NCT02390882已完成3 期
A Multicenter, Randomized, Double-blind, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of HGP0412 and HIP1402 in Patients With Benign Prostatic Hyperplasia
Hanmi Pharmaceutical Company Limited1 个研究点 分布在 1 个国家目标入组 494 人开始时间: 2014年10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
- 494
- 试验地点
- 1
- 主要终点
- Total International Prostate Symptom Score
研究概览
简要总结
The main objective of this study is to evaluate efficacy and safety of (Tamsulosin) HGP0412 and HIP1402 in patients with Benign Prostatic Hyperplasia
详细描述
A multicenter, randomized, double-blind, phase 3 clinical trial to evaluate the efficacy and safety of (Tamsulosin) HGP0412 and HIP1402 in patients with benign prostatic hyperplasia
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
- •age>=45, male, diagnosed on BPH, Total IPSS>=13
排除标准
- •Hypersensitivity to investigational products or components
- •PSA>=4ng/ml
研究组 & 干预措施
Placebo
Placebo Comparator
Tamsulosin placebo (12 weeks)
干预措施: Placebo (Drug)
Treatment 1
Experimental
HGP0412 capsule (12 weeks)
干预措施: HGP0412 capsule (Drug)
Treatment2
Experimental
HIP1402 capsule (12 weeks)
干预措施: HIP1402 capsule (Drug)
结局指标
主要结局
Total International Prostate Symptom Score
时间窗: 12 weeks
次要结局
- Total International Prostate Symptom Score(4, 8 weeks)
研究者
研究点 (1)
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