Hypertension,EssentialNCT05413057
An OS to Evaluate Effectiveness and Safety of Fixed-dose Combinations of FMS/AML or FMS/AML/HCTZ
An observational study of Hypertension,Essential, run by Boryung Pharmaceutical Co., Ltd at 1 site in South Korea.
Trial 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/amlodipine or fimasartan/amlodipine/hydrochlorothiazide, based on fimasartan. (Stage 1). Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Hypertension,Essential
- How many people
- 20,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- 23 Jun 2022to Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Essential hypertensive patients in need of a combination treatment with two or more antihypertensive agents
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Bundang Hospital
Seoul
InHo Chae, M.D., Ph.D.
InHo Chae, M.D., Ph.D.
About this study
Official title: A Multicenter, Prospective, Observational Study to Evaluate Effectiveness and Safety of Fixed-dose Combinations of Fimasartan/Amlodipine or Fimasartan/Amlodipine/Hydrochlorothiazide in Essential Hypertensive Patients
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)
Read the 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 hypertension and meet the inclusion and exclusion criteria after obtaining voluntary written consent for participation in the study and use of personal information.
This study is a non-interventional observational study and is based on decisions by the investigator about the choice of antihypertensive drugs, the period of treatment, and the medication change status etc.
During this study period, the scope of data to be collected is as follows:
- Demographic information
- Disease information (historical diseases and concomitant diseases )
- Physical measurements and vital signs
- Blood pressure Central Blood pressure and hemodynamic values (if applicable)
- Information on antihypertensive drugs and other concomitant medications
- Adverse drug reaction(ADR) and serious adverse drug reactions(SADR) related to fimasartan/amlodipine or fimasartan/amlodipine/hydrochlorothiazide
- Information on cardiovascular events (Only if subjects are in long term follow-up)
- Death information (Only if subjects are in long term follow-up)
- Conditions
- Hypertension,Essential
- Keywords
- Fimasartan, Essentail hypertension
- Medical subject headings
- Essential Hypertension
What is being measured
The primary outcome is the main question the study is designed to answer.
The blood pressure control rate
The blood pressure control rate (< 140/90 mmHg)(Systolic and Diastolic) at Week 12
Measured: Week 12
Secondary outcomes (6)
The blood pressure control rate
The blood pressure control rate (< 140/90 mmHg) at Week 8
Measured: Week 8
The target blood pressure control rate
The target blood pressure control rate (< 140/90 mmHg) at Week 12
Measured: Week 12
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)
Measured: Week 12
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
Measured: Week 36, Week 48, Week 96
The target blood pressure control rate
The target blood pressure control rate at Week 36 , 48 and 96
Measured: Week 36, Week 48, Week 96
The incidence rate of major cardiovascular event(MACE)
The incidence rate of major cardiovascular event(MACE)
Measured: Week 96
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2022
- Study start23 Jun 2022
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension,EssentialStudies of the same condition, open and under way.
- More trials run by Boryung Pharmaceutical Co., LtdThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boryung Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MyungSook Hong, Study director, Boryung Co.,Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05413057
- Sponsor's protocol ID
- BR-FMS-OS-408
- Status last verified
- Sep 2025
- First submitted
- 7 Jun 2022
- Last updated
- 12 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Observational Study to Evaluate Effectiveness and Safety of Fixed-dose Combinations of Fimasartan/Amlodipine or Fimasartan/Amlodipine/Hydrochlorothiazide in Essential Hypertensive Patients
- ClinicalTrials.gov ID
- NCT05413057
- Acronym / sponsor ID
- BR-FMS-OS-408
- Conditions
- Hypertension,Essential
- Keywords
- Fimasartan, Essentail hypertension
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- Boryung Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 23 Jun 2022 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 9 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
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 hypertension and meet the inclusion and exclusion criteria after obtaining voluntary written consent for participation in the study and use of personal information.
This study is a non-interventional observational study and is based on decisions by the investigator about the choice of antihypertensive drugs, the period of treatment, and the medication change status etc.
During this study period, the scope of data to be collected is as follows:
- Demographic information
- Disease information (historical diseases and concomitant diseases )
- Physical measurements and vital signs
- Blood pressure Central Blood pressure and hemodynamic values (if applicable)
- Information on antihypertensive drugs and other concomitant medications
- Adverse drug reaction(ADR) and serious adverse drug reactions(SADR) related to fimasartan/amlodipine or fimasartan/amlodipine/hydrochlorothiazide
- Information on cardiovascular events (Only if subjects are in long term follow-up)
- Death information (Only if subjects are in long term follow-up)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Essential hypertensive patients in need of a combination treatment with two or more antihypertensive agents
Key inclusion criteria (8 listed)
- If the patient is applicable, one of the following;
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The blood pressure control rate
Time frame: Week 12
The blood pressure control rate (< 140/90 mmHg)(Systolic and Diastolic) at Week 12
6 secondary outcomes
The blood pressure control rate
Time frame: Week 8
The target blood pressure control rate
Time frame: Week 12
Change in central systolic pressure(CSP) and Central diastolic pressure(CDP)
Time frame: Week 12
Control rate of The Blood pressure control rate
Time frame: Week 36, Week 48, Week 96
The target blood pressure control rate
Time frame: Week 36, Week 48, Week 96
The incidence rate of major cardiovascular event(MACE)
Time frame: Week 96
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
MyungSook Hong study director
Boryung Co.,Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension,Essential, run by Boryung Pharmaceutical Co., Ltd at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact MyungSook Hong (+8227088238, mshong@boryung.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The blood pressure control rate (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2025.