Essential HypertensionPhase 3NCT05878561
A Study to Evaluate the Efficacy and Safety of BR1015 Combination Therapy
A Phase 3 study testing Fimasartan + Indapamide in people with Essential Hypertension, run by Boryung Pharmaceutical Co., Ltd at 1 site in South Korea.
Trial summary
The objective of this clinical trial is to evaluate the efficacy and safety of BR1015 Combination therapy group in comparison with Fimasartan monotherapy group at Week 8 for essential hypertension patients who do not adequately responded by Fimasartan 30 mg Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Essential Hypertension
- What is being tested?
- Fimasartan + Indapamide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 248 participants
- Where
- 1 siteSouth Korea
- Study dates
- 9 Nov 2022to 2 Dec 2024
- Phase
- Phase 3
- 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
Who may be able to join
- Patients with uncontrolled essential hypertension at screening(V1) under the following criteria:
- Naïve : 140 mmHg ≤ SiSBP < 180 mmHg
- Use antihypertensive drugs : 130 mmHg ≤ SiSBP < 180 mmHg
- Patients with uncontrolled essential hypertension at randomization(V2) after Fimasartan 30mg monotherapy for 4 weeks under the following criteria:
- Selected reference arm : 140 mmHg ≤ SiSBP < 180 mmHg (For patients with cardiovascular disease, diabetes or chronic kidney disease (CKD) with albuminuria, 130 mmHg ≤ SiSBP < 180 mmHg)
- Treatment compliance of Fimasartan 30 mg ≥70% at baseline visit (V2)
- Voluntarily provided a written consent to participate in this clinical study
- Able to understand this study, be cooperative in the execution of the study, and participate in the study until its completion
Who cannot join
- Patients taking three or more antihypertensive drugs of different families
- Patients with blood pressure results showing SiSBP ≥ 180 mmHg or SiDBP ≥ 110 mmHg in the selected reference arm at screening(V1) and randomization(V2)
- Patients with a difference of SiSBP ≥ 20 mmHg and SiDBP ≥ 10 mmHg in blood pressure measured three times on both arms at screening(V1)
- Patients with secondary hypertension: Secondary hypertension is not limited to the following diseases; (e.g., coarctation of the aorta, Primary hyperaldosteronism, renal artery stenosis, Cushing's syndrome, pheochromocytoma and polycystic kidney disease, etc.)
- Patients with orthostatic hypotension accompanied by symptoms
- Patients who need to be administered in combination with antihypertensive drugs other than investigational product while participating in clinical trials
Trial locations and contacts
1 site in 1 country.
South Korea1 site
The Catholic University of Korea, Bucheon St.Mary's Hospital
Bucheon-si, Gyeonggi-do, 14647
About this study
Official title: A Randomized, Double-blind, Multicenter, Phase III Study to Evaluate the Efficacy and Safety of BR1015 Combination Therapy in Comparison With Fimasartan Monotherapy for Essential Hypertension Patients Not Adequately Responded by Fimasartan 30 mg
The objective of this clinical trial is to evaluate the efficacy and safety of BR1015 Combination therapy group in comparison with Fimasartan monotherapy group at Week 8 for essential hypertension patients who do not adequately responded by Fimasartan 30 mg
- Conditions
- Essential Hypertension
- Being tested
- Fimasartan + Indapamide, Fimasartan + Indapamide placebo
- Medical subject headings
- Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fimasartan + IndapamideDrug
Also called I : BR1015-3 + BR1015-2, II : BR1015-1 + BR1015-2
a fixed dose combination
Fimasartan + Indapamide placeboDrug
Also called I : BR1015-3 + BR1015-4, II : BR1015-1 + BR1015-4
a fixed dose combination
| Study group | Role | What they receive |
|---|---|---|
| Fimasartan + Indapamide | Experimental | Treatment Period I, II Receives: Drug: Fimasartan + Indapamide |
| Fimasartan + Indapamide placebo | Active comparator | Treatment Period I, II Receives: Drug: Fimasartan + Indapamide placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sitting systolic blood pressure
The change of sitting systolic blood pressure
Measured: 8weeks from Baseline Visit
Secondary outcomes (1)
Sitting systolic blood pressure
The change of sitting systolic blood pressure
Measured: 4weeks from Baseline Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2023
- Study start9 Nov 2022
- Primary completion2 Dec 2024
- Study completion2 Dec 2024
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 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 248 participants (actual)
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
- NCT05878561
- Sponsor's protocol ID
- BR-FIC-CT-301
- Status last verified
- Dec 2024
- First submitted
- 18 May 2023
- Last updated
- 20 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Youn JC, Lee SY, Yu CW, Sung KC, Shin J, Oh JH, Na JO, Kim DH, Cho EJ, Yoon HJ, Lee CJ, Lee HC, Lee HY, Sohn IS, Lee KS, Kim DI, Choi WG, Chung WJ, Lee EM, Choi SH, Choi S, Kang TS, Ihm SH. Efficacy and Safety of Fimasartan/Indapamide Combination Therapy versus Fimasartan Monotherapy in Patients with Essential Hypertension Inadequately Responding to Fimasartan 30 mg (FINEDUO): A Randomized, Double-Blind, Multicenter, Phase III Study. Drug Des Devel Ther. 2026 May 15;20:578736. doi: 10.2147/DDDT.S578736. eCollection 2026.
PubMed 42163997
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Multicenter, Phase III Study to Evaluate the Efficacy and Safety of BR1015 Combination Therapy in Comparison With Fimasartan Monotherapy for Essential Hypertension Patients Not Adequately Responded by Fimasartan 30 mg
- ClinicalTrials.gov ID
- NCT05878561
- Acronym / sponsor ID
- BR-FIC-CT-301
- Conditions
- Essential Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 248 participants (actual)
- Lead sponsor
- Boryung Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 9 Nov 2022 (actual)
- Primary completion
- 2 Dec 2024 (actual)
- Study completion
- 2 Dec 2024 (actual)
- First posted
- 26 May 2023 (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 objective of this clinical trial is to evaluate the efficacy and safety of BR1015 Combination therapy group in comparison with Fimasartan monotherapy group at Week 8 for essential hypertension patients who do not adequately responded by Fimasartan 30 mg
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fimasartan + Indapamide | Experimental | Drug: Fimasartan + IndapamideTreatment Period I, II |
| Fimasartan + Indapamide placebo | Active comparator | Drug: Fimasartan + Indapamide placeboTreatment Period I, II |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
Key exclusion criteria (6 listed)
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 |
|---|---|---|
| Fimasartan + IndapamideAlso: I : BR1015-3 + BR1015-2, II : BR1015-1 + BR1015-2a fixed dose combination | Drug | Fimasartan + Indapamide |
| Fimasartan + Indapamide placeboAlso: I : BR1015-3 + BR1015-4, II : BR1015-1 + BR1015-4a fixed dose combination | Drug | Fimasartan + Indapamide placebo |
Primary outcome
Sitting systolic blood pressure
Time frame: 8weeks from Baseline Visit
The change of sitting systolic blood pressure
1 secondary outcome
Sitting systolic blood pressure
Time frame: 4weeks from Baseline Visit
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 20 Dec 2024.
- Derived from this study: PubMed 42163997Youn JC, Lee SY, Yu CW, Sung KC, Shin J, Oh JH, Na JO, Kim DH, Cho EJ, Yoon HJ, Lee CJ, Lee HC, Lee HY, Sohn IS, Lee KS, Kim DI, Choi WG, Chung WJ, Lee EM, Choi SH, Choi S, Kang TS, Ihm SH. Efficacy and Safety of Fimasartan/Indapamide Combination Therapy versus Fimasartan Monotherapy in Patients with Essential Hypertension Inadequately Responding to Fimasartan 30 mg (FINEDUO): A Randomized, Double-Blind, Multicenter, Phase III Study. Drug Des Devel Ther. 2026 May 15;20:578736. doi: 10.2147/DDDT.S578736. eCollection 2026.
- 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. 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?
A Phase 3 study testing Fimasartan + Indapamide in people with 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 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: finished, as of the sponsor's last update on 20 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Sitting systolic blood pressure (time frame: 8weeks from Baseline Visit). 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 NCT05878561, 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 20 Dec 2024.