A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of Pletaal(Cilostazol) in Subjects With Vasospastic Angina
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Chest Pain Frequency
研究概览
简要总结
This study will be conducted in accordance with the local regulation of New Drug Application. Overall duration of this trial will be 3 years after approval of KFDA.
Each subject will participate around 7 weeks, which include the 2 weeks Amlodipine run-in period, 4 weeks double blind period and 1 week safety follow up period
详细描述
A Multicenter, Randomized, Double-Blind, Placebo-controlled, Parallel group, Therapeutic confirmatory Study.
The subject who has at least one episode of chest pain weekly and at least two episodes of chest pain during last week despite Amlodipine 5mg qd taking during 2 weeks will have treatment of Pletaal(Cilostazol) or Placebo for 4 weeks. Pletaal(Cilostazol) is taken 100mg oral tablets bid during 2 weeks after dosing of Pletaal(Cilostazol) 50mg oral tablets bid during 2 weeks. Placebo of Pletaal(Cilostazol) is used as the control medication.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 79 Years（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
group 1
Cilostazol 50mg, Cilostzaol 100mg
干预措施: Cilostazol (Drug)
group 2
placebo
干预措施: placebo (Drug)
结局指标
主要结局
Chest Pain Frequency
时间窗: Baseline and Week 4
Change of the chest pain frequency on the final a week after IP dosing from a week before IP dosing
次要结局
- Percent change of the chest pain frequency(Baseline and Week 4)
- Proportion of subjects without chest pain(4 weeks)
- total nitroglycerin sublingual consumption(Baseline and Week 4)
- total chest pain intensity(Baseline and Week 4)
- average pain intensity(the total pain intensity/the number of pain)(Baseline and Week 4)