An OS to Evaluate Effectiveness and Safety of Fixed-dose Combinations of FMS/AML or FMS/AML/HCTZ

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age19+
SponsorBoryung Pharmaceutical Co., Ltd

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

The blood pressure control rate

The blood pressure control rate (\< 140/90 mmHg)(Systolic and Diastolic) at Week 12

Time frame
Week 12

Secondary outcomes

1

The blood pressure control rate

The blood pressure control rate (\< 140/90 mmHg) at Week 8

Time frame
Week 8
2

The target blood pressure control rate

The target blood pressure control rate (\< 140/90 mmHg) at Week 12

Time frame
Week 12
3

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)

Time frame
Week 12
4

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

Time frame
Week 36, Week 48, Week 96

Other outcomes

1

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)

Time frame
Week 12, Week 96
2

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)

Time frame
Week 12, Week 96

Sponsors and contacts

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