Status:
RECRUITING
An OS to Evaluate Effectiveness and Safety of Fixed-dose Combinations of FMS/AML or FMS/AML/HCTZ
Lead Sponsor:
Boryung Pharmaceutical Co., Ltd
Conditions:
Hypertension,Essential
Eligibility:
All Genders
19+ years
Brief Summary
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/amlodi...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
June 23 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
20000 Patients enrolled
Trial Details
Trial ID
NCT05413057
Start Date
June 23 2022
End Date
June 1 2026
Last Update
September 12 2025
Active Locations (1)
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1
Seoul National University Bundang Hospital
Seoul, South Korea