Essential HypertensionFRESHNCT03649646
FimasaRtan-basEd BP Targets After Drug SwitcHing
An observational study of Essential Hypertension, run by Boryung Pharmaceutical Co., Ltd at 1 site in South Korea.
Trial summary
The recent hypertension clinical practice guidelines published by American College of Cardiology (ACC) and American Heart Association (AHA) reduced the target BP to 130/80 mmHg, indicating the needs for more aggressive efforts in hypertension treatment. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Essential Hypertension
- How many people
- 4,542 participants
- Where
- 1 siteSouth Korea
- Study dates
- 3 Jul 2018to 29 Oct 2020
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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: Patients with hypertension uncontrolled by antihypertensive drugs* whose antihypertensive regimens are changed to angiotensin receptor blocker (ARB) monotherapy or concomitant antihypertensive drug therapy containing ARB. *Including patients who previously received angiotensin receptor blocker (ARB); in this case, changing to other therapy using an ARB with different ingredient is allowed.
Who may be able to join
- Provided written consent to the use of personal information after receiving the explanation of the objective, methodology, etc. of this clinical study
- Male or female adults ≥ 19 years who are diagnosed with essential hypertension
- Receiving outpatient treatment at the time of study enrollment
- Patients with hypertension uncontrolled by existing antihypertensive drugs (including ARB) whose antihypertensive regimens decided and scheduled to be changed to ARB monotherapy or ARB-containing combination therapy (the result of the arm with a higher mean BP [systolic BP preferred] when measured twice with at least a 2-minute interval in both arms at the medical office on the study enrollment date, will become the reference)
- Definition of uncontrolled hypertension: Target BP (SBP <140 mmHg and DBP <90 mmHg) not achieved even after the treatment using the existing antihypertensive drugs for 4 weeks or longer
Who cannot join
- Patients who were hospitalized or are scheduled to be hospitalized 4 weeks before or after the study enrollment date
- Patients with suspected or confirmed secondary hypertension
- Pregnant or breast-feeding women
- Patients who received investigational product within 12 weeks or are scheduled to participate in another clinical study while participating in this study
- Patients who are determined inappropriate for participating in the study by investigators for other reasons
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-center, Open, Longitudinal, Observational Study to Assess the Treatment Trend and the Proportion of Target BP Attainment in Patients Whose Antihypertensive Regimens Are Changed to ARB-based Therapy
The recent hypertension clinical practice guidelines published by American College of Cardiology (ACC) and American Heart Association (AHA) reduced the target BP to 130/80 mmHg, indicating the needs for more aggressive efforts in hypertension treatment. However, studies in Koreans must be preceded before applying such new overseas guidelines; thus, this study has been designed to establish clinical materials reflecting treatment setting in Korea. In this study, patients with uncontrolled hypertension whose antihypertensive regimens are changed to ARB-based therapy (ARB monotherapy or ARB-containing combination therapy) will be followed to assess the treatment trend, treatment effect, and risk of cardiovascular disease.
Read the detailed description
This study will be performed in patients with blood pressure (BP) uncontrolled by existing antihypertensive drugs (including ARB) among hypertensive patients visiting outpatient clinic of medical institutions in Korea. The study enrollment number will be assigned to the subjects who provide a written consent to the use of personal information and meet the inclusion/exclusion criteria. Follow-up will be conducted for 12 weeks in total and prespecified study related data will be collected in the case report form.
- Conditions
- Essential Hypertension
- Keywords
- Hypertension, Fimasartan
- Medical subject headings
- Essential Hypertension, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients with hypertension uncontrolled by antihypertensive drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients With Controlled Blood Pressure (<140/90 mmHg)
Percentage of patients who attain the target blood pressure (BP) (<140(SBP)/90(DBP) mmHg) at Week 12 after the treatment regimen change
Measured: Week 12 after the treatment regimen change
Secondary outcomes (3)
Percentage of Patients With Controlled BP According to 2018 KSH Guideline
Percentage of patients who attain the target BP specified in 2018 hypertension clinical practice guidelines* suggested by Korean Society of Hypertension at Week 12 after the treatment regimen change.
*2018 hypertension clinical practice guidelines : Target BP <140(SBP)/90(DBP) mmHg.
For patients meeting any of the conditions listed below, each corresponding criterion will be applied.
- Patients with cardiovascular disease :<130/80 mmHg
- Patients with diabetes : <140/85 mmHg
- Patients with diabetes accompanying cardiovascular disease :<130/80 mmHg
- Patients with chronic kidney disease accompanying albuminuria: <130/80 mmHg
Measured: Week 12 after the treatment regimen change
Percentage of Patients With Controlled BP According to 2017 ACC/AHA Guideline
Percentage of patients who attain the target BP(<130(SBP)/80(DBP)mmHg) specified in 2017 clinical practice guidelines for hypertension suggested by American College of Cardiology(ACC)/American Heart Association(AHA) at Week 12 after the treatment regimen change
Measured: Week 12 after the treatment regimen change
Prcentage of Patients With Controlled BP According to Investigator's Target BP
Percentage of patients who attain the investigator's target BP* at Week 12 after the treatment regimen change.
*Investigator's target BP: Target BP for each patient set by the investigator at baseline.
Measured: Week 12 after the treatment regimen change
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2018
- Study start3 Jul 2018
- Primary completion29 Oct 2020
- Study completion29 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Essential HypertensionStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 4,542 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boryung Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Myung Sook Hong, Study director, Boryung Pharmaceutical Co., Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03649646
- Sponsor's protocol ID
- BR-FMS-OS-404
- Acronym
- FRESH
- Status last verified
- Aug 2018
- First submitted
- 8 Aug 2018
- Last updated
- 12 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Open, Longitudinal, Observational Study to Assess the Treatment Trend and the Proportion of Target BP Attainment in Patients Whose Antihypertensive Regimens Are Changed to ARB-based Therapy
- ClinicalTrials.gov ID
- NCT03649646
- Acronym / sponsor ID
- FRESH / BR-FMS-OS-404
- Conditions
- Essential Hypertension
- Keywords
- Hypertension, Fimasartan
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,542 participants (actual)
- Lead sponsor
- Boryung Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 3 Jul 2018 (actual)
- Primary completion
- 29 Oct 2020 (actual)
- Study completion
- 29 Oct 2020 (actual)
- First posted
- 28 Aug 2018 (actual)
- Results
- Posted 21 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The recent hypertension clinical practice guidelines published by American College of Cardiology (ACC) and American Heart Association (AHA) reduced the target BP to 130/80 mmHg, indicating the needs for more aggressive efforts in hypertension treatment. However, studies in Koreans must be preceded before applying such new overseas guidelines; thus, this study has been designed to establish clinical materials reflecting treatment setting in Korea. In this study, patients with uncontrolled hypertension whose antihypertensive regimens are changed to ARB-based therapy (ARB monotherapy or ARB-containing combination therapy) will be followed to assess the treatment trend, treatment effect, and risk of cardiovascular disease.
Detailed description
This study will be performed in patients with blood pressure (BP) uncontrolled by existing antihypertensive drugs (including ARB) among hypertensive patients visiting outpatient clinic of medical institutions in Korea. The study enrollment number will be assigned to the subjects who provide a written consent to the use of personal information and meet the inclusion/exclusion criteria. Follow-up will be conducted for 12 weeks in total and prespecified study related data will be collected in the case report form.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | –Patients with hypertension uncontrolled by antihypertensive drug |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with hypertension uncontrolled by antihypertensive drugs* whose antihypertensive regimens are changed to angiotensin receptor blocker (ARB) monotherapy or concomitant antihypertensive drug therapy containing ARB. *Including patients who previously received angiotensin receptor blocker (ARB); in this case, changing to other therapy using an ARB with different ingredient is allowed.
Key inclusion criteria (5 listed)
- Provided written consent to the use of personal information after receiving the explanation of the objective, methodology, etc. of this clinical study
- Male or female adults ≥ 19 years who are diagnosed with essential hypertension
- Receiving outpatient treatment at the time of study enrollment
- Patients with hypertension uncontrolled by existing antihypertensive drugs (including ARB) whose antihypertensive regimens decided and scheduled to be changed to ARB monotherapy or ARB-containing combination therapy (the result of the arm with a higher mean BP [systolic BP preferred] when measured twice with at least a 2-minute interval in both arms at the medical office on the study enrollment date, will become the reference)
Key exclusion criteria (5 listed)
- Patients who were hospitalized or are scheduled to be hospitalized 4 weeks before or after the study enrollment date
- Patients with suspected or confirmed secondary hypertension
- Pregnant or breast-feeding women
- Patients who received investigational product within 12 weeks or are scheduled to participate in another clinical study while participating in this study
- Patients who are determined inappropriate for participating in the study by investigators for other reasons
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
Percentage of Patients With Controlled Blood Pressure (<140/90 mmHg)
Time frame: Week 12 after the treatment regimen change
Percentage of patients who attain the target blood pressure (BP) (<140(SBP)/90(DBP) mmHg) at Week 12 after the treatment regimen change
3 secondary outcomes
Percentage of Patients With Controlled BP According to 2018 KSH Guideline
Time frame: Week 12 after the treatment regimen change
Percentage of Patients With Controlled BP According to 2017 ACC/AHA Guideline
Time frame: Week 12 after the treatment regimen change
Prcentage of Patients With Controlled BP According to Investigator's Target BP
Time frame: Week 12 after the treatment regimen change
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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. This study is not recruiting at the moment.
Myung Sook Hong study director
Boryung Pharmaceutical 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 Essential Hypertension, 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 5 inclusion and 5 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: finished, as of the sponsor's last update on 12 Jan 2021. 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?
Yes. Results are posted in the registry (first posted 21 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Patients With Controlled Blood Pressure (<140/90 mmHg) (time frame: Week 12 after the treatment regimen change). 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 Jan 2021.