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    The EU Clinical Trials Register currently displays   43845   clinical trials with a EudraCT protocol, of which   7282   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).

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    Summary
    EudraCT Number:2005-005665-11
    Sponsor's Protocol Code Number:KMD3213-IT-CL 0215
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-03-22
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2005-005665-11
    A.3Full title of the trial
    Evaluation Of The Efficacy And Safety Of Silodosin Vs. Tamsulosin And Placebo In The Treatment Of The Signs And Symptoms Of Benign Prostatic Hyperplasia. Multicentre, Randomised, Double-Blind, Controlled Trial With An Optional Long-Term Open-Label Extension Phase
    A.4.1Sponsor's protocol code numberKMD3213-IT-CL 0215
    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 SponsorRecordati S.p.A
    B.1.3.4CountryItaly
    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 Information not present in EudraCT
    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 nameSilodosin
    D.3.2Product code KMD 3213
    D.3.4Pharmaceutical form Capsule, hard
    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 INNSilodosin
    D.3.9.1CAS number 160970-54-7
    D.3.9.2Current sponsor codeKMD 3213
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 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 Information not present in EudraCT
    D.2.1.1.1Trade name Omnic 0.4mg Capsules
    D.2.1.1.2Name of the Marketing Authorisation holderYamanouchi Pharma S.p.A.
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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
    D.3.4Pharmaceutical form Modified-release capsule, hard
    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 hydrochloride
    D.3.9.1CAS number 106463-17-6
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 placeboCapsule, hard
    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
    Benign prostatic hyperplasia (BPH) is a non malignant enlargement of the prostate due to cellular hyperplasia of both glandular and stromal elements. As the prostate increases in size it may exert pressure on the lumen of the prostatic urethra, resulting in a gradual obstruction to urine flow.
    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.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to test the hypothesis that the effectiveness of silodosin 8 mg given once daily for 12 weeks is superior to placebo and non-inferior to tamsulosin 0.4 mg given once daily for the relief of symptoms of BPH as measured by a baseline to endpoint change in the total score (questions 1 to 7) of the International Prostate Symptom Score-1 (IPSS-1).
    E.2.2Secondary objectives of the trial
    The secondary objectives are to compare the effectiveness and safety of silodosin to tamsulosin in a baseline to endpoint change in the following parameters: irritative symptoms subscore; obstructive symptoms subscore; QoL due to urinary symptoms (question 8 of IPSS-1); maximum urine flow (Qmax); percentage of treatment responders by IPSS-1 and by Qmax; and evaluation of adverse events, vital signs, ECGs, clinical laboratory tests and physical examinations.
    In a further step, as an optional extension to this protocol, the objective of the long-term open-label study period is to obtain long-term (6 and 12 months) safety data on silodosin 8 mg given as once daily treatment. Efficacy parameters will be also evaluated during long-term treatment.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. Male subjects aged 50 years or older;
    2. Presence at Visits 2 (start of placebo run-in) and 3 (baseline), of an IPSS-1 score of ≥13;
    3. Presence of less than 25% decrease of the IPSS-1 score between Visit 2 (start of placebo run-in) and Visit 3 (baseline);
    4. Presence at Visits 2 (start of placebo run-in) and 3 (baseline), of bladder outlet obstruction, as defined by a Qmax (peak urine flow rate) between 4 and 15 mL/sec, with a minimum voided volume of ≥125 mL;
    5. Presence of a satisfactory compliance to study medication (80-120%) at Visit 3 (baseline);
    6. Able to comply with protocol procedures;
    7. Able to give written informed consent before beginning any investigational procedures.
    E.4Principal exclusion criteria
    1. Post void bladder residual volume of greater than 250 mL determined by ultrasound (not evaluated at Visit 2);
    2. Intravesical obstruction from any cause other than BPH including vesicle neck contracture, Mullerian duct cysts, urethral stricture, valves, sclerosis, or other urethral tumor;
    3. Bladder calculi;
    4. History of, or current, neurogenic bladder and other conditions that may affect bladder function including detrusor-sphincter dyssynergia, spinal cord injury, brain or spinal cord tumors, multiple sclerosis, diabetic neuropathies or dementia;
    5. History of any type of procedure in the past that is considered intervention for BPH or bladder neck obstruction including prior TURP, bladder neck resection, thermotherapy, laser therapy, TUNA therapy, or any other minimally invasive surgical therapies specifically designed for relief of BPH;
    6. An active urinary tract infection, or a history of recurrent urinary tract infections defined as greater than 3 per year in the past two years;
    7. Current prostatitis or a diagnosis of chronic prostatitis, or at Visit 1, a history of prostatitis within the past 3 months or recurrent prostatitis more than 3 times in the last year;
    8. History of urinary retention, from a cause other than BPH, within the past 3 months;
    9. History of prior prostate cancer, or prostate cancer as suspected by TRUS, DRE or clinical acumen. Subjects with a PSA greater than 10.0 ng/ml will be excluded. Subjects with a PSA between 4.0 and 10.0 should have prostate cancer ruled out to the satisfaction of the clinical Investigator with appropriate documentation of the physician’s assessment;
    10. History of prior invasive bladder cancer. Subjects with superficial bladder cancers that have not recurred in 5 years are eligible for protocol inclusion;
    11. Prior radiation to the pelvis regardless of the reason or dosage of radiation;
    12. Bladder catheterization or bladder or prostate instrumentation within the past 30 days;
    13. History of, or current significant postural hypotension, and/or have experienced significant postural hypotension upon initiating therapy with an α-blocker. Significant postural hypotension is defined as any one of the following observations upon standing: a) systolic blood pressure (SBP) decrease >30 mmHg, b) diastolic blood pressure (DBP) decrease >20 mmHg, c) heart rate (HR) decrease >20 bpm, d) symptoms upon change of position such as lightheadedness, fainting, blurring or temporary loss of vision, profound weakness, or syncope;
    14. Clinical significant cardiovascular and cerebrovascular disease in the last 6 months including: angina pectoris (with the exception of chronic stable angina occurring with strenuous, rapid or prolonged exertion), severe CHF (NYHA classes III-IV, see section 17.5.), acute myocardial infarction, poorly controlled hypertension (sustained SBP>160, DBP>95 mmHg), endocarditis, cardiac arrhythmias, prosthetic heart valves, cardiac devices, stroke, transient ischemic attacks;
    15. Poorly controlled diabetes (HbA1c >8%);
    16. Renal insufficiency (serum creatinine >2.0 mg/dL);
    17. Liver insufficiency (any LFT >2xULN);
    18. Hematuria which has not been appropriately evaluated to determine safe subject participation;
    19. Recurrent episodes of dizziness, vertigo, or loss of consciousness;
    20. Pelvic surgery for malignancy or bowel resection;
    21. History or current evidence of drug or alcohol abuse within the last 12 months;
    22. History of allergy to α-blockers, or to any of the inactive agents used in this formulation;
    23. Uncontrolled hypo- or hyperthyroidism;
    24. Participation in a study involving the administration of an investigational compound within the past 30 days, or within 5 times the half life of the prior investigational drug, whichever is longer;
    25. Any subject, in the investigator’s opinion, not considered suitable for enrolment.
    26. History of inadequate clinical response to the use of alpha blockers specifically for the relief of BPH symptoms;
    27. Receiving medications after Visit 1, which preclude safe participation in the study or that may produce a confounding effect on the variables under study
    E.5 End points
    E.5.1Primary end point(s)
    The International Prostate Symptom Score (IPSS-1) is a 8-item questionnaire designed to quantify the symptoms encountered most frequently with BPH and it has become the international standard. For questions 1-6, questions are graded on a 6-point scale with 0 = "not at all" and 5 = "almost always". For question 7, the descriptors are 0 = "none" to 5 = "5 or more times".
    The total score (questions 1 to 7) is a sum of each question's result. The primary efficacy parameter is based on this total score. The standard IPSS-1 (see Appendix 14.8 of the study protocol) will be assessed at visit 2 (entry criteria), visit 3 (entry criteria and baseline value) and at visit 6, 7 and 8. Validated local translations will be used in each country.
    A time-adapted modified version asking questions about symptoms observed in the previous week (instead of the previous month) will be used at Visit 4 and 5, because these visits occur after 7 and 14 days of therapy, respectively (see Appendix 14.8 of the study protocol).
    For subjects entering the Open-Label Extension period, IPSS-1 (standard version) will be also assessed at visit 10, 11 and 12.
    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 Information not present in EudraCT
    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 Yes
    E.8.1.7.1Other trial design description
    Optional Open Label Extension Phase
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    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.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    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 patient
    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 days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months9
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state120
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 960
    F.4.2.2In the whole clinical trial 1400
    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 Decision2006-05-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-04-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-05-10
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