A Multicenter, Prospective, Observational Study to Evaluate Effectiveness and Safety of Fixed-dose Combinations of Fimasartan/Amlodipine or Fimasartan/Amlodipine/Hydrochlorothiazide in Essential Hypertensive Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20,000
- 试验地点
- 1
- 主要终点
- The blood pressure control rate
研究概览
简要总结
The main purpose of this observation study is to collect data on the effects and side effects for 12 weeks of the medication administration of the single-pill combinations, which are fimasartan/amlodipine or fimasartan/amlodipine/hydrochlorothiazide, based on fimasartan. (Stage 1).
Also, this study will evaluate major cardiovascular events, long-term blood pressure control, and the safety by follow-up of those who consent to the extended study for about 2 years (96 weeks).(Stage 2)
详细描述
This study will be conducted as a prospective observational study in about 600 domestic medical institutions, which are at least clinical level.
The investigator will enroll those who have essential hypertension and meet the inclusion and exclusion criteria after obtaining voluntary written consent for participation in the study and use of personal information.
This study is a non-interventional observational study and is based on decisions by the investigator about the choice of antihypertensive drugs, the period of treatment, and the medication change status etc.
During this study period, the scope of data to be collected is as follows:
- Demographic information
- Disease information (historical diseases and concomitant diseases )
- Physical measurements and vital signs
- Blood pressure Central Blood pressure and hemodynamic values (if applicable)
- Information on antihypertensive drugs and other concomitant medications
- Adverse drug reaction(ADR) and serious adverse drug reactions(SADR) related to fimasartan/amlodipine or fimasartan/amlodipine/hydrochlorothiazide
- Information on cardiovascular events (Only if subjects are in long term follow-up)
- Death information (Only if subjects are in long term follow-up)
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
- •Patients who voluntarily consent on the informed consent form and understand the study's purpose, methods, and so on
- •Males and females over the age of 19
- •Patients who have been diagnosed with essential hypertension and plan to be treated with fimasartan/amlodipine or fimasartan/amlodipine/hydrochlorothiazide
- •If the patient is applicable, one of the following;
- •If the patients have severe hypertension, stage 2 or higher(sit SBP ≥ 160 mmHg or sit DBP ≥ 100 mmHg), or high-risk hypertension (The cardiovascular risk score of the 2018 hypertension treatment guidelines by the Korean Society of Hypertension is applied.) The patients have never been treated with antihypertensive drugs for essential hypertension.
- •If the patients are on concomitant administration of fimasartan/amlodipin and hydrochlorothiazide for essential hypertension or, If the patients are on concomitant administration of a fimasartan/hydrochlorothiazide combination and amlodipine for essential hypertension
- •If the patients have a blood pressure of sitSBP ≥ 140 mmHg or sitDBP ≥ 90 mmHg even though they have been treated with antihypertensive drugs for essential hypertension
- •The patients who understand this study and are available to participate in this study until the end of the study period with a cooperative attitude.
排除标准
- •The patients who are suspected of having secondary hypertension or confirmed to have secondary hypertension
- •The patients who are contraindicated to taking fimasartan complex according to the drug labelling
- •The patients who are currently participation in another clinical trials (Drugs or medical devices) The patients who took an investigational drug within 12 weeks of the enrollment date
- •However, the following patients can participate in this study:
- •The patients who are currently enrolled in non-interventional clinical studies or who are being followed up on after the administration of investigational drugs has ended.
- •The patients who are not suitable for this study by the investigators
结局指标
主要结局
The blood pressure control rate
时间窗: Week 12
The blood pressure control rate (\< 140/90 mmHg)(Systolic and Diastolic) at Week 12
次要结局
- The incidence rate of major cardiovascular event(MACE)(Week 96)
- The target blood pressure control rate(Week 36, Week 48, Week 96)
- Change in central systolic pressure(CSP) and Central diastolic pressure(CDP)(Week 12)
- The blood pressure control rate(Week 8)
- Control rate of The Blood pressure control rate(Week 36, Week 48, Week 96)