NCT00527605已完成3 期
A Randomized, Double-blind, Placebo-controlled, Six-month Parallel-group Study to Assess Efficacy and Safety of Dutasteride 0.5mg Once Daily in Chinese Patients With Benign Prostatic Hyperplasia (BPH), Followed by a 12-month Open-label Treatment Phase
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 253
- 试验地点
- 1
- 主要终点
- Percent Change From Baseline in the Prostate Volume at Month 6
研究概览
简要总结
This randomized, double-blind, placebo-controlled, six-month parallel-group study assess efficacy and safety of dutasteride 0.5mg once daily in Chinese patients with Benign Prostatic Hyperplasia (BPH) , followed by a 12-month open-label treatment phase
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
A
Experimental
dutasteride 0.5mg once daily orally
干预措施: Dutasteride 0.5mg capsule (Drug)
B
Placebo Comparator
Placebo matched once daily orally
干预措施: Dutasteride matched placebo (Drug)
结局指标
主要结局
Percent Change From Baseline in the Prostate Volume at Month 6
时间窗: Baseline and Month 6
Percent change from baseline was calculated as the prostate volume at Month 6 minus the volume at baseline, divided by the prostate volume at baseline and multiplied by 100. Prostate volume was measured by transrectal ultrasound.
次要结局
- Percent Change From Baseline in the Prostate Volume at Month 3(Baseline and Month 3)
- Change From Baseline in the Prostate Volume at Month 6(Baseline and Month 6)
- Change From Baseline in the Prostate Volume at Month 3(Baseline and Month 3)
- Percent Change From Baseline in the Serum Dihydrotestosterone (DHT) at Month 6(Baseline and Month 6)
- Percent Change From Baseline in the Serum DHT at Month 3(Baseline and Month 3)
- Change From Baseline in the Serum DHT at Month 6(Baseline and Month 6)
- Change From Baseline in the Serum DHT at Month 3(Baseline and Month 3)
- Percent Change From Baseline in the American Urological Association Symptom Index (AUA-SI) Score at Month 6(Baseline and Month 6)
- Percent Change From Baseline in the AUA-SI Score at Month 3(Baseline and Month 3)
- Change From Baseline in the AUA-SI Score at Month 6(Baseline and Month 6)
- Change From Baseline in the AUA-SI Score at Month 3(Baseline and Month 3)
- Percent Change From Baseline in Maximum Urinary Flow Rate (Qmax) at Month 6(Baseline and Month 6)
- Percent Change From Baseline in Qmax at Month 3(Baseline and Month 3)
- Change From Baseline in Qmax at Month 6(Baseline and Month 6)
- Change From Baseline in Qmax at Month 3(Baseline and Month 3)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Lurasidone Pediatric Autism StudyAutismNCT01911442Sumitomo Pharma America, Inc.150
已完成
2 期
ACP-104 in Acutely Psychotic Subjects With SchizophreniaSchizophreniaNCT00490516ACADIA Pharmaceuticals Inc.247
已完成
3 期
A 6 Month Safety and Efficacy Study of Once Daily Ciclesonide Hydrofluoroalkane (HFA) in the Treatment of Perennial Allergic Rhinitis (PAR) in Subjects 12 Years and OlderAllergic RhinitisPerennial Allergic RhinitisNCT00953147Sumitomo Pharma America, Inc.1,110
已完成
3 期
SLV308 for Treatment of Patients With Early Parkinson's DiseaseEarly Stage Parkinson's DiseaseNCT00269516Solvay Pharmaceuticals468
已完成
3 期
Study of the Efficacy of Lurasidone in Cognitive Functioning in Bipolar PatientsBipolar DisorderNCT02731612Lakshmi N Yatham100