An Observational Study to Evaluate the Efficacy and Safety of Amosartan Plus Tablet in Uncontrolled Essential Hypertension Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 4,785
- 试验地点
- 1
- 主要终点
- Change from baseline in SBP/DBP
研究概览
简要总结
This study was to evaluate the therapeutic effect and safety of Amosartan Plus tablet administration in uncontrolled essential hypertension patients.
During the routine medical visit, Amosartan Plus tablets were administered to patients in need of blood pressure control according to the investigator's judgment.
In this study, effectiveness and safety information of treatment of Amosartan Plus tablets was followed for 6 months (up to 12 months), and observation of the target patients was terminated after collecting relevant data.
As this study was a non-interventional observational study, all patients received prescriptions according to the routine treatment procedure, and there were no visits or procedures required according to the observational study protocol.
详细描述
This study was a multi-center, prospective, non-interventional, observational study of factors affecting blood pressure after treatment with Amosartan Plus tablet in uncontrolled essential hypertension patients.
Data was collected from patients receiving routine treatment at hospitals in South Korea. Each patient visited the institution according to the protocol that designed the follow-up visits for six months to examine the effectiveness and safety of Amosartan Plus tablet.
This study approved by the institutions' IRBs and was conducted in compliance with clinical research ethics regulations.
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
- •Uncontrolled essential hypertension patients
- •Those who have already decided to administer Amosartan Plus tablet under the medical judgment of the researcher
- •Those who voluntarily decided to participate in this study and consented in writing to the consent form
排除标准
- •Patients for whom use of Amosartan Plus tablet is prohibited
研究组 & 干预措施
Single arm, Single group(No interventional)
Observational
干预措施: Amosartan Plus Tab. (Drug)
结局指标
主要结局
Change from baseline in SBP/DBP
时间窗: 24 weeks
Percentage from baseline in SBP/DBP
时间窗: 24 weeks
Percentage of patients achieving target blood pressure
时间窗: 24 weeks
次要结局
未报告次要终点