EUCTR2005-001627-11-PT进行中（未招募）不适用
A randomized, double-blind, placebo-controlled study to assess the effect of Tamsulosin OCAS 0.4 mg tablets, once daily on nocturia, compared to placebo, in patients with lower urinary tract symptoms associated with benign prostatic hyperplasia - RESTORE
Yamanouchi Europe B.V. (to be renamed Astellas Pharma Europe B.V., as of August 2005)0 个研究点目标入组 1,051 人开始时间: 2005年11月11日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,051
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
- •At study entry (visit 1):
- •1.Male subject aged 45 years or over
- •2.Written informed consent has been obtained
- •3.Diagnosed as having LUTS associated with BPH
- •4.A total I-PSS score of greater than / equal to 13
- •5.A maximum urinary flow rate of greater than / equal to 4.0 mL/s and less than / equal to 12.0 mL/s, with a voided volume greater than / equal to 120 ml during free flow (a minimum of 2 flows are to be performed within 3 months of visit 1)
- •6.PSA levels are within normal ranges, or if outside of normal ranges are not of clinical significance according to the investigator. A recent PSA value (determined within 3 months of visit 1) is acceptable. If a recent value is not available, a blood sample should be taken at visit 1 to determine PSA levels.
- •7.On average, at least 2 voids per night over the last week
- •8.A maximum of 4 hours of undisturbed sleep expected per night (night time is defined as the time from going to bed with the purpose of sleeping until waking up with the purpose of getting up)
- •At randomization (visit 2):
- •9.A total I-PSS score of greater than / equal to 13
- •10.Compliance to run-in medication has been at least 80%
- •11.Based on the sleep diary given to subject at the screening visit, on average at least 2 voids per night over 3 consecutive days (Monday-Thursday) before visit 2
- •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
- •At study entry (visit 1):
- •1.Previous surgery to the bladder neck, prostate or pelvic region (including thermo-therapies)
- •2.Previous pelvic radiation for any cause
- •3.A post-voiding residual volume >250 ml by ultrasound or catheterization in at least two assessments over the last 3 months
- •4.A known history or diagnosis or any of the following urinary conditions:
- •a)Neurological bladder disorder (including disorders due to diabetic neuropathy)
- •b)Bladder neck stenosis
- •c)Stone in bladder or urethra
- •d)Recurrent urinary tract infection (defined as at least two UTIs within the last 6 months)
- •e)Bladder cancer (including polyposis)
- •f)Prostate cancer
- •g)Urethral stricture
- •h)Other condition which may affect micturition (such as large bladder diverticulae)
- •5.A symptomatic urinary tract infection within 1 month prior to visit 1
- •6.Subject has nocturnal polyuria (defined as >33% of 24 h urine produced between 11p.m. and 7 a.m.) as determined by a 3-day frequency/volume chart completed between visit 1 and visit 2
- •7.Known hepatic or renal insufficiency
- •8.Alcohol consumption of more than 15 units per week (1 unit = 270 ml of beer or 40 ml of spirits or 125 ml of wine)
- •9.Clinically significant cardiovascular or cerebrovascular diseases within 6 months prior to visit 1, such as myocardial infarction, uncontrolled angina, significant ventricular arrthymias, heart failure (NYHA class III/IV), orthostatic hypotension or stroke.
- •10.Central nervous system conditions, such as senile dementia, multiple sclerosis, Parkinson’s Disease and psychiatric disorders.
- •11.Known life-threatening diseases, such as concurrent neoplasms under treatment, AIDS/HIV
- •12.Hypersensitivity to the study drug (alpha-AR-antagonists) or any of their components.
- •13.Any clinical condition, which in the opinion of the investigator would not allow safe completion of the study
- •14.Subject is currently taking 5alpha-reductase inhibitors or took these within the last 3 months prior to visit 1
- •15.Subject is currently taking any diuretics
- •16.Subject is currently taking other pharmacological treatment for BPH, such as alpha-AR-antagonists (including tamsulosin) and plant extracts, or took these within the last month prior to visit 1
- •17.Subject is currently taking other drugs which may influence the pharmacodynamic effects of tamsulosin, such as combined alpha / beta-AR-antagonists, alpha-agonists, cholinergics or anti-cholinergics
- •18.Subject is currently taking other investigational drugs, or took part in a clinical study within the last 3 months prior to visit 1, or took part in more than 3 clinical studies within 12 months prior to visit 1
- •19.Subject is unwilling or unlikely to fulfill the study requirements in terms of visits, compliance and time commitment
- •20.Subjects who work shift hours and whose hours of work include any time between 23.00 and 06.00h
- •21.Employees of the sponsor, CRO or investigator site involved in the study.
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