NCT01782833已完成不适用
A Prospective, Post Marketing Observational Study to Evaluate the Safety of Pletaal® SR Capsule
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,635
- 试验地点
- 4
- 主要终点
- The Incidence Rate and the Number of AE/ADRs
研究概览
简要总结
This is a Post Marketing Observational Study of cilostazol (Pletaal® SR capsule). As this study is observational in nature to collect the safety data after administrating the Pletaal SR capsule, from baseline to 16 weeks.
详细描述
This study will be conducted in a prospective, single-arm, multi-center format. As this study is observational in nature, the patient's follow-up is not prescriptive in nature and must be left up to the judgment of the physician (investigator), within the period of observation set forth in the protocol.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must meet all of the following inclusion criteria to be eligible for enrollment into the study :
- •Patients who are prescribed Pletaal® SR capsule treatment as per investigator's medical judgment for adults aged 19 and over.
- •Patients who gave written authorization to use their personal and health data Physician (Investigator) will refer to the product market authorization (package insert) for inclusion criteria.
排除标准
- •Patients presenting with any of the following will not be included in the study
- •Patients with hemorrhage
- •Patients with congestive heart failure
- •Patients with known hypersensitivity to Cilostazole or any ingredients of Pletaal®
- •Women who are pregnant or may possibly become pregnant
- •Patients who is not eligible to participate this study as investigator's medical judgment Physician (Investigator) will refer to the product market authorization (package insert) for exclusion criteria.
结局指标
主要结局
The Incidence Rate and the Number of AE/ADRs
时间窗: Follow-up at least once from baseline to 16 weeks
Incidence rates of overall AEs and ADRs that occurred during the study period
次要结局
- The Incidence Rate of Tarchycardia and Palpitation After Pletaal® SR Capsule Administration(Follow-up at least once from baseline to 16 weeks)
- The Number and Percentage of Drop-out Patients According to Aes(Follow-up at least once from baseline to 16 weeks)
研究者
研究点 (4)
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