NCT00249730已完成4 期
A Prospective Multicenter, Parallel Group Study With A Single Blind Phase And A Double Blind Randomised Phase, To Evaluate The Efficacy And Satisfaction Of Viagra (Sildenafil Citrate) High Dose (100mg) Titration Compared With 50mg Dose, In Men With Erectile Dysfunction
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.39 个研究点 分布在 8 个国家目标入组 510 人开始时间: 2005年10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
- 510
- 试验地点
- 39
- 主要终点
- Change in IIEF erectile function domain score at the end of double blind treatment.
研究概览
简要总结
To evaluate the efficacy of Viagra dose titration to 100mg versus 50mg in men with erectile dysfunction, based on responses to the IIEF questionnaire as measured at the beginning and at the end of double blind treatment, comparing the group titrated to 100mg vs. the group maintained on 50mg.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
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
- •Documented clinical diagnosis of ED by using IIEF-EF domain with score of ≤
- •Subjects must be in a stable relationship with the same partner for at least 6 months and willing to attempt sexual intercourse.
排除标准
- •Subjects in whom sexual activity is inadvisable in the opinion of the investigator such as significant cardiovascular disease in the last 6 months; including cardiac failure, myocardial infarction, unstable angina, stroke or transient ischemic attack (TIA), symptomatic or clinically significant cardiac arrhythmias including atrial fibrillation.
- •Subjects who are currently taking or are likely to be treated with nitrates or nitric oxide donors in any form (oral, sublingual, buccal, transdermal, inhalational or as aerosols) on either regular or intermittent basis.
结局指标
主要结局
Change in IIEF erectile function domain score at the end of double blind treatment.
次要结局
- Change in other IIEF domain scores; Response to other questionnaires regarding treatment satisfaction, safety and tolerability.
研究者
研究点 (39)
Loading locations...
相似试验
已完成
4 期
Effectiveness and Safety of Viagra in Men With ED and LUTS Due to Benign Prostatic Hyperplasia (BPH)ImpotenceNCT00143221Pfizer's Upjohn has merged with Mylan to form Viatris Inc.350
已完成
4 期
Study Of Men With Mild To Moderate Erectile Dysfunction To Evaluate The Efficacy Of Viagra 8 Hours Post-DoseImpotenceNCT00143260Pfizer's Upjohn has merged with Mylan to form Viatris Inc.250
已完成
4 期
Mild To Moderate Erectile Dysfunction StudyImpotenceNCT00137072Pfizer's Upjohn has merged with Mylan to form Viatris Inc.355
已完成
4 期
To Yield Further Information On The Efficacy And Safety Of Viagra Among Subjects With Arterial Hypertension .ImpotenceHypertensionNCT00150358Pfizer's Upjohn has merged with Mylan to form Viatris Inc.253
已完成
4 期
Assessment Of Sildenafil On Erectile Function And Intercourse Satisfaction And To Validate A New Subject QuestionnaireImpotenceNCT00147628Pfizer's Upjohn has merged with Mylan to form Viatris Inc.209