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    Summary
    EudraCT Number:2008-001212-20
    Sponsor's Protocol Code Number:905-CL-057
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2009-05-29
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2008-001212-20
    A.3Full title of the trial
    An open-label, long term multi-center study to assess the safety and efficacy of fixed dose combinations of solifenacin succinate (6 mg and 9 mg) with tamsulosin hydrochloride OCAS 0.4 mg, in male subjects with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) with a substantial storage component
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A long-term study to examine the safety and efficacy of a combination of solifenacin succinate and tamsulosin hydrochloride to treat male patients with lower urinary tract symptoms associated with prostate gland enlargement with a substantial storage component (such as increased urinary frequency, urgency and need to get up in the night to urinate).
    A.3.2Name or abbreviated title of the trial where available
    Neptune II
    A.4.1Sponsor's protocol code number905-CL-057
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01021332
    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
    B.5.3 Address:
    B.5.3.1Street AddressGlobal Development Operations, Elisabethhof 19
    B.5.3.2Town/ cityLeiderdorp
    B.5.3.3Post code2353 EW
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+317154 55 878
    B.5.5Fax number+317154 55 224
    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 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 nameTamsulosin OCAS + Solifenacin 6 mg
    D.3.2Product code EC905
    D.3.4Pharmaceutical form 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 INNTAMSULOSIN HYDROCHLORIDE
    D.3.9.1CAS number 106463176
    D.3.9.2Current sponsor codeYM617
    D.3.9.3Other descriptive nametamsulosin
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.4
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSolifenacin succinate
    D.3.9.1CAS number 242478372
    D.3.9.2Current sponsor codeYM905
    D.3.9.3Other descriptive nameSOLIFENACIN SUCCINATE
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6
    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 Yes
    D.3.11.13.1Other medicinal product typeImmediate release / prolonged release combination tablet, film-coated.
    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 nameTamsulosin OCAS + Solifenacin 9 mg
    D.3.2Product code EC905
    D.3.4Pharmaceutical form 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 INNTAMSULOSIN HYDROCHLORIDE
    D.3.9.1CAS number 106463176
    D.3.9.2Current sponsor codeYM617
    D.3.9.3Other descriptive nametamsulosin
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.4
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSolifenacin succinate
    D.3.9.1CAS number 242478372
    D.3.9.2Current sponsor codeYM905
    D.3.9.3Other descriptive nameSOLIFENACIN SUCCINATE
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number9
    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 Yes
    D.3.11.13.1Other medicinal product typeImmediate release / prolonged release combination tablet, film-coated.
    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
    Lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH).
    E.1.1.1Medical condition in easily understood language
    Lower urinary tract symptoms associated with prostate gland enlargement.
    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 14.0
    E.1.2Level PT
    E.1.2Classification code 10004446
    E.1.2Term Benign prostatic hyperplasia
    E.1.2System Organ Class 10038604 - Reproductive system and breast 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 of fixed dose combinations of tamsulosin OCAS 0.4 mg and solifenacin (6 mg and 9 mg) in male subjects with LUTS associated with BPH with a substantial storage component.
    E.2.2Secondary objectives of the trial
    To assess the efficacy of long-term treatment of fixed dose combinations of tamsulosin OCAS 0.4 mg and solifenacin (6 mg and 9 mg) in male subjects with LUTS associated with BPH with a substantial storage component.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Completion of 12 weeks double-blind treatment in Study 905-CL-055.
    2. Written informed consent has been obtained.
    3. Subject is willing and able to complete the micturition diary and questionnaires correctly.
    E.4Principal exclusion criteria
    1. Any significant PVR (>150 mL).
    2. Known history or diagnosis of any of the following urinary conditions:
    - Recurrent symptomatic urinary tract infection defined as two or more episodes of such infection occurring in the preceding 12 months
    - Urological Pain Syndromes as classified by the European Association of Urology (EAU) Guideline on Chronic Pelvic Pain, up-date 2008, such as interstitial cystitis including bladder pain syndrome, urethral pain syndrome, penile pain syndrome, prostate pain syndrome, scrotal pain syndrome, testicular pain syndrome, post-vasectomy pain and epididymal pain syndrome
    - Chronic prostatitis comprising type A (inflammatory) and type B (noninflammatory)
    - Evidence of current symptomatic or asymptomatic urolithiasis
    - Previous or current malignant disease of the pelvic and urogenital organs with the exception of carcinoma of bladder if longer than 5 years recurrence-free
    - Previous pelvic radiation therapy
    - Previous surgery to the bladder neck or prostate
    - Bladder neck stenosis
    - Urethral stricture
    3. Narrow angle glaucoma, myasthenia gravis, severe gastrointestinal condition (including toxic megacolon), hiatal hernia, gastroesophageal reflux or subjects at risk for these conditions, urinary or gastric retention or any other medical condition, which in the opinion of the investigator presents a contraindication for the use of anticholinergics.
    4. Any other cardiovascular or cerebrovascular diseases such as a clinically relevant history of orthostatic hypotension, which in the opinion of the investigator makes the subject unsuitable for participation in the study.
    5. Use of prohibited concomitant medication:
    - Other pharmacological treatment used for LUTS/BPH, such as alpha-adrenoceptor (α-AR)-antagonists, plant extracts and 5α-reductase inhibitors.
    - Other drugs which may influence the pharmacodynamic effects of solifenacin or tamsulosin, anticholinergics, or cytochrome P450 (CYP) 3A4 inhibitors or inducers that may influence the PK of solifenacin or tamsulosin.
    6. Use of combined α/ß-AR-antagonists, α2-agonists, oral and systemic β-agonists, cholinergics and any drugs with cholinergic or anticholinergic side effects, or diuretics. However, long term therapy (>1 month prior to randomization in Study 905-CL-055) with a stable dose of these drugs is permitted. Phosphodiesterase type 5 (PDE5) inhibitors are only permitted on demand for erectile dysfunction.
    7. Diabetic neuropathy.
    8. Planned cataract surgery during the study or within 30 days after completion of the study.
    9. Severe renal impairment (including hemodialysis) or moderate or severe hepatic impairment.
    10. Any clinically significant condition, which in the opinion of the investigator makes the subject unsuitable for the trial.
    11. Employee of the Astellas Group, the Contract Research Organizations (CROs) involved, or the investigator site executing the study.
    E.5 End points
    E.5.1Primary end point(s)
    Incidence, severity and relationship of AEs to the study drug
    Vital signs
    ECG parameters
    Laboratory parameters (including hematology, biochemistry, urinalysis and urine culture)
    Physical examination
    PVR volume
    Qmax and Qmean
    E.5.1.1Timepoint(s) of evaluation of this end point
    Incidence, severity and relationship of AEs to the study drug: Visits 5B, 6, 7, 8 and 9.
    Vital signs: Visits 6, 7, 8 and 9.
    ECG parameters: Visits 6, 7, 8 and 9 (plus unscheduled visits if necessary).
    Laboratory parameters (including hematology, biochemistry, urinalysis and urine culture): Sample collection at visits 6, 7, 8 and 9/premature termination of treatment for evaluation by central laboratory).
    Physical examination: At visit 9 or at last visit if subject withdraws prematurely from study.
    PVR volume: Visits 6, 7, 8 and 9.
    Qmax and Qmean: : Visits 6, 7, 8 and 9.
    E.5.2Secondary end point(s)
    Efficacy Variables:
    ● Change from baseline (Visit 2 of Study 905-CL-055) to endpoint in total I-PSS
    ● Change from baseline (Visit 2 of Study 905-CL-055) to endpoint in TUS (from
    micturition diary)
    Change from baseline (Visit 2 of Study 905-CL-055) to endpoint in:
    From micturition diary:
    ● Mean number of micturitions per 24 hours
    ● Mean volume voided per micturition
    ● Maximum volume voided per micturition
    ● Mean number of urgency episodes (PPIUS grade 3 or 4) per 24 hours
    ● Mean number of urgency incontinence episodes per 24 hours
    ● Mean number of incontinence episodes per 24 hours
    ● Mean number of nocturia episodes per 24 hours
    ● Mean number of pads used per 24 hours
    From I-PSS questionnaire:
    ● I-PSS voiding scores
    ● I-PSS storage scores
    ● I-PSS QoL scores
    ● Individual I-PSS item scores
    Other variables:
    ● OAB Questionnaire (OAB-q) (total and subscores)
    ● EQ-5D
    ● Increase/decrease in solifenacin dose
    ● Reason for dose change
    E.5.2.1Timepoint(s) of evaluation of this end point
    Visits 6, 7, 8 and 9.
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA131
    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
    Belarus
    Belgium
    Czech Republic
    France
    Germany
    Hungary
    Italy
    Netherlands
    Poland
    Slovakia
    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
    Last patient, last visit
    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 months9
    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 months9
    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: 473
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 594
    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 Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state55
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1029
    F.4.2.2In the whole clinical trial 1067
    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)
    Treatment of care after the subject has ended his/her participation in the trial will be the expected normal treatment of the condition
    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 Decision2009-06-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-07-16
    P. End of Trial
    P.End of Trial StatusOngoing
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