NCT01484119已完成3 期
Multi-center, Double-blind, Double-dummy, Randomized, Placebo-controlled, Active-reference, Parallel-group Study to Evaluate the Efficacy, Safety, and Tolerability of ACT-129968 in Adolescent, Adult & Elderly Patients With Seasonal Allergic Rhinitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 630
- 试验地点
- 7
- 主要终点
- The mean change in Daytime Nasal Symptom Score
研究概览
简要总结
This study will assess the efficacy and safety of ACT-129968 in adolescent, adult and elderly patients with seasonal allergic rhinitis, due to mountain cedar pollen.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 12 Years 至 76 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Investigational Drug
Active Comparator
ACT-129968
干预措施: ACT-129968 (Drug)
Comparative Drug
Placebo Comparator
matching placebo tablets and capsules
干预措施: Placebo (Drug)
Reference Drug
Active Comparator
Cetirizine
干预措施: Cetirizine (Drug)
结局指标
主要结局
The mean change in Daytime Nasal Symptom Score
时间窗: baseline to end of treatment period (2 weeks)
次要结局
- The mean change in other daytime/nighttime symptom scores of allergic rhinitis(baseline to end of treatment period (2 weeks))
研究者
研究点 (7)
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