NCT00150358已完成4 期
Open Label, Multicenter, Non Comparative Study, To Confirm The Efficacy And Tolerability Of Viagra In Subjects With Erectile Dysfunction And Arterial Hypertension Who Are Taking Antihypertensive Treatment.
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.17 个研究点 分布在 1 个国家目标入组 253 人开始时间: 2005年3月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 253
- 试验地点
- 17
- 主要终点
- The primary efficacy measure is the percent of ITT subjects at week 8 with positive response to the Global Efficacy Assessment question regarding the effectiveness of the medication in improving erections over no treatment at all for ED.
研究概览
简要总结
To assess changes with respect to Erectile Dysfunction in subjects treated with Viagra and antihypertensive therapy.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Subjects with arterial hypertension treated with one or more antihypertensive agents, the doses of which have been stable for at least 4 weeks prior to the baseline visit, with a documented clinical diagnosis of ED and a confirmation of this by a qualification of 21 or less on the SHI-M.
排除标准
- •Subjects with resting sitting systolic blood pressure >170 or <110mmHg or resting sitting diastolic blood pressure >90 or <50mmHg, with significant cardiovascular disease and retinitis pigmentosa, treatment with nitrates, alfablockers or CYP3A4 inhibitors.
结局指标
主要结局
The primary efficacy measure is the percent of ITT subjects at week 8 with positive response to the Global Efficacy Assessment question regarding the effectiveness of the medication in improving erections over no treatment at all for ED.
次要结局
- The evaluation of change from baseline to week 8 on the toal SHI-M (Sexual Health Inventory-Male) score and the 5 individual items on the SHI-M. Global Efficacy Assessment Questions 2 and 3 at week 8.
研究者
研究点 (17)
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