Double-Blind, Placebo-Controlled, Active-Referenced, Parallel-Group Comparative Study in Patients With Benign Prostatic Hyperplasia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 320
- 主要终点
- Change from baseline in total IPSS (International Prostate Symptom Score)
研究概览
简要总结
The purpose of this study is to compare the efficacy of ASP4901 with placebo in patients with benign prostatic hyperplasia. The safety and tolerability of ASP4901 will also be evaluated.
详细描述
This is a multicenter, randomized, parallel-group, placebo-controlled, active-referenced, double-blind study. After obtaining the written consent, patients meeting the eligibility criteria at the preliminary enrollment will receive oral administration of placebo in a single-blinded manner (single-blind placebo run-in period). Then, patients meeting the eligibility criteria at the main enrollment will receive drug or placebo (double-blind treatment period) for 4 weeks. Furthermore, patients will be followed up for 1 week to confirm the safety of the study drugs after the treatment period (safety follow-up period).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 74 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •dysuria associated with BPH for at least 12 weeks before providing consent
- •a total IPSS core of 13 or higher
- •a QOL score of 3 or higher
- •a maximum urinary flow rate (Qmax) of ≥4 mL/sec and <15 mL/sec.
- •a prostate volume of ≥20 mL.
排除标准
- •A postvoid residual volume (PVR) of >350 mL
- •A previous or concurrent symptomatic urinary tract infection within 4 weeks of the study
- •A cataract operation scheduled to be performed during the study period
- •Previous or concurrent clinically relevant cardiovascular or cerebrovascular disorder within 24 weeks prior to the study
- •Hypersensitivity to ASP4901 or tamsulosin hydrochloride
- •Presence of serious hepatic diseases, renal diseases, immunological diseases, or pulmonary diseases that are clinically relevant
研究组 & 干预措施
ASP4901 group
After the main enrollment, patients will receive an oral dose of ASP4901 once daily for 4 weeks (double-blind treatment period).
干预措施: ASP4901 (Drug)
Placebo group
After the main enrollment, patients will receive an oral dose of placebo once daily for 4 weeks (double-blind treatment period).
干预措施: Placebo (Drug)
Tamsulosin group
After the main enrollment, patients will receive an oral dose of tamsulosin once daily for 4 weeks (double-blind treatment period).
干预措施: Tamsulosin (Drug)
结局指标
主要结局
Change from baseline in total IPSS (International Prostate Symptom Score)
时间窗: baseline and at the final evaluation (up to 5 weeks)
次要结局
- Change from baseline in each symptom score of IPSS(baseline and at the final evaluation (up to 5 weeks))
- Change from baseline in IPSS QOL (quality of life) score(baseline and at the final evaluation (up to 5 weeks))
- Safety assessed by the incidence of adverse events, vital signs, labo-tests and 12-lead ECGs(up to 5 weeks)
- Proportion of IPSS responder(baseline and at the final evaluation (up to 5 weeks))
- Plasma concentration of ASP4901(up to 5 weeks)