Essential HypertensionPhase 3FIRSTNCT03156842
Combination of Fimasartan/Amlodipine/Rosuvastatin in Patients With Essential Hypertension and Dyslipidemia
A Phase 3 study testing Fimasartan/Amlodipine, Rosuvastatin, Fimasartan/Amlodipine and Fimasartan, Rosuvastatin in people with Essential Hypertension and Dyslipidemia, 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 fimasartan/amlodipine/rosuvastatin treatment group to the fimasartan/amlodipine treatment group and the fimasartan/rosuvastatin treatment group respectively at Week 8 in patients with essential hypertension and dyslipidemia… Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Essential Hypertension, Dyslipidemia
- What is being tested?
- Fimasartan/Amlodipine, Rosuvastatin, Fimasartan/Amlodipine and Fimasartan, Rosuvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteSouth Korea
- Study dates
- 29 May 2017to 7 Dec 2018
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily provided a written consent to participate in this clinical study
- Male or female adults aged 19-70 years
- Patients must have been confirmed essential hypertension and dyslipidemia at Screening visit (V1)
- Uncontrolled blood pressure (140 mmHg ≤ mean Sitting systolic blood pressure(SiSBP) < 180 mmHg) at the baseline visit (V3) after the fimasartan 60 mg monotherapy
- Subjects who meet the following criteria of fasting serum lipid levels confirmed at the baseline visit (V3) after undergoing the therapeutic lifestyle change (TLC)
- Treatment compliance of fimasartan 60 mg ≥70% at the baseline visit (V3)
- Able to understand this study, be cooperative in the execution of the study, and participate in the study until its completion
Who cannot join
- Severe hypertension with mean Sitting systolic blood pressure(SiSBP) ≥180 mmHg or Sitting diastolic blood pressure(SiDBP) ≥110 mmHg at the screening visit (V1) and the baseline visit (V2, or orthostatic hypotension accompanied by symptoms
- Differences between arms greater than 20 mmHg for Sitting systolic blood pressure(SiSBP) and 10 mmHg for Sitting diastolic blood pressure(SiDBP) are present on 3 consecutive readings at the screening visit (V1)
- Secondary hypertension patients: Secondary hypertension is not limited to the following diseases; (e.g., renovascular disease, adrenal medullary and cortical hyperfunctions, coarctation of the aorta, hyperaldosteronism, unilateral or bilateral renal artery stenosis, Cushing's syndrome, pheochromocytoma, and polycystic kidney disease)
- Uncontrolled diabetes mellitus (currently on insulin, or HbA1c >9% at the pre-baseline visit (V2)), or uncontrolled hypothyroidism (TSH ≥1.5 times the upper limit of normal at the pre-baseline visit (V2))
- Heart disease (heart failure of New York Heart Association (NYHA) class 3 and 4), or ischemic heart disease (angina pectoris, myocardial infarction), peripheral vascular disease, percutaneous transluminal coronary angioplasty, or coronary artery bypass graft, etc. within 6 months prior to the screening visit (V1)
- Clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter; or other arrhythmia conditions that are determined to be clinically significant by the investigator
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- Hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, or hemodynamically significant aortic valve stenosis or mitral valve stenosis
- Cerebrovascular disorder (stroke, cerebral infarction, transient cerebral ischemic attack, cerebral hemorrhage, etc. within 6 months prior to the screening visit (V1)
- Pregnant or lactating women
- Planning pregnancy during the study period or have childbearing potential but are not using acceptable contraceptive methods (Contraceptive methods: Refer to Section 10.1 in this document.)
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 Combination Treatment of Fimasartan/Amlodipine/Rosuvastatin in Patients With Essential Hypertension and Dyslipidemia Who Fail to Respond Adequately to Fimasartan Monotherapy
The objective of this clinical study is to evaluate the efficacy and safety by comparing the fimasartan/amlodipine/rosuvastatin treatment group to the fimasartan/amlodipine treatment group and the fimasartan/rosuvastatin treatment group respectively at Week 8 in patients with essential hypertension and dyslipidemia who fail to respond to the fimasartan monotherapy.
- Conditions
- Essential Hypertension, Dyslipidemia
- Being tested
- Fimasartan/Amlodipine, Rosuvastatin, Fimasartan/Amlodipine, Fimasartan, Rosuvastatin
- Keywords
- Hypertension, Dyslipidemia, Fimasartan, Rosuvastatin
- Medical subject headings
- Essential Hypertension, Dyslipidemias, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fimasartan/Amlodipine, RosuvastatinDrug
"A fixed dose combination tablet of Fimasartan and Amlodipine" and "Rosuvastatin" will be administrated once daily on treatment period.
Fimasartan/AmlodipineDrug
"A fixed dose combination tablet of Fimasartan and Amlodipine" will be administrated once daily on treatment period.
Fimasartan, RosuvastatinDrug
"Fimasartan" and "Rosuvastatin" will be administrated once daily on treatment period.
| Study group | Role | What they receive |
|---|---|---|
| Fimasartan/Amlodipine, Rosuvastatin | Experimental | Co-administration of a fixed dose combination of Fimasartan/Amlodipine and Rosuvastatin Receives: Drug: Fimasartan/Amlodipine, Rosuvastatin |
| Fimasartan/Amlodipine | Active comparator | a fixed dose combination of Fimasartan/Amlodipine Receives: Drug: Fimasartan/Amlodipine |
| Fimasartan, Rosuvastatin | Active comparator | Co-administration of Fimasartan and Rosuvastatin Receives: Drug: Fimasartan, Rosuvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
LDL-C
The percent change in LDL-C from baseline in the test group at Week 8 compared to the fimasartan 60 mg/amlodipine 10 mg combination treatment group
Measured: 8weeks from Baseline Visit
Sitting systolic blood pressure(SiSBP)
The change in Sitting systolic blood pressure(SiSBP) from baseline in the test group at Week 8 compared to the fimasartan 60 mg and rosuvastatin 20 mg concomitant treatment group
Measured: 8weeks from Baseline Visit
Secondary outcomes (2)
Sitting systolic blood pressure(SiSBP)
The change in Sitting systolic blood pressure(SiSBP) from baseline in the test group at Week 8 compared to the fimasartan 60 mg/amlodipine 10 mg combination treatment group
Measured: 8weeks from Baseline Visit
LDL-C
The percent change in LDL-C from baseline in the test group at Week 8 compared to the fimasartan 60 mg and rosuvastatin 20 mg concomitant treatment group
Measured: 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 posted17 May 2017
- Study start29 May 2017
- Primary completion7 Dec 2018
- Study completion7 Dec 2018
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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 138 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
- NCT03156842
- Sponsor's protocol ID
- BR-FARC-CT-301
- Acronym
- FIRST
- Status last verified
- Jun 2019
- First submitted
- 14 May 2017
- Last updated
- 10 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jeon ES, Lim SW, Kim SY, Yang HM, Kim MH, Rhee MY, Han SH, Shin J, Kim KI, Jeong JO, Sung KC, Hong GR, Kim HS, Kwon K, Kang TS, Lee HY, Han SE. A randomized, double-blind, multicenter, phase III study on the efficacy and safety of a combination treatment involving fimasartan, amlodipine, rosuvastatin in patients with essential hypertension and dyslipidemia who fail to respond adequately to fimasartan monotherapy. Clin Hypertens. 2022 Dec 1;28(1):40. doi: 10.1186/s40885-022-00223-4.
PubMed 36451242
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2019. 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 Combination Treatment of Fimasartan/Amlodipine/Rosuvastatin in Patients With Essential Hypertension and Dyslipidemia Who Fail to Respond Adequately to Fimasartan Monotherapy
- ClinicalTrials.gov ID
- NCT03156842
- Acronym / sponsor ID
- FIRST / BR-FARC-CT-301
- Conditions
- Essential Hypertension, Dyslipidemia
- Keywords
- Hypertension, Dyslipidemia, Fimasartan, Rosuvastatin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Boryung Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 29 May 2017 (actual)
- Primary completion
- 7 Dec 2018 (actual)
- Study completion
- 7 Dec 2018 (actual)
- First posted
- 17 May 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 objective of this clinical study is to evaluate the efficacy and safety by comparing the fimasartan/amlodipine/rosuvastatin treatment group to the fimasartan/amlodipine treatment group and the fimasartan/rosuvastatin treatment group respectively at Week 8 in patients with essential hypertension and dyslipidemia who fail to respond to the fimasartan monotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fimasartan/Amlodipine, Rosuvastatin | Experimental | Drug: Fimasartan/Amlodipine, RosuvastatinCo-administration of a fixed dose combination of Fimasartan/Amlodipine and Rosuvastatin |
| Fimasartan/Amlodipine | Active comparator | Drug: Fimasartan/Amlodipinea fixed dose combination of Fimasartan/Amlodipine |
| Fimasartan, Rosuvastatin | Active comparator | Drug: Fimasartan, RosuvastatinCo-administration of Fimasartan and Rosuvastatin |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Voluntarily provided a written consent to participate in this clinical study
- Male or female adults aged 19-70 years
- Patients must have been confirmed essential hypertension and dyslipidemia at Screening visit (V1)
- Uncontrolled blood pressure (140 mmHg ≤ mean Sitting systolic blood pressure(SiSBP) < 180 mmHg) at the baseline visit (V3) after the fimasartan 60 mg monotherapy
- Subjects who meet the following criteria of fasting serum lipid levels confirmed at the baseline visit (V3) after undergoing the therapeutic lifestyle change (TLC)
Key exclusion criteria (10 listed)
- Severe hypertension with mean Sitting systolic blood pressure(SiSBP) ≥180 mmHg or Sitting diastolic blood pressure(SiDBP) ≥110 mmHg at the screening visit (V1) and the baseline visit (V2, or orthostatic hypotension accompanied by symptoms
- Differences between arms greater than 20 mmHg for Sitting systolic blood pressure(SiSBP) and 10 mmHg for Sitting diastolic blood pressure(SiDBP) are present on 3 consecutive readings at the screening visit (V1)
- Secondary hypertension patients: Secondary hypertension is not limited to the following diseases; (e.g., renovascular disease, adrenal medullary and cortical hyperfunctions, coarctation of the aorta, hyperaldosteronism, unilateral or bilateral renal artery stenosis, Cushing's syndrome, pheochromocytoma, and polycystic kidney disease)
- Uncontrolled diabetes mellitus (currently on insulin, or HbA1c >9% at the pre-baseline visit (V2)), or uncontrolled hypothyroidism (TSH ≥1.5 times the upper limit of normal at the pre-baseline visit (V2))
- Heart disease (heart failure of New York Heart Association (NYHA) class 3 and 4), or ischemic heart disease (angina pectoris, myocardial infarction), peripheral vascular disease, percutaneous transluminal coronary angioplasty, or coronary artery bypass graft, etc. within 6 months prior to the screening visit (V1)
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/Amlodipine, Rosuvastatin"A fixed dose combination tablet of Fimasartan and Amlodipine" and "Rosuvastatin" will be administrated once daily on treatment period. | Drug | Fimasartan/Amlodipine, Rosuvastatin |
| Fimasartan/Amlodipine"A fixed dose combination tablet of Fimasartan and Amlodipine" will be administrated once daily on treatment period. | Drug | Fimasartan/Amlodipine |
| Fimasartan, Rosuvastatin"Fimasartan" and "Rosuvastatin" will be administrated once daily on treatment period. | Drug | Fimasartan, Rosuvastatin |
Primary outcome
LDL-C
Time frame: 8weeks from Baseline Visit
The percent change in LDL-C from baseline in the test group at Week 8 compared to the fimasartan 60 mg/amlodipine 10 mg combination treatment group
Sitting systolic blood pressure(SiSBP)
Time frame: 8weeks from Baseline Visit
The change in Sitting systolic blood pressure(SiSBP) from baseline in the test group at Week 8 compared to the fimasartan 60 mg and rosuvastatin 20 mg concomitant treatment group
2 secondary outcomes
Sitting systolic blood pressure(SiSBP)
Time frame: 8weeks from Baseline Visit
LDL-C
Time frame: 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 10 Jun 2019.
- Derived from this study: PubMed 36451242Jeon ES, Lim SW, Kim SY, Yang HM, Kim MH, Rhee MY, Han SH, Shin J, Kim KI, Jeong JO, Sung KC, Hong GR, Kim HS, Kwon K, Kang TS, Lee HY, Han SE. A randomized, double-blind, multicenter, phase III study on the efficacy and safety of a combination treatment involving fimasartan, amlodipine, rosuvastatin in patients with essential hypertension and dyslipidemia who fail to respond adequately to fimasartan monotherapy. Clin Hypertens. 2022 Dec 1;28(1):40. doi: 10.1186/s40885-022-00223-4.
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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, Rosuvastatin, Fimasartan/Amlodipine and Fimasartan, Rosuvastatin in people with Essential Hypertension and Dyslipidemia, 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 7 inclusion and 10 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 10 Jun 2019. 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?
LDL-C (time frame: 8weeks from Baseline Visit). The study lists 2 primary outcomes in all. 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 NCT03156842, 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 10 Jun 2019.