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

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 design

Treatments tested in this trial

  • Not listed

Trial groups

No trial groups listed

Locations

1
Seoul National University Bundang Hospital Seoul South Korea

Sponsors and collaborators

Boryung Pharmaceutical Co., Ltd

Lead sponsor