Blood Pressure Control and Safety of Ex-one or Ex-one Plus in Essential Hypertension
A Multicenter, Prospective, Observational Study to Evaluate Blood Pressure Control Rates and Safety of Ex-one Tablet or Ex-one Plus Tablet in Patients With Essential Hypertension in Real-world Clinical Practice
This study aims to assess the proportion of patients with essential hypertension who achieve blood pressure control rates at Week 24 following treatment with Ex-one tablets or Ex-one Plus tablets, and to collect safety information observed during the study period.
研究概览
地位
条件
详细说明
This study aims to evaluate the efficacy of Ex-one tablets, a two-drug fixed-dose combination of amlodipine and valsartan, or Ex-one Plus tablets, a three-drug fixed-dose combination of amlodipine, valsartan, and chlorthalidone, in patients with essential hypertension in a real-world setting, focusing on the proportion of patients who achieve blood pressure control rates. In addition, safety data will be collected and evaluated in a large patient population.
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名：Yong-an Jeong
- 电话号码：+82-31-5176-4673
- 邮箱：yongan.jeong@inno-n.com
研究联系人备份
- 姓名：Seung Kye Cho
- 电话号码：+82-31-5176-4676
- 邮箱：seungkye.cho@inno-n.com
学习地点
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Seoul、韩国
- 招聘中
- HK inno.N
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接触：
- Seung Kye Cho
- 电话号码：+82-31-5176-4676
- 邮箱：seungkye.cho@inno-n.com
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接触：
- Ahrong Kim
- 电话号码：+82-31-5176-4666
- 邮箱：ahrong.kim@inno-n.com
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
University-affiliated hospitals and general hospitals where the study drug is administered
描述
Inclusion Criteria:
- Aged 19 years or older
- Patients for whom a decision has been made to administer the study medication for the treatment of essential hypertension in accordance with the approved prescribing information
- Patients who voluntarily provide written informed consent
Exclusion Criteria:
- Patients for whom administration of the study medication is contraindicated according to the approved prescribing information
- Patients whom the investigator considers medically unsuitable for participation in this study for reasons other than those specified above
学习计划
研究是如何设计的？
设计细节
- 观测模型：CASE_ONLY
- 时间观点：PROSPECTIVE
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Proportion of patients achieving blood pressure control rates at Week 24 after treatment with Ex-one tablets or Ex-one Plus tablets
大体时间：At Week 24 after enrollment
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Blood pressure treatment target of <140/90 mmHg, according to the 2022 Guidelines for the Management of Hypertension issued by the Korean Society of Hypertension |
At Week 24 after enrollment
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.