Actively Recruiting
An OS to Evaluate Effectiveness and Safety of Fixed-dose Combinations of FMS/AML or FMS/AML/HCTZ
Led by Boryung Pharmaceutical Co., Ltd · Updated on 2025-09-12
20000
Participants Needed
1
Research Sites
205 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
An OS to Evaluate Effectiveness and Safety of Fixed-dose Combinations of FMS/AML or FMS/AML/HCTZ
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients who voluntarily consent to participate and understand the study
- Male or female patients aged 19 years or older
- Diagnosed with essential hypertension and planning treatment with fimasartan/amlodipine or fimasartan/amlodipine/hydrochlorothiazide
- Patients with severe hypertension (sitting SBP ≥ 160 mmHg or DBP ≥ 100 mmHg), high-risk hypertension, and never treated with antihypertensive drugs
- Patients currently taking fimasartan/amlodipine and hydrochlorothiazide together or fimasartan/hydrochlorothiazide and amlodipine together
- Patients with blood pressure of sitting SBP ≥ 140 mmHg or DBP ≥ 90 mmHg despite antihypertensive treatment
- Patients willing and able to participate cooperatively until the study ends
You will not qualify if you...
- Patients suspected or confirmed to have secondary hypertension
- Patients contraindicated to take fimasartan combination according to drug labeling
- Patients currently in other clinical trials or who took investigational drugs within 12 weeks, except those in non-interventional studies or follow-ups after investigational drug administration
- Patients deemed unsuitable for this study by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Seoul National University Bundang Hospital
Seoul, South Korea
Actively Recruiting
Research Team
M
MyungSook Hong
CONTACT
J
JiYeon Kim
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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