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    Summary
    EudraCT Number:2020-004101-32
    Sponsor's Protocol Code Number:D4325C00001
    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:2021-06-08
    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 number2020-004101-32
    A.3Full title of the trial
    A Phase 2b Multicentre, Randomised, Double-Blind, PlaceboControlled, Parallel Group Dose-Ranging Study to Assess the Efficacy, Safety and Tolerability of Zibotentan and Dapagliflozin in Patients with Chronic Kidney Disease with Estimated Glomerular Filtration Rate (eGFR) Between 20 and 60 mL/min/1.73 m2
    Studio di determinazione della dose di fase 2b, multicentrico, randomizzato, in doppio cieco, controllato verso placebo, a gruppi paralleli per valutare l’efficacia, la sicurezza e la tollerabilità di zibotentan e dapagliflozin in pazienti con malattia renale cronica e velocità di filtrazione glomerulare stimata (eGFR) tra 20 e 60 mL/min/1,73 m2
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Zibotentan and Dapagliflozin for the Treatment of Chronic Kidney Disease (ZENITH-CKD trial)
    Zibotentan e dapagliflozin per il trattamento della CKD (studio ZENITH-CKD)
    A.3.2Name or abbreviated title of the trial where available
    Zenith-CKD
    Zenith-CKD
    A.4.1Sponsor's protocol code numberD4325C00001
    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 AB
    B.5.2Functional name of contact pointInformation Center
    B.5.3 Address:
    B.5.3.1Street AddressNA
    B.5.3.2Town/ cityNA
    B.5.3.3Post codeNA
    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 No
    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 nameZibotentan capsule
    D.3.2Product code [NA]
    D.3.4Pharmaceutical form Capsule, hard
    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 INNZibotentan
    D.3.9.1CAS number 186497-07-4
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameZIBOTENTAN
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 No
    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 nameZibotentan capsule
    D.3.2Product code [NA]
    D.3.4Pharmaceutical form Capsule, hard
    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 INNZibotentan
    D.3.9.1CAS number 186497-07-4
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameZIBOTENTAN
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1500
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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: 3
    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 No
    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 nameZibotentan capsule
    D.3.2Product code [NA]
    D.3.4Pharmaceutical form Capsule, hard
    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 INNZibotentan
    D.3.9.1CAS number 186497-07-4
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameZIBOTENTAN
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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: 4
    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.3.2Product code [NA]
    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.3.9.2Current sponsor codeBMS-512148-05
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 placeboCapsule, hard
    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
    Chronic Kidney Disease
    Malattia renale cronica
    E.1.1.1Medical condition in easily understood language
    Chronic Kidney Disease
    Malattia renale cronica
    E.1.1.2Therapeutic area Body processes [G] - Metabolic Phenomena [G03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.1
    E.1.2Level PT
    E.1.2Classification code 10064848
    E.1.2Term Chronic kidney disease
    E.1.2System Organ Class 10038359 - Renal and urinary disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the effect of zibotentan and dapagliflozin in combination and alone versus placebo on UACR.
    Valutare l’effetto sul UACR di zibotentan e dapagliflozin in combinazione e in monoterapia rispetto a placebo.
    E.2.2Secondary objectives of the trial
    1. To determine the change in UACR for doses of zibotentan combined with 10 mg dapagliflozin versus 10 mg dapagliflozin alone.
    2. To determine the change in office systolic and diastolic BP for doses of zibotentan combined with 10 mg dapagliflozin and for zibotentan and 10 mg dapagliflozin alone versus placebo.
    3. To characterise the dose-response relationship (relationship between different doses of zibotentan/a fixed dose of dapagliflozin and UACR reduction).
    4. To determine the effect of ranging doses of zibotentan and dapagliflozin in combination and alone on eGFR.
    1. Determinare la variazione del UACR ottenuta con dosi di zibotentan associate a dapagliflozin 10 mg rispetto a dapagliflozin 10 mg in monoterapia.
    2. Determinare la variazione della PA sistolica e diastolica misurata presso lo studio del medico ottenuta con dosi di zibotentan associate a dapagliflozin 10 mg e con zibotentan e dapagliflozin 10 mg in monoterapia rispetto a placebo
    3. Caratterizzare la relazione dose-risposta (relazione tra dosi differenti di zibotentan/una dose fissa di dapagliflozin e la riduzione del UACR).
    4. Determinare l’effetto sulla eGFR di dosi diverse di zibotentan e dapagliflozin in combinazione e in monoterapia.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Diagnosis of CKD, defined as:
    (a) Part A: eGFR (CKD-EPI) >= 30 and <= 60 mL/min/1.73 m2
    Part B, if safety data from Part A allow (otherwise same as in Part A):
    eGFR
    (CKD-EPI) >= 20 and <= 60 mL/min/1.73 m2
    2. Urine albumin to creatinine ratio (UACR) >= 200 and <= 5000 mg albumin/g creatinine, based on a single first morning void spot urine sample at screening Medical Treatment
    3. No current or prior (within 1 month of screening) medical treatment with an SGLT2i or any FDC with SGLT2i (such as SGLT2i + metformin).
    4. On a stable dose of ACEi and/or ARB (>= 4 weeks before screening).
    5. No current or prior treatment within 3 months prior to screening with cytotoxic therapy,
    immunosuppressive therapy or other immunotherapy.
    Weight
    6 Body mass index (BMI) <= 40 kg/m2 .
    Sex
    7 Male or female of non-childbearing potential.
    Reproduction
    8 Female participants must have a negative pregnancy test at screening, must not be lactating, and must be of non-childbearing potential, confirmed at screening by fulfilling one of the following criteria:
    (a) Postmenopausal defined as amenorrhoea for at least 12 months or more following cessation of all exogenous hormonal treatments and FSH and LH levels in the postmenopausal range.
    (b) Documentation of irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy but not tubal ligation.
    9 Male participants must be surgically sterile, abstinent, or in conjunction with a female sexual partner, using a highly effective method of contraception for the duration of the study (from the time they sign consent) and for 3 months after the last dose of investigational product to prevent any
    pregnancies. Male study participants must not donate or bank sperm during this same time period.

    PLEASE REFER TO THE PROTOCOL FOR FURTHER INCLUSION CRITERIA
    1. Diagnosi di malattia renale cronica (CKD), definita come:
    (a) Parte A: eGFR (CKD-EPI) > = 30 e <=60 ml/min/1,73 m2
    Parte B, se i dati di sicurezza della Parte A lo consentono (altrimenti come nella Parte A):
    eGFR
    (CKD-EPI) >=20 e <=60 ml/min/1,73 m2
    2. Rapporto albumina/creatinina nelle urine (UACR) >=200 e <=5000 mg albumina/g creatinina, sulla base di un unico campione di urina estemporanea dalla prima minzione del mattino, allo screening del Trattamento Medico
    3. Nessun trattamento medico in corso o precedente (entro 1 mese dallo screening) con un SGLT2i o qualsiasi combinazione a dose fissa (FDC) con SGLT2i (come SGLT2i + metformina).
    4. In terapia con una dose stabile di ACE-inibitori e/o ARB (>= 4 settimane prima dello screening).
    5. Nessun trattamento in corso o precedente nei 3 mesi prima dello screening con terapia citotossica, terapia immunosoppressiva o altra immunoterapia.
    Peso
    6 Indice di massa corporea (IMC) <= 40 kg/m2.
    Sesso
    7 Pazienti di sesso maschile o femminile non in età fertile.
    Riproduzione
    8 Le partecipanti di sesso femminile devono avere un test di gravidanza negativo allo screening, non devono allattare al seno e non in età fertile, confermato allo screening tramite il soddisfacimento di uno dei seguenti criteri:
    (a) Essere in postmenopausa definita come amenorrea per almeno 12 mesi dopo la cessazione di tutti i trattamenti ormonali esogeni e presentare livelli di ormone follicolo-stimolante (FSH) e di ormone luteinizzante (LH) nell’intervallo post-menopausale.
    (b) Documentazione di sterilizzazione chirurgica irreversibile mediante isterectomia, ovariectomia bilaterale o salpingectomia bilaterale, ma non legatura delle tube.
    9 I partecipanti di sesso maschile devono essere chirurgicamente sterili, praticare l’astinenza o utilizzare, unitamente alla propria partner, un metodo contraccettivo altamente efficace per l’intera durata dello studio (dal momento della firma del consenso) e per 3 mesi dopo l’ultima dose del farmaco sperimentale, allo scopo di prevenire una gravidanza. I partecipanti allo studio di sesso maschile non devono donare o conservare sperma durante questo periodo di tempo.

    SI PREGA DI FARE RIFERIMENTO AL PROTOCOLLO PER ULTERIORI CRITERI DI INCLUSIONE
    E.4Principal exclusion criteria
    1 Minimal change disease, unstable rapidly progressing renal disease, and/or renal disease requiring significant immunosuppression, autosomal dominant or autosomal recessive polycystic kidney disease, or anatomical causes of CKD.
    2 History of epilepsy syndrome.
    3 Participants with NYHA functional HF class III or IV.
    4 Acute coronary syndrome (ACS) events within 3 months prior to screening.
    5 Participants with a confirmed BNP >= 200 pg/mL or BNP >= 400 pg/mL if with atrial fibrillation.
    6 Participants with unstable HF requiring hospitalisation for optimization of HF treatment and/or who have not been stable on HF therapy within 6 months prior to screening.
    7 Heart failure due to cardiomyopathies that would primarily require specific other treatment: eg, cardiomyopathy due to pericardial disease, amyloidosis or other infiltrative diseases, cardiomyopathy related to congenital heart disease, primary hypertrophic cardiomyopathy,
    cardiomyopathy related to toxic or infective conditions (ie, chemotherapy, infective myocarditis, septic cardiomyopathy).
    8 High output HF (eg, due to hyperthyroidism or Paget's disease).
    9 Heart failure due to primary cardiac valvular disease/dysfunction, severe functional mitral or tricuspid valve insufficiency, or planned cardiac valve repair/replacement.
    10 Participants with uncontrolled diabetes mellitus (HbA1c > 12%).

    PLEASE REFER TO THE PROTOCOL FOR FURTHER EXCLUSION CRITERIA
    1 Malattia a cambiamento minimo, malattia renale instabile a rapida progressione e/o malattia renale che richiede immunosoppressione significativa, malattia renale policistica autosomica dominante o autosomica recessiva o cause anatomiche di CKD.
    2 Anamnesi di sindrome epilettica.
    3 Partecipanti con insufficienza cardiaca (IC) funzionale di classe III o IV secondo la NYHA.
    4 Eventi di sindrome coronarica acuta (SCA) nei 3 mesi precedenti lo screening.
    5 Partecipanti con valori confermati di peptide natriuretico di tipo B (BNP) >= 200 pg/ml o BNP >= 400 pg/ml se affetti da fibrillazione atriale.
    6 Partecipanti con IC instabile che richiede ricovero per l’ottimizzazione del trattamento per IC e/o che non sono rimasti stabili in terapia per IC nei 6 mesi precedenti lo screening.
    7 Insufficienza cardiaca dovuta a cardiomiopatie che richiederebbero principalmente altri trattamenti specifici: per es. cardiomiopatia dovuta a malattia pericardica, amiloidosi o altre malattie infiltrative, cardiomiopatia correlata a cardiopatia congenita, cardiomiopatia ipertrofica primaria, cardiomiopatia correlata a condizioni tossiche o infettive (ovvero chemioterapia, miocardite infettiva, cardiomiopatia settica).
    8 IC ad alto rendimento (per es., dovuta a ipertiroidismo o malattia di Paget).
    9 Insufficienza cardiaca dovuta a malattia/insufficienza valvolare cardiaca primaria, grave insufficienza funzionale della valvola mitrale o tricuspide o riparazione/sostituzione della valvola cardiaca programmata.
    10 Partecipanti con diabete mellito non controllato (HbA1c >12%).

    SI PREGA DI FARE RIFERIMENTO AL PROTOCOLLO PER ULTERIORI CRITERI DI ESCLUSIONE
    E.5 End points
    E.5.1Primary end point(s)
    Change in log-transformed UACR from baseline to Week 12.
    Variazione del UACR log-trasformato dal basale alla Settimana 12.
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 12
    Settimana 12
    E.5.2Secondary end point(s)
    1. Change in log-transformed UACR from baseline to Week 12.
    2. Change in BP from baseline (Visit 2) to Week 12
    3. The least squares mean change of UACR at Week 12 from the 3 Zibo/Dapa dose groups and the dapagliflozin monotherapy group.
    4. Change in eGFR from baseline to Week 1.
    -Change in eGFR from baseline to Week 12.
    -Change in eGFR from baseline to Week 14.
    -Change in eGFR from Week 1 to Week 12.
    1. Variazione del UACR log-trasformato dal basale alla Settimana 12.
    2. Variazione della PA dal basale (Visita 2) alla Settimana 12.
    3. Variazione media dei minimi quadrati del UACR alla Settimana 12 osservata nei 3 gruppi in terapia combinata Zibo/Dapa e nel gruppo trattato con dapagliflozin in monoterapia.
    4. Variazione della eGFR dal basale alla Settimana 1.
    -Variazione della eGFR dal basale alla Settimana 12.
    -Variazione della eGFR dal basale alla Settimana 14.
    -Variazione della eGFR dalla Settimana 1 alla Settimana 12.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. week 12
    2. week 12
    3. week 12
    4.
    week 1
    week 12
    week 14
    week 12
    1. settimana 12
    2. settimana 12
    3. settimana 12
    4.
    settimana 1
    settimana 12
    settimana 14
    settimana 12
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 trial10
    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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA69
    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 Information not present in EudraCT
    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
    Bosnia and Herzegovina
    Brazil
    Canada
    Georgia
    Japan
    Korea, Republic of
    Malaysia
    Serbia
    South Africa
    Taiwan
    Ukraine
    United States
    Belgium
    Bulgaria
    Denmark
    Hungary
    Italy
    Netherlands
    Poland
    Spain
    United Kingdom
    Argentina
    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
    LPLV
    LPLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days0
    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: 330
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 330
    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 state80
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 189
    F.4.2.2In the whole clinical trial 660
    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
    Nessuno
    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 Decision2021-05-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-06-09
    P. End of Trial
    P.End of Trial StatusOngoing
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