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   35504   clinical trials with a EudraCT protocol, of which   5838   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).
     
    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:2007-001452-39
    Sponsor's Protocol Code Number:178-CL-049(TAURUSstudy)
    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:2008-04-23
    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 number2007-001452-39
    A.3Full title of the trial
    A Randomized, Double-Blind, Parallel Group, Active Controlled, Multi-center Long-term Study to Assess the Safety and Efficacy of the Beta-3 Agonist YM178 (50 mg qd and 100 mg qd) in Subjects with Symptoms of Overactive Bladder
    A Randomized, Double-Blind, Parallel Group, Active Controlled, Multi-center Long-term Study to Assess the Safety and Efficacy of the Beta-3 Agonist YM178 (50 mg qd and 100 mg qd) in Subjects with Symptoms of Overactive Bladder
    A.3.2Name or abbreviated title of the trial where available
    taurus
    taurus
    A.4.1Sponsor's protocol code number178-CL-049(TAURUSstudy)
    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 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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 nameYM178
    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 INNOTHER UROLOGICALS, INCL. ANTISPASMODICS
    D.3.9.1CAS number 223673-61-8
    D.3.9.2Current sponsor codeYM178
    D.3.10 Strength
    D.3.10.1Concentration unit mg/h milligram(s)/hour
    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.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 nameYM178
    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 INNOTHER UROLOGICALS, INCL. ANTISPASMODICS
    D.3.9.1CAS number 223673-61-8
    D.3.9.2Current sponsor codeYM178
    D.3.10 Strength
    D.3.10.1Concentration unit mg/h milligram(s)/hour
    D.3.10.3Concentration number100
    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 RoleComparator
    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 SR 4 mg
    D.2.1.1.2Name of the Marketing Authorisation holderPharmacia Ltd
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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, 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 INNOTHER UROLOGICALS, INCL. ANTISPASMODICS
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Symptoms of overactive bladder
    vescica iperattiva sintomatica
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level SOC
    E.1.2Classification code 10038359
    E.1.2Term Renal and urinary disorders
    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 assess the safety and tolerability of long-term treatment with YM178 (50 mg
    qd and 100 mg qd) in subjects with symptoms of overactive bladder.
    Determinare la sicurezza e la tollerabilita' del trattamento a lungo termine con YM178 (50 mg qd e 100 mg qd) in soggetti con sintomi di vescica iperattiva (OAB).
    E.2.2Secondary objectives of the trial
    To assess the efficacy of long-term treatment with YM178 (50 mg qd and 100
    mg qd) in subjects with symptoms of overactive bladder.
    To compare the long-term safety and efficacy of YM178 with tolterodine ER 4
    mg qd in the treatment of subjects with symptoms of overactive bladder.
    Determinare l'efficacia del trattamento a lungo termine con YM178 (50 mg qd e 100 mg qd) in soggetti con sintomi di vescica iperattiva.
    Confrontare la sicurezza e l'efficacia a lungo termine di YM178 con tolterodina ER 4 mg qd nel trattamento di soggetti con sintomi di vescica iperattiva.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subject is eligible for the study if all of the following apply:
    Inclusion criteria at Visit 1/screening
    1. Male or female subject aged &#8805; 18 years.
    2. Institutional Review Board (IRB)-/Independent Ethics Committee (IEC)-
    approved written Informed Consent and privacy language as per national
    regulations is obtained from the subject or legally authorized representative
    (prior to any study-related procedures; including withdrawal of prohibited
    medication, if applicable).
    3. Subject is willing and able to complete the micturition diary and
    questionnaires correctly.
    4. Subject has symptoms of overactive bladder (urinary frequency and
    urgency with or without urge incontinence) for &#8805; 3 months.
    Inclusion criteria at Visit 2/baseline
    5. Subject experiences frequency of micturition on average &#8805; 8 times per 24-
    hour period during the 3-day micturition diary period.
    6. Subject must experience at least 3 episodes of urgency with or without
    incontinence (grade 3 or 4), during the 3-day micturition diary period.
    7. Subject must still fulfill all inclusion criteria and none of the exclusion
    criteria from Visit 1.
    Il soggetto e' idoneo per lo studio se si applicano tutti i seguenti:

    Criteri di inclusione alla Visita 1/screening
    1. Soggetto di entrambi I sessi di eta' &#8805; 18 anni.
    2. E' stato ottenuto, dal soggetto o dal tutore legale, il consenso informato scritto assieme all'approvazione delle clausole relative alla privacy, nella forma approvata dalla Commissione di Revisione dell'Istituzione (Institutional Review Board, IRB)-/Comitato Etico Indipendente (Independent Ethics Committee, IEC) conformemente alle normative nazionali (prima di qualsiasi procedura connessa allo studio; compresa, se si applica, la sospensione dei medicinali non ammessi).
    3. Il soggetto intende compilare, ed e' in grado di farlo correttamente, il diario e i questionari sulla minzione.
    4. Il soggetto presenta sintomi di iperattivita' della vescica (frequenza e urgenza urinaria con o senza incontinenza da urgenza) per &#8805; 3 mesi.

    Criteri di inclusione alla Visita 2/basale
    5. Il soggetto manifesta frequenza della minzione in media &#8805; 8 volte nelle 24 ore durante il periodo di 3 giorni di compilazione del diario della minzione.
    6. Il soggetto deve manifestare almeno 3 episodi di urgenza con o senza incontinenza(di grado 3 o 4), durante il periodo di 3 giorni di compilazione del diario della minzione.
    7. Dalla Visita 1, il soggetto soddisfa ancora tutti i criteri di inclusione e non presenta alcuno dei criteri di esclusione.
    E.4Principal exclusion criteria
    Subject will be excluded from participation if any of the following apply:
    Exclusion criteria at Visit 1/screening
    1. Subject is breastfeeding, pregnant, intends to become pregnant during the
    study, or of childbearing potential, sexually active and not practicing a
    highly reliable method of birth control (these are methods with a failure
    quotient of <1% per year such as hormonal implants, injectable
    contraceptives, oral contraceptives of combination type, intra-uterine
    pessaries restricted to hormone contraceptive coil, sexual abstinence or
    vasectomy of the partner). The pregnancy test (&#946;-HCG in serum) at Visit 1
    needs to be negative in women of childbearing potential.
    2. Subject has clinically significant bladder outflow obstruction at risk of
    urinary retention (at the discretion of the investigator).
    3. Subject has significant stress incontinence or mixed stress/urge incontinence
    where stress is the predominant factor as determined by the investigator (for
    female subjects confirmed by a cough provocation test (Appendix 4)).
    4. Subject has an indwelling catheter or practices intermittent selfcatheterization.5. Subject has diabetic neuropathy.
    6. Subject has evidence of a symptomatic urinary tract infection, chronic
    inflammation such as interstitial cystitis, bladder stones, previous pelvic
    radiation therapy or previous or current malignant disease of the pelvic
    organs.
    7. Subject has uncontrolled narrow angle glaucoma, urinary or gastric
    retention, severe colitis ulcerosa, toxic megacolon, myasthenia gravis or any
    other medical condition which in the opinion of the investigator makes the
    use of anticholinergics contraindicated.
    8. Subject receives current non-drug treatment including electro-stimulation
    therapy (a bladder training program or pelvic floor exercises which started
    more than 30 days prior to entry into the study can be continued).
    9. Subject is using medications intended to treat OAB or prohibited
    medications listed in Appendix 1 Part A. Subject is excluded if using
    restricted medications (Appendix 1, Part B) and conditions specified in
    Appendix 1, Part B are not met.
    10. Subject has a known or suspected hypersensitivity to tolterodine, other
    anticholinergics, YM178, other ß-AR agonists, or lactose or any of the other
    inactive ingredients.
    11. Subject has any clinically significant condition, which in the opinion of the
    investigator makes the subject unsuitable for the study.
    12. Subject has been treated with any investigational drug within 30 days (90 in
    the UK for all clinical studies except 178-CL-046) prior to Visit 1
    /screening.
    13. Subject is an employee of the Astellas Group, third parties associated with
    the study, or the clinical study site team.
    Exclusion criteria at Visit 2/baseline
    14. Subject has an average total daily urine volume > 3000 mL as recorded in
    the 3-day micturition diary period.
    15. Subject has - in the opinion of the investigator - clinically significant
    increases in laboratory values as assessed in Visit 1 samples (e.g. serum
    creatinine >150 umol/L, AST and/or ALT > 2x upper limit of normal range
    (ULN), or &#947;-GT > 3x ULN)
    16. Subject has an abnormal ECG, which in the opinion of the investigator
    makes the subject unsuitable for the study.
    Il soggetto verra' escluso dalla partecipazione se si applica uno qualsiasi dei seguenti:

    Criteri di esclusione alla Visita 1/screening
    1. Il soggetto sta allattando al seno, e' incinta, intende avviare una gravidanza durante lo studio, o, essendo in grado di avere figli, e' sessualmente attiva e non segue alcun metodo di controllo delle nascita altamente affidabile (vale a dire i metodi con un tasso di fallimento &lt;1% annuo quali impianti ormonali, contraccettivi iniettabili, contraccettivi orali combinati, pessari intrauterini, limitatamente alle spirali medicate a rilascio ormonale, astinenza sessuale o vasectomia del partner). Nelle donne in grado di avere figli il test di gravidanza (&#946;-HCG nel siero) alla Visita 1 deve essere negativo.
    2. Il soggetto presenta una significativa ostruzione allo svuotamento vescicale che lo pone a rischio di ritenzione urinaria (a discrezione dello sperimentatore).
    3. Il soggetto presenta una significativa incontinenza da sforzo o incontinenza mista da sforzo/urgenza dove lo sforzo rappresenti il fattore predominante, in base a quanto accertato dallo sperimentatore (per i soggetti di sesso femminile, confermato da un test di provocazione con tosse (Appendice 4)).
    4. Il soggetto ha un catetere permanente o pratica l'autocateterizzazione intermittente.
    5. Il soggetto presenta una neuropatia diabetica.
    6. Il soggetto presenta evidenza di infezione sintomatica del tratto urinario, infiammazione cronica quale la cistite interstiziale, calcoli vescicali, precedente terapia radiante nella regione pelvica o precedente o attuale patologia maligna a carico degli organi pelvici.
    7. Il soggetto presenta glaucoma ad angolo acuto non controllato, ritenzione urinaria o gastrica, colite ulcerosa severa, megacolon tossico, miastenia grave o qualsiasi altra condizione medica che, a giudizio dello sperimentatore, renda controindicato l'uso di anticolinergici.
    8. Il soggetto riceve terapia non farmacologica compresa la terapia mediante elettrostimolazione (un programma di riabilitazione della vescica o di esercizi per il pavimento pelvico iniziati piu' di 30 giorni prima dell'ingresso nello studio puo' essere proseguito).
    9. Il soggetto sta facendo uso di medicinali per la cura della OAB o di medicinali non ammessi elencati in Appendice 1, Parte A.Il soggetto e' escluso se sta usando medicinali soggetti a limitazione (Appendice 1, Parte B) e non sono soddisfatte le condizioni specificate nell'Appendice 1, Parte B.
    10. Il soggetto ha una nota o sospetta ipersensibilita' a tolterodina, ad altri anticolinergici, a YM178, ad altri ß-AR agonisti, o al lattosio o a uno qualsiasi degli altri ingredienti inattivi.
    11. Il soggetto presenta qualsiasi altra condizione clinicamente significativa che, a giudizio dello sperimentatore, renda il soggetto inadatto allo studio.
    12. Il soggetto e' stato trattato con un farmaco o un dispositivo sperimentale di qualsiasi tipo nei 30 giorni (90 giorni nel regno Unito) precedenti la Visita 1/screening.
    13. Il soggetto e' un dipendente del Gruppo Astellas, di soggetti terzi associati allo studio, o fa parte del personale del sito dove si svolge lo studio clinico.

    Criteri di esclusione alla Visita 2/basale
    14. Il soggetto ha prodotto un volume urinario totale &gt; 3000 mL in base a quanto registrato durante il periodo di 3 giorni di compilazione del diario della minzione.
    15. Il soggetto presenta - a giudizio dello sperimentatore - un aumento clinicamente significativo dei parametri di laboratorio rilevata sui campioni prelevati nel corso della Visita 1 (p.es.creatinina sierica &gt;150 umol/L, AST e/o ALT &gt; 2x il limite superiore della norma (ULN), o &#947;-GT &gt; 3x ULN).
    16. Il soggetto presenta alterazioni dell'ECG che, a giudizio dello sperimentatore, lo rendono inadatto per lo studio.
    E.5 End points
    E.5.1Primary end point(s)
    Incidence and severity of adverse events.
    Incidenza e severita' degli eventi avversi.
    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 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 Yes
    E.8.2.3.1Comparator description
    - Stesso farmaco ad altro dosaggio
    - same IMP used at different dosage
    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 concerned15
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    . L'ultimo soggetto terminera' lo studio nel trimestre Ottobre - Dicembre del 2010.
    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 months30
    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 months30
    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.1.3Elderly (>=65 years) Yes
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2008-04-23. Yes
    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 1000
    F.4.2.2In the whole clinical trial 2500
    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 Decision2008-06-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-03-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-05-06
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2019 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA