临床试验/NCT00909233

NCT00909233已完成不适用

LEVITRA® 20mg Special Drug Use Investigation (Long-term)

Bayer0 个研究点目标入组 1,221 人开始时间: 2007年8月最近更新: 2014年12月15日

适应症

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方: Bayer
入组人数: 1,221
主要终点: Efficacy of patients with LEVITRA treatment

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

This investigation targets either the patients of 18 years-old or older and under 65 years-old with organic or mixed erectile dysfunction (ED) who cannot obtain sufficient efficacy by dose 10mg of Levitra, and the target patients dose is increased to Levitra 20mg. This investigation will be limited to the patients whose tolerability of Levitra 10mg is judged to be no problem.

研究设计

研究类型: Observational
观察模型: Cohort
时间视角: Prospective

入排标准

年龄范围: 18 Years 至 64 Years（Adult）
性别: Male
接受健康志愿者: 否

入选标准

•This investigation targets either the patients of 18 years-old or older and under 65 years-old with organic or mixed erectile dysfunction who cannot obtain sufficient efficacy by dose 10mg of Levitra, and the target patients dose is increased to Levitra 20mg. This investigation will be limited to the patients whose tolerability of Levitra 10mg is judged to be no problem.

排除标准

未提供

研究组 & 干预措施

Group 1

干预措施: Vardenafil, (Levitra, BAY38-9456) (Drug)

结局指标

主要结局

Efficacy of patients with LEVITRA treatment

时间窗: After 6 months

次要结局

LEVITRA treatment improved the patient's erection(After 6 months)
LEVITRA improved the patient's erection after Minimum and Maximum Intervals between LEVITRA intake and the start of intercourse(After 6 months)
Reporting a second successful intercourse within 24 hours of dosing(After 6 months)
Tolerability of patients with LEVITRA treatment(After 6 months)
Patients prefer LEVITRA over last Erectile Dysfunction treatment(After 6 months)

研究者

发起方

Bayer

申办方类型

Industry

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