Essential HypertensionPhase 3NCT02152306
Fimasartan/Amlodipine Combination Phase III
A Phase 3 study testing Fimasartan and Amlodipine and Fimasartan in people with Essential Hypertension, run by Boryung Pharmaceutical Co., Ltd at 1 site in South Korea.
Trial summary
The aim of this study is to ensure the superiority of Fimasartan/Amlodipine combination in hypotensive effect after 8 weeks of treatment over Fimasartan monotherapy in patients with hypertension who have no response to Fimasartan 60mg monotherapy. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Essential Hypertension
- What is being tested?
- Fimasartan and Amlodipine and Fimasartan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 143 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2014to Jul 2015
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who voluntarily signed informed consent for participating in this clinical trial
- Male and Female between 20 and 75 years old
- Patients with essential hypertension
- Patients who is unresponsive to Fimasartan 60mg monotherapy for 4 weeks (i.e. the mean SiDBP from 3 times of measurement is 140mmHg ≤ SiSBP <180 mmHg)
- Understand the trial procedures and be willing to cooperate and complete the trial.
Who cannot join
- Severe Hypertension patients (SiDBP ≥ 110mmHg and/or SiSBP ≥ 180mmHg)
- Subjects with the difference between blood pressures from a selected arm, SiDBP ≥10 mmHg or SiSBP ≥20 mmHg, at screening assessment
- Secondary hypertension patients, but not limited to the following disease;(example: renovascular disease, adrenal medullary and cortical hyperfunctions, coarctation of the aorta, hyperaldosteronism, unilateral or bilateral renal artery stenosis, Cushing's syndrome, pheochromo-cytoma, polycystic kidney disease, etc.)
- Clinically significant renal function abnormality in the laboratory results at screening (i.e. serum creatine ≥ 1.5 times upper normal limit (UNL)), liver function abnormality (ALT, AST ≥ 2 times upper normal limit (UNL)), severe fatty liver disease that requires medication
- Clinically significant Hypokalemia(Less than 3.5mmol/L), Hyperkalemia(exceeded 5.5mmol/L)
- Subjects with following surgical and internal disease that may affect absorption, distribution, metabolism or excretion of drugs and have conditions which include the following (but are not limited to): history of major gastrointestinal surgeries including gastrectomy, gastro-enterostomy or bowel resection, gastrointestinal bypass graft and stapling; current active gastritis, ulcer, gastrointestinal and rectal bleeding, presence of active inflammatory bowel syndrome within the past 12 months; or clinically significant urinary obstruction at discretion of investigator
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- Subjects with depletion of body fluid or sodium ion not able to correct
- Subjects with severe insulin-dependent Diabetes Mellitus (DM) or chronic DM (HbA1c>9%, dosage of an oral hypoglycemic agent was modified within the past 12 weeks, or use of active insulin treatment at screening)
- Subjects with severe heart disease (heart failure New York Heart Association(NYHA) Class III and IV), or history of any of the followings within the past 6 months; ischemic heart disease(e.g. angina pectoris, myocardial infarction), peripheral vascular disease, percutaneous transluminal coronary angioplasty, or coronary artery bypass graft.
- Subjects with clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter or any other clinical significant arrhythmia conditions at discretion of investigator.
- Subjects with hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, hemodynamically significant aortic valve stenosis, or mitral valve stenosis.
- Subjects with severe cerebrovascular disorder (e.g. stroke, cerebral infarction or cerebral hemorrhage within the past 6 months).
- Subjects with chronic inflammatory disease requiring an chronic anti-inflammatory therapy, Past or current medical history with wasting disease, autoimmune diseases (e.g. rheumatoid arthritis, systemic lupus erythematosus ) or connective tissue disease.
- Subjects with known moderate or malignant retinosis (e.g. retinal hemorrhage, visual disturbance or retinal microaneurysm in the past 6 months).
- Subjects with hepatitis B (including positive test for HBsAg), hepatitis C-positive.
- Subjects with history or evidence of abusing drugs or alcohol within the past 2 years.
- Medical history with hypersensitivity to angiotensin II antagonist-based drugs or calcium-channel blockers
- Subjects with hereditary disorders of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
- Pregnant women and lactating female
- Women of childbearing potential who are not using effective contraceptive methods. (Excluding subjects who had surgically sterilized. All women of childbearing potential who did not have surgical sterilization must prove negative in a pregnancy test, and continue to use accepted and effective contraceptive methods until the end of the study in order to participate. Not accepted contraceptive method: Periodic abstinence and celibacy (e.g. Basic body temperature method, menstrual cycle calculation), hormonal contraceptives.
- Subject who is participating in another trial or took other investigational product within12 weeks from the screening visit
- Medical history of all kinds of malignant tumor including leukemia and lymphoma in the past 5 years
- A subject with other reasons not specified above that, ineligible to participate in this clinical trial at discretion of study investigators.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Bundang, Gyeonggi-do, 463-707
About this study
Official title: A Randomized, Double-blind Multicenter, Phase III Study to Evaluate the Efficacy and Safety of Combination of Fimasartan/Amlodipine Versus Fimasartan Monotherapy in Patients With Essential Hypertension Who Fail to Respond Adequately to Fimasartan Monotherapy.
The aim of this study is to ensure the superiority of Fimasartan/Amlodipine combination in hypotensive effect after 8 weeks of treatment over Fimasartan monotherapy in patients with hypertension who have no response to Fimasartan 60mg monotherapy.
- Conditions
- Essential Hypertension
- Being tested
- Fimasartan and Amlodipine, Fimasartan
- Keywords
- Fimasartan, Fimasartan and Amlodipine, Antihypertension
- 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 and AmlodipineDrug
FimasartanDrug
| Study group | Role | What they receive |
|---|---|---|
| Fimasartan and Amlodipine | Experimental | Combination of Fimasartan and Amlodipine Receives: Drug: Fimasartan and Amlodipine |
| Fimasartan | Active comparator | Fimasartan Monotherapy Receives: Drug: Fimasartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Sitting Systolic Blood Pressure(SiSBP) at week 8 of Investigational Product(IP) Administration from the Baseline
To compare the difference of Mean Systolic Blood Pressure at 8 weeks from baseline visit
Measured: 8 weeks from Baseline Visit
Secondary outcomes (4)
Change of Sitting Systolic Blood Pressure(SiSBP) at week 4 of Investigational Product(IP) Administration from the Baseline
Measured: 4 weeks from Baseline Visit
Changes of Sitting Diastolic Blood Pressure(SiDBP) at week 4 and 8 of Investigational Product(IP) Administration from the Baseline
Measured: 4 and 8 weeks from Baseline Visit
Response rate of the Blood Pressure at week 8 of Investigational Product(IP) Administration
Measured: 8 weeks from Baseline Visit
The Normalization ratio of Blood Pressure at week 8 of Investigational Product(IP) Administration
Measured: 8 weeks 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 posted2 Jun 2014 (estimated)
- Study startApr 2014
- Primary completionMar 2015
- Study completionJul 2015
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
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boryung Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Gachon University Gil Medical Center, The Catholic University of Korea, Kangbuk Samsung Hospital, Kyungpook National University Hospital, Keimyung University Dongsan Medical Center, Korea University Guro Hospital, Korea University Anam Hospital, DongGuk University, Dong-A University Hospital, Pusan National University Hospital, Seoul National University Bundang Hospital, Seoul National University Hospital, Asan Medical Center, Pusan National University Yangsan Hospital, Wonju Severance Christian Hospital, Gangnam Severance Hospital, Severance Hospital, Ulsan University Hospital, Inje University, Inje University Haeundae Paik Hospital, Chonnam National University Hospital, Jeju National University Hospital, Chungnam National University, Hanyang University Seoul Hospital
- Responsible party
- Sponsor
- Investigators
- Cheol Ho Kim, Ph.D., Study chair, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02152306
- Sponsor's protocol ID
- BR-FAC-CT-301
- Status last verified
- Jul 2015
- First submitted
- 29 May 2014
- Last updated
- 27 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kim KI, Shin MS, Ihm SH, Youn HJ, Sung KC, Chae SC, Nam CW, Seo HS, Park SM, Rhee MY, Kim MH, Cha KS, Kim YJ, Kim JJ, Chun KJ, Yoo BS, Park S, Shin ES, Kim DS, Il Kim D, Kim KH, Joo SJ, Jeong JO, Shin J, Kim CH. A Randomized, Double-blind, Multicenter, Phase III Study to Evaluate the Efficacy and Safety of Fimasartan/Amlodipine Combined Therapy Versus Fimasartan Monotherapy in Patients With Essential Hypertension Unresponsive to Fimasartan Monotherapy. Clin Ther. 2016 Oct;38(10):2159-2170. doi: 10.1016/j.clinthera.2016.07.008. Epub 2016 Aug 5.
PubMed 27502326
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2015. 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 of Fimasartan/Amlodipine Versus Fimasartan Monotherapy in Patients With Essential Hypertension Who Fail to Respond Adequately to Fimasartan Monotherapy.
- ClinicalTrials.gov ID
- NCT02152306
- Acronym / sponsor ID
- BR-FAC-CT-301
- Conditions
- Essential Hypertension
- Keywords
- Fimasartan, Fimasartan and Amlodipine, Antihypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Boryung Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Gachon University Gil Medical Center, The Catholic University of Korea, Kangbuk Samsung Hospital, Kyungpook National University Hospital, Keimyung University Dongsan Medical Center, Korea University Guro Hospital, Korea University Anam Hospital, DongGuk University, Dong-A University Hospital, Pusan National University Hospital, Seoul National University Bundang Hospital, Seoul National University Hospital, Asan Medical Center, Pusan National University Yangsan Hospital, Wonju Severance Christian Hospital, Gangnam Severance Hospital, Severance Hospital, Ulsan University Hospital, Inje University, Inje University Haeundae Paik Hospital, Chonnam National University Hospital, Jeju National University Hospital, Chungnam National University, Hanyang University Seoul Hospital
- Study start
- Apr 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 2 Jun 2014 (estimated)
- 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 aim of this study is to ensure the superiority of Fimasartan/Amlodipine combination in hypotensive effect after 8 weeks of treatment over Fimasartan monotherapy in patients with hypertension who have no response to Fimasartan 60mg monotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fimasartan and Amlodipine | Experimental | Drug: Fimasartan and AmlodipineCombination of Fimasartan and Amlodipine |
| Fimasartan | Active comparator | Drug: FimasartanFimasartan Monotherapy |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects who voluntarily signed informed consent for participating in this clinical trial
- Male and Female between 20 and 75 years old
- Patients with essential hypertension
- Patients who is unresponsive to Fimasartan 60mg monotherapy for 4 weeks (i.e. the mean SiDBP from 3 times of measurement is 140mmHg ≤ SiSBP <180 mmHg)
- Understand the trial procedures and be willing to cooperate and complete the trial.
Key exclusion criteria (23 listed)
- Severe Hypertension patients (SiDBP ≥ 110mmHg and/or SiSBP ≥ 180mmHg)
- Subjects with the difference between blood pressures from a selected arm, SiDBP ≥10 mmHg or SiSBP ≥20 mmHg, at screening assessment
- Secondary hypertension patients, but not limited to the following disease;(example: renovascular disease, adrenal medullary and cortical hyperfunctions, coarctation of the aorta, hyperaldosteronism, unilateral or bilateral renal artery stenosis, Cushing's syndrome, pheochromo-cytoma, polycystic kidney disease, etc.)
- Clinically significant renal function abnormality in the laboratory results at screening (i.e. serum creatine ≥ 1.5 times upper normal limit (UNL)), liver function abnormality (ALT, AST ≥ 2 times upper normal limit (UNL)), severe fatty liver disease that requires medication
- Clinically significant Hypokalemia(Less than 3.5mmol/L), Hyperkalemia(exceeded 5.5mmol/L)
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 and Amlodipine | Drug | Fimasartan and Amlodipine |
| Fimasartan | Drug | Fimasartan |
Primary outcome
Change of Sitting Systolic Blood Pressure(SiSBP) at week 8 of Investigational Product(IP) Administration from the Baseline
Time frame: 8 weeks from Baseline Visit
To compare the difference of Mean Systolic Blood Pressure at 8 weeks from baseline visit
4 secondary outcomes
Change of Sitting Systolic Blood Pressure(SiSBP) at week 4 of Investigational Product(IP) Administration from the Baseline
Time frame: 4 weeks from Baseline Visit
Changes of Sitting Diastolic Blood Pressure(SiDBP) at week 4 and 8 of Investigational Product(IP) Administration from the Baseline
Time frame: 4 and 8 weeks from Baseline Visit
Response rate of the Blood Pressure at week 8 of Investigational Product(IP) Administration
Time frame: 8 weeks from Baseline Visit
The Normalization ratio of Blood Pressure at week 8 of Investigational Product(IP) Administration
Time frame: 8 weeks 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 27 Jul 2015.
- Derived from this study: PubMed 27502326Kim KI, Shin MS, Ihm SH, Youn HJ, Sung KC, Chae SC, Nam CW, Seo HS, Park SM, Rhee MY, Kim MH, Cha KS, Kim YJ, Kim JJ, Chun KJ, Yoo BS, Park S, Shin ES, Kim DS, Il Kim D, Kim KH, Joo SJ, Jeong JO, Shin J, Kim CH. A Randomized, Double-blind, Multicenter, Phase III Study to Evaluate the Efficacy and Safety of Fimasartan/Amlodipine Combined Therapy Versus Fimasartan Monotherapy in Patients With Essential Hypertension Unresponsive to Fimasartan Monotherapy. Clin Ther. 2016 Oct;38(10):2159-2170. doi: 10.1016/j.clinthera.2016.07.008. Epub 2016 Aug 5.
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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.
Cheol Ho Kim, Ph.D. study chair
Seoul National University Bundang Hospital
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 and Amlodipine and Fimasartan 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 5 inclusion and 23 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 Jul 2015. 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?
Change of Sitting Systolic Blood Pressure(SiSBP) at week 8 of Investigational Product(IP) Administration from the Baseline (time frame: 8 weeks 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 NCT02152306, 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 Jul 2015.