JPRN-jRCT2080222226已完成2 期
KRP-AM1977X Phase II Clinical Study -To assess efficacy, safety and pharmacokinetics of KRP-AM1977X in the patients with community acquired pneumonia
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 129
研究概览
简要总结
The cure rate at the test-of-cure was more than 90% each in the 75 mg/day group and the 150 mg/day group. The cure rate at the test-of-cure in the 150 mg/day group was higher than that in the 75 mg/day group. In the safety assessment, no major problem was observed in the 75 mg/day group, and a drug related serious adverse event was observed in the 150 mg/day group.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 74age old(—)
- 性别
- All
入选标准
- •Community acquired pneumonia with clear infection symptoms
排除标准
- •Pneumonia patient except the community-acquired pneumonia
- •Patient with serious functional disorder that would unsuitable for the study
- •Patient showing the tendency to improve pneumonia symptoms by other agents
研究者
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