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    Summary
    EudraCT Number:2007-004555-11
    Sponsor's Protocol Code Number:A0221009
    National Competent Authority:Slovakia - SIDC (Slovak)
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-04-18
    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 ConcernedSlovakia - SIDC (Slovak)
    A.2EudraCT number2007-004555-11
    A.3Full title of the trial
    A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO
    EVALUATE THE EFFICACY AND SAFETY OF FESOTERODINE AS AN
    "ADD-ON" THERAPY IN MEN WITH PERSISTENT OVERACTIVE BLADDER
    SYMPTOMS UNDER MONOTHERAPY OF ALPHA BLOCKER FOR LOWER
    URINARY TRACT SYMPTOMS
    A.4.1Sponsor's protocol code numberA0221009
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    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. US
    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 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 Yes
    D.2.1.1.1Trade name TOVIAZ
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Limited, Ramsgate Road, Sandwich, Kent CT13 9NJ, Veľká Británia
    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 nameFesoterodine Fumarate
    D.3.2Product code PF-00695838
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 286930-03-8
    D.3.9.2Current sponsor codePF-00695838
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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.2.1.2Country 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 nameFesoterodine Fumarate
    D.3.2Product code PF-00695838
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 286930-03-8
    D.3.9.2Current sponsor codePF-00695838
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 (OAB)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10059617
    E.1.2Term Overactive bladder
    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 effect of fesoterodine on OAB symptom improvement, vs. placebo, as an “add-on” therapy, in men with persistent OAB symptoms of urinary frequency and urgency with/without urgency incontinence who are receiving alpha-blocker monotherapy for lower urinary tract symptoms (LUTS) at a stable dose for at least 6 weeks.
    E.2.2Secondary objectives of the trial
    1. To evaluate the effect of “add-on” fesoterodine on international prostate symptom scale (IPSS) vs. placebo.
    2. To evaluate the effect of “add-on” fesoterodine on patient reported outcomes, vs.
    placebo.
    3. To evaluate the safety and tolerability of “add-on” fesoterodine.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Men aged 40 years and above
    2. On a stable and well-tolerated dose of an alpha-blocker prescribed for LUTS for at least 6 weeks prior to screening (Visit 1)
    3. Persistent symptoms of OAB as verified by the screening 3-day bladder diary, defined by:
    a. Mean urinary frequency ≥8 times/24 hours
    b. Mean number of micturition-related urgency episodes ≥3 episode/24 hours (with a
    Urinary Sensation Scale rating of ≥3 marked for the corresponding micturition in the
    bladder diary)
    4. A rating of the bladder condition at Baseline (visit 2) prior to randomization as “Some Moderate Problems,” “Severe Problems,” or “Many Severe Problems” on the Patient Perception of Bladder Condition (PPBC) questionnaire
    5. The ability and willingness to correctly complete the bladder diary and various
    questionnaires, comply with scheduled visits and trial procedures
    6. The capability of understanding and having signed the informed consent form after full discussion of the research, nature of the treatment, and its risks and benefits.
    E.4Principal exclusion criteria
    1. Any condition that would contraindicate their usage of fesoterodine including:
    hypersensitivity to the active substance (fesoterodine fumarate) or to peanut or soya or any of the excipients, urinary retention, gastric retention, uncontrolled narrow angle glaucoma, myasthenia gravis, severe hepatic impairment (Child Pugh C), severe ulcerative colitis, and toxic megacolon
    2. Poor tolerability to the ongoing alpha blocker treatment or deemed unsuitable or unlikely to continue alpha blocker treatment at the current dose for the duration of the study by the investigator according to the approved product labeling for each drug in each country
    3. Previous history of acute urinary retention requiring catheterization or existing clinically significant bladder outlet obstruction in the judgment of the investigator
    4. A post void residual urinary volume greater than 200 ml at Baseline (Visit 2)
    5. Clinically significant hepatic or renal disease, and/or with a screening test of AST, ALT, Alk Phos, urea nitrogen, or creatinine greater than 1.5 times of the upper limit of normal (ULN)
    6. Known history or evidence at screening visit of symptomatic postural hypotension or syncope while on alpha blocker(s) (a measured reduction of greater than 20 mmHg in systolic blood pressure or 10 mmHg in diastolic blood pressure on standing with relevant postural symptoms)
    7. History, evidence or suspicion of prostate cancer. A total prostate specific antigen (total PSA) value of greater than 10 ng/ml at screening would exclude subjects, unless documented evidence can be provided to rule out prostate malignancy
    8. Neurologic conditions such as stroke, multiple sclerosis, spinal cord injury, or
    Parkinson’s disease
    9. A known history of 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
    10. A known history of uninvestigated hematuria, interstitial cystitis, genitourinary
    tuberculosis, bladder calculi or detrusor-sphincter dyssynergia
    11. History of radiation treatment to pelvic organs or external
    genitalia for any reason
    12. Previous history of prostatic surgery/intervention (including minimally invasive
    treatments), or other major urethral and/or bladder surgery
    13. Urinary tract infection (UTI) as shown by the results of the urinalysis at Screening or recurrent UTI defined as treatment for UTI >3 times in the last year
    14. Treatment with potent CYP3A4 inhibitors, such as clarithromycin, ketoconazole, and itraconazole within 2 weeks prior to Visit 1, or the expectation to start such a treatment during the trial
    15. Treatment with hepatic enzyme inducers, eg, barbiturates, rifampicin, carbamazepine, phenytoin, primidone, or St. John’s Wort, within 2 weeks prior to Visit 1, or the expectation to start such a treatment during the trial
    16. Treatment with the following medications within 3 weeks prior to Visit 1, or the
    expectation to start such a treatment during the trial
    • Any drug treatment for overactive bladder, including antimuscarinic OAB
    medications
    • Any drugs with significant anticholinergic or antispasmodic effects
    17. Treatment with a 5-alpha reductase inhibitor initiated within 6 months prior to Screening (Visit 1), or the expectation to start such a treatment during the trial
    18. Treatment with any medication for BPH other than alpha blocker and 5-alpha reductase inhibitor, eg, saw palmetto, if started less than 4 weeks prior to Visit 1, or the expectation to start such a treatment during the trial
    19. Treatment with tricyclic or tetracyclic antidepressant initiated within 4 weeks prior to Visit 1, or on intermittent or unstable use, or the expectation to start such a treatment during the trial
    20. Treatment with diuretics initiated within 2 weeks prior to Visit 1, or on intermittent or unstable use, or the expectation to start such a treatment during the trial
    21. Use of any electrostimulation, or a formal program of bladder training or pelvic floor exercises under the supervision of a physician or other medical provider within 4 weeks of Visit 1 or the expectation to start such a program during the trial
    22. Use of an indwelling catheter or an intermittent self-catheterization program
    23. Participation in any clinical trial or receipt of any investigational drug within 4 weeks prior to Visit 1, or the expectation to start such a drug during the trial
    24. Subjects who, in the opinion of the investigator, abuse alcohol or drugs or who have been alcohol- or drug-dependent within the last 6 months
    25. Subjects who have any medical 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
    26. Subjects who, in the opinion of the investigator, are not likely to complete the study for whatever reason.
    E.5 End points
    E.5.1Primary end point(s)
    Numeric change of micturition-related urgency episodes per 24 hours at Week 12
    relative to baseline (micturition-related urgency episodes are defined as those with
    Urinary Sensation Scale rating of ≥3 marked for the corresponding micturition in the
    diary)
    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.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 No
    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.8.3 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA80
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    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 months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months2
    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.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 400
    F.4.2.2In the whole clinical trial 900
    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 Decision2008-02-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-02-06
    P. End of Trial
    P.End of Trial StatusCompleted
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