NCT00645034已完成2 期
A Double-blind, Placebo-controlled, Randomized, 2-way Crossover Study to Investigate the Hemodynamic Effects of a Single Dose of Sildenafil (100mg) in Subjects With Benign Prostatic Hyperplasia Being Treated With Doxazosin
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 20 人开始时间: 2002年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Pharmacodynamic parameters of blood pressure and pulse rate
研究概览
简要总结
To investigate the effects of a single dose of sildenafil (100 mg) or placebo on blood pressure and pulse rate in subjects taking doxazosin for benign prostatic hyperplasia (BPH). To investigate the pharmacokinetics of doxazosin when co-administered with sildenafil 100 mg, and to investigate the safety and toleration of sildenafil 100 mg when co-administered with doxazosin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •patients who weighed between 132 and 220 lb (60 and 100 kg) with benign prostatic hyperplasia (BPH)
- •a total PSA (prostate specific antigen) measurement of less than or equal to 10 µg/L within the 12 months prior to screening, were currently on doxazosin treatment for BPH, had been treated with doxazosin for a minimum of 2 months prior to first dose of study medication, and had received a minimum of 4 mg doxazosin once daily (from doxazosin supplied for this study) for 2 weeks prior to the first dose of study medication.
排除标准
- •subjects with a recent history (i.e. within 6 months prior to screening) of stroke or myocardial infarction
- •subjects with severe cardiovascular disorders such as unstable angina or severe congestive heart failure
- •subjects with known hereditary degenerative retinal disorders, such as retinitis pigmentosa
- •subjects with a supine systolic/diastolic blood pressure of >170/100 mmHg or <100/60 mmHg either at screening or at the pre-dose measurements
- •subjects receiving any other antihypertensive therapy other than doxazosin in the 3 weeks prior to the first dose of study medication.
研究组 & 干预措施
Arm 1
Active Comparator
干预措施: sildenafil (Drug)
Arm 2
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Pharmacodynamic parameters of blood pressure and pulse rate
时间窗: immediately predose, 15, 30, and 45 minutes and 1, 1.5, 2, 2.5, 3, 4, 6, and 8 hours postdose
次要结局
- Safety and toleration of simultaneously co-administering sildenafil and doxazosin.(continuous)
- Blood samples for doxazosin pharmacokinetic parameters(time 0 (pre-dose), and at 1, 2, 3, 4, 6, and 8 hours post-dose)
研究者
研究点 (1)
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