Essential HypertensionPhase 3FINALNCT03991442
BR1010 in Patients With Essential Hypertension Patients Who do Not Adequately Respond to Fimasartan/Amlodipine Combination
A Phase 3 study testing Fimasartan/Amlodipine in people with Essential Hypertension, run by Boryung Pharmaceutical Co., Ltd at 1 site in South Korea.
Trial summary
The objective of this clinical study is to evaluate the efficacy and safety by comparing the BR1010 treatment group to the fimasartan/amlodipine treatment group at Week 8 in patients with essential hypertension who do not adequately respond to Fimasartan/Amlodipine combination 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/Amlodipine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 257 participants
- Where
- 1 siteSouth Korea
- Study dates
- 17 Jun 2019to 2 Mar 2021
- 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
- 1.Voluntarily provided a written consent to participate in this clinical study 2.19 years old or above Koreans living in Korea 3.Patients with uncontrolled essential hypertension at screening time(Visit 1)
- Use antihypertensive drugs:140 mmHg ≤ sitSBP < 200 mmHg
- Naïve: 160 mmHg ≤ sitSBP < 200 mmHg 4.Patients with uncontrolled hypertension after Fimasartan/Amlodipine 30/5mg treatment for 4 weeks at randomization(Visit 2) (Selected Arm:140 mmHg ≤ sitSBP < 200 mmHg 5.Able to understand this study, be cooperative in the execution of the study, and participate in the study until its completion
Who cannot join
- Difference of SiSBP ≥ 20 mmHg and SiDBP ≥ 10 mmHg in 3 blood pressure measurements in the selected reference arm at the screening visit
- Blood pressure results showing sitDBP ≥ 120 mmHg at screening and baseline visit(Visit 1; Both Arm, Visit 2: Selected Arm)
- Treatment Compliance of Fimasartan/Amlodipine 30/5mg < 70%
- Heart failure(New York Heart Association class 3 and 4), ischemic heart disease, peripheral vascular disease
- Percutaneous Coronary Artery within 6 months prior to study
- Clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter; or other arrhythmia conditions that are determined to be clinically significant by the investigator
Show all 13Show fewer
- Patients who have history of severe cerebrovascular disease within 6 months prior to study
- Type I Diabetes Mellitus or Uncontrolled Type II Diabetes Mellitus(HbA1c > 9% at screening visit
- Patients who have history of severe or malignant retinopathy within 6 months prior to study
- Pregnant or lactating women
- Planning pregnancy during the study period or have childbearing potential but are not using acceptable contraceptive methods
- Patients taking other clinical trial drugs within 4 weeks from the time of visit for screening
- Patients who are judged unsuitable to participate in this study by investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Multicenter, Phase III Study to Evaluate the Efficacy and Safety of BR1010 in Essential Hypertension Patients Who do Not Adequately Respond to Fimasartan/Amlodipine Combination
The objective of this clinical study is to evaluate the efficacy and safety by comparing the BR1010 treatment group to the fimasartan/amlodipine treatment group at Week 8 in patients with essential hypertension who do not adequately respond to Fimasartan/Amlodipine combination
- Conditions
- Essential Hypertension
- Being tested
- Fimasartan/Amlodipine
- 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/AmlodipineDrug
Also called BR1010 or placebo
Active Comparator: a fixed dose combination of Fimasartan/Amlodipine or placebo
| Study group | Role | What they receive |
|---|---|---|
| BR1010 and Fimasartan/Amlodipine placebo | Experimental | BR1010 or Fimasartan/Amlodipine Receives: Drug: Fimasartan/Amlodipine |
| BR1010 placebo and Fimasartan/Amlodipine | Active comparator | BR1010 or Fimasartan/Amlodipine Receives: Drug: Fimasartan/Amlodipine |
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 (4)
sitting systolic blood pressure
The change of sitting systolic blood pressure
Measured: 2weeks and 4weeks from Baseline Visit
sitting systolic blood pressure and sitting diastolic blood pressure
The change of sitting systolic blood pressure and sitting diastolic blood pressure
Measured: 2weeks, 4weeks and 8weeks from Baseline Visit
The ratio of subjects who get normalized blood pressure
The ratio of subjects who get normalized blood pressure
Measured: 2weeks, 4weeks and 8weeks from Baseline Visit
Response Rate
Response Rate
Measured: 2weeks, 4weeks and 8weeks 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 posted19 Jun 2019
- Study start17 Jun 2019
- Primary completion2 Mar 2021
- Study completion2 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 257 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
- NCT03991442
- Sponsor's protocol ID
- BR-FAHC-CT-301
- Acronym
- FINAL
- Status last verified
- Jul 2021
- First submitted
- 17 Jun 2019
- Last updated
- 30 Jul 2021
- Results posted
- No
- 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 30 Jul 2021. 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 BR1010 in Essential Hypertension Patients Who do Not Adequately Respond to Fimasartan/Amlodipine Combination
- ClinicalTrials.gov ID
- NCT03991442
- Acronym / sponsor ID
- FINAL / BR-FAHC-CT-301
- Conditions
- Essential Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 257 participants (actual)
- Lead sponsor
- Boryung Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 17 Jun 2019 (actual)
- Primary completion
- 2 Mar 2021 (actual)
- Study completion
- 2 Mar 2021 (actual)
- First posted
- 19 Jun 2019 (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 study is to evaluate the efficacy and safety by comparing the BR1010 treatment group to the fimasartan/amlodipine treatment group at Week 8 in patients with essential hypertension who do not adequately respond to Fimasartan/Amlodipine combination
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BR1010 and Fimasartan/Amlodipine placebo | Experimental | Drug: Fimasartan/AmlodipineBR1010 or Fimasartan/Amlodipine |
| BR1010 placebo and Fimasartan/Amlodipine | Active comparator | Drug: Fimasartan/AmlodipineBR1010 or Fimasartan/Amlodipine |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 1.Voluntarily provided a written consent to participate in this clinical study 2.19 years old or above Koreans living in Korea 3.Patients with uncontrolled essential hypertension at screening time(Visit 1)
- Use antihypertensive drugs:140 mmHg ≤ sitSBP < 200 mmHg
- Naïve: 160 mmHg ≤ sitSBP < 200 mmHg 4.Patients with uncontrolled hypertension after Fimasartan/Amlodipine 30/5mg treatment for 4 weeks at randomization(Visit 2) (Selected Arm:140 mmHg ≤ sitSBP < 200 mmHg 5.Able to understand this study, be cooperative in the execution of the study, and participate in the study until its completion
Key exclusion criteria (13 listed)
- Difference of SiSBP ≥ 20 mmHg and SiDBP ≥ 10 mmHg in 3 blood pressure measurements in the selected reference arm at the screening visit
- Blood pressure results showing sitDBP ≥ 120 mmHg at screening and baseline visit(Visit 1; Both Arm, Visit 2: Selected Arm)
- Treatment Compliance of Fimasartan/Amlodipine 30/5mg < 70%
- Heart failure(New York Heart Association class 3 and 4), ischemic heart disease, peripheral vascular disease
- Percutaneous Coronary Artery within 6 months prior to study
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/AmlodipineAlso: BR1010 or placeboActive Comparator: a fixed dose combination of Fimasartan/Amlodipine or placebo | Drug | BR1010 and Fimasartan/Amlodipine placebo, BR1010 placebo and Fimasartan/Amlodipine |
Primary outcome
sitting systolic blood pressure
Time frame: 8weeks from Baseline Visit
The change of sitting systolic blood pressure
4 secondary outcomes
sitting systolic blood pressure
Time frame: 2weeks and 4weeks from Baseline Visit
sitting systolic blood pressure and sitting diastolic blood pressure
Time frame: 2weeks, 4weeks and 8weeks from Baseline Visit
The ratio of subjects who get normalized blood pressure
Time frame: 2weeks, 4weeks and 8weeks from Baseline Visit
Response Rate
Time frame: 2weeks, 4weeks and 8weeks 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 30 Jul 2021.
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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/Amlodipine 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 3 inclusion and 13 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 30 Jul 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.
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?
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 30 Jul 2021.