Post Marketing Surveillance of Telostop TAB (Telmisartan/Rosuvastatin) for Evaluating the Safety and Efficacy
试验速览
- 阶段
- 不适用
- 入组人数
- 600
- 主要终点
- Incidence of adverse event after this drug administration in general medical practice
研究概览
简要总结
Post-marketing surveillance of Telostop TAB (Telmisartan/Rosuvastatin)
详细描述
Telostop TAB is fixed-dose combination of telmisartan and rosuvastatin, which was approved in 2015 in the Republic of Korea for the treatment of patients with hypertention and dyslipidemia. A post-marketing surveillance was conducted following the approval to obtain data on the safety and efficacy of Telostop TAB in real-world practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •The patient who is first prescribed and administered Telostop plus Tab.
排除标准
- •The patients who are overreacting to this drug or its components
- •The patients to the "Do not administer to the next patient" section of the approved instructions for use
结局指标
主要结局
Incidence of adverse event after this drug administration in general medical practice
时间窗: 24 weeks
Any adverse events occurred after this drug dosing will be recorded. Description of adverse event(s) including type of adverse event(s), onset/end date, severity, action taken, causal relationship to the drug and investigator's view on the adverse event(s) will be captured, whether it is related to the drug or not and until follow up visit more than 1 time during the surveillance period. Lab abnormalities and changes in vital signs are considered to be adverse events only if they result in discontinuation from the study, necessitate therapeutic medical intervention, and/or if the investigator considers them to be adverse events.
次要结局
- The change from baseline to week 24 in the LDL cholesterol(24 weeks)
- The change from baseline to week 24 in the blood pressure(24 weeks)