NCT01203371撤回3 期
PHASE III, DOUBLE-BLIND, RANDOMIZED STUDY COMPARING THE EFFICACY AND SAFETY OF NAFTOPIDIL AND TAMSULOSIN TO TREATMENT THE SYMPTOMS OF LOWER URINARY TRACT IN PATIENTS WITH BENIGN PROSTATE HYPERPLASIA
Apsen Farmaceutica S.A.2 个研究点 分布在 1 个国家开始时间: 2011年1月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- International Prostate Symptom Score
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness and safety of Naftopidil and Tamsulosin in the treatment of lower urinary tract symptoms through a comparative study of patients with benign prostatic hyperplasia.
详细描述
Inclusion Criteria:
Men ≥ 50 years Signs and symptoms of BPH A total IPSS of ≥ 10 Prostate volume of ≥20 mL (estimated by ultrasonography) PVR > 150mL
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men ≥ 50 years
- •Signs and symptoms of BPH
- •IPSS of ≥ 10
- •Prostate volume of ≥ 20 mL
- •PVR > 150 mL
排除标准
- •History of allergy to a AR antagonists
- •Treatment with antiandrogen drugs
- •Drugs with anticholinergic activity
- •Significant history of orthostatic hypotension
- •Concomitant neurological diseases
- •Known or suspected neurogenic bladder dysfunction
- •Carcinoma of the prostate or bladder
- •Previous surgery for BPH or bladder neck obstruction
- •History of recurrent UTI
- •Concomitant active UTI
研究组 & 干预措施
Naftopidil
Experimental
0,25 mg (2 weeks) and 0,50 mg (10 weeks)
干预措施: Naftopidil (Drug)
Tamsusolin
Active Comparator
0,4 mg/day
干预措施: Tamsulosin (Drug)
结局指标
主要结局
International Prostate Symptom Score
时间窗: 2, 4, 8 and 12 weeks
次要结局
- Adverse Effect(2, 4, 8 and 12 weeks)
研究者
研究点 (2)
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