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    The EU Clinical Trials Register currently displays   42782   clinical trials with a EudraCT protocol, of which   7047   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2006-002072-18
    Sponsor's Protocol Code Number:905-CL-052
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-12-01
    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 ConcernedFrance - ANSM
    A.2EudraCT number2006-002072-18
    A.3Full title of the trial
    A randomized, double-blind, parallel group, placebo controlled, multi center dose ranging study of solifenacin succinate (3 mg, 6 mg and 9 mg) in combination with tamsulosin OCAS 0.4 mg compared with solifenacin succinate monotherapy (3 mg, 6 mg and 9 mg) and tamsulosin OCAS 0.4 mg monotherapy in males with lower urinary tract symptoms (LUTS) associated with begnin prostatic hyperplasia (BPH) - [SATURN]
    A.3.2Name or abbreviated title of the trial where available
    SATURN
    A.4.1Sponsor's protocol code number905-CL-052
    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 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 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.3.2Product code EC905 (3 mg)
    D.3.4Pharmaceutical form Film-coated 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.3.8INN - Proposed INNsolifenacin
    D.3.9.1CAS number 242478-38-2
    D.3.9.2Current sponsor codeEC905
    D.3.9.3Other descriptive nameYM905 / YM-67905 / BY-235H / solifenacin succinate
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    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 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.3.2Product code EC905 (6 mg)
    D.3.4Pharmaceutical form Film-coated 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.3.8INN - Proposed INNsolifenacin
    D.3.9.1CAS number 242478-38-2
    D.3.9.2Current sponsor codeEC905
    D.3.9.3Other descriptive nameYM905 / YM-67905 / BY-235H / solifenacin 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) 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: 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 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.3.2Product code EC905 (9 mg)
    D.3.4Pharmaceutical form Film-coated 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.3.8INN - Proposed INNsolifenacin
    D.3.9.1CAS number 242478-38-2
    D.3.9.2Current sponsor codeEC905
    D.3.9.3Other descriptive nameYM905 / YM-67905 / BY-235H / solifenacin 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) 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: 4
    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 Omnic Ocas
    D.2.1.1.2Name of the Marketing Authorisation holderAstellas Pharma Europe B.V
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameOmnic Ocas
    D.3.4Pharmaceutical form Film-coated 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.3.8INN - Proposed INNtamsulosin
    D.3.9.1CAS number 106463-17-6
    D.3.9.2Current sponsor codeYM617
    D.3.9.3Other descriptive nametamsulosin hydrochloride / amsulosin hydrochloride
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.4
    D.3.11 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 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
    Lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10004446
    E.1.2Term Benign prostatic hyperplasia
    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 whether the combination of solifenacin succinate (3, 6, 9 mg) and tamsulosin OCAS 0.4 mg provides improved efficacy compared to tamsulosin OCAS 0.4 mg alone in males with LUTS associated with BPH.
    E.2.2Secondary objectives of the trial
    •Safety and the tolerability of the combination of different doses of solifenacin succinate (0, 3, 6 and 9 mg) and tamsulosin OCAS (0 and 0.4 mg)
    •Dose response relationship of the combination of different doses of solifenacin succinate (0, 3, 6 and 9 mg) and tamsulosin OCAS (0 and 0.4 mg) in relieving voiding and storage symptoms
    •Efficacy of the combination of solifenacin succinate (3, 6, 9 mg) and tamsulosin OCAS 0.4 mg compared with solifenacin succinate (3, 6, 9 mg) alone
    •Pharmacokinetics of the combination of different doses of solifenacin succinate (0, 3, 6 and 9 mg) and tamsulosin OCAS (0 and 0.4 mg)
    •Exposure (AUC) response relationship of the combination of different doses of solifenacin succinate (0, 3, 6 and 9 mg) and tamsulosin OCAS (0 and 0.4 mg) in relieving voiding and storage symptoms
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Males with LUTS associated with BPH fulfilling the following criteria:
    Inclusion criteria

    At study entry:
    1. Male aged more than 45 years.
    2. Written informed consent has been obtained.
    3. Patient is willing and able to complete the micturition diary and questionnaires correctly.
    4. Voiding symptoms (including incomplete emptying of the bladder, intermittency, weak stream or hesitancy) and storage symptoms (including frequency, urgency or nocturia), diagnosed as LUTS associated with BPH (formerly known as symptomatic BPH) for more than 3 months.
    5. A total I-PSS score of more than 13.
    6. A maximum urinary flow rate of more than 4.0 mL/s and ≤ 15.0 mL/s, with a voided volume more than 120 mL during free flow (minimum of 2 flows to be performed).

    At randomization:
    7. A total I-PSS score of more than 13.
    8. Patient continues to meet all inclusion criteria of visit 1.
    E.4Principal exclusion criteria
    At study entry:
    1. Any significant post void residual volume (PVR > 200 mL) (at least 2 assessments to be performed).
    2. Evidence of a symptomatic urinary tract infection or a known history or diagnosis of any of the following urinary conditions:
    - Recurrent symptomatic urinary tract infection
    - Chronic inflammation such as interstitial cystitis
    - Stone in bladder or urethra
    - Previous pelvic radiation therapy
    - Previous or current malignant disease of the pelvic organs
    - Previous surgery to the bladder neck or prostate
    - Bladder neck stenosis
    - Urethral stricture
    3. Narrow angle glaucoma, myasthenia gravis, severe gatro-intestinal condition (including toxic megacolon) or patients at risk for these conditions, urinary or gastric retention or any other medical condition which in the opinion of the investigator makes the use of anticholinergics contra-indicated.
    4. Clinically significant cardiovascular or cerebrovascular diseases within 6 months prior to visit 1, such as myocardial infarction, uncontrolled angina, significant ventricular arrhythmias, heart failure (NYHA class III/IV), a history of orthostatic hypotension or stroke.
    5. Non-drug treatment for BPH or overactive bladder, including electrostimulation therapy at the start of the study or start of a bladder training program during the 2 weeks prior to or during the study.
    6. Use of forbidden concomitant medication:
    • Other pharmacological treatment for BPH, such as alpha-AR-antagonists and plant extracts (within the 2 weeks prior to visit 1).
    • 5alpha-reductase inhibitors (within the 3 months prior to visit 1).
    • Other drugs which may influence the pharmacodynamic effects of solifenacin or tamsulosin, combined alpha/beta-AR-antagonists, alpha-agonists, cholinergics or anti-cholinergics or CYP 3A4 inhibitors or inducers. This medication should be discontinued ultimately at visit 1 (see Appendix 1 Part A).
    7. Use of any drugs with cholinergic or anticholinergic side effects, diuretics, oral beta2-agonists or PDE 5 inhibitors (see Appendix 1 Part B). However, long term therapy (>1 month prior to randomization) on a stable dosage of these drugs is permissible.
    8. Diabetic neuropathy.
    9. A planned cataract surgery within 30 days after completion of the study.
    10. Severe renal impairment (including hemodialysis) or moderate or severe hepatic impairment.
    11. Known or suspected hypersensitivity to solifenacin, other anticholinergics, tamsulosin, other alpha-AR-antagonists, lactose or any of the other inactive ingredients of the study medication.
    12. Any clinically significant condition, which in the opinion of the investigator makes the patient unsuitable for the trial.
    13. Participation in any clinical trial within 30 days (or the limit set by national law, whichever is longer) prior to randomization.
    14. Employees of the Astellas Group, the CROs involved, or the investigator site executing the study.

    At randomization:
    15. Patient did not complete the micturition diary or I-PSS questionnaire according to the instructions.
    16. Total daily urine volume > 3000 mL as verified in the micturition diary.
    17. Any clinically significant abnormal ECG, which in the opinion of the investigator makes the patient unsuitable for the trial.
    18. ALAT, ASAT or creatinine outside 2 times the normal range, gamma GT outside 3 times the normal range.
    19. Any other clinically significant out of the normal range result of urinalysis, biochemistry (including PSA) or hematology, which in the opinion of the investigator makes the patient unsuitable for the trial.
    20. Patient fulfils any exclusion criteria of visit 1
    E.5 End points
    E.5.1Primary end point(s)
    Primary efficacy variable:
    - Change from baseline to endpoint in total I-PSS score

    Secondary efficacy variables:
    - Change from baseline to endpoint in:
    from I-PSS questionnaire:
    - I-PSS voiding scores
    - I-PSS storage scores
    - Individual I-PSS item scores
    - Number of I-PSS responders
    from micturition diary:
    - Mean number of micturitions per 24 hrs
    - Mean number of urge incontinence episodes per 24 hours
    - Mean number of incontinence episodes per 24 hours
    - Mean number of urgency episodes of grade 3 or 4 per 24 hours (PPIUS)
    - Mean level of urgency (PPIUS)
    - Mean volume voided per micturition
    - Mean number of nocturia episodes per 24 hours
    other assessments:
    - Symptom and bother scores as assessed by ICIQ-MLUTS questionnaire
    - PPBC
    - VAS-TS
    - Qmax
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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) 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 concerned10
    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 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
    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 months1
    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 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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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 state72
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 660
    F.4.2.2In the whole clinical trial 840
    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 Decision2007-01-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-01-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-09-06
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