A Phase 2, Randomized, Double-blind, Parallel Group, Placebo Controlled, Multi-center Study to Evaluate the Urodynamics and Safety of YM178 in Male Subjects With Lower Urinary Tract Symptoms (LUTS) and Bladder Outlet Obstruction (BOO)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 200
- 主要终点
- Change From Baseline to End of Treatment in Maximum Flow Rate (Qmax)
研究概览
简要总结
This study examined the safety, tolerability, and efficacy of mirabegron (YM178) 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
- Triple (Participant, Care Provider, 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
- •Men 45 years of age or older
- •Documented bladder outlet obstruction
排除标准
- •History of urinary retention
- •Symptomatic and recurrent urinary tract infection (UTI)
研究组 & 干预措施
Placebo
Participants received matching mirabegron placebo tablets orally once daily for 12 weeks.
干预措施: Placebo (Drug)
Mirabegron 50 mg
Participants received 50 mg mirabegron tablets orally once daily for 12 weeks.
干预措施: Mirabegron (Drug)
Mirabegron 100 mg
Participants received 100 mg mirabegron tablets orally once daily for 12 weeks.
干预措施: Mirabegron (Drug)
结局指标
主要结局
Change From Baseline to End of Treatment in Maximum Flow Rate (Qmax)
时间窗: Baseline and Week 12
Maximum urinary flow rate (Qmax) was measured by the Investigator using cystometry and was sent to an independent central reading center for review and interpretation. Least squares means (LSM) were derived from an analysis of covariance (ANCOVA) model with the pooled study center and treatment as factors and the baseline value as a covariate.
Change From Baseline to End of Treatment in Detrusor Pressure at Maximum Flow Rate (PdetQmax)
时间窗: Baseline and Week 12
Detrusor pressure at maximum urinary flow rate (PdetQmax) was measured by the Investigator using cystometry and was sent to an independent central reading center for review and interpretation. Least squares means (LSM) were derived from an analysis of covariance (ANCOVA) model with the pooled study center and treatment as factors and the baseline value as a covariate.
次要结局
- Change From Baseline to End of Treatment in Bladder Contractile Index (BCI)(Baseline and Week 12)
- Change From Baseline to End of Treatment in Bladder Voiding Efficiency (BVE)(Baseline and Week 12)
- Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in Postvoid Residual Volume (PVR)(Baseline and Weeks 1, 4, 8 and 12)
- Safety Assessed by Adverse Events (AEs), Electrocardiogram (ECG), Vital Signs, Physical Exam and Laboratory Tests(From first dose to within 30 days after last dose of double blind study medication (up to 16 weeks).)
- Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in International Prostate Symptoms Score (IPSS) Total Score(Baseline and Weeks 1, 4, 8 and 12)
- Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in International Prostate Symptoms Score (IPSS) Voiding Score(Baseline and Weeks 1, 4, 8 and 12)
- Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in International Prostate Symptoms Score (IPSS) Storage Symptom Score(Baseline and Weeks 1, 4, 8 and 12)
- Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in Patient Perception of Bladder Condition (PPBC)(Baseline and Weeks 1, 4, 8 and 12)
- Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in Mean Number of Micturitions Per 24 Hours(Baseline and Weeks 1, 4, 8 and 12)
- Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in Mean Number of Urgency Episodes With Urgency Severity ≥ 3 Per 24 Hours(Baseline and Weeks 1, 4, 8 and 12)
- Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in Mean Number of Incontinence Episodes Per 24 Hours(Baseline and Weeks 1, 4, 8 and 12)
- Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in Mean Voided Volume Per Micturition(Baseline and Weeks 1, 4, 8 and 12)
- Change From Baseline to Weeks 4, 8, 12 and End of Treatment in International Consultation on Incontinence Questionnaire - Male Lower Urinary Tract Symptom (ICIQ MLUTS) Total Symptom Score(Baseline and Weeks 4, 8 and 12)
- Change From Baseline to Weeks 4, 8, 12 and End of Treatment in International Consultation on Incontinence Questionnaire - Male Lower Urinary Tract Symptom (ICIQ MLUTS) Total Bother Score(Baseline and Weeks 4, 8 and 12)
- Change From Baseline to Weeks 4, 8, 12 and End of Treatment in International Consultation on Incontinence Questionnaire - Lower Urinary Tract Symptom Quality of Life (ICIQ-LUTSqol) Symptom Score(Baseline and Weeks 4, 8 and 12)
- Change From Baseline to Weeks 4, 8, 12 and End of Treatment in International Consultation on Incontinence Questionnaire - Lower Urinary Tract Symptom Quality of Life (ICIQ-LUTSqol) Overall Symptom Interference of Life Score(Baseline and Weeks 4, 8 and 12)