EUCTR2008-001212-20-CZ进行中（未招募）不适用
An open-label, long term multi-center study to assess the safety and efficacy of fixed dose combinations of solifenacin succinate (6 mg and 9 mg) with tamsulosin hydrochloride OCAS 0.4 mg, in male subjects with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) with a substantial storage component - Neptune II
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •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.
研究者
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