S-amlodipine in Essential HypertensIon and Assessment of Blood Pressure Targets Achievement According to 2022 KSH(Korean Society of Hypertension) Guidelines (SHIFT)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 5,000
- 试验地点
- 1
- 主要终点
- The ratio(%) of patients whose blood pressure measured at 6 months from the baseline was confirmed to be within the target blood pressure range according to the 2022 hypertension treatment guidelines
研究概览
简要总结
Evaluate the ratio(%) of patients whose blood pressure measured at 6 months from the baseline was confirmed to be within the target blood pressure range according to the 2022 hypertension treatment guidelines for essential hypertension patients who received the study drug.
详细描述
Primary purpose:
Evaluate the ratio(%) of patients whose blood pressure measured at 6 months from the baseline was confirmed to be within the target blood pressure range according to the 2022 hypertension treatment guidelines for essential hypertension patients who received the study drug.
Secondary purpose:
- Evaluate the efficacy by comparing the change in blood pressure for each drug pattern (monotherapy or combination therapy) at 6 months after administration of the drug to be studied in patients with essential hypertension.
- Evaluate the safety by checking the incidence (%) of adverse events after administration of the drug to be studied in patients with essential hypertension.
- Evaluate the safety by checking the peripheral edema incidence rate (%) after administration of the drug to be studied in patients with essential hypertension.
- Evaluate the safety by checking the headache incidence rate (%) after administration of the drug to be studied in patients with essential hypertension.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Adults over 19 years of age
- •A person who was diagnosed with essential hypertension at the time of participation in the study or was previously diagnosed with essential hypertension and is taking antihypertensive drugs for treatment (Essential hypertension: Systolic blood pressure greater than 140mmHg or diastolic blood pressure greater than 90mmHg)
- •A person whose prescription for the study drug under study was confirmed at the time of participation in the study
- •A person who voluntarily decided to participate in this observational study and gave written consent to the consent form
排除标准
- •Patients who are contraindicated in administration of study drug according to the permission
- •Patients with a history of hypersensitivity to the study drug or its components or other dihydropyridine-based drugs
- •Women who are pregnant or may be pregnant, and women who are lactating
- •Patients with shock (including cardiogenic shock), severe aortic valve stenosis, unstable angina, within 1 month after myocardial infarction, severe hypotension, severe liver dysfunction
- •Patients who are inappropriate to participate in the study in the judgement of the investigator
结局指标
主要结局
The ratio(%) of patients whose blood pressure measured at 6 months from the baseline was confirmed to be within the target blood pressure range according to the 2022 hypertension treatment guidelines
时间窗: after 6 months of prescription for S-Amlodipine compared to baseline
The ratio(%) of patients whose blood pressure measured at 6 months from the baseline was confirmed to be within the target blood pressure range according to the 2022 hypertension treatment guidelines for essential hypertension patients who received the study drug
次要结局
未报告次要终点