NCT01922375已完成4 期
A Randomized, Double-blind, Double-dummy, Placebo-controlled, Parallel Design Clinical Trial to Evaluate the Efficacy and Safety of Naftopidil in Male Patients With Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 411
- 试验地点
- 1
- 主要终点
- Efficacy(IPSS score change)
研究概览
简要总结
This study is designed to evaluate the efficacy and safety of Naftopidil in Korean male patients with with lower urinary tract symptoms associated with benign prostatic hyperplasia.
The investigators hypothesized that Naftopidil which came onto marcket in Japan would effect in improvement of voiding and storage difficulty.
Design:
Placebo-controlled, Randomized, Double-blind, Double-dummy, Parallel group, Fixed dose design
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
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male patients aged 4 years or more diagnosed with BPH
排除标准
- •subjects with uncontrolled blood pressure
- •subjects with hepatic or renal dysfunction
- •subjects with prostate cancer
- •Had treatments for BPH using other alpha receptor antagonists within 2 weeks
研究组 & 干预措施
Naftopidil dose 2
Experimental
PO administration
干预措施: Naftopidil (Drug)
Naftopidil dose 1
Experimental
PO administration
干预措施: Naftopidil (Drug)
结局指标
主要结局
Efficacy(IPSS score change)
时间窗: From 0 week(baseline) to 12 week(end of the treatment)
次要结局
- Efficacy(IPSS, Uroflowmetry parameter, LUTS-GAQ)(From 0 week(baseline) to 12 week(end of the treatment))
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Evaluate Safety, Pharmacokinetics and Pharmacodynamics of BBT-877 in Healthy Japanese MaleHealthy ParticipantsNCT04138849Bridge Biotherapeutics, Inc.24
已完成
1 期
A Study of CDX-0159 in Patients With Prurigo NodularisPrurigo NodularisNCT04944862Celldex Therapeutics24
已完成
2 期
Efficacy and Safety of Fuke Qianjin Capsule in Patients With Pelvic Inflammatory DiseasesPelvic Inflammatory DiseaseNCT04723069University of Karachi198
终止
1 期
Safety, Tolerability, Pharmacokinetics, and Preliminary Pharmacodynamics of QBW251 in Healthy Subjects and Cystic Fibrosis PatientsCystic FibrosisNCT02190604Novartis Pharmaceuticals153
进行中（未招募）
2 期
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary FibrosisPulmonary Fibrosis Secondary to Systemic SclerosisPulmonary Fibrosis, Interstitial Lung DiseaseInterstitial Lung Disease Due to Connective Tissue Disease (Disorder)Interstitial Lung Disease in Patients With Rheumatoid ArthritisInterstitial Lung Disease With Progressive Fibrotic Phenotype in Diseases Classified ElsewhereInterstitial Lung Disease With Systemic SclerosisPulmonary FibrosisHypersensitivity PneumonitisInterstitial Lung DiseaseNCT06329401Avalyn Pharma Inc.375