A Multicenter, One Group, Open-label Study to Evaluate the Safety and Efficacy of Pletaal(Cilostazol) as BID for up to 24 Weeks Exposure in Subjects With Vasospastic Angina (STELLA Extension)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Proportion of the subjects whose chest pain was not present in the final 1 week/2 weeks after the 24-week treatment period
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 MFDS.
Each subject will participate around 26 weeks, which include the 24 weeks treatment period and 2 weeks safety follow up period. Withdrawn subjects due to efficacy after 4 weeks treatment will participate in 6 weeks in total including 2 weeks safety follow up. Withdrawn subjects with other reason also have 2 weeks follow up period.
详细描述
A Multicenter, One group, Open-label Study. Cilostazol will be treated for additional 24 weeks to the subject who had completed 021-KOA-1301i study. PletaalÒ(Cilostazol) is taken 100mg oral tablets bid during 2 3weeks after dosing of PletaalÒ(Cilostazol) 50mg oral tablets bid during 1 week. The dose can be adjusted by investigator's discretion during the study and the detailed method is described in the Protocol. Subject who has 2 or more chest pain at 4th week will be withdrawn from the study (But, subjects who show 50% or more of chest pain decrease compared to 1st week would not be withdrawn.). Subjects who participated in this trial will have 2 weeks follow-up after study completion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects aged 20 to 80 years, and subjects whose age at the time of enrollment was 80 in 021-KOA-1301i clinical trial and is 81 in this clinical trial
- •Subjects who completed 021-KOA-1301i clinical trial
- •Women of childbearing potential with negative pregnancy test at enrollment and who agree to practice a contraceptive measure throughout the clinical trial (e.g., hormonal contraceptives, intrauterine devices, condom + spermicidal agents, diaphragm + spermicidal agents, and partner's infertility)
- •Subjects who signed a written agreement indicating that they were given full explanations of the clinical trial and are willing to participate in the clinical trial
排除标准
- •Subjects who fell under one of the exclusion criteria at the time of enrollment for 021-KOA-1301i
- •Subjects who reported any of the following events, which fall under the exclusion criteria for KOA-1301i, between the initiation of 021-KOA-1301i participation and enrollment visit for 021-KOA-1302i
- •Myocardial infarction or myocardial infarction induced by vasospastic angina
- •Life-threatening vasospastic episodes (e.g., ventricular tachycardia, ventricular fibrillation, or syncope)
- •Stroke, intracranial hemorrhage, or transient ischemic attack (TIA)
- •Hemorrhage (hemophilia, capillary fragility, intracranial hemorrhage, upper gastrointestinal bleeding, urinary tract bleeding, hemoptysis, vitreous hemorrhage, etc.)
- •Subjects who are currently using any of the medications contraindicated in 021-KOA-1301i (excluding the investigational product of 021-KOA-1301i) at baseline
- •Subjects who meet the following criteria for baseline laboratory findings
- •severe anemia with hemoglobin ≤6.5 g/dl at baseline
- •Creatinine level ≥ 1.5 mg/dL at baseline
- •AST or ALT >3x ULN at baseline
- •Platelet count < 100,000mm3 at baseline
- •Pulse rate exceeding 100 bpm when measured for vital signs at baseline: Tachycardia
- •Hypotension with systolic pressure < 90mmHg at baseline
- •Uncontrolled hypertension defined as systolic pressure ≥ 160 mmHg or diastolic pressure ≥ 100 mmHg at baseline
- •QT prolongation defined as QTcB > 450 msec for men and QTcB > 470 msec for women at baseline
- •Women of childbearing potential with positive pregnancy test at baseline
- •Women who do not agree to practice a contraceptive measure, or are pregnant or lactating
- •Subjects who are not expected to have the potential to benefit from additional administration of Cilostazol, according to the investigator's judgment
- •Subjects otherwise judged by the investigator to be inappropriate for inclusion in the trial
研究组 & 干预措施
Cilostazol
Cilostazol 50mg and 100mg
干预措施: Cilostazol (Drug)
结局指标
主要结局
Proportion of the subjects whose chest pain was not present in the final 1 week/2 weeks after the 24-week treatment period
时间窗: 24 weeks
Proportion of the subjects whose chest pain was not present in the final 1 week/2 weeks after the 24-week treatment period
次要结局
- secondary 2(4 weeks)
- secondary 1(24 week)
- secondary 3(4 weeks)