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    Summary
    EudraCT Number:2012-005736-29
    Sponsor's Protocol Code Number:178-CL-102
    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:2013-11-28
    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 number2012-005736-29
    A.3Full title of the trial
    A Randomized, Double-Blind, Parallel-Group, Active-Controlled, Multi-center Study to Evaluate the Long-Term Safety and Efficacy of Combination of Solifenacin Succinate with Mirabegron Compared to Solifenacin Succinate and Mirabegron Monotherapy in Subjects with Overactive Bladder
    Studio multicentrico randomizzato, in doppio cieco, a gruppi paralleli, controllato verso controllo attivo per valutare la sicurezza a lungo termine e l’efficacia della combinazione di solifenacina succinato e mirabegron rispetto alle corrispondenti monoterapie in soggetti con vescica iperattiva.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to assess the long-term efficacy and safety of two medicines, solifenacin succinate and mirabegron, taken together or separately, in patients with overactive bladder
    Questo studio intende valutare la sicurezza a lungo termine e l’efficacia di due farmaci, solifenacina succinato e mirabegron, presi assieme o separatamente, in soggetti con vescica iperattiva.
    A.4.1Sponsor's protocol code number178-CL-102
    A.5.4Other Identifiers
    Name:SYNERGY IINumber:Study Name
    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 SponsorAstellas Pharma Europe B.V.
    B.1.3.4CountryNetherlands
    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 Europe B.V.
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstellas Pharma Europe B.V.
    B.5.2Functional name of contact pointService Desk - Gobal Clinical Dev't
    B.5.3 Address:
    B.5.3.1Street AddressSylviusweg 62
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2300 AH
    B.5.3.4CountryNetherlands
    B.5.6E-mailcontact@nl.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 Vesiker
    D.2.1.1.2Name of the Marketing Authorisation holderAstellas Pharma SpA
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 namesolifenacin succinate
    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 INNsolifenacin succinate
    D.3.9.1CAS number 242478-38-2
    D.3.9.2Current sponsor codeYM905
    D.3.9.3Other descriptive nameSOLIFENACIN SUCCINATE
    D.3.9.4EV Substance CodeSUB21028
    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 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 Betmiga
    D.2.1.1.2Name of the Marketing Authorisation holderAstellas Pharma Europe B.V.
    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 YM178
    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.3.9.3Other 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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    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
    Overactive Bladder
    Sindrome della vescica iperattiva.
    E.1.1.1Medical condition in easily understood language
    Overactive Bladder
    vescica iperattiva
    E.1.1.2Therapeutic area Body processes [G] - Physical Phenomena [G01]
    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 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 safety and tolerability of long-term combination treatment of solifenacin (5 mg) with mirabegron (50 mg) compared to solifenacin and mirabegron monotherapy in subjects with overactive bladder (OAB)
    Valutare la sicurezza e la tollerabilità a lungo termine del trattamento combinatoa base di solifenacina (5 mg) e mirabegron (50 mg) rispetto alla monoterapia di solifenacina e mirabegron nei soggetti con vescica iperattiva.
    E.2.2Secondary objectives of the trial
    To evaluate efficacy of long-term combination treatment with solifenacin and mirabegron

    To evaluate Patient Reported Outcomes (PRO) during long-term combination treatment with solifenacin and mirabegron
    Valutare l’efficacia a lungo termine del trattamento combinatoa base di solifenacina e mirabegron

    Valutare i PRO (Patient Reported Outcomes) a lungo termine deltrattamentocombinatoa base di solifenacina e mirabegron
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Subject is male or female and at least 18 years of age;
    • Subject is willing and able to complete the micturition diary and questionnaires correctly and able to measure his/her vital signs at home at stipulated time points, using the device provided by the study personnel, and to adequately record the readings;
    • Subject has symptoms of “wet” OAB for at least three months
    - Il soggetto è di sesso maschile o femminile, e di almeno 18 anni di età.
    - Il soggetto è disposto ed è in grado di compilare il diario sulla minzione e i questionari correttamente, ed è in grado di misurare i propri segni vitali a casa alle scadenze convenute, utilizzando il dispositivo fornito dal personale dello studio, e di registrare correttamente le letture.
    - Il soggetto ha sintomi di OAB "bagnata" da almeno 3 mesi.
    E.4Principal exclusion criteria
    • Subject has neurological cause for detrusor overactivity (e.g.
    neurogenic bladder, diabetic neuropathy or systemic or central
    neurological disease such as multiple sclerosis and Parkinson's disease).
    • Subject has chronic inflammation such as bladder pain syndrome /
    interstitial cystitis, symptomatic bladder stones or any previous or
    current radiation cystitis.
    • Subject has moderate to severe hepatic impairment
    • Subject has severe renal impairment
    • Subject has a clinically significant abnormal ECG
    • Subject has a concurrent malignancy or history of cancer (except
    noninvasive skin cancer) within the last 5 years prior to screening.
    • Subject has a QTcF interval > 450 ms for males or > 470 ms for
    females or is at risk of QT prolongation (e.g., family history of long QT
    syndrome, hypokalaemia).
    • Subject has severe hypertension, which is defined as a sitting
    average systolic blood pressure ≥ 180 mmHg and/or average diastolic
    blood pressure ≥ 110 mmHg.
    • In the opinion of the investigator the subject has clinically significant bladder outflow obstruction at risk of urinary retention;
    • Subject has significant PVR volume (> 150 mL);
    • Subject has significant stress incontinence or mixed stress/urgency incontinence where stress is the predominant factor as determined by the investigator;
    • Subject has an indwelling catheter or practices intermittent self-catheterization;
    • Subject has evidence of urinary tract infection (UTI), chronic inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation therapy or previous or current malignant disease of the pelvic organs;
    • Subject has had intravesical treatment in the past 12 months with e.g., botulinum toxin, resiniferatoxin, capsaicin;
    - Il soggetto presenta una causa neurologica di iperattività detrusoriale (per es. vescica neurogena, neuropatia diabetica o malattia neurologica sistemica o centrale come sclerosi multipla e morbo
    di Parkinson).
    - Il soggetto presenta un’infiammazione cronica come per esempio sindrome della vescica dolorosa/cistite interstiziale, calcoli vescicali sintomatici o qualunque forma presente o passata
    di cistite da radiazioni.
    - Il soggetto è affetto da compromissione epatica da moderata a grave.
    - Il soggetto è affetto da compromissione renale grave.
    - Il soggetto presenta un ECG non nella norma in modo clinicamente significativo.
    -Il soggetto è affetto o è stato affetto da una patologia maligna o tumore ( ad eccezione del tumore della pelle) nei 5 anni precedenti lo screening.
    - Il soggetto ha un intervallo QTcF > 450 ms nel caso di pazienti di sesso maschile o > 470 ms nel caso di pazienti di sesso femminile o è a rischio di prolungamento dell’intervallo QT (per es. anamnesi familiare che presenta sindrome del QT lungo, ipocalemia).
    - Il soggetto è affetto da ipertensine grave, definita come pressione sistolica media rilevata in posizione seduta ≥ 180 mmHg e/o pressione arteriosa diastolica media ≥ 110 mmHg.
    - A parere del ricercatore, il soggetto presenta un’ostruzione del flusso urinario clinicamente significativa, con rischio di ritenzione urinaria.
    - Il soggetto presenta un volume di PVR significativo (> 150 mL).
    - Secondo quanto determinato dal ricercatore, il soggetto presenta un’incontinenza da stress significativa o un’incontinenza mista da stress/urgenza in cui lo stress è il fattore predominante.
    - Il soggetto ha un catetere a dimora o pratica l’autocateterizzazione intermittente
    - Il soggetto presenta un’infiammazione cronica come per esempio sindrome della vescica dolorosa/cistite interstiziale, calcoli vescicali sintomatici o qualunque forma presente o passata di cistite da radiazioni.
    - Il soggetto ha ricevuto trattamento intravescicale negli ultimi 12 mesi come per esempio tossina botulinica, resiniferatossina, capsaicina.
    E.5 End points
    E.5.1Primary end point(s)
    • Incidence and severity of treatment emergent adverse events (TEAEs)

    Primary Efficacy Variables
    • Change from baseline in mean number of incontinence episodes per 24 hours at EoT
    • Change from baseline in mean number of micturitions per 24 hours at EoT
    Incidenza e severità degli eventi avversi derivanti dal trattamento (TEAE)

    Variabili di efficacia primarie
    • Variazione nel numero medio di episodi di incontinenza ogni 24 ore dalla baseline alla fine del trattamento
    • Variazione nel numero medio di episodidi minzione ogni 24 ore dalla baseline alla fine del trattamento
    E.5.1.1Timepoint(s) of evaluation of this end point
    EoT
    Fine del trattamento
    E.5.2Secondary end point(s)
    • Vital signs
    • Laboratory test
    • ECG parameters
    • PVR
    • Segni vitali
    • Test di laboratorio
    • Parametri ECG
    • Resistenza vascolare polmonare (Pulmonary Vascular Resistance - PVR)
    E.5.2.1Timepoint(s) of evaluation of this end point
    EoT
    Fine del trattamento
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 EEA188
    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
    Argentina
    Australia
    Belgium
    Brazil
    Bulgaria
    Canada
    Chile
    China
    Colombia
    Czech Republic
    Denmark
    Estonia
    Finland
    France
    Germany
    Greece
    Hong Kong
    Hungary
    India
    Indonesia
    Italy
    Korea, Republic of
    Latvia
    Lithuania
    Malaysia
    Mexico
    Netherlands
    New Zealand
    Norway
    Peru
    Philippines
    Poland
    Romania
    Russian Federation
    Singapore
    Slovakia
    Slovenia
    South Africa
    Spain
    Sweden
    Taiwan
    Thailand
    Turkey
    Ukraine
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    Ultima visita dell'ultimo soggetto in studio
    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 months1
    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 months1
    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: 1728
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 672
    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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 600
    F.4.2.2In the whole clinical trial 1800
    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 Decision2014-01-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-12-11
    P. End of Trial
    P.End of Trial StatusOngoing
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