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    Summary
    EudraCT Number:2015-000804-24
    Sponsor's Protocol Code Number:D1690C00024
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-05-19
    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 ConcernedItaly - Italian Medicines Agency
    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
    Studio multicentrico di fase III, randomizzato, in doppio cieco, controllato verso placebo, a gruppi paralleli, per valutare la sicurezza a livello renale e l’efficacia di Dapagliflozin sul controllo glicemico in pazienti con diabete mellito di tipo 2 , insufficienza renale moderata (CKD 3A) e che hanno un controllo glicemico inadeguato.
    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
    Studio per valutare l’effetto di Dapagliflozin sul livello di glucosio e sulla funzionalità renale in pazienti con diabete di 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 Sponsor AstraZeneca 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 support AstraZeneca AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca
    B.5.2Functional name of contact pointInformation Centre
    B.5.3.4CountryUnited States
    B.5.6E-mailinformation.center@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)
    Diabete mellito di tipo II con insufficienza renale moderata (CKD 3A)
    E.1.1.1Medical condition in easily understood language
    Diabetes
    Diabete
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    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 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.
    Confrontare la variazione di HbA1della media dal basale c tra dapagliflozin 10mg e placebo, dopo 24 settimane di somministrazione orale del trattamento in doppio cieco in pazienti con diabete mellito di tipo 2 e CKD stadio 3 A.
    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.Confrontare la percentuale di variazione del peso corporeo totale con il basale tra dapagliflozin 10mg e placebo, dopo 24 settimane di somministrazione orale del trattamento in doppio cieco.
    2.Confrontare la variazione di glucosio nel plasma a digiuno (FPG) con il basale tra dapagliflozin 10mg e placebo, dopo 24 settimane di somministrazione orale del trattamento in doppio cieco.
    3.Confrontare la variazione della pressione sanguigna sistolica da seduti (SBP) con il basale tra dapagliflozin 10mg e placebo, dopo 24 settimane di somministrazione orale del trattamento in doppio cieco.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1, Female or male aged ≥18 years and <75 years.
    2, History of T2DM for more than 12 months.
    3, Inadequate glycemic control, defined as HbA1c ≥7.0% and ≤11% measured at Screening. Note that HbA1c will be rechecked at Visit 4, and must then be ≥7.0 and ≤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]
    Per essere incluso nello studio il paziente deve soddisfare i criteri seguenti:
    1.Maschi e femmine di età compresa tra i 18 e i 75 anni inclusi al momento dell’arruolamento.
    2.Diabete Mellito di Tipo 2 da più di 12 mesi.
    3.Inadeguato controllo glicemico, definito come HbA1c ≥7.0% e ≤11% misurato allo screening. Il valore di HbA1c sarà rimisurato alla Visita 4. E dovrà essere ≥7.0 e ≤10.5% (valore ottenuto dal campione di sangue della Visita 3) per i pazienti che devono essere randomizzati.
    4.Essere a regime stabile per quanto riguarda la terapia anti-diabetica, definito da una dieta stabile e una terapia di esercizi da soli o in combinazione, con una o entrambe delle seguenti alternative:
    •Un regime di qualsiasi farmaco anti-diabetico orale approvato (tranne gli inibitori di SGLT2) per cui non sia mai cambiato il dosaggio nelle 12 settimane prima della randomizzazione.
    •Insulina a lunga o intermedia durata di azione e mix di insulina permessa purché la dose rimanga stabile nelle 12 settimane precedenti la randomizzazione, sono consentite variazioni del ± 10% (in relazione al numero di unità alla randomizzazione). Per esempio, se il paziente sta assumendo 50 unità/giorno di insulina alla randomizzazione, la dose giornaliera nelle settimane precedenti non deve aver superato le 55 unità, o essere stata inferiore a 45 unità. Sono comunque permesse eccezioni (≤ un giorno/settimana) in questo intervallo di tempo.
    5.Insufficienza renale: CKD 3A
    •eGFR* 40 – 65 mL/minuto/1.73 m2 alla Visita 2 (valore ottenuto dal campione di sangue della Visita 1) per entrare nel periodo di lead-in.
    •eGFR* 45 – 59 mL/minuto/1.73 m2 alla Visita 4 (valore medio calcolato sulla base dei valori di eGFR della Visita 2 e Visita 3) per la randomizzazione.
    *in accordo con l’equazione di studio ri-espressa abbreviata MDRD, utilizzando le misurazioni della creatinina del laboratorio centralizzato (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]
    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 μmol/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 ≤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 ≥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 ≥180 mmHg and/or DBP ≥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.Donne in età fertile che non vogliano o non possano utilizzare un metodo contraccettivo accettabile per evitare possibili gravidanze per l’intera durata dello studio.
    2.Donne in gravidanza o in fase di allattamento
    3.Aspartato Aminotransferasi (AST) >3X ULN.
    4.Alanina Aminotransferasi (ALT) >3X ULN.
    5.Bilirubina Totale (TB) >2 mg/dL (35 μmol/L).
    6.Potassio Sierico (K) >5.5 meq/L (5.5 mmol/L).
    7.Calcio Sierico (Ca) <8 mg/dL o > ULN (<1.99 mmol/L o > ULN).
    8.Positività per l’antigene di superficie dell’epatite B.
    9.Positività per l’anticorpo del virus dell’epatite C.
    10.Emoglobina ≤9.0 g/dL (90 g/L).
    11.Storia di diabete insipido.
    12.Sintomi di diabete non controllato che precludono la partecipazione a questo studio, inclusi (ma non limitati a questi) marcata poliuria e polidipsia con perdita di peso maggiore del 10% nei 3 mesi prima della firma del consenso alla Visita 1, o altri segnali e sintomi.
    13.Storia di chetoacidosi diabetica o coma iperglicemico-iperosmolare non chetosico.
    14.Storia di ≥2 gravi eventi ipoglicemici nei 3 mesi precedenti l’arruolamento, definiti come eventi sintomatici che hanno richiesto assistenza esterna a causa di una seria compromissione della coscienza o del comportamento, con livelli di zuccheri nel sangue <3.0 mmol/L, <54 mg/dL (livelli di glucosio nel plasma <3.5 mmol/L, <63 mg/dL) e rapido recupero dopo somministrazione di glucosio o glucagone.
    15.Ipertensione grave e non controllata definita come Pressione Sanguigna Sistolica (SBP) ≥180 mmHg e/o Pressione Sanguigna Diastolica (DBP) ≥110 mmHg ad ogni visita precedente la randomizzazione.
    17.Qualsiasi delle seguenti patologie CV/Vascolari nei 3 mesi precedenti la firma del consenso alla Visita 1: Infarto del miocardio,Chirurgia cardiaca o rivascolarizzazione (CABG/PTCA),Angina non stabile,Insufficienza cardiaca (HF) non stabile,HF New York Heart Association (NYHA) di Classe IV,Attacco Ischemico Transitorio (TIA) o patologia cerebrovascolare rilevante, Aritmia instabile o non precedentemente diagnosticata.
    18.Storia di biopsie o tecniche di imaging che abbiano portato alla diagnosi di patologia renale (come glomerulonefrite o segni di stenosi dell’arteria renale) diversa dalla nefropatia diabetica o nefropatia diabetica con nefrosclerosi.
    19.Storia di trapianto renale.
    20.Emodialisi, terapia di ultrafiltrazione o dialisi peritoneale nei 6 mesi precedenti la firma del consenso informato alla Visita 1.
    21.Patologia epatica significativa, comprese, ma non limitate a, epatite cronica attiva e/o grave insufficienza epatica.
    22.Storia documentata di epatotossicità con qualsiasi farmaco.
    23.Storia documentata di patologie epatobiliari.
    24.Tumori maligni nei 5 anni precedenti la visita di arruolamento (ad eccezione dei carcinomi basocellulari trattati o dei carcinomi a cellule squamose trattati).
    25.Noto stato di compromissione del sistema immunitario, inclusi ma non limitati a, individui che hanno subito trapianto d’organo o che sono positivi al virus dell’immunodeficienza umana (HIV).
    26.Storia di micro o macroematuria inspiegabile, o ematuria microscopica alla Visita 2.
    27.Trattamento a lungo termine con glucocorticoidi (durante lo studio sono concessi due periodi temporanei di trattamento non superiori ai 10 giorni ciascuno); sono permessi corticosteroidi per via topica o inalatoria.
    28.Dosi di metformina che non sono incluse nel range specificato per l’insufficienza renale moderata (eGFR 30– 59 mL/minute/1.73m2, MDRD formula) seguendo le linee guida locali e il giudizio dello sperimentatore.
    29.Trattamenti in atto con inibitori di SGLT2 allo screening.
    30.Storia di chirurgia bariatrica o bendaggio gastrico.
    31.Somministrazione di sibutramina, fentermina, orlistat, rimonabant, benzfetamina, dietilpropione, metanfetamina, Victoza (liraglutide) utilizzata per trattamenti anti obesità, e/o fendimetrazina, nei 30 giorni precedenti la firma del consenso informato alla Visita 1.
    32.Il paziente è considerato, secondo il giudizio dello Sperimentatore, a rischio di disidratazione o deplezione di volume a causa di condizioni concomitanti.
    33.Il paziente presenta condizioni che, secondo il giudizio dello Sperimentatore, possono renderlo incapace di terminare lo studio o che lo mettono a significativo rischio.
    34.Il paziente sta abusando di alcol o altri farmaci o ne ha abusato nei 6 mesi precedenti la firma del consenso alla Visita 1.
    35.Coinvolgimento nella pianificazione e/o conduzione dello studio (si applica sia allo staff AstraZeneca che allo staff del centro).
    36.Precedente arruolamento in questo stesso studio.
    37.Partecipazione ad un altro studio clinico con un farmaco sperimentale nei 30 giorni precedenti la firma del consenso alla Visita 1.
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline in HbA1c at Week 24
    Variazione rispetto al basale di HbA1c alla settimana 24
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline to end of treatment
    Basale alla fine del trattamento
    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.Percentuale della variazione del peso corporeo totale dal basale alla settimana 24
    2.Variazione rispetto al basale in FPG alla settimana 24
    3.Variazione dal basale della SBP da seduti alla settimana 24
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline to the end of treatment
    Basale alla fine del trattamento
    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 concerned20
    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
    LSLV
    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 months3
    E.8.9.1In the Member State concerned days7
    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 state30
    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
    I trattamenti saranno quelli della normale pratica clinica.
    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 Decision2015-06-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-07-30
    P. End of Trial
    P.End of Trial StatusOngoing
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