NCT00457457已完成2 期
A Multi-center, Randomized, Parallel Group, Double-blind, Placebo Controlled Proof of Concept and Dose Ranging Study With an Active Control to Assess the Efficacy and Safety/Tolerability of UK-369,003 Immediate Release (IR) and Modified Release (MR) in the Treatment of Men With Lower Urinary Tract Symptoms (LUTS) With and Without Erectile Dysfunction (ED)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 609
- 试验地点
- 1
- 主要终点
- Change in international prostate symptom score
研究概览
简要总结
This is a 12 week study in which different doses and formulations of UK-369,003 will be administered to patients with a diagnosis of enlarged prostate. Patients will complete a series of questionnaires before, during and after treatment to assess if UK-369,003 has improved their urinary symptoms and erectile function . There will be several blood samples taken during the study to asses the level of drug in the blood and correlate it with the responses to the questionnaires.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male subjects aged 40 years and above, with documented LUTS with an International Prostate Symptom Score (IPSS) ≥13
- •Clinical diagnosis of BPH.
- •Qmax 5 to 15ml/sec with a voided volume of ≥150ml at visit 1 (screening).
排除标准
- •Urinary tract infection
- •Primary neurological conditions affecting bladder function
研究组 & 干预措施
Comparator
Active Comparator
Tamsulosin 0.4 mg prolonged release
干预措施: Tamsulosin (Drug)
Treatment Arm
Experimental
There are 5 possible UK-369,003 arms as follows: UK-369,003 MR (10mg, 25mg, 50mg & 100mg), UK-369,003 IR (40mg),
干预措施: UK-369,003 (Drug)
结局指标
主要结局
Change in international prostate symptom score
时间窗: 12 weeks
次要结局
- Qmax(12 weeks)
- Erectile Function (EF) domain of International Index of Erectile(12 weeks)
- Function (IIEF)(12 weeks)
- Quality of Erection questionnaire (QEQ)(12 weeks)
- Population pharmacokinetics(12 weeks)
研究者
研究点 (1)
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