HypertensionNCT03254914
Fimasartan Optimal Reduction Targeting Elevated Blood Pressure: the FORTE Study
An observational study of Hypertension, run by Boryung Pharmaceutical Co., Ltd at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the effect of home blood pressure monitoring on controlling blood pressure and correlation between home blood pressure and clinic blood pressure in hypertensive patients receiving two or more concomitant antihypertensive agents including fimasartan Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Home Blood Pressure
- Type of treatment
- Surgery or procedure
- How many people
- 3,554 participants
- Where
- 1 siteSouth Korea
- Study dates
- 9 Aug 2017to 28 Feb 2019
- How long will I take part?
- 12 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Hypertensive patients
Who may be able to join
- Subjects who voluntarily signed informed consent for participating in this clinical study
- Male and female over the age of 19
- Hypertensive patients receiving two or more concomitant anti-hypertensive agents including fimasartan
Who cannot join
- Renal dialysis patients.
- Diabetic nephropathy patients taking angiotensin-converting enzyme inhibitor.
- Severe renal disorder
- Subjects with hereditary disorders of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
- Medical history with hypersensitivity to Fimasartan
- Pregnant women or lactating female.
- Participate in another clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-center, Cluster-randomized, Prospective, Observational Study
The purpose of this study is to evaluate the effect of home blood pressure monitoring on controlling blood pressure and correlation between home blood pressure and clinic blood pressure in hypertensive patients receiving two or more concomitant antihypertensive agents including fimasartan
Read the detailed description
A multi-center, cluster-randomized, prospective, observational study
- Conditions
- Hypertension
- Being tested
- Home Blood Pressure
- Keywords
- Home Blood Pressure, Fimasartan
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home Blood PressureProcedure or surgery
Measure Home Blood Pressure
| Study group | Role | What they receive |
|---|---|---|
| Control Site | Measure Clinic Blood Pressure | |
| Test Site | Measure Clinic Blood Pressure and Home Blood Pressure Receives: Procedure: Home Blood Pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of reaching target blood pressure
Rate of reaching target blood pressure after treatment for 12 weeks
Measured: 12 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2017
- Study start9 Aug 2017
- Primary completion31 Oct 2018
- Study completion28 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,554 participants (actual)
- Target duration
- 12 Weeks
Sponsor and investigators
- Lead sponsor
- Boryung Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03254914
- Sponsor's protocol ID
- BR-FMS-OS-403
- Status last verified
- Dec 2024
- First submitted
- 17 Aug 2017
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Choi JY, Kim KI, Kim CH. Effect of home blood pressure monitoring for blood pressure control in hypertensive patients taking multiple antihypertensive medications including fimasartan (the FORTE study). Clin Hypertens. 2020 Dec 15;26(1):24. doi: 10.1186/s40885-020-00154-y.
PubMed 33317628
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Cluster-randomized, Prospective, Observational Study
- ClinicalTrials.gov ID
- NCT03254914
- Acronym / sponsor ID
- BR-FMS-OS-403
- Conditions
- Hypertension
- Keywords
- Home Blood Pressure, Fimasartan
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,554 participants (actual)
- Lead sponsor
- Boryung Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 9 Aug 2017 (actual)
- Primary completion
- 31 Oct 2018 (actual)
- Study completion
- 28 Feb 2019 (actual)
- First posted
- 21 Aug 2017 (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 purpose of this study is to evaluate the effect of home blood pressure monitoring on controlling blood pressure and correlation between home blood pressure and clinic blood pressure in hypertensive patients receiving two or more concomitant antihypertensive agents including fimasartan
Detailed description
A multi-center, cluster-randomized, prospective, observational study
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Site | – | –Measure Clinic Blood Pressure |
| Test Site | – | Procedure: Home Blood PressureMeasure Clinic Blood Pressure and Home Blood Pressure |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hypertensive patients
Key inclusion criteria (3 listed)
- Subjects who voluntarily signed informed consent for participating in this clinical study
- Male and female over the age of 19
- Hypertensive patients receiving two or more concomitant anti-hypertensive agents including fimasartan
Key exclusion criteria (7 listed)
- Renal dialysis patients.
- Diabetic nephropathy patients taking angiotensin-converting enzyme inhibitor.
- Severe renal disorder
- Subjects with hereditary disorders of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
- Medical history with hypersensitivity to Fimasartan
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home Blood PressureMeasure Home Blood Pressure | Procedure or surgery | Test Site |
Primary outcome
Rate of reaching target blood pressure
Time frame: 12 weeks after treatment
Rate of reaching target blood pressure after treatment for 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Derived from this study: PubMed 33317628Choi JY, Kim KI, Kim CH. Effect of home blood pressure monitoring for blood pressure control in hypertensive patients taking multiple antihypertensive medications including fimasartan (the FORTE study). Clin Hypertens. 2020 Dec 15;26(1):24. doi: 10.1186/s40885-020-00154-y.
- Individual participant dataSharing planned: No
Related trials for Hypertension
Not yet recruitingPhase 4
An Investigator-initiated, Prospective, Open-label, Multicenter Randomized Controlled Trial, Comparing the Efficacy of Sacubitril/Valsartan and Standard Treatment on Atrial Fibrillation Recurrence After Catheter Ablation in Persistent Atrial Fibrillation Patients Without Hypertensive
Atrial Fibrillation (Persistent), Catheter Ablation
Recruiting
Effects of Balance Training in Individuals With Glaucoma
Glaucoma
RecruitingPhase 4
Osilodrostat in Patients With Hypertension Caused by Hypercortisolaemia Due to Cushing's Syndrome
Hypertension, Hypercortisolemia
Not yet recruitingObservational study
Development and Validation of a TIPS Prognostic Model
Portal Hypertension Related to Cirrhosis, Ascites
RecruitingPhase 2
Study to Evaluate Sotatercept (MK-7962) in Children With Pulmonary Arterial Hypertension (PAH) (MK-7962-008)
Pulmonary Arterial Hypertension
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.
The record lists no contact. Use the official record to reach the sponsor.
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, 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 3 inclusion and 7 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 27 Dec 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Rate of reaching target blood pressure (time frame: 12 weeks after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03254914, which also lists 1 linked publication.
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 27 Dec 2024.