A Multicenter, Randomized, Double-blind, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of HCP1303 Capsules
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 510
- 主要终点
- Change of Total IPSS (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 HCP1301 capsule in patients with Benign Prostatic Hyperplasia and Erectile Dysfunction
详细描述
A multicenter, randomized, double-blind, phase 3 clinical trial to evaluate the efficacy and safety of HCP1303 capsule
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •At Visit 1
- •BPH(Benign Prostatic Hyperplasia) + Total IPSS(International Prostate Symptom Score) ≥ 13
- •Abnormal Erectile function ≥ at least 3months based on screening date
- •At Visit 2
- •Total IPSS ≥ 13
排除标准
- •History of hypersensitivity to Tamsulosin or Tadalafil
- •History of allergy for Sulfonamide
- •PSA (Prostate Specific Antigen) ≥4ng/mL
研究组 & 干预措施
Active Comparator
HCP1303 capsule 5/0.2mg placebo+ HCP1303 capsule 5/0.4mg placebo+ HGP1201
干预措施: HCP1303 capsule 5/0.4mg placebo (Drug)
Treatment 1
HCP1303 capsule 5/0.2mg + HCP1303 capsule 5/0.4mg placebo+ HGP1201 placebo
干预措施: HCP1303 capsule 5/0.2mg (Drug)
Treatment 1
HCP1303 capsule 5/0.2mg + HCP1303 capsule 5/0.4mg placebo+ HGP1201 placebo
干预措施: HCP1303 capsule 5/0.4mg placebo (Drug)
Treatment 1
HCP1303 capsule 5/0.2mg + HCP1303 capsule 5/0.4mg placebo+ HGP1201 placebo
干预措施: HGP1201 placebo (Drug)
Treatment 2
HCP1303 capsule 5/0.2mg placebo+ HCP1303 capsule 5/0.4mg + HGP1201 placebo
干预措施: HCP1303 capsule 5/0.4mg (Drug)
Treatment 2
HCP1303 capsule 5/0.2mg placebo+ HCP1303 capsule 5/0.4mg + HGP1201 placebo
干预措施: HCP1303 capsule 5/0.2mg placebo (Drug)
Treatment 2
HCP1303 capsule 5/0.2mg placebo+ HCP1303 capsule 5/0.4mg + HGP1201 placebo
干预措施: HGP1201 placebo (Drug)
Active Comparator
HCP1303 capsule 5/0.2mg placebo+ HCP1303 capsule 5/0.4mg placebo+ HGP1201
干预措施: HGP1201 (Drug)
Active Comparator
HCP1303 capsule 5/0.2mg placebo+ HCP1303 capsule 5/0.4mg placebo+ HGP1201
干预措施: HCP1303 capsule 5/0.2mg placebo (Drug)
结局指标
主要结局
Change of Total IPSS (International Prostate Symptom Score)
时间窗: baseline and 12 weeks
次要结局
- Change of Total IPSS(baseline and 4weeks, 8sweeks)