NCT00648323已完成4 期
A Prospective, Open-Labeled Trial of the Safety and Efficacy of Doxazosin GITS in Patients With Benign Prostate Hyperplasia
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2003年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change in the maximum urinary flow rate (Qmax) from baseline
研究概览
简要总结
The primary objectives were to determine the efficacy and safety of the GITS formulation of Doxazosin in Taiwanese patients with prostate enlargement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Taiwanese male subjects between 50 and 80 years of age who had: a primary diagnosis of BPH, defined as having an enlarged prostate (confirmed by digital rectal examination [DRE] and/or B-mode ultrasound); an IPSS score of ≥12; and a Qmax in the range of 5 to 15 mL/sec in a total voided volume of ≥150 mL, were eligible for the study.
- •Exclusion criteria include but not limited to:
- •Previous prostate surgery, presence of a prostate stent or microwave thermotherapy and/or balloon dilatation within the previous 6 months
- •Concomitant therapy or previous therapy within 14 days with agents known to affect bladder or urethral function.
排除标准
- 未提供
研究组 & 干预措施
A
Experimental
干预措施: Doxazosin mysylate GITS (Drug)
结局指标
主要结局
Change in the maximum urinary flow rate (Qmax) from baseline
时间窗: 8 weeks
Change in the International Prostate Symptom Score (IPSS) total score from baseline
时间窗: 8 weeks
次要结局
- Change in the International Prostate Symptom Score (IPSS) total score from baseline(4 weeks)
- Change in the maximum urinary flow rate (Qmax) from baseline(4 weeks)
- Change in the quality of life (QoL) assessment index score from baseline(8 weeks)
研究者
研究点 (1)
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