STUDIO MULTICENTRICO, RANDOMIZZATO, IN DOPPIO CIECO, A GRUPPI PARALLELI, CONTROLLATO VERSO PLACEBO PER VALUTARE LE COMBINAZIONI A DOSE FISSA DI SOLIFENACINA SUCCINATO (6 MG E 9 MG) IN ASSOCIAZIONE A TAMSULOSINA CLORIDRATO OCAS 0.4 MG E TAMSULOSINA CLORIDRATO OCAS 0.4 MG IN MONOTERAPIA, IN SOGGETTI DI SESSO MASCHILE AFFETTI DA SINTOMATOLOGIA DELLE BASSE VIE URINARIE (LUTS) ASSOCIATA AD IPERPLASIA PROSTATICA BENIGNA (BPH) CON PREVALENTE SINTOMATOLOGIA DA ACCUMULO - Neptune

Conditions: ower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH)
MedDRA version: 14.1Level: PTClassification code 10004446Term: Benign prostatic hyperplasiaSystem Organ Class: 10038604 - Reproductive system and breast disorders
Therapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]

Registration Number: EUCTR2008-001211-37-IT

Lead Sponsor: Astellas Pharma Europe B.V.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Male

Target Recruitment: 1452

Inclusion Criteria

At study entry (Visit 1): 1. Male subjects aged ≥45 years. 2. Written informed consent has been obtained. 3.Subject 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 and urgency), diagnosed as LUTS associated with BPH for ≥3 months. 5. Total I-PSS of ≥13. 6. Substantial amount of storage symptoms for ≥3 months (at the discretion of the investigator, expected to have a micturition frequency of ≥8 and at least 2 episodes of urgency with PPIUS grade 3 or 4 per day). 7. A maximum urinary flow rate of ≥4.0 mL/s and ≤12.0 mL/s, with a voided volume of ≥120 mL during free flow. At randomization (Visit 2): 8. Total I-PSS of ≥13. 9. Maximum urinary flow rate of ≥4.0 mL/s and ≤12.0 mL/s, with a voided volume of ≥120 mL during free flow. 10. A micturition frequency of ≥8 and at least 2 episodes of urgency (PPIUS grade 3 or 4) per day on average during the 3 day micturition diary. 11. Subject continues to meet all inclusion criteria of Visit 1.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

At study entry(V1):1.Any significant PVR >150mL 2.Prostate with estimated weight ≥75g as assessed by transvesical or transrectal ultrasound.3.Evidence of symptomatic urinary tract infection or known history or diagnosis of any of the following urinary conditions:- Recurrent symptomatic urinary tract infection -Urological Pain Syndromes as classified by the EAU Guideline on Chronic Pelvic Pain,update 2008 -Chronic prostatitis comprising type A (inflammatory) and type B (noninflammatory) -Evidence of current symptomatic or asymptomatic urolithiasis -Previous or current malignant disease of pelvic and urogenital organs with exception of carcinoma of bladder if longer than 5 years recurrence-free -Previous pelvic radiation therapy -Previous surgery to bladder neck or prostate -Bladder neck stenosis -Urethral stricture.4.Narrow angle glaucoma, myasthenia gravis, severe gastrointestinal condition (incl.toxic megacolon),hiatal hernia,gastroesophageal reflux or subject is 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.5.Clinically significant significant cardiovascular or cerebrovascular diseases within 6 months prior to V1.6.Any other cardiovascular or cerebrovascular disease which in the opinion of the investigator makes the subject unsuitable for participation in study.7.Non-drug treatment for LUTS associated with BPH or OAB,including electrostimulation therapy at start of the study or start of a bladder training program during the 2weeks prior to or during the study.8.Use of prohibited concomitant medication -Other pharmacological treatment used for LUTS/BPH, such as alpha-adrenoceptor (α-AR)-antagonists and plant extracts.-5α-reductase inhibitors (within 3 months prior to V1) -Other drugs which may influence the pharmacodynamic effects of solifenacin or tamsulosin,phosphodiesterase type 5 (PDE5) inhibitors,anticholinergics,or CYP 3A4 inhibitors or inducers that may influence the PK of solifenacin or tamsulosin.9.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 dosage stable therapy (>1month prior to randomization) is permitted.10.Diabetic neuropathy.11.Planned cataract surgery during Study 905-CL-055 or Study 905-CL-057 or within 30 days after completion of any of the studies.12.Severe renal impairment (including hemodialysis) or moderate or severe hepatic impairment.13.Known polyuria.14.Known or suspected hypersensitivity to solifenacin,other anticholinergics,tamsulosina,other α-AR-antagonists,lactose or any of the other excipients of study medication.15.Any clinically significant condition,which in the opinion of the investigator makes the subject unsuitable for the trial.16.Participation in any clinical trial within 30 days (or limit set by national law,whichever is longer) prior to randomization.17.Employee of Astellas, of CROs involved or of investigator site executing study.At randomization (V2):18.Subject did not complete micturition diary or I-PSS questionnaire according to instructions.19.Significant PVR>150 mL.20.Total daily urine volume >3L/day on any day during the 3days of micturition diary.21.Any clinically significant abnormal ECG,which in the opinion of the investigator makes the subject unsuitable for the trial.22.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the efficacy of fixed dose combinations of tamsulosin OCAS 0.4 mg and solifenacin (6 mg and 9 mg) in comparison with tamsulosin OCAS 0.4 mg monotherapy in male subjects with LUTS associated with BPH with a substantial storage component;Secondary Objective: To assess the safety and tolerability 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; To assess the efficacy of fixed dose combinations of tamsulosin OCAS 0.4 mg and solifenacin (6 mg and 9 mg) in comparison with placebo in male subjects with LUTS associated with BPH with a substantial storage component.;Primary end point(s): Primary endpoint 1: change from baseline to endpoint in total I-PSS. Primary endpoint 2: change from baseline to endpoint in Total Urgency Score (TUS, from micturition diary)

Secondary Outcome Measures