NCT01003886已完成不适用
A Post Marketing Surveillance Study To Determine The Safety, Tolerability And Effectiveness Of Doxazosin Mesylate GITS Among Filipino Adult Males With Benign Prostatic Hyperplasia (BPH)
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 989 人开始时间: 2009年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 989
- 试验地点
- 1
- 主要终点
- Number of Participants With Adverse Events (AEs)
研究概览
简要总结
This study aims to assess the safety, tolerability and efficacy of Doxazosin GITS in Filipino patients diagnosed with Benign Prostatic Hyperplasia (BPH) under the usual clinical care setting.
详细描述
This is an open label study. All patients prescribed with Doxazosin GITS can be enrolled in this study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Subjects that will be included must be consistent with the approved label indication of Doxazosin mesylate GITS in the Philippines, which includes adult male diagnosed with BPH, and who are prescribed with Doxazosin mesylate GITS.
排除标准
- •Subjects with condition that are contraindicated with Doxazosin mesylate GITS based on the approved labeling in the Philippines.
研究组 & 干预措施
Open Label
Adult male diagnosed with BPH and prescribed with Doxazosin mesylate GITS
干预措施: Doxazosin mesylate GITS (Drug)
结局指标
主要结局
Number of Participants With Adverse Events (AEs)
时间窗: Baseline up to Week 13 (7 days after last dose)
Any untoward medical occurrence in a participant who received study drug was considered an AE, without regard to possibility of causal relationship.
次要结局
- Percent Change From Baseline in the International Prostate Symptom (IPSS) Total Score at Week 4 and Week 12(Baseline, Week 4 and Week 12)
- Percent Change From Baseline in the IPSS Quality of Life (QoL) Score at Week 4 and Week 12(Baseline, Week 4 and Week 12)
- Change From Baseline in Diastolic BP at Week 4 and Week 12(Baseline through Week 12)
- Percentage of Participants With Postural Hypotension(Baseline up to Week 13 (7 days after last dose))
- Change From Baseline in Systolic BP at Week 4 and Week 12(Baseline through Week 12)
研究者
研究点 (1)
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