Lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH). MedDRA version: 14.0 Level: PT Classification code 10004446 Term: Benign prostatic hyperplasia System Organ Class: 10038604 - Reproductive system and breast disorders
Conditions
Sponsors
Astellas Pharma Europe B.V.
Eligibility
Sex/Gender
Male
Inclusion criteria
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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 473 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 594
Exclusion criteria
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 (a-AR)-antagonists, plant extracts and 5a-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 a/ß-AR-antagonists, a2-agonists, oral and systemic ß-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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: 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.;Primary 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 ;Main Objective: 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.;Timepoint(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. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary 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 ;Timepoint(s) of evaluation of this end point: Visits 6, 7, 8 and 9. | — |
Countries
Austria, Belarus, Belgium, Czech Republic, France, Germany, Hungary, Italy, Netherlands, Poland, Slovakia, United Kingdom
Contacts
Public ContactService Desk
Astellas Pharma Europe B.V.
Outcome results
None listed