A randomized, double-blind, parallel group, placebo controlled, multi-center study of fixed dose combinations of solifenacin succinate (6 mg and 9 mg) with tamsulosin hydrochloride OCAS 0.4 mg and tamsulosin hydrochloride OCAS 0.4 mg monotherapy, in male subjects with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) with a substantial storage component - Neptune

• Conditions: ower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH).; MedDRA version: 9.1Level: LLTClassification code 10004446Term: Benign prostatic hyperplasia

• Registration Number: EUCTR2008-001211-37-NL
• Lead Sponsor: Astellas Pharma Europe B.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05-29
• Last Update Posted: 19 March 2012

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:
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 (Visit 1):
1. Any significant PVR volume (>150 mL).
2. Prostate with estimated weight =75 g 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 defined as 2 or more episodes of such infection occurring in preceding 12 months,
- Urological Pain Syndromes as classified by the EAU Guideline on Chronic Pelvic Pain, update 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 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 Visit 1, such as myocardial infarction, uncontrolled angina, significant ventricular arrhythmias, heart failure (NYHA class III/IV) and stroke.
6. 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 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 2 weeks prior to or during the study.
8. Use of prohibited concomitant medication
- Other pharmacological treatment used for LUTS/BPH, such as alpha-adrenoceptor (a-AR)-antagonists and plant extracts.
- 5a-reductase inhibitors (within 3 months prior to Visit 1),
- 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 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) with a stable dosage of these drugs 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, tamsulosin (including drug-induced angioedema), other a-AR-antagonists, lactose or any of the other excipients of study medication.
15. Any clinically significant condition, which i

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified