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    Summary
    EudraCT Number:2010-024179-18
    Sponsor's Protocol Code Number:A0221094
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-12-27
    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 number2010-024179-18
    A.3Full title of the trial
    A 14 WEEK RANDOMIZED PARALLEL GROUP PLACEBO-CONTROLLED DOUBLE-BLIND MULTICENTRE STUDY OF FESOTERODINE 8 MG IN OVERACTIVE BLADDER PATIENTS WITH SUB-OPTIMAL RESPONSE TO TOLTERODINE 4 MG ER
    STUDIO DI 14 SETTIMANE, MULTICENTRICO, RANDOMIZZATO, A GRUPPI PARALLELI, CONTROLLATO CON PLACEBO, IN DOPPIO CIECO, SU FESOTERODINA 8 MG IN PAZIENTI CON VESCICA IPERATTIVA CON RISPOSTA SUBOTTIMALE A TOLTERODINA 4 MG A RILASCIO PROLUNGATO
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study in patients with overactive bladder with leakage of urine, to find out if the medicine, fesoterodine, works in those patients who did not have enough response to the medicine, tolterodine.
    Uno studio clinico in pazienti con vescica iperattiva con perdita di urina, volto a valutare se il farmaco fesoterodine funziona in quei pazienti che non hanno avuto risposta soddisfacente al farmaco tolterodine.
    A.3.2Name or abbreviated title of the trial where available
    AFTER
    AFTER
    A.4.1Sponsor's protocol code numberA0221094
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01302054
    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 SponsorPFIZER 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 supportPfizer Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPfizer Inc.
    B.5.2Functional name of contact pointClinical Trials.gov Calla Center
    B.5.3 Address:
    B.5.3.1Street Address235 East 42nd Street
    B.5.3.2Town/ cityNew York
    B.5.3.3Post codeNY 10017
    B.5.3.4CountryUnited States
    B.5.4Telephone number001 800 7181021
    B.5.5Fax number001 303 739 1119
    B.5.6E-mailClinicalTrials.govCallCentrere@pfizer.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 Toviaz
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Ltd.
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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.3.4Pharmaceutical 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 INNFESOTERODINE FUMARATE
    D.3.9.1CAS number 286930-03-8
    D.3.9.3Other descriptive namefesoterodine fumarate
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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 Toviaz
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Ltd.
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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.3.4Pharmaceutical 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 INNFESOTERODINE FUMARATE
    D.3.9.1CAS number 286930-03-8
    D.3.9.3Other descriptive namefesoterodine fumarate
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 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: 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 Yes
    D.2.1.1.1Trade name Detrusitol
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer AB
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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.3.4Pharmaceutical form Prolonged-release capsule
    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 INNTOLTERODINE L-TARTRATE
    D.3.9.1CAS number 124937526
    D.3.9.3Other descriptive namePNU-200583E, tolterodine tartrate
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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 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
    Vescica iperattiva
    E.1.1.1Medical condition in easily understood language
    Overactive bladder
    Vescica iperattiva
    E.1.1.2Therapeutic area Diseases [C] - Symptoms and general pathology [C23]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10059617
    E.1.2Term Overactive bladder
    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 determine the efficacy of 8 mg fesoterodine on UUI reduction in OAB patients with suboptimal response to tolterodine over time and in comparison with placebo.
    Determinare l’efficacia di fesoterodina 8 mg sulla riduzione dell’incontinenza urinaria da urgenza(UUI) nei pazienti con vescica iperattiva (OAB) con risposta subottimale a tolterodina nel tempo e in confronto al placebo.
    E.2.2Secondary objectives of the trial
    - To determine the efficacy of 8 mg fesoterodine on frequency and urgency in OAB patients with suboptimal response to tolterodine over time and in comparison with placebo; - To determine the efficacy of 8 mg fesoterodine on quality of life patients reported outcomes in OAB patients with suboptimal response to tolterodine, over time and in comparison with placebo; - To determine the tolerability and safety of 8 mg fesoterodine in OAB patients with suboptimal response to tolterodine.
    - Determinare l’efficacia di fesoterodina 8 mg per quanto riguarda la frequenza e l’urgenza nei pazienti OAB con risposta subottimale a tolterodina nel tempo e in confronto al placebo; - Determinare l’efficacia di fesoterodina 8 mg negli esiti riferiti dai pazienti sulla qualità della vita nei pazienti OAB con risposta subottimale a tolterodina nel tempo e in confronto al placebo; - Determinare la tollerabilità e la sicurezza di fesoterodina 8 mg nei pazienti OAB con risposta subottimale a tolterodina.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study. 2. Male or female subjects aged ≥18. 3. Overactive bladder symptoms (subject-reported) for ≥6 months prior to Screening Visit 1 according to ICS guidelines. 4. Rate their bladder condition as ''Some Moderate Problems'', ''Severe Problems'', or ''Many Severe Problems'' on the Patient Perception of Bladder Condition (PPBC) questionnaire. 5. Female subjects of childbearing potential must not be pregnant, lactating or intending to become pregnant during the course of the study. Those who are heterosexually active must use an adequate form of contraception to prevent pregnancy during the study. Reliable contraceptive methods may include intrauterine devices (IUD), the combined oral contraceptive pill, hormonal implants, injectable contraceptives or latex condoms with a spermicide. 6. Subjects who are willing and able to comply with scheduled visits, the self completion of study questionnaires and symptom diaries, and other study-related activities. In addition at Visit 2 Eligibility (Week -2) 1. Mean urinary frequency of ≥8 micturitions per 24 hours as verified by the screening bladder diary. 2. ≥2 and <15 mean UUI episodes per 24 hours prior to Visit 2 (UUI episodes are defined as those with Urinary Sensation Scale rating of 5). In addition at Visit 3 Randomization (Week 0) 1. Change in mean UUI per 24 hours of ≤50% between Visit 2 and Visit 3.
    1. Evidenza di un documento di consenso informato personalmente firmato e datato indicante che il soggetto (o un suo rappresentante legalmente accettabile) è stato informato di tutti gli aspetti pertinenti allo studio. 2. Soggetti di sesso maschile o femminile di età ≥18 anni. 3. Sintomi di vescica iperattiva (riportati dal soggetto) per ≥ 6 mesi precedenti la Visita di screening 1 secondo le linee guida ICS. 4. Valutazione della condizione della loro vescica come “Alcuni problemi moderati”, “Problemi gravi” o “Molti problemi gravi” nel questionario sulla percezione del paziente riguardo alla patologia della vescica (PPBC). 5. I soggetti di sesso femminile potenzialmente fertili non devono essere in stato di gravidanza, in allattamento o intenzionati ad iniziare una gravidanza nel corso dello studio. Gli eterosessuali attivi devono usare un’adeguata forma di contraccezione per prevenire la gravidanza durante lo studio. Metodi contraccettivi affidabili possono includere dispositivi intrauterini (IUD), la pillola contraccettiva orale combinata, impianti ormonali, contraccettivi iniettabili o preservativi in lattice con uno spermicida. 6. Soggetti che siano disposti e siano in grado di sottoporsi alle visite programmate, a compilare da sé i questionari di studio e i diari dei sintomi e altre attività relative allo studio. In aggiunta alla Visita 2 di idoneità (Settimana -2) 1. Frequenza urinaria media di ≥ 8 minzioni in 24 ore, verificata dal diario della vescica. 2. Una media di ≥2 e &lt;15 di episodi UUI nelle 24 ore precedenti la Visita 2 (sono definiti episodi UUI quelli con valutazione della scala della sensazione urinaria pari a 5). In aggiunta alla Visita 3 di Randomizzazione(Settimana 0) 1. Variazione nella media UUI nelle 24 ore di ≤50% fra la Visita 2 e la Visita 3.
    E.4Principal exclusion criteria
    1. Subjects who are investigational site staff members or subjects who are Pfizer employees directly involved in study conduct 2.Any condition that would contraindicate their use of tolterodine or fesoterodine including: hypersensitivity to tolterodine tartrate or fesoterodine fumarate or to peanut, soya or to any of excipients, urinary retention, gastric retention, uncontrolled narrow angle glaucoma, myasthenia gravis, severe hepatic impairment (Child Pugh C), severe ulcerative colitis and toxic megacolon. 3. Conditions or prior treatment that may also affect bladder function: a. Neurologic conditions such as spinal dysraphism, stroke, multiple sclerosis, spinal cord injury, or Parkinson's disease, which are known or suspected of influencing subject's bladder function. b. Significant pelvic organ prolapse defined as tissue visible through introitus in lithotomy position at rest, without increase in intra abdominal pressure. c. Symptoms of predominately stress urinary incontinence as determined by investigator. d. Any history of major lower urinary tract/pelvic surgery with permanent or ongoing effects on bladder function. e. A known history of interstitial cystitis/bladder pain syndrome or a significant pain component associated with OAB symptoms, uninvestigated hematuria, urogenital cancer, interstitial or external radiation to the pelvis or external genitalia, or bladder outlet obstruction due to vesical neck contracture, clinical suspicion of prostate carcinoma, mullerian duct cysts, urethral obstruction due to stricture/valves/sclerosis or urethral tumor, genito-urinary tuberculosis, bladder calculi, or detrusor-sphincter dyssynergia. f. Bladder outlet obstruction evidenced by previous history of acute urinary retention requiring catheterization, use of indwelling catheter or intermittent selfcatheterization program, urodynamic evidence of obstruction or severe voiding symptoms and any ongoing clinically significant post-void residual volume of >200 mL.
    1. Soggetti membri del personale del centro di sperimentazione o dipendenti di Pfizer direttamente coinvolti nella conduzione dello studio. 2. Qualsiasi condizione che controindicherebbe l’uso da parte dei soggetti di tolterodina o fesoterodina, tra cui: l’ipersensibilità al tolterodina tartrato o al fesoterodina fumarato o alle arachidi o alla soia o a un qualunque eccipiente, ritenzione urinaria, ritenzione gastrica, glaucoma acuto ad angolo stretto, miastenia grave, gravi problemi epatici (Child Pugh C), colite ulcerosa grave e megacolon tossico. 3. Patologie o trattamenti precedenti che potrebbero compromettere anche la funzionalità della vescica: a. Patologie neurologiche come disrafismo spinale, colpo apoplettico, sclerosi multipla,lesioni del midollo spinale, o morbo di Parkinson, che hanno nota o sospetta influenza sulla funzione della vescica del soggetto. b. Significativo prolasso dell’organo pelvico definito come tessuto visibile attraverso l’orifizio vaginale in posizione litotomica a riposo, senza aumento in pressione intra-addominale. c. Sintomi di incontinenza prevalentemente causata da stress in base alla valutazione dallo sperimentatore. d. Qualsiasi tipo di storia relativa a chirurgia maggiore del tratto urinario inferiore/pelvica con effetti permanenti o in corso sulla funzione della vescica. e. Una nota storia di cistite interstiziale/sindrome di dolore alla vescica o una significativa componente di dolore associata a sintomi OAB, ematuria non esaminata, cancro urogenitale, radiazione interstiziale o esterna della pelvi o dei genitali esterni, o ostruzione dell’apertura della vescica dovuta a contrazione del collo della vescica, sospetto clinico di carcinoma prostatico, cisti del canale di Muller, ostruzione uretrale dovuta a restringimento/valvole/sclerosi o tumore uretrale, tubercolosi genitourinaria, calcoli alla vescica, o dissinergia detrusore-sfintere. f. Ostruzione dell’orifizio vescicale, evidenziata da una storia precedente di ritenzione urinaria acuta richiedente cateterizzazione, uso di un catetere permanente o di un programma di autocateterizzazione intermittente, evidenza urodinamica di ostruzione o gravi sintomi di evacuazione e qualsiasi volume post-evacuazione residuo clinicamente significativo di &gt;200 ml in corso.
    E.5 End points
    E.5.1Primary end point(s)
    Change in mean number of urgency urinary incontinence (UUI) episodes per 24 hours at Week 12 (Visit 5) relative to Week 0 (Visit 3), defined as those micturitions with Urinary Sensation Scale rating of 5 in the diary.
    Variazione del numero medio di episodi da incontinenza da urgenza urinaria (UUI) per 24 ore alla settimana 12 (Visita 5) rispetto alla settimana 0 (Visita 3), definito come quelle minzioni con valore della scala Urinary Sensation urinaria pari a 5 nel diario.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12 (visit 5) compared to Week 0 (visit 3).
    Settimana 12 (visita 5) in confronto alla settimana 0 (visita 3).
    E.5.2Secondary end point(s)
    Efficacy - Change in mean number of micturitions (frequency) per 24 hours at Week 12 (Visit 5) relative to Week 0 (Visit 3); Change in mean number of micturition-related urgency episodes per 24 hours at Week 12 (Visit 5) relative to Week 0 (Visit 3), defined as those micturitions with Urinary Sensation Scale rating of ≥3 in the bladder diary; Change in Patient Perception of Bladder Condition (PPBC) at Week 12 (Visit 5)relative to Week 0 (Visit 3); Change in Urgency Perception Scale (UPS) at Week 12 (Visit 5) relative to Week 0; Change in Overactive Bladder Questionnaire (OAB-q) symptom bother score and change in the Total Health-Related Quality of Life (HRQL) score of the OAB-q and score of each HRQL domain of the OAB-q at Week 12 (Visit 5) relative to Week 0 (Visit 3); Responder rates from Week -2 (Visit 2) to Week 12 (Visit 5) and from Week 0 (Visit 3) to Week 12 (Visit 5), defined as a >50% reduction in UUI episode frequency; Diary dry rate at Week 4 (Visit 4) and Week 12 (EOT). Safety and tolerability: Adverse events; Vital Signs; Urinalysis and urine culture at Screening (Visit 1), Week -2 (Visit 2) and Week 12, (Visit 5).
    Efficacia - variazione nel numero medio di minzioni (in termini di frequenza) per 24 ore alla settimana 12 (visita 5) rispetto alla settimana 0 (visita 3);variazione nel numero medio di episodi di urgenza legati alla minzione per 24 ore alla settimana 12 (visita 5) rispetto alla settimana 0 (visita 3), definita come quelle monzioni con valore della scala urinary sensation ≥3 nel diario della vescica. Cambiamento nella PPBC alla settimana 12 (visita 5) rispetto alla settimana 0 (visita 3); cambiamwento nella scala UPS alla settimana 12 (visita 5) rispetto alla visita 0 (settimana 3); cambiamento nei sintomi nel questionario OAB-q e cambiamento nel punteggio della scala HRQL e nel punteggio di ciascun dominio HRQL della OAB-q alla settimana 12 (Visita 5) rispetto alla settimana 0 (Visita 3); Percentuale di risposta da Settimana -2 (Visita 2) alla settimana 12 (Visita 5) e da Settimana 0 (Visita 3) alla settimana 12 (Visita 5), definita come una riduzione del 50% nella frequenza degli episodi UUI; Diary dry rate alla settimana 4 (Visita 4) e alla settimana 12 (EOT). Sicurezza e tollerabilità: Gli eventi avversi, segni vitali; analisi delle urine e urinocultura allo screening (Visita 1), Settimana -2 (Visita 2) e alla settimana 12, (Visita 5).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 12 (visit 5) compared to week 0 (visit 3).
    Settimana 12 (visita 5) in confronto alla settimana 0 (visita 3).
    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 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 Yes
    E.6.13.1Other scope of the trial description
    tolerability
    tollerabilità
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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
    run-in di 2 settimane con tolterodine in aperto
    2 week open label tolterodine run-in
    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 trial1
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA100
    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
    Brazil
    Colombia
    Egypt
    India
    Korea, Democratic People's Republic of
    Korea, Republic of
    Mexico
    Russian Federation
    South Africa
    Turkey
    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
    LVLS.
    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 months17
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months17
    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.1.1Number of subjects for this age range: 0
    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: 379
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 187
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 160
    F.4.2.2In the whole clinical trial 566
    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)
    In countries where legisation requires, the sponsor agrees to provide an uninterrupted supply of study drug to study participants after they leave the trial, for a maximum period of 6 months which will coincide with launch of the study drug in each respective country.
    Nei paesi dove la legislazione lo consente, lo sponsor accetta di fornire il farmaco ai partecipanti allo studio per un periodo di tempo non superiore a 6 mesi dalla conclusione dello studio stesso che coinciderà con il lancio del farmaco nei rispettivi paesi.
    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 Decision2011-10-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-10-03
    P. End of Trial
    P.End of Trial StatusCompleted
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