NCT00517179已完成不适用
Effect of Vardenafil on Blood Pressure in Patients With Erectile Dysfunction Who Received Concomitant Doxazosin GITS for the Treatment of Benign Prostatic Hyperplasia
Hospital Authority, Hong Kong1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2006年4月1日最近更新:
适应症
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
- 40
- 试验地点
- 1
- 主要终点
- Mean maximal change of the standing systolic blood pressure (SBP) from half hour prior to till six hour after administration of the drug (baseline) with vardenafil administration versus placebo
研究概览
简要总结
The purpose of this study is to investigate the interaction between doxazosin GITS and vardenafil on blood pressure (Both systolic and diastolic blood pressure) in patients with both ED and BPH.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double
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
- •Age between 50 to 80 years old
- •Clinically diagnosed to have lower urinary tract symptoms secondary to BPH:
- •Suffered from lower urinary tract symptoms with International Prostate Symptom Score (IPSS) >=8
- •Detectable prostatic enlargement determined by Digital Rectum Examination (DRE)
- •Urinary flow between 5 to 15ml/second in a total void volume >=150mL
- •Currently on regular doxazosin GITS once-daily for at least 4 weeks without clinically significant side effects
- •Complaints of erectile dysfunction with Erectile Function domain (EF) of the International Index of Erectile Function (IIEF) score <= 21
排除标准
- •Congestive heart failure, unstable angina, arrhythmia, myocardial infraction
- •Hypertension or on any antihypertensive agents
- •Take nitrate and medication contradicted to vardenafil
- •Uncontrolled or poorly controlled diabetes mellitus
- •Intolerance or contra-indicated for the use of vardenafil
- •Hepatic disorder
结局指标
主要结局
Mean maximal change of the standing systolic blood pressure (SBP) from half hour prior to till six hour after administration of the drug (baseline) with vardenafil administration versus placebo
时间窗: From half hour prior to till six hour after administration of the drug (baseline)
次要结局
- Mean maximal post-baseline change of the standing and supine diastolic blood pressure (DBP)(From half hour prior to till six hour after administration of the drug (baseline))
- Mean maximal post-baseline change supine SBP, and (3) the pattern of changes of the SBP and DBP from half hour prior to till six hours after administration of the drug(From half hour prior to till six hour after administration of the drug (baseline))
研究者
研究点 (1)
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