NCT00867815终止4 期
Prospective Case Crossover Study to Assess Whether PDE5 Inhibitor Exposure in Men Increases the Risk for the Development of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- Bayer
- 入组人数
- 10
- 试验地点
- 12
- 主要终点
- Number of Participants With Confirmed Diagnosis of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)
研究概览
简要总结
The primary objective of this study is to determine whether the use of PDE5 inhibitors (vardenafil, sildenafil, or tadalafil) increases the risk for the development of NAION.
详细描述
Collected data will be compared to historic data of the same participant in case-crossover design.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •NAION onset within 45 days before entry to the study
- •NAION onset definable by the subject within a 2 calendar day window
- •Men who have taken at least 1 dose of PDE5 inhibitor(s) at any time in the 1 year prior to enrollment in the study
- •Age 40 years or older
排除标准
- •History of multiple sclerosis or optic neuritis
- •Evidence of temporal arteritis
- •History of vasculitis or collagen vascular disease
- •Previous history of NAION
研究组 & 干预措施
Arm 1
Other
干预措施: Diagnostic procedures (Drug)
结局指标
主要结局
Number of Participants With Confirmed Diagnosis of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)
时间窗: Up to 45 days prior to study enrollment
The study population consisted of adult men, first diagnosed with NAION which started within 45 days before study start and took PDE5 inhibitors (vardenafil, sildenafil, tadalafil or avanafil) in the 1 year prior to enrollment.
次要结局
- Number of Participants With Most Frequent Medical History Findings by Primary System Organ Class at Visit 1(Day 1)
- Number of Participants With Any Adverse Events Reported at Visit 2(From informed consent signed up to Visit 2 (Day 90+/-30))
研究者
研究点 (12)
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