Essential Hypertension, DyslipidemiaPhase 3FIESTANCT03338426
A Study to Evaluate the Efficacy and Safety of Combination Treatment of Fimasartan/Atorvastatin in Patients With Essential Hypertension and Dyslipidemia
A Phase 3 study testing Fimasartan 120mg and Atorvastatin 40mg in people with Essential Hypertension, 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/atorvastatin treatment group to the fimasartan/placebo treatment group and the placebo/atorvastatin treatment group respectively at Week 8 in patients with essential hypertension and dyslipidemia. Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Essential Hypertension, Dyslipidemia
- What is being tested?
- Fimasartan 120mg and Atorvastatin 40mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 133 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Jan 2018to 22 Apr 2019
- 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 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 SiSBP < 180 mmHg) at the pre- baseline visit (V2) after wash-out period
- 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 pre-baseline visit (V2), or orthostatic hypotension accompanied by symptoms
- Difference of Sitting systolic blood pressure(SiSBP) ≥ 20 mmHg and Sitting diastolic blood pressure(SiDBP) ≥ 10 mmHg between Lt and Rt arms for 3 consecutive times 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 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 diseasenewly diagnosed within 6 months prior to the screening visit (V1), percutaneous transluminal coronary angioplasty, or coronary artery bypass graft, etc.
- 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
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/Atorvastatin in Patients With Essential Hypertension and Dyslipidemia
The objective of this clinical study is to evaluate the efficacy and safety by comparing the fimasartan/atorvastatin treatment group to the fimasartan/placebo treatment group and the placebo/atorvastatin treatment group respectively at Week 8 in patients with essential hypertension and dyslipidemia.
- Conditions
- Essential Hypertension, Dyslipidemia
- Being tested
- Fimasartan 120mg, Atorvastatin 40mg, Placebo for Fimasartan 120mg, Placebo for Atorvastatin 40mg
- Medical subject headings
- Essential Hypertension, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fimasartan 120mgDrug
Fimasartan 120mg will be administrated once daily for 8 weeks treatment period
Atorvastatin 40mgDrug
Atorvastatin 40mg will be administrated once daily for 8 weeks treatment period
Placebo for Fimasartan 120mgDrug
Placebo for Fimasartan 120mg will be administrated once daily for 8 weeks treatment period
Placebo for Atorvastatin 40mgDrug
Placebo for Atorvastatin 40mg will be administrated once daily for 8 weeks treatment period
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Co-administration of a fixed dose combination of Fimasartan 120mg and Atorvastatin 40mg Receives: Drug: Fimasartan 120mg; Drug: Atorvastatin 40mg |
| Active Comparator 1 | Active comparator | Co-administration of Fimasartan 120mg and Placebo for Atorvastatin 40mg Receives: Drug: Fimasartan 120mg; Drug: Placebo for Atorvastatin 40mg |
| Active Comparator 2 | Active comparator | Co-administration of Atorvastatin 40mg and Placebo for Fimasartan 120mg Receives: Drug: Atorvastatin 40mg; Drug: Placebo for Fimasartan 120mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
SiSBP
The change in Sitting systolic blood pressure(SiSBP) from baseline in the test group(Fimasartan 120mg/Atorvastatin 40mg) at Week 8 compared to the Active Comparator group 2(Atorvastatin 40mg)
Measured: 8weeks from Baseline Visit
LDL-C
The change in LDL-C from baseline in the test group at Week 8 compared to the active comparator group 1(fimasartan 120 mg)
Measured: 8weeks from Baseline Visit
Secondary outcomes (2)
SiSBP
The change in Sitting systolic blood pressure(SiSBP) from baseline in the test group(Fimasartan 120mg/Atorvastatin 40mg) at Week 8 compared to the Active Comparator group 1(Fimasartan 120mg)
Measured: 8weeks from Baseline Visit
LDL-C
The change in LDL-C from baseline in the test group(Fimasartan 120mg/Atorvastatin 40mg) at Week 8 compared to the Active Comparator group 2(Atorvastatin 40mg)
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 posted9 Nov 2017
- Study start15 Jan 2018
- Primary completion22 Apr 2019
- Study completion22 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential Hypertension, DyslipidemiaStudies 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
- 133 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
- NCT03338426
- Sponsor's protocol ID
- BR-FAVC-CT-301
- Acronym
- FIESTA
- Status last verified
- Oct 2019
- First submitted
- 30 Oct 2017
- Last updated
- 5 Nov 2019
- 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 5 Nov 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/Atorvastatin in Patients With Essential Hypertension and Dyslipidemia
- ClinicalTrials.gov ID
- NCT03338426
- Acronym / sponsor ID
- FIESTA / BR-FAVC-CT-301
- Conditions
- Essential Hypertension, Dyslipidemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Boryung Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 15 Jan 2018 (actual)
- Primary completion
- 22 Apr 2019 (actual)
- Study completion
- 22 Apr 2019 (actual)
- First posted
- 9 Nov 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/atorvastatin treatment group to the fimasartan/placebo treatment group and the placebo/atorvastatin treatment group respectively at Week 8 in patients with essential hypertension and dyslipidemia.
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 |
|---|---|---|
| Experimental | Experimental | Drug: Fimasartan 120mg, Drug: Atorvastatin 40mgCo-administration of a fixed dose combination of Fimasartan 120mg and Atorvastatin 40mg |
| Active Comparator 1 | Active comparator | Drug: Fimasartan 120mg, Drug: Placebo for Atorvastatin 40mgCo-administration of Fimasartan 120mg and Placebo for Atorvastatin 40mg |
| Active Comparator 2 | Active comparator | Drug: Atorvastatin 40mg, Drug: Placebo for Fimasartan 120mgCo-administration of Atorvastatin 40mg and Placebo for Fimasartan 120mg |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 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 SiSBP < 180 mmHg) at the pre- baseline visit (V2) after wash-out period
- Able to understand this study, be cooperative in the execution of the study, and participate in the study until its completion
Key exclusion criteria (9 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 pre-baseline visit (V2), or orthostatic hypotension accompanied by symptoms
- Difference of Sitting systolic blood pressure(SiSBP) ≥ 20 mmHg and Sitting diastolic blood pressure(SiDBP) ≥ 10 mmHg between Lt and Rt arms for 3 consecutive times 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 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 diseasenewly diagnosed within 6 months prior to the screening visit (V1), percutaneous transluminal coronary angioplasty, or coronary artery bypass graft, etc.
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 120mgFimasartan 120mg will be administrated once daily for 8 weeks treatment period | Drug | Active Comparator 1, Experimental |
| Atorvastatin 40mgAtorvastatin 40mg will be administrated once daily for 8 weeks treatment period | Drug | Active Comparator 2, Experimental |
| Placebo for Fimasartan 120mgPlacebo for Fimasartan 120mg will be administrated once daily for 8 weeks treatment period | Drug | Active Comparator 2 |
| Placebo for Atorvastatin 40mgPlacebo for Atorvastatin 40mg will be administrated once daily for 8 weeks treatment period | Drug | Active Comparator 1 |
Primary outcome
SiSBP
Time frame: 8weeks from Baseline Visit
The change in Sitting systolic blood pressure(SiSBP) from baseline in the test group(Fimasartan 120mg/Atorvastatin 40mg) at Week 8 compared to the Active Comparator group 2(Atorvastatin 40mg)
LDL-C
Time frame: 8weeks from Baseline Visit
The change in LDL-C from baseline in the test group at Week 8 compared to the active comparator group 1(fimasartan 120 mg)
2 secondary outcomes
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 5 Nov 2019.
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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 120mg and Atorvastatin 40mg in people with Essential Hypertension, 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 5 inclusion and 9 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 5 Nov 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?
SiSBP (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?
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 5 Nov 2019.