Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   42758   clinical trials with a EudraCT protocol, of which   7042   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .

    Clinical Trials marked as "Trial now transitioned" were transitioned to the Clinical Trial Regulation 536/2014 and can be further followed in the Clinical Trial Information System  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2016-001767-37
    Sponsor's Protocol Code Number:178-CL-204
    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:2021-01-25
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2016-001767-37
    A.3Full title of the trial
    A Phase 3, Double blind, Randomized, Multicenter, Parallel Group, Placebo controlled Sequential Dose Titration Study to Evaluate Efficacy, Safety and Pharmacokinetics of Mirabegron in Pediatric Subjects from 5 to < 18 Years of Age with Overactive Bladder
    Studio di Fase 3, in doppio cieco, randomizzato, multicentrico, a gruppi paralleli, controllato verso placebo, di titolazione sequenziale della dose, volto a valutare l’efficacia, la sicurezza e la farmacocinetica di mirabegron in soggetti pediatrici da 5 a <18 anni di età con vescica iperattiva
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to investigate how effective and safe the study medication 'mirabegron' is and how long it stays in the body in children aged 5 to less than 18 years with symptoms of an overactive bladder
    E' uno studio per valutare quanto è efficace e sicuro il farmaco in studio 'mirabegron' e per conoscere quanto tempo rimane nel corpo nei bambini di età compresa tra 5 e meno di 18 anni con sintomi di vescica iperattiva
    A.3.2Name or abbreviated title of the trial where available
    Dolphin Study
    Studio Dolphin
    A.4.1Sponsor's protocol code number178-CL-204
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/350/2019
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorASTELLAS PHARMA GLOBAL DEVELOPMENT, INC.
    B.1.3.4CountryUnited States
    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 supportAstellas Pharma Global Development Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstellas Pharma Europe B.V., Global Development Operations
    B.5.2Functional name of contact pointService Desk
    B.5.3 Address:
    B.5.3.1Street AddressSylviusweg 62
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333 BE
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031715455050
    B.5.5Fax number000000
    B.5.6E-mailCTU@astellas.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 Betmiga
    D.2.1.1.2Name of the Marketing Authorisation holderAstellas Pharma Europe B.V. EU/1/12/809/001-007, 015-016
    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 nameMirabegron
    D.3.2Product code [-]
    D.3.4Pharmaceutical form Prolonged-release 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 INNMIRABEGRON
    D.3.9.1CAS number 223673-61-8
    D.3.9.2Current sponsor code-
    D.3.9.3Other descriptive nameMIRABEGRON
    D.3.9.4EV Substance CodeSUB32690
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 Yes
    D.2.1.1.1Trade name Betmiga
    D.2.1.1.2Name of the Marketing Authorisation holderAstellas Pharma Europe B.V. EU/1/12/809/008–014, 017-018
    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 nameMirabegron
    D.3.2Product code [-]
    D.3.4Pharmaceutical form Prolonged-release 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 INNMIRABEGRON
    D.3.9.1CAS number 223673-61-8
    D.3.9.2Current sponsor code-
    D.3.9.3Other descriptive nameMIRABEGRON
    D.3.9.4EV Substance CodeSUB32690
    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 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 namemirabegron
    D.3.2Product code [YM178]
    D.3.4Pharmaceutical form Granules for oral/rectal suspension
    D.3.4.1Specific paediatric formulation Yes
    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 INNMIRABEGRON
    D.3.9.1CAS number 223673-61-8
    D.3.9.2Current sponsor codeYM178
    D.3.9.3Other descriptive nameMIRABEGRON
    D.3.9.4EV Substance CodeSUB32690
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number8
    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 placeboTablet
    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 placeboGranules for oral/rectal suspension
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 3
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    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
    Overactive bladder (OAB)
    Vescica iperattiva (OAB)
    E.1.1.1Medical condition in easily understood language
    a sudden and uncontrollable urge to urinate (urinary incontinence)
    un bisogno improvviso e incontrollabile di urinare (incontinenza urinaria)
    E.1.1.2Therapeutic area Body processes [G] - Biological Phenomena [G16]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.1
    E.1.2Level LLT
    E.1.2Classification code 10059617
    E.1.2Term Overactive bladder
    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 evaluate the efficacy of mirabegron in children (5 to < 12 years of age) with OAB
    Valutare l’efficacia di mirabegron in bambini (da 5 a <12 anni di età) con OAB
    E.2.2Secondary objectives of the trial
    • To evaluate the efficacy of mirabegron in children (5 to < 12 years of age) with OAB
    • To evaluate the safety and tolerability of mirabegron in pediatric subjects with OAB
    • To evaluate the pharmacokinetics after multiple dose administration of mirabegron in pediatric subjects with OAB
    • Valutare l’efficacia di mirabegron in bambini (da 5 a <12 anni di età) con OAB
    • Valutare la sicurezza e la tollerabilità di mirabegron in soggetti pediatrici con OAB
    • Valutare la farmacocinetica dopo la somministrazione di dosi multiple di mirabegron in soggetti pediatrici con OAB
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion at Visit 1/Week -4 (Screening)
    2. Subject has OAB defined according to the ICCS criteria.
    4. Subject weighs at least 11 kg at screening.
    5. Subject is able to take the IP in accordance with the protocol.
    6. Subject agrees to drink an adequate fluid volume during urine collection weekends, as instructed by the investigator.
    7. Subject and subject's parent(s)/legal guardian(s) agree that the subject will not participate in another interventional study while participating in the present study.
    8. Subject and subject's parent(s)/legal guardian(s) are willing and able to comply with the study requirements and with the concomitant medication restrictions.
    9. At least 1 of the following conditions apply:
    a. Not a woman of childbearing potential (WOCBP)
    b. WOCBP who agrees to follow the contraceptive guidance from the time of informed consent/assent through at least 30 days after final IP administration.
    10. Female subject must agree not to breastfeed starting at screening and throughout the study period and for 30 days after final IP administration.
    11. Female subject must not donate ova starting at first dose of IP and throughout the study period and for 30 days after final IP administration.
    12. Male subject with female partner(s) of childbearing potential (including breastfeeding partner[s]) must agree to use contraception throughout the treatment period and for 30 days after final IP
    administration.
    13. Male subject must not donate sperm during the treatment period and for 30 days after final IP administration.
    14. Male subject with pregnant partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy throughout the study period and for 30 days after final IP administration.
    Additional Inclusion at Visit 3/Week 0 (Baseline)
    15. Subject must have a micturition frequency of at least 8 times (on average) per day, in the 7 days prior to visit 3/week 0 (baseline), as recorded in the bladder e-diary.
    16. Subject must have at least 1 daytime incontinence episode (on average) per day, during the 7-day period before visit 3/baseline, as recorded in the bladder e-diary.
    17. Subject whose symptoms are not satisfactorily controlled with urotherapy and still fulfills the inclusion/exclusion criteria will enter the study.
    Inclusione alla Visita 1/Settimana -4 (Screening)
    2. Il soggetto presenta OAB definita in base ai criteri dell’ICCS.
    4. Il soggetto pesa almeno 11 kg allo screening.
    5. Il soggetto è in grado di assumere l’IP in conformità al protocollo.
    6. Il soggetto accetta di bere un adeguato volume di liquidi durante i fine settimana di raccolta delle urine, come indicato dallo sperimentatore.
    7. Il soggetto e il/i genitore/i /tutore/i legale/i del soggetto convengono che il soggetto non parteciperà a un altro studio interventistico durante la partecipazione al presente studio.
    8. Il soggetto e il/i genitore/i /tutore/i legale/i del soggetto sono disposti e in grado di attenersi ai requisiti dello studio e alle restrizioni del farmaco concomitante.
    9. Almeno 1 delle seguenti condizioni:
    a. Non è una donna in età fertile (WOCBP)
    b. È una WOCBP che accetta di seguire le linee guida sulla contraccezione dal momento del consenso/assenso informato fino ad almeno 30 giorni dopo l’ultima somministrazione dell’IP.
    10. Il soggetto di sesso femminile deve acconsentire a non allattare a partire dallo screening e per l’intera durata del periodo di studio e per 30 giorni dopo l’ultima somministrazione dell’IP.
    11. Il soggetto femminile non deve donare ovuli a partire dalla prima dose dell’IP e per l’intera durata del periodo di studio e per 30 giorni dopo l’ultima somministrazione dell’IP.
    12. I soggetti di sesso maschile con una o più partner in età fertile (comprese partner in allattamento) devono acconsentire a utilizzare metodi contraccettivi per l’intera durata del periodo di trattamento e per almeno 30 giorni dopo l’ultima somministrazione dell’IP.
    13. I soggetti di sesso maschile non devono donare sperma durante il periodo di trattamento e per almeno 30 giorni dopo l’ultima somministrazione dell’IP.
    14. I soggetti di sesso maschile con una o più partner in gravidanza devono accettare di praticare l’astinenza o utilizzare il preservativo durante la gravidanza per l’intero periodo di studio e per 30 giorni dopo l’ultima somministrazione dell’IP.
    Criteri di inclusione aggiuntivi alla Visita 3/Settimana 0 (Basale)
    15. Il soggetto deve presentare una frequenza della minzione di almeno 8 volte (in media) al giorno, nei 7 giorni precedenti la visita 3/settimana 0 (basale), come registrato nel diario elettronico della vescica.
    16. Il soggetto deve avere almeno 1 episodio di incontinenza diurna (in media) al giorno, durante il periodo di 7 giorni prima della visita 3/basale, come registrato nel diario elettronico della vescica.
    17. Il soggetto i cui sintomi non sono controllati in maniera soddisfacente con l’uroterapia ma ancora soddisfa i criteri di inclusione/esclusione sarà ammesso nello studio.
    E.4Principal exclusion criteria
    Exclusion at Visit 1/Week -4 (Screening)
    1. Subject has extraordinary daytime only urinary frequency according to the ICCS definition
    • This applies to a toilet-trained child who has the frequent need to void that is associated with small micturition volumes solely during the day
    • The daytime voiding frequency is at least once per hour with an average voided volume of < 50% of expected bladder capacity (EBC) (typically 10% to 15%)
    • Incontinence is rare and nocturia is absent
    Subject has
    2. an uroflow indicative of pathology other than OAB
    3. monosymptomatic enuresis
    4. dysfunctional voiding
    5. bladder outlet obstruction, except if successfully treated
    6. anatomical anomalies (surgically treated or untreated) that affect lower urinary tract function
    7. Subject with hematuria on dipstick test. In the case of hematuria on dipstick test in a female during menstruation, the test can be repeated before randomization (after the end of menstruation)
    8. Subject with diabetes insipidus
    Subject has
    9. kidney or bladder stones
    10. suffered from chronic UTI or has had more than 3 UTIs in the 2 months prior to visit 1/week -4 (screening)
    11. a pulse > 99th percentile for age
    12. stage 2 hypertension or subject has stage 1 hypertension that is not well controlled, as defined by the 2017 American Academy of Pediatrics Clinical Practice Guidelines
    13. QTcF > 440 msec on screening ECG or a risk of QT prolongation (e.g., hypokalemia, long QT syndrome [LQTS] or family history of LQTS or exercise-induced syncope)
    14. Subject's aspartate aminotransferase (AST) or alanine aminotransferase (ALT) is >= 2 × upper limit of normal (ULN) or total bilirubin (TBL) is >= 1.5 × ULN according to age and sex (subjects with
    Gilbert's syndrome are excepted from the bilirubin threshold)
    Subject has
    15. mild or moderate renal impairment (estimated glomerular filtration rate according to the modified Schwartz of < 60 mL/min per 1.73 m2)
    16. a symptomatic (symptoms can include pain, fever, hematuria, new onset foul-smelling urine) UTI. Note: if the UTI is treated successfully (clinical recovery: confirmed by dipstick test and repeated dipstick test after 14 days [both should be negative]), the subject can be rescreened
    17. a history or presence of any malignancy
    18. Subject uses any drugs that are sensitive cytochrome P450 2D6 (CYP2D6) substrates with a narrow therapeutic index or sensitive Pglycoprotein (P-gp) substrates after the start of washout
    19. Subject is using or has used prohibited prior and/or concomitant medication(s)
    Subject has
    20. known or suspected hypersensitivity to mirabegron or any components of the formulations used
    21. participated in another clinical study (and/or subject has received any investigational therapy within 30 days (or 5 half-lives of the drug, or the limit set by national law, whichever is longer) prior to visit 1/week - 4 (screening)
    22. Subject received urinary catheterization within 2 weeks prior to screening
    23. Constipation as defined by the Rome IV criteria that cannot be successfully treated prior to study entry
    24. Female subject who has been pregnant within 6 months prior to screening or breastfeeding within 3 months prior to screening
    25. Subject has any condition which makes the subject unsuitable for study participation
    Additional Exclusion at Visit 3/Week 0 (Baseline)
    Subject has
    26. extraordinary daytime only urinary frequency according to the ICCS definition based on the bladder e-diary
    27. monosymptomatic enuresis confirmed by the bladder e-diary
    28. a maximum voided volume (morning volume excluded) > EBC for age ([age +1] × 30) in mL, based on the bladder e-diary
    29. polyuria defined as voided urine volumes of > 40 mL/kg baseline body weight during 24 hours or > 2.8 L urine for a child weighing = 70 kg (ICCS definition) [Austin et al, 2014], based on bladder e-diary
    30. PVR volume > 20 mL (lowest PVR volume result) as measured by ultrasonography
    (Please see Protocol for further details)
    Esclusione alla Visita 1/Settimana -4 (Screening)
    1. Il soggetto presenta frequenza urinaria straordinaria solo diurna in base alla definizione dell’ICCS.
    • Ciò si applica a un bambino in grado di utilizzare la toilette che presenta frequente bisogno di svuotamento, associato a piccoli volumi di minzione esclusivamente durante il giorno.
    • La frequenza di minzione diurna è di almeno una volta all’ora con un volume di svuotamento medio <50% della prevista capacità della vescica (EBC) (tipicamente dal 10% al 15%).
    • L’incontinenza è rara e la nicturia è assente.
    Il soggetto presenta
    2. un flusso urinario indicativo di una patologia diversa dall’OAB.
    3. enuresi mono-sintomatica.
    4. svuotamento disfunzionale.
    5. ostruzione del collo vescicale, tranne se trattato con successo.
    6. anomalie anatomiche (trattate o non trattate chirurgicamente) che influiscono sulla funzionalità del tratto urinario inferiore.
    7. soggetto con ematuria al test con striscia reattiva. In caso di ematuria nel test con striscia reattiva in un soggetto di sesso femminile durante le mestruazioni, il test può essere ripetuto prima della randomizzazione (dopo la fine delle mestruazioni).
    8. soggetto con diabete insipido.
    Il soggetto presenta
    9. calcoli renali o vescicali.
    10. ha sofferto di UTI cronica o ha avuto più di 3 UTI nei 2 mesi precedenti la Visita 1/settimana -4 (screening).
    11. un polso >99° percentile per l’età.
    12. ipertensione di stadio 2 o ipertensione di stadio 1 non ben controllata, come definito dalle Linee guida di pratica clinica dell’Accademia americana di pediatria (American Academy of Pediatrics Clinical Practice Guidelines) del 2017.
    13. QTcF >440 msec all ECG di screening o un rischio di prolungamento del QT (per es., ipokaliemia, sindrome del QT lungo [LQTS] o anamnesi familiare di LQTS o sincope indotta dall’esercizio).
    14. L’aspartato aminotransferasi (AST) o alanina aminotransferasi (ALT) del soggetto è >=2 × il limite superiore alla norma (ULN) o la bilirubina totale (TBL) è >=1,5 × ULN in base a età e sesso (i soggetti affetti da sindrome di Gilbert sono esclusi dalla soglia della bilirubina).
    Il soggetto presenta
    15. insufficienza renale lieve o moderata (velocità di filtrazione glomerulare stimata in base alla Schwartz modificata <60 ml/min/1,73 m2).
    16. un’UTI sintomatica (i sintomi possono comprendere dolore, febbre, ematuria, nuova insorgenza di urine maleodoranti). Nota: se l’UTI è trattata con successo, (recupero clinico: confermato da test con striscia reattiva e test con striscia reattiva ripetuto dopo 14 giorni [entrambi devono essere negativi]), il soggetto può essere sottoposto a nuovo screening.
    17. un’anamnesi o presenza di eventuale neoplasia.
    18. Il soggetto utilizza eventuali farmaci che sono sensibili ai substrati del citocromo P450 2D6 (CYP2D6) con un indice terapeutico ristretto o sensibili ai substrati della P-glicoproteina (P-gp) dopo l’inizio del washout.
    19. Il soggetto sta utilizzando o ha utilizzato uno o più farmaci proibiti precedenti e/o concomitanti.
    Il soggetto presenta
    20. ipersensibilità nota o sospetta a mirabegron o a uno qualsiasi dei componenti delle formulazioni utilizzate.
    21. ha partecipato a un altro studio clinico (e/o il soggetto ha ricevuto eventuale terapia sperimentale nei 30 giorni (o 5 emivite del farmaco, o il limite stabilito dalle leggi nazionali, a seconda di quale sia più lungo) precedenti alla Visita 1/settimana -4 (screening).
    22. Il soggetto è stato sottoposto a cateterismo urinario entro 2 settimane prima dello screening.
    23. presenta stitichezza, come definita dai criteri di Roma IV, che non può essere trattata con successo prima dell’ingresso nello studio.
    24. Il soggetto di sesso femminile che è stato in gravidanza entro i 6 mesi prima dello screening o sta allattando entro i 3 mesi prima dello screening.
    25. Il soggetto presenta una patologia che, a giudizio dello sperimentatore, rende il soggetto non idoneo alla...
    (Fare riferimento al Protocollo per ulteriori dettagli)
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline at the end of the 12-week treatment period: Mean number of micturitions per 24 hours
    Variazione dal basale alla fine del periodo di trattamento di 12 settimane: Numero medio di minzioni nelle 24 ore
    E.5.1.1Timepoint(s) of evaluation of this end point
    at the end of the 12-week treatment period
    al termine del periodo di trattamento di 12 settimane
    E.5.2Secondary end point(s)
    • Change from baseline at the end of the 12-week treatment period:
    o Mean volume voided per 24 hours
    o Maximum volume voided
    o Mean number of daytime incontinence episodes per 24 hours
    o Mean number of nighttime incontinence episodes per 24 hours
    o Mean number of daytime micturitions per 24 hours
    • Number of dry (incontinence-free) days per 7 days at the end of the 12-week treatment
    • Nature, frequency and severity of AEs
    • Clinical laboratory tests (hematology, biochemistry and urinalysis)
    • Vital signs (blood pressure and pulse)
    • Routine 12-lead ECG
    • PVR volume
    • Acceptability and palatability questionnaire
    • Appropriate pharmacokinetic parameters will be calculated based on the population pharmacokinetic model used
    • Variazione dal basale alla fine del periodo di trattamento di 12 settimane:
    o Volume medio di svuotamento nelle 24 ore
    o Volume massimo di svuotamento
    o Numero medio di episodi di incontinenza diurni nelle 24 ore
    o Numero medio di episodi di incontinenza notturni nelle 24 ore
    o Numero medio di minzioni diurne nelle 24 ore
    • Numero di giorni senza perdite (liberi da incontinenza) per 7 giorni alla fine del periodo di trattamento di 12 settimane
    • Natura, frequenza e gravità degli EA
    • Test clinici di laboratorio (ematologia, biochimica e analisi delle urine)
    • Parametri vitali (pressione sanguigna e polso)
    • ECG a 12 derivazioni di routine
    • Volume PVR
    • Questionario su palatabilità e accettabilità
    • I parametri farmacocinetici appropriati saranno calcolati in base al modello farmacocinetico di popolazione utilizzato
    E.5.2.1Timepoint(s) of evaluation of this end point
    throughout and at the end of the 12-week treatment period
    durante e alla fine del periodo di trattamento di 12 settimane
    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 Yes
    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 Yes
    E.8.1.7.1Other trial design description
    titolazione sequenziale della dose
    sequential dose titration
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA23
    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
    Belgium
    Canada
    Denmark
    France
    Germany
    Italy
    Korea, Republic of
    Malaysia
    Mexico
    Netherlands
    Norway
    Philippines
    Poland
    Russian Federation
    Serbia
    South Africa
    Spain
    Turkey
    Ukraine
    United Kingdom
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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 Yes
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 368
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 64
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Subjects may be hospitalized for medical care under direction of their parents or PI's decision
    I soggetti possono essere ricoverati in ospedale per cure mediche dietro richiesta dei genitori o per decisione dello sperimentatore
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 226
    F.4.2.2In the whole clinical trial 432
    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 Decision2020-12-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-02-03
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, visit the EMA Service Desk , log in using your EMA account and open a ticket specifying "EU CTR" in your request.
    If you do not have an account, please visit the EMA Account management page page click on "Create an EMA account" and follow the instructions.
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2022 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA