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    Summary
    EudraCT Number:2010-024179-18
    Sponsor's Protocol Code Number:A0221094
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-04-11
    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 ConcernedHungary - National Institute of Pharmacy
    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
    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.
    A.3.2Name or abbreviated title of the trial where available
    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.235 East 42nd Street, New York, NY 10017
    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 Call 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.5.4Telephone number0018007181021
    B.5.5Fax number001303739 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 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.3.4Pharmaceutical 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
    D.3.9.1CAS number 286930-03-8
    D.3.9.2Current sponsor codeA0221094
    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 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.3.4Pharmaceutical 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
    D.3.9.1CAS number 286930-03-8
    D.3.9.2Current sponsor codeA0221094
    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
    D.3.9.1CAS number 124937-52-6
    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
    E.1.1.1Medical condition in easily understood language
    Overactive Bladder
    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 13.1
    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.
    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.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subject eligibility should be reviewed and documented by an appropriately qualified member of the investigator’s study team before subjects are included in the study.
    Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:
    At Screening Visit 1
    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.
    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 self-catheterization program, urodynamic evidence of obstruction or severe voiding symptoms and any ongoing clinically significant post-void residual volume of >200 mL. 4.Clinically significant urinary tract infection (UTI) as shown by results of urinalysis at Screening or Visit 2 or recurrent UTI defined as microbiologically proven UTI >3 times in the last year or >2 times in the last 6 months; Urine microscopy, culture and sensitivity testing will be performed in event of symptoms (eg, fever, dysuria), or positive leucocytes, nitrites and/or protein on urinalysis. Re-screening may be performed when UTI has been treated and urine is culture negative, assuming the subject does not subsequently meet the definition for recurrent UTI. 5. Use of any electrostimulation, participation in a formal program of bladder training or pelvic floor exercises under supervision of a physician or other medical provider within 4 weeks of Visit 1; subjects who are already established on a stable therapy should continue with their regimen at a stable level through the course of the study. 6. Treated with the following medications prior to Visit 1 (Screening): (a) Treatment with intra-vesical Botulinum toxin within 6 months of screening (b) Any drugs with significant anticholinergic and antispasmodic effects continuing at screening. Therefore, prior OAB medication should be stopped at Screening and patients stopping solifenacin should have a 3 week period between Screening (Visit 1) and Week-2 (Visit 2). (c) Subjects who may be antimuscarinic treatment resistant: previously treated with three or more antimuscarinic OAB medications within 12 months prior to Screening, which may include darifenacin, fesoterodine, oxybutynin, propiverine, solifenacin, tolterodine or trospium. (d) Has started treatment with tricyclic antidepressants or estrogens within 4 weeks and/or is not on a stable dose. (e) Has started treatment with diuretics, alpha blockers or 5-alpha reductase inhibitors within 2 weeks and/or is not on a stable dose. (f) Hepatic Metabolism influencers with potential for drug-drug interaction: (i) Treatment with potent CYP3A4 inhibitors such as clarithromycin, ketoconazole and itraconazole within 2 weeks prior to Visit 1 (ii) Administration of medications capable of inducing hepatic enzyme metabolism or transport (eg, barbiturates, rifampicin, carbamazepine, phenytoin, primidone, or St. John’s Wort) in the past 30 days. Subjects should be advised to continue on established stable doses of concomitant medications when necessary and maintain their regimen at a stable dose through the course of the study. 7. Participation in other studies within 30 days prior to study entry. 8. Alcohol abuse or misuse and/or any other drug/substance abuse or misuse within 2 years in opinion of investigator. 9. Subjects who have any medical (including known history of major hematological, renal, cardiovascular or hepatic abnormalities) or psychological condition or social circumstances that would impair their ability to participate reliably in the study, or those who may increase the risk to themselves or others by participating.
    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.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12 (visit 5) compared to Week 0 (visit 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).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 12 (visit 5) compared to Week 0 (visit 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 No
    E.6.13.1Other scope of the trial description
    tolerability
    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
    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 Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Information not present in EudraCT
    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
    Austria
    Brazil
    Bulgaria
    Colombia
    Czech Republic
    Egypt
    Finland
    France
    Germany
    Greece
    Hungary
    India
    Italy
    Korea, Republic of
    Lithuania
    Mexico
    Poland
    Russian Federation
    South Africa
    Spain
    Sweden
    Turkey
    Ukraine
    United Kingdom
    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
    As per protocol
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days22
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days22
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    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 state40
    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.
    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 Decision2011-05-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-04-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-05-25
    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
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