NCT02303769已完成3 期
A Multicenter, Randomized, Double -Blind, Parallel, Comparative, Phase III Study to Investigate the Efficacy and Safety of GL2702 GLARS-NF1 Tablet in BPH Patients With LUTS
GL Pharm Tech Corporation1 个研究点 分布在 1 个国家目标入组 309 人开始时间: 2014年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 309
- 试验地点
- 1
- 主要终点
- Change from baseline to endpoint in total International Prostate Symptom Score
研究概览
简要总结
Study to investigate the efficacy and safety of GL2702 GLARS-NF1tablet and Harnal-D - tablet in benign prostatic hyperplasia patients with lower urinary tract symptomatic
详细描述
GL2702 GLARS-NF1 tablet is controlled released formation which is made by GL Pharm Tech
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Over 50 years old, BPH diagnosted, Adult Male Subject
- •IPSS ≥ 13 point
- •PSA < 4ng/mL
- •5ml/sec < Qmax ≤ 15ml/sec
排除标准
- •Prostatic cancer
- •250ml < PVR
- •ALT or AST > 2 times (Upper Normal Range)
- •Total Bilirubin > 1.5 times (Upper Normal Range)
- •Treated with α-adrenalin receptor blocker within 2weeks before screening
- •Treated with 5Alpha-Reductase Inhibitor within 6 months before screening
- •Treated with phytotherapy within 2weeks before screening
- •Treated with Anabolic Steroid within 6 months before screening
研究组 & 干预措施
Tamsulosin HCL 0.2mg
Active Comparator
Harnal-D tablet (Tamsulosin HCL 0.2mg)
干预措施: Tamsulosin HCL 0.2mg (Drug)
Tamsulosin HCL 0.4mg
Experimental
GL2702 GLARS-NF1 tablet (Tamsulosin HCL 0.4mg)
干预措施: Tamsulosin HCL 0.4mg (Drug)
结局指标
主要结局
Change from baseline to endpoint in total International Prostate Symptom Score
时间窗: 8 weeks
次要结局
- Change from baseline to endpoint in total International Prostate Symptom Score(4 weeks)
- Change from baseline to endpoint in voiding score(4 weeks, 8 weeks)
- Change from baseline to endpoint in IPSS QoL(4 weeks, 8 weeks)
- Change from baseline to endpoint in Qmax(4 weeks, 8 weeks)
- Change from baseline to endpoint in PVR(4 weeks, 8 weeks)
- Time to event/proportion of subjects with AUR(8 weeks)
- Time to event/proportion of subjects undergoing BPH related prostatic surgery(8 weeks)
研究者
研究点 (1)
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