Dapagliflozina.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline to end of treatment
    Momento basal hasta el final del tratamiento.
    E.5.2Secondary end point(s)
    Outcome Measure for the Saxagliptin/Dapagliflozin treatment arm: 1.
    Percent change from baseline in total body weight at Week 24 2. Change from baseline in FPG at Week 24 3. 30% reduction in UACR at Week 24 4. HbA1c < 7.0 % at Week 24 5. Change from baseline in seated SBP at Week 24 Outcome Measure for the Dapagliflozin treatment arm: 1. Percent change from baseline in total body weight at Week 24 2. 30% reduction in UACR at Week 24 3. Change from baseline in seated SBP at Week 24 4. Change from baseline in HbA1c at Week 24 5. Change from baseline in FPG at Week 24 6. HbA1c < 7.0 % at Week 24
    Variables secundarias de resultados para las comparaciones de tratamiento con saxagliptina/dapagliflozina:

    1. Cambio porcentual respecto al momento basal en el peso corporal (kg) en la semana 24
    2. Cambio respecto al momento basal en la GPA (mg/dl) en la semana 24.
    3. Reducción del 30 % en el CACo en la semana 24.
    4. HbA1c <7,0 % en la semana 24.
    5. Cambio respecto al momento basal en la PAS en sedestación (mmHg) en la semana 24.
    Variables secundarias de resultados para las comparaciones de tratamiento con dapagliflozina:

    1. Cambio porcentual respecto al momento basal en el peso corporal (kg) en la semana 24.
    2. Reducción del 30 % en el CACo en la semana 24.
    3. Cambio respecto al momento basal en la PAS en sedestación (mmHg) en la semana 24.
    4. Cambio respecto al momento basal en la HbA1c (%) en la semana 24.
    5. Cambio respecto al momento basal en la GPA (mg/dl) en la semana 24.
    6. HbA1c <7,0 % en la semana 24.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline to the end of treatment
    Momento basal al finalizar el tratamiento.
    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 Yes
    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) Yes
    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.8.2.4Number of treatment arms in the trial3
    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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    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
    Canada
    Japan
    Mexico
    Spain
    Taiwan
    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
    Last Patient Last Visit
    Última visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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: 225
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 225
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state225
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 225
    F.4.2.2In the whole clinical trial 1125
    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. Standard Routine Medical Care
    Ninguno. Cuidados médicos rutinarios.
    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 Decision2015-11-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-11-16
    P. End of Trial
    P.End of Trial StatusCompleted
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