NCT01404637Unknown不适用
The Effects of Tamsulosin 0.4mg on Clinical Outcomes in Korean Men With Severe Symptomatic BPH
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 主要终点
- Changes of the total International Prostate Symptom Score (IPSS) score from baseline to 12 weeks of treatment in patients with severe symptomatic BPH refractory to tamsulosin 0.2mg (Harnal® 0.2mg, 1T)
研究概览
简要总结
The purpose of this study is to compare the efficacy and safety of tamsulosin 0.4mg (Harnal® D. 0.2mg, 2T) with tamsulosin 0.2mg (Harnal® D 0.2mg, 1T) in patients with severe symptomatic benign prostatic hyperplasia as a first line therapy.
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
- Single (Participant)
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Severe LUTS : IPSS ≥ 20
排除标准
- •Post voided residual urine ≥ 150mL
- •Patients performing catheterization
- •Urinary tract infection patients
- •Patients taking 5 alpha reductase inhibitor
- •Known hypersensitivity to tamsulosin
- •History of postural hypotension or syncope
- •Hypertension patients treated with other alpha1-blockers
- •Patients newly taking anticholinergic medication within 1 month
- •Hepatic insufficiency (AST/ALT ≥ 2 times of normal range)
- •Renal insufficiency (s-Cr ≥ 2mg/dL)
研究组 & 干预措施
tamsulosin 0.2mg
Active Comparator
干预措施: Tamsulosin 0.2mg (Drug)
Tamsulosin 0.4mg
Experimental
干预措施: Tamsulosin 0.4mg (Drug)
结局指标
主要结局
Changes of the total International Prostate Symptom Score (IPSS) score from baseline to 12 weeks of treatment in patients with severe symptomatic BPH refractory to tamsulosin 0.2mg (Harnal® 0.2mg, 1T)
时间窗: 12 weeks of treatment
次要结局
- Changes of maximal flow rate and post-voided residual urine volume after 4 and 12 weeks treatment.(4 weeks and 12 weeks of treatment)
- Changes of parameters in voiding diary after 4 and 12 weeks treatment.(4 weeks and 12 weeks of treatment)
研究者
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