NCT00918983已完成3 期
Phase III Multicenter Prospective Randomized Parallel-Group Placebo-Controlled Double Blind Clinical Evaluation of NX-1207 for the Treatment of BPH NX02-0017
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- International Prostate Symptom Score (IPSS)
研究概览
简要总结
This study will evaluate the safety and efficacy of a 2.5 mg dose of NX-1207 for the treatment of BPH (benign prostatic hyperplasia) as compared to placebo.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Provide signed informed consent prior to enrolment in the study
- •Prostate Volume ≥ 30 mL ≤ 70 mL
- •Qmax < 15 mL/sec based on a minimum void of 125 mL
- •Agree not to use any other approved or experimental BPH or OAB medication anytime during the study
排除标准
- •History of illness or condition that may interfere with study or endanger subject
- •Use of prescribed medications that may interfere with study or endanger subject
- •Presence of a median lobe of the prostate
- •Previous surgery or MIST for treatment of BPH
- •Post-void residual urine volume > 200 mL
- •PSA ≥ 10 ng/mL; prostate cancer must be ruled out (negative biopsy) for PSA ≥ 4 ng/mL
- •Participation in a study of any investigational drug or device within the previous 90 days
- •Prostate cancer
研究组 & 干预措施
NX-1207
Experimental
干预措施: NX-1207 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
International Prostate Symptom Score (IPSS)
时间窗: 365 days
次要结局
- International Prostate Symptom Score (IPSS)(270 days)
- Peak urine flow rate (Qmax)(180 days)
研究者
研究点 (2)
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