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    Summary
    EudraCT Number:2017-004641-25
    Sponsor's Protocol Code Number:201700823
    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:2019-04-11
    Trial 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 number2017-004641-25
    A.3Full title of the trial
    Rotation for Optimal Targeting of Albuminuria and Treatment Evaluation.
    Rotazione di diversi farmaci per la valutazione del farmaco ottimale per la riduzione dell'albuminuria.
    ROTACIÓN FARMACOLÓGICA PARA LA EVALUACIÓN Y CONTROL ÓPTIMO DE LA MICROALBUMINURIA
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A rotation study of different albuminuria lowering drug classes to study individual drug response in diabetic and non diabetic Chronic Kideny Disease
    Uno studio che prevede la rotazione di piú farmaci che riducono l'albuminuria per valutare quale sia il miglior farmaco per il singolo paziente
    Estudio para evaluar la acción individal de diferentes clases de fármacos sobre la albuminuria en pacientes diabéticos y no diabéticos con enfermedad renal crónica
    A.3.2Name or abbreviated title of the trial where available
    ROTATE 3
    ROTATE 3
    ROTATE 3
    A.4.1Sponsor's protocol code number201700823
    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 SponsorUniversity Medical Center Groningen
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportUniversity Medical Center Groningen
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Medical Center Groningen
    B.5.2Functional name of contact pointUniversity Medical Center Groningen
    B.5.3 Address:
    B.5.3.1Street AddressDe Brug 50D-1-015; EB70
    B.5.3.2Town/ cityGroningen
    B.5.3.3Post code9700 AD
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031050361 7859
    B.5.5Fax number0031050361 7889
    B.5.6E-mailh.j.lambers.heerspink@umcg.nl
    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 AuthorisationNetherlands
    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 nameDapaglifozin
    D.3.4Pharmaceutical form 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 461432-26-8
    D.3.9.3Other descriptive nameDAPAGLIFLOZIN
    D.3.9.4EV Substance CodeSUB31650
    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 Eplerenone
    D.2.1.1.2Name of the Marketing Authorisation holderMorningside Healthcare Ltd
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameEplerenone
    D.3.4Pharmaceutical form 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 INNEplerenone
    D.3.9.1CAS number 107724-20-9
    D.3.9.3Other descriptive nameEPLERENONE
    D.3.9.4EV Substance CodeSUB06574MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Proteinuric Kidney disease
    Insufficienza Renale Cronica Proteinurica
    Enfermedad Renal Crónica Proteinúrica
    E.1.1.1Medical condition in easily understood language
    Reduction in kidney function with increasing in protein in the urine
    Peggioramento della funzione renale con aumento delle proteine nelle urine
    Deterioro de la función renal con aumento de la proteinuria en orina
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    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 determine the individual albuminuria lowering response to eplerenone, dapaglifozin and their combination
    Determinare la risposta antiproteinurica individuale all'eplerenone, al dapaglifozin ed alla loro combinazione
    Determinar la respuesta antiproteinúrica individual a la eplerenona, la dapaglifozina y a la combinación de ambos fármacos.
    E.2.2Secondary objectives of the trial
    To determine the individual office blood pressure lowering response to eplerenone, dapaglifozin and their combination
    To determine the individual home blood pressure lowering response to eplerenone, dapaglifozin and their combination
    Determinare la risposta antiipertensiva (pressione arteriosa ambulatoriale) individuale all'eplerenone, al dapaglifozin ed alla loro combinazione
    Determinare la risposta antiipertensiva (pressione arteriosa domiciliare) individuale all'eplerenone, al dapaglifozin ed alla loro combinazione
    Determinar la respuesta indiviual antihipertensiva (reducción de la presión arterial) en la consulta a la eplerenona, la dapaglifozina o a la combinación de ambas.
    Determinar la respuesta indiviual antihipertensiva (reducción de la presión arterial) en el domicilio a la eplerenona, la dapaglifozina o a la combinación de ambas
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    To determine which patients characteristics as well as plasma or urinary biomarkers predict the albuminuria and blood pressure response to eplerenone, dapagliflozin and their combination
    Determinare quali fattori legati al paziente cosí come biomarcatori plasmatici ed urinari possano predire la risposta antiproteinurica ed antiipertensiva individuale all'eplerenone, al dapaglifozin ed alla loro combinazione
    Determinar que características individuales de cada paciente, estudiadas a través de marcadores tanto plasmáticos como urinarios, predicen la reducción de la albuminuria y la presión arterial a la eplerenona, la dapaglifozina o a la combinación de ambos
    E.3Principal inclusion criteria
    eGFR > 30 and < 90 ml/min/1.73m2; albuminuria ≥ 100 mg/24 hour and ≤ 3500 mg/24 hour; serum potassium ≤ 5.0 mmol/L; treatment with ACEi or ARB ; age ≥ 18 years; written informed consent
    eGFR > 30 and < 90 ml/min/1.73m2; albuminuria ≥ 100 mg/24 ore and ≤ 3500 mg/24 ore; potassio serico ≤ 5.0 mmol/L; trattamento con ACEi o ARB ; etá ≥ 18 anni; consenso informato scritto
    Filtrado Glomerular estimado > 30 y < 90 ml/min/1.73m2; albuminuria ≥ 100 mg/24 horas y ≤ 3500 mg/24 horas; potasio sérico ≤ 5.0 mmol/L; tratamiento con IECA o ARA II ; edad ≥ 18 años; firma de consentimiento informado
    E.4Principal exclusion criteria
    - Diagnosis of type 1 diabetes mellitus
    - Urinary protein excretion > 3500 mg/24 hour
    - Autosomal dominant polycystic kidney disease or autosomal recessive polycystic kidney disease, lupus nephritis, or ANCA-associated vasculitis
    - Indication for immunosuppressants as per the treating physician’s judgment.
    - Receiving cytotoxic therapy, immunosuppressive therapy, or other immunotherapy for primary or secondary renal disease within 6 months prior to enrolment.
    - Active malignancy aside from treated squamous cell or basal cell carcinoma of the skin.
    - Diabetes type 2 patients with recent (last 6 months) of hyperosmolar hyperglicemic state who are prone to development redistributive hyperkalemia (movement of potassium out of the cells)
    - Pregnant women and women of child-bearing potential who are not using reliable contraception
    - Cardiovascular disease: myocardial infarction, angina pectoris, percutanous transluminal coronary angioplasty, coronary artery bypass grafting, stroke, heart failure (NYHA I-IV) < 6 months before inclusion
    - Uncontrolled blood pressure (office blood pressure > 160 / 100 mmHg)
    - History of autonomic dysfunction (e.g. history of fainting or clinically significant orthostatic hypotension)
    - History of amputations
    - eGFR change > 30% in the last six months before study randomization
    - Current therapy with renin inhibitor or MRA
    - Concomitant treatment with ACEi and ARB
    - Intolerance or contraindications to drugs inhibiting the Renin-Angiotensin-Aldosterone System (RAAS). Cyclosporine A, tacrolimus, trimethoprim due to increased risk of hyperkalemia in combination with eplerenone. Ketoconazole, itraconazole, ritonavir, nelfinavir, clarithromycin, telithromycin and nefazadone, lithium, amiodarone, diltiazem, verapamil due to increase in toxicity when combined with eplerenone. Rifampicin, carbamazepine, phenytoin, phenobarbital due the risk of decreased eplerenone efficacy.
    - Participation in any clinical investigation within 3 months prior to initial dosing or longer if required by local regulations, and for any other limitation of participation based on local regulations.
    - Donation or loss of 400 ml or more of blood within 8 weeks prior to initial dosing
    - History of drug or alcohol abuse within the 12 months prior to dosing, or evidence of such abuse as indicated by the laboratory assays conducted during the screening.
    - Any medication, surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of medications including, but not limited to any of the following:major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection;
    gastro-intestinal ulcers and/or gastrointestinal or rectal bleeding within last six months; evidence of hepatic disease as determined by any one of the following: ALT or AST values exceeding 3x ULN at inclusion visit, a history of hepatic encephalopathy, a history of esophageal varices, or a history of portocaval shunt
    - Diagnosi di diabete mellito tipo 1
    - Albuminuria > 3500 mg/24 ore
    - Malattia del rene policistico autosomica dominante o recessiva, nefrite lupica o vasculiti ANCA-associate
    - Indicazione al trattamento immunosoppressivo a discrezione del medico.
    - Pazienti in trattamento con terapie citotossiche, immunosoppressive o oltre immunoterapie per malatite renali pimitive o secondarie nei precedenti 6 mesi.
    - Neoplasie malige tranne il carcinoma basocellulare o squamoso della cute precedentemente trattato.
    - Pazienti con diabete tipo 2 e con recente storia (precedenti 6 mesi) di stato iperglicemico iperosmolare che sono suscettibili a sviluppare iperpotassiemia redistributiva (fuoriuscita di potassio all'esterno delle cellule).
    - Donne gravide o donne in etá fertile che non usano un metodo contraccettivo affidabile.
    - Malattia cardiovascolare: infarto del miocardio, angina pectoris, angioplastica coronarica percutanea, bypass aorto-coronarico, ictus, scompenso cardiaco (NYHA I-IV) nei 6 mesi che precedono l'inclusione.
    - Pressione arteriosa non controllata (valore ambulatoriale di pressione arteriosa > 160 / 100 mmHg)
    - Storia di disfunzione autonomica (es. storia di svenimenti o ipotensione ortostatica clinicamente significativa)
    - Storia di amputazione
    - cambiamento dell'eGFR > 30% nei 6 mesi che precedono la randomizzazione
    - Terapia in atto con inibitori della renina o MRA
    - Trattamento concomitante con ACEi e ARB
    - Intolleranza o controindicazioni a farmaci che inibiscono il sistema Renina-Angiotensina-Aldosterone (RAAS). Ciclosporina A, tacrolimus, trimethoprim per l’aumentato rischio di sviluppare iperpotassiemia in combinazione con eplerenone. Ketoconazolo, itraconazolo, ritonavir, nelfinavir, claritromicina, telitromcina e nefazadone, litio, amiodarone, diltiazem, verapamil per l’aumentata tossicitá quando combinati con eplerenone. Rifampicina, carbamazepina, fenitoina, fenobarbitale per il rischio di ridurre l’efficacia dell’eplerenone.
    - Inclusione in qualunque protocollo di ricerca clinica nei 3 mesi precedenti la somministrazione iniziale del trattamento o più a lungo se richiesto dalle normative locali e per qualsiasi altra limitazione di partecipazione in base alle normative locali.
    - Donazione o perdita di 400 ml o piú di sangue entro 8 settimane dalla prima somministrazione del trattamento in studio
    - Storia di abuso di farmaci o alcol nei precedenti 12 mesi, o evidenza di tale abuso come risultato degli esami di laboratorio condotti durante lo screening.
    - Qualsiasi farmaco, condizione chirurgica o medica che potrebbe alterare in modo significativo l'assorbimento, la distribuzione, il metabolismo o l'escrezione dei trattamenti in studio, tra i quali i seguenti (ed altri): chirurgia del tratto gastrointestinale maggiore come gastrectomia, gastroenterostomia o resezione intestinale, gastro-intestinale ulcere e / o emorragia gastrointestinale o rettale negli ultimi sei mesi; evidenza di malattia epatica determinata da uno dei seguenti valori: valori di ALT o AST superiori a 3 x ULN alla visita di screening, anamnesi di encefalopatia epatica, anamnesi di varici esofagee o anamnesi di shunt portocavale.
    •Diagnóstico de diabetes mellitus tipo 1.
    • Excreción urinaria de proteínas > 3500 mg / 24 horas.
    •Mujeres gestantes o en periodo de lactancia o con test de embarazo positivo en la visita de screening

    • Enfermedad renal poliquística autosómica dominante o enfermedad renal poliquística autosómica recesiva, nefritis lúpica o vasculitis asociada a ANCA
    • Indicación de inmunosupresores según el criterio del médico tratante.
    • Recibir terapia citotóxica, terapia inmunosupresora u otra inmunoterapia para la enfermedad renal primaria o secundaria dentro de los 6 meses anteriores a la inscripción.
    • Enfermedad maligna activa aparte del carcinoma de células escamosas o células basales de la piel.
    • Pacientes con diabetes tipo 2 con estado hiperglucémico hiperosmolar reciente (últimos 6 meses) que son propensos a desarrollar hipercaliemia redistributiva (movimiento de potasio fuera de las células)
    •Historia de hipoglucemia (síntomas como mareos, sensación de hambre intensa, confusión, dolor de cabeza o incapacidad para concentrase, sudoración profusa, temblores, visión borrosa o o test de glucosa < 54 mg/dl en los últimos tres meses.
    • Mujeres embarazadas y mujeres en edad fértil que no estén usando anticoncepción segura
    • Enfermedad cardiovascular: infarto de miocardio, angina de pecho, angioplastia coronaria transluminal percutánea, cirugía de revascularización coronaria, accidente cerebrovascular, insuficiencia cardíaca (NYHA I-IV) <6 meses antes de la inclusión
    • Presión arterial no controlada (presión arterial de oficina> 160/100 mmHg)
    • Historial de disfunción autonómica (por ejemplo, historial de desmayos o clínicamente
    hipotensión ortostática significativa)
    • Historia de amputaciones.
    • Cambio de eGFR> 30% en los últimos seis meses antes de la aleatorización del estudio.
    • Terapia actual con inhibidor de renina o antagonista mineralcorticode
    • Tratamiento simultáneo con ACEi y ARB.
    • Intolerancia o contraindicaciones a fármacos que inhiban el Sistema Renina-Angiotensina-Aldosterona (RAAS). Tratamiento con Ciclosporina A, tacrolimus, trimetoprima debido al aumento del riesgo de hiperpotasemia en combinación con eplerenona. Tratamiento con Ketoconazol, itraconazol, ritonavir, nelfinavir, claritromicina, telitromicina y nefazadona, litio, amiodarona, diltiazem, verapamil debido al aumento de la toxicidad cuando se combina con eplerenona. Tratamiento con Rifampicina, carbamazepina, fenitoína, fenobarbital debido al riesgo de disminución de la eficacia de la eplerenona.
    • Participación en cualquier investigación clínica dentro de los 3 meses anteriores al inicio del periodo de tratamiento
    • Donación o pérdida de 400 ml o más de sangre dentro de las 8 semanas anteriores al inicio del periodo de tratamiento
    • Historial de abuso de drogas o alcohol dentro de los 12 meses anteriores a la dosificación, o
    evidencia de tal abuso si así lo indican los análisis de laboratorio realizados durante la selección.
    • Cualquier medicamento, condición quirúrgica o médica que pueda alterar significativamente
    la absorción, distribución, metabolismo o excreción de medicamentos que incluyen, entre otros, cualquiera de los siguientes:
    - Cirugía mayor del tracto gastrointestinal, como gastrectomía, gastroenterostomía o resección intestinal;
    - Úlceras gastrointestinales y / o hemorragia gastrointestinal o rectal en los últimos seis meses;
    - Evidencia de enfermedad hepática según lo determinado por cualquiera de los siguientes: valores de ALT o AST superiores a 3 x ULN en la visita de inclusión, antecedentes de encefalopatía hepática, antecedentes de varices esofágicas o antecedentes de derivación portocava
    E.5 End points
    E.5.1Primary end point(s)
    correlation between individual albuminuria lowering responses of eplerenone, dapagliflozin and their combination
    correlazione tra risposte antiproteinuriche individuali all'eplerenone al dapaglifozin e alla loro combinazione
    Correlación entre respuesta individual a la reducción de la albuminuria a la eplerenona, la dapaglifozina y la combinación de ambas
    E.5.1.1Timepoint(s) of evaluation of this end point
    correlation between home blood pressure-lowering responses of eplerenone, dapaglifozin and their combination; correlation between office blood pressure-lowering responses of eplerenone, dapaglifozin and their combination
    correlazione tra risposte antiipertensive individuali (pressione arteriosa ambulatoriale) all'eplerenone al dapaglifozin e alla loro combinazione;correlazione tra risposte antiipertensive individuali (pressione arteriosa domiciliare) all'eplerenone al dapaglifozin e alla loro combinazione
    Correlación entre la disminución de la presión arterial en domicilio como respuesta al tratamiento con eplerenona, dapaglifozina o su combinación; correlación entre la disminucón de la presión arterial en consulta al tratamiento con eplerenona, dapaglifozina o su cominación
    E.5.2Secondary end point(s)
    To determine the correlation between office/home blood pressure-lowering responses of eplerenone, dapaglifozin and their combination.
    To determine which patients characteristics predict the albuminuria and blood pressure response to eplerenone, dapagliflozin and their combination
    Determinar la correlación entre la respuesta depresora de la presión arterial en la consulta y en casa a eplerenona, dapaglifozina y la combinación de ambos.
    Determinar cuáles son las caracteristicas de cada paciente que predicen la disminución de la albuminuria y la presión arterial con eplerenona, dapaglifozina y la combinación de ambas
    E.5.2.1Timepoint(s) of evaluation of this end point
    maximally 42 weeks
    42 semanas máximo
    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 No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial6
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA3
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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 de estudio
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months11
    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: 23
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 23
    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 state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 41
    F.4.2.2In the whole clinical trial 46
    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
    Ninguno
    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 Decision2019-04-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-03-29
    P. End of Trial
    P.End of Trial StatusOngoing
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