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    Summary
    EudraCT Number:2015-000804-24
    Sponsor's Protocol Code Number:D1690C00024
    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:2015-07-10
    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 number2015-000804-24
    A.3Full title of the trial
    A Multicenter, Double-Blind, Placebo-Controlled, Parallel Group, Randomized, Phase III study to Evaluate the Glycemic Efficacy and Renal Safety of dapagliflozin in patients with Type 2 Diabetes Mellitus and Moderate Renal Impairment (CKD 3A) who have Inadequate Glycemic Control
    Ensayo fase III aleatorizado multicéntrico, doble ciego, controlado con placebo, de grupos paralelos para evaluar la eficacia glucémica y la seguridad renal de dapagliflozina en pacientes con diabetes mellitus tipo 2 e insuficiencia renal moderada (ERC 3A) con control glucémico inadecuado
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate the effect of dapagliflozin on blood glucose level and renal safety in patients with Type 2 Diabetes
    Ensayo para evaluar el efecto de dapaglifozina en los niveles de glucosa en sangre y en la seguridad renal en pacientes con Diabetes tipo 2.
    A.4.1Sponsor's protocol code numberD1690C00024
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation PlanP/310/2014
    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
    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.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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Type 2 Diabetes Mellitus with Moderate Renal Impairment (CKD 3A)
    Diabetes mellitus tipo 2 e insuficiencia renal moderada (ERC 3A)
    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
    To compare the mean change from baseline in HbA1c 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 3A.
    Comparar la media del cambio respecto al momento basal en la HbA1c entre dapagliflozina 10 mg y placebo, después de 24 semanas de administración oral de tratamiento doble ciego en pacientes con diabetes tipo 2 y ERC en estadio 3A.
    E.2.2Secondary objectives of the trial
    1, To compare the percent change from baseline in total body weight between dapagliflozin 10 mg and placebo, after 24 weeks of oral administration of double-blind treatment.
    2, To compare the change from baseline in fasting plasma glucose (FPG) between dapagliflozin 10 mg and placebo, after 24 weeks of oral administration of double-blind treatment.
    3, To compare the change from baseline in seated systolic blood pressure (SBP) between dapagliflozin 10 mg and placebo, after 24 weeks of oral administration of double-blind treatment.
    1. Comparar el cambio porcentual respecto al momento basal en el peso corporal total entre dapagliflozina 10 mg y placebo, después de 24 semanas de administración oral de tratamiento doble ciego.
    2. Comparar el cambio respecto al momento basal en la glucosa plasmática en ayunas (GPA) entre dapagliflozina 10 mg y placebo, después de 24 semanas de administración oral de tratamiento doble ciego.
    3. Comparar el cambio respecto al momento basal en la presión arterial sistólica (PAS) en sedestación entre dapagliflozina 10 mg y placebo, después de 24 semanas de administración oral de tratamiento doble ciego.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1, Female or male aged > or = 18 years and <75 years.
    2, History of T2DM for more than 12 months.
    3, Inadequate glycemic control, defined as HbA1c > or = 7.0% and < or = 11% measured at Screening. Note that HbA1c will be rechecked at Visit 4, and must then be > or = 7.0 and < or =10.5% (value from blood sample obtained at Visit 3) for patient to be randomized.
    4, Stable anti-diabetic treatment regimen, defined as stable diet and exercise therapy alone or in combination with any or both of the two following alternatives:
    -A regimen of any approved oral anti-diabetic medication (except SGLT2-inhibitors) where no dose-changes have occurred during 12 weeks before randomization
    -Long acting or intermediate acting insulin and mixed insulin permitted as long as the dose is stable during last 12 weeks before randomization, changes ± 10% are allowed (in relation to number of units at randomization).
    5, Renal impairment: CKD 3A
    -eGFR* 40 - 65 mL/minute/1.73 m2 at Visit 2 (value from blood sample obtained at Visit 1) to enter the lead-in period.
    -eGFR* 45 - 59 mL/minute/1.73 m2 at Visit 4 (average value calculated from the eGFR values at Visit 2 and Visit 3) for randomization.
    *according to the re-expressed abbreviated (four-variable) MDRD Study equation, using central laboratory measurements of serum creatinine(sCr). [eGFR (mL/min/1.73m2) = 175 x (standardized sCr)-1.154 x (Age)-0.203 x (0.742 if female) x (1.212 if Black)] [Note: sCr reported in mg/dL]
    1.Mujer o varón de > o = 18 años y <75 años
    2.Antecedentes de DMT2 durante más de 12 meses.
    3.Control glucémico inadecuado, definido como HbA1c > o = 7,0% y < o = 11% medida en la inclusión. Obsérvese que la HbA1c se volverá a comprobar en la visita 4 y debe ser > o = 7,0 y < o = 10,5% (valor de la muestra de sangre obtenida en la visita 3) para aleatorizar al paciente.
    4.Régimen de tratamiento antidiabético estable, definido como terapia con dieta estable y ejercicio sola o en combinación con cualquiera de las dos siguientes alternativas o con ambas:
    -Un régimen de cualquier medicación antidiabética oral aprobada (salvo inhibidores de SGLT2) y en el que no se hayan producido cambios en la dosis durante las 12 semanas anteriores a la aleatorización.
    -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).
    5. Insuficiencia renal: ERC 3A
    - TFGe* 40 - 65 ml/minuto/1,73 m2 en la visita 2 (valor de la muestra de sangre obtenida en la visita 1) para entrar en el período de preinclusión.
    - TFGe* 45 - 59 ml/minuto/1,73 m2 en la visita 4 (valor promedio calculado a partir de los valores de la TFGe en la visita 2 y la visita 3) para la aleatorización.
    *de acuerdo con la ecuación del ensayo MDRD reformulada abreviada (cuatro variables), usando las mediciones del laboratorio central de creatinina sérica (SCr). [TFGe (ml/min/1,73m2) = 175 x (SCr normalizada)-1.154 x (Edad)-0.203 x (0,742 si es mujer) x (1,212 si es de raza negra)] [Nota: SCr expresada en mg/dl]
    E.4Principal exclusion criteria
    1, Women of childbearing potential (WOCBP) who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period.
    2, Women who are pregnant or breastfeeding.
    3, Aspartate Aminotransferase (AST) >3X ULN.
    4, Alanine Aminotransferase (ALT) >3X ULN.
    5, Total Bilirubin (TB) >2 mg/dL (35 ?mol/L).
    6, Serum Potassium (K) >5.5 meq/L (5.5 mmol/L).
    7, Serum Calcium (Ca) <8 mg/dL or > ULN (<1.99 mmol/L or > ULN).
    8, Positive for hepatitis B surface antigen.
    9, Positive for anti-hepatitis C virus antibody.
    10, Hemoglobin < or = 9.0 g/dL (90 g/L).
    11, History of diabetes insipidus.
    12, Symptoms of poorly controlled diabetes that would preclude participation in this study including but not limited to marked polyuria and polydipsia with greater than 10% weight loss during the three months prior to signing the consent at visit 1, or other signs and symptoms.
    13, History of diabetic ketoacidosis or hyperosmolar nonketotic coma.
    14, History of > or = 2 major hypoglycemic events in the 3 months prior to enrolment, 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.
    15, Severe uncontrolled hypertension defined as SBP > or = 180 mmHg and/or DBP > or = 110 mmHg at any visit up to randomization.
    17, Any of the following CV/Vascular Diseases within 3 months of prior to signing the consent at visit 1:Myocardial infarction, Cardiac surgery or revascularization (CABG/PTCA), Unstable angina, Unstable heart failure (HF), HF New York Heart Association (NYHA) Class IV,Transient ischemic attack (TIA) or significant cerebrovascular disease, Unstable or previously undiagnosed arrhythmia.
    18, History of any biopsy or imaging verifying intercurrent kidney disease (such as glomerular nephritis or sign of renal artery stenosis) other than diabetic nephropathy or diabetic nephropathy with nephrosclerosis.
    19, History of renal transplant.
    20, Hemodialysis, ultrafiltration therapy, or peritoneal dialysis within 6 months prior to signing the consent at visit 1.
    21, Significant hepatic disease, including, but not limited to, chronic active hepatitis and/or severe hepatic insufficiency.
    22, Documented history of hepatotoxicity with any medication.
    23, Documented history of severe hepatobiliary disease.
    24, Malignancy within 5 years of the enrolment visit (with the exception of treated basal cell or treated squamous cell carcinoma).
    25, Known immunocompromised status, including but not limited to, individuals who have undergone organ transplantation or who are positive for the human immunodeficiency virus (HIV).
    26, History of unexplained microscopic or gross hematuria, or microscopic hematuria at visit 2.
    27, Long term treatment with glucocorticoids (two temporary periods of no longer than 10 days each are allowed during the study); topical or inhaled corticosteroids are allowed.
    28, A metformin dose which is outside the specified dose range for moderate renal impairment (eGFR 30-59 mL/minute/1.73m2, MDRD formula) according to local guidelines and investigator´s judgement.
    29, Ongoing treatment with any SGLT2-inhibitor at screening.
    30, History of bariatric surgery or lap-band procedure.
    31, Administration of sibutramine, phentermine, orlistat, rimonabant, benzphetamine, diethylpropion, methamphetamine, Victoza (liraglutide) indicated for anti-obesity treatment, and/or phendimetrazine, within 30 days prior to signing the consent at visit 1.
    32, Patient who, in the judgment of the Investigator, may be at risk for dehydration or volume depletion due to co-existing conditions.
    33, Patient with any condition which, in the judgment of the Investigator, may render the patient unable to complete the study or which may pose a significant risk to the patient.
    34, Patient is currently abusing alcohol or other drugs or has done so within the last 6 months prior to signing the consent at visit 1.
    35, Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
    36, Previous enrolment in the present study.
    37, Participation in another clinical study with an IP during the last 30 days prior to signing the consent at visit 1.
    1.Las mujeres fértiles (MF) que no acepten o no puedan usar un método anticonceptivo aceptable durante el período de ensayo completo.
    2.Mujeres que estén embarazadas o en periodo de lactancia.
    3.Aspartato aminotransferasa (AST) >3X LSN.
    4.Alanina aminotransferasa (ALT) >3X LSN.
    5.Bilirrubina total (BT) >2 mg/dl (35 ?mol/l).
    6.Potasio (K) sérico >5,5 meq/l (5,5 mmol/l).
    7.Calcio (Ca) sérico <8 mg/dl o >LSN (<1,99 mmol/l o >LSN).
    8.Positivo para el antígeno de superficie del virus de la hepatitis B.
    9Positivo para el anticuerpo contra el virus de la hepatitis C.
    10.Hemoglobina < o = 9,0 g/dl (90 g/l).
    11.Antecedentes de diabetes insípida.
    12.Síntomas de diabetes mal controlada que imposibilite la participación en este ensayo, incluyendo, entre otros, poliuria y polidipsia marcadas con más de un 10% de pérdida de peso durante los tres meses anteriores a la firma del consentimiento en la visita 1 u otros signos y síntomas.
    13.Antecedentes de cetoacidosis diabética o coma hiperosmolar no cetónico.
    14.Antecedentes de > o = 2 acontecimientos hipoglucémicos mayores en los 3 meses previos al reclutamiento, definido como acontecimientos sintomáticos que requieren ayuda externa debido a una pérdida de consciencia grave o a una grave alteración del comportamiento, con niveles de glucosa en sangre <3,0 mmol/l, <54 mg/dl (nivel de glucosa plasmática <3,5 mmol/l, <63 mg/dl) y una recuperación rápida después de la administración de glucosa o glucagón.
    15.Hipertensión grave no controlada definida como PAS > o = 180 mmHg y/o PAD > o = 110 mmHg en cualquier visita hasta la aleatorización.
    16.Cualquiera de las siguientes enfermedades CV/vasculares en los 3 meses anteriores a 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 IV de la New York Heart Association (NYHA), accidente isquémico transitorio (AIT) o enfermedad cerebrovascular importante, arritmia inestable o sin diagnosticar previamente.
    17.Antecedentes de cualquier biopsia o estudio de imagen que verifique enfermedad renal intercurrente (tal como nefritis glomerular o signo de estenosis arterial renal) diferente de nefropatía diabética o nefropatía diabética con nefroesclerosis.
    18.Antecedentes de trasplante renal.
    19. Hemodiálisis, terapia de ultrafiltración o diálisis peritoneal en los 6 meses anteriores a la firma del consentimiento en la visita 1.
    20. Enfermedad hepática significativa, incluyendo, entre otras, hepatitis activa crónica y/o insuficiencia hepática grave.
    21.Antecedentes documentados de hepatotoxicidad con cualquier medicación.
    22.Antecedentes documentados de enfermedad hepatobiliar grave.
    23. Neoplasia maligna en los 5 años anteriores a la visita de reclutamiento (salvo en el caso de carcinoma basocelular o carcinoma espinocelular tratado).
    24. Estado inmunodeprimido conocido, incluyendo, entre otros, individuos que se han sometido a trasplante de órganos o con serología positiva para el virus de la inmunodeficiencia humana (VIH).
    25.Antecedentes de hematuria microscópica o macroscópica inexplicada o hematuria microscópica en la visita 2.
    26. Tratamiento a largo plazo con glucocorticoides (se permiten dos períodos temporales de no más de 10 días cada uno durante el ensayo); se permiten los corticosteroides tópicos o inhalados.
    27. Una dosis de metformina que esté fuera del intervalo de dosis especificado para la insuficiencia renal moderada (TFGe 30-59 ml/minuto/1,73m2, fórmula MDRD) de acuerdo con las directrices locales y a juicio del investigador.
    28. El tratamiento con cualquier inhibidor de SGLT2 en la inclusión.
    29. Antecedentes de cirugía bariátrica o banda gástrica.
    30. Administración de sibutramina, fentermina, orlistat, rimonabant, benzfetamina, dietilpropiona, metamfetamina, Victoza (liraglutida) indicado para el tratamiento anti-obesidad y/o fendimetrazina, en los 30 días previos a la firma del consentimiento en la visita 1.
    31. Pacientes que, a juicio del investigador, podrían tener riesgo de deshidratación o hipovolemia debido a trastornos coexistentes.
    32. Cualquier trastorno que, a juicio del investigador, podría hacer que el paciente fuese incapaz de completar el ensayo o que pudiera exponer al paciente a un riesgo importante.
    33. Paciente que abusa en la actualidad del alcohol o de otra drogas o que lo ha hecho en los 6 meses previos a la firma del consentimiento en la visita 1.
    34. Implicación en la planificación y/o realización del ensayo (aplicable al personal de AstraZeneca y/o al personal del centro del ensayo).
    35. Inclusión previa en el presente ensayo.
    36. Participación en otro ensayo clínico con un PI durante los últimos 30 días antes de la firma del consentimiento en la visita 1.
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline in HbA1c at Week 24
    Cambio respecto al momento basal en la HbA1c en la semana 24.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline to end of treatment
    Momento basal al final del tratamiento
    E.5.2Secondary end point(s)
    1, Percent change from baseline in total body weight at Week 24
    2, Change from baseline in FPG at Week 24
    3, Change from baseline in seated SBP at Week 24
    1. Cambio porcentual respecto al momento basal en el peso corporal total en la semana 24.
    2. Cambio respecto al momento basal en la GPA en la semana 24
    3. Cambio respecto al momento basal en la PAS en sedestación 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 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) No
    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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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
    Canada
    Italy
    Spain
    Sweden
    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
    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 years1
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months8
    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: 151
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 151
    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 state72
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 132
    F.4.2.2In the whole clinical trial 302
    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
    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 Decision2015-08-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-08-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-11-07
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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