New combo pills for high blood pressure under Real-World study
NCT ID NCT05413057
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This large observational study will follow 20,000 adults with essential hypertension who are prescribed one of two combination pills containing fimasartan. The main goal is to see how well these pills control blood pressure over 12 weeks, and a longer follow-up of up to 2 years will check for heart events and safety. Participants take their medication as part of routine care, and researchers collect data on effectiveness and side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- fimasartan/amlodipine or fimasartan/amlodipine/hydrochlorothiazide (single-pill combinations)
- What this could lead to
- If successful, this study could confirm that these combination pills effectively control blood pressure and reduce long-term heart risks in people with essential hypertension.
- What could go wrong
- This is an observational study, not a controlled trial, so results may be less reliable. Side effects are possible, and the 12-week main phase is too short to assess long-term safety or outcomes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 20,000 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2022
- Expected to finish
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Jun 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Essential hypertensive patients in need of a combination treatment with two or more antihypertensive agents
- Ages
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19 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* Inclusion Criteria: 1. Patients who voluntarily consent on the informed consent form and understand the study's purpose, methods, and so on 2. Males and females over the age of 19 3. 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 4. 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 Criteria: 1. The patients who are suspected of having secondary hypertension or confirmed to have secondary hypertension 2. The patients who are contraindicated to taking fimasartan complex according to the drug labelling 3. 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. 4. The patients who are not suitable for this study by the investigators
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Seoul National University Bundang Hospital
RECRUITINGSeoul, South Korea
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