About this trial
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)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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 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.
Disqualifiers
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
The patients who are not suitable for this study by the investigators
Trial population
Essential hypertensive patients in need of a combination treatment with two or more antihypertensive agents
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
The blood pressure control rate
The blood pressure control rate (\< 140/90 mmHg)(Systolic and Diastolic) at Week 12
Secondary outcomes
The blood pressure control rate
The blood pressure control rate (\< 140/90 mmHg) at Week 8
The target blood pressure control rate
The target blood pressure control rate (\< 140/90 mmHg) at Week 12
Change in central systolic pressure(CSP) and Central diastolic pressure(CDP)
Change in central systolic pressure(CSP) and Central diastolic pressure(CDP) at Week 12 from baseline (Only the subjects who measured the central blood pressure)
Control rate of The Blood pressure control rate
Control rate of The Blood pressure control rate(\< 140/90 mmHg) at Week 36 , 48 and 96
Other outcomes
Adverse drug reactions(ADR) related to fimasartan/amlodipine or fimasartan/amlodipine/hydrochlorothiazide
Adverse drug reactions(ADR) related to fimasartan/amlodipine or fimasartan/amlodipine/hydrochlorothiazide (From the baseline to Week 12, From the baseline to Week 96)
Serious Adeverse Drug Reaction(Serious ADR) related to fimasartan/amlodipine or fimasartan/amlodipine/hydrochlorothiazide
Serious Adeverse Drug Reaction(Serious ADR) related to fimasartan/amlodipine or fimasartan/amlodipine/hydrochlorothiazide (From the baseline to Week 12, From the baseline to Week 96)
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