HypertensionPhase 2NCT01518998
A Randomized, Double-Blind, Placebo-Controlled, 3x3 Factorial Design, Phase II Study to Evaluate the Antihypertensive Efficacy and Safety of Combination of Fimasartan and Amlodipine in Patients With Essential Hypertension
A Phase 2 study of Hypertension, run by Boryung Pharmaceutical Co., Ltd at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the antihypertensive efficacy and safety of Fimasartan Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Hypertension
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 420 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2011to Nov 2013
- Phase
- Phase 2
- 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 agreed to participate in this study and submitted the written informed consent
- Subjects aged 20 to 75 years
- Essential hypertension subjects who are measured more 90mmHg, less than 114mmHg of sitting diastolic blood pressure (SiDBP) at baseline(day 0).
- Subjects who considered to understand this study , be cooperative, and able to be followed-up whole of the study period.
Who cannot join
- Severe hypertension patients; more 115mmHg of SiDBP and/or more 185 mmHg of Sitting systolic blood pressure (SiSBP)
- Patients with secondary hypertension
- Patients with significant investigations - abnormal renal function (Creatinine more 1.5 times than upper limit of normal), abnormal liver function (AST, ALT more 2 times than upper normal), moderate fatty lever needed medication
- Patients with significant investigations - Hypokalemia(Less than 3.5mmol/L), Hyperkalemia(exceeded 5.5mmol/L)
- Patients with sodium ion or body fluid is depleted and not able to correct
- Patients with hypotension who has sign and symptom
Show all 24Show fewer
- Patients with surgical and medical disease it is able to be affect to absorption, distribution, metabolism, excretion
- Patients with severe insulin dependent or uncontrolled diabetes mellitus (HbA1c > 9%, regimen change of oral hypoglycemic agent, using insulin)
- Patients with severe heart disease, ischemic heart disease within 6months, peripheral vascular disease, Percutaneous Transluminal Coronary Angiography (PTCA), Coronary Artery Bypass Graft (CABG)
- Patients with significant ventricular tachycardia, atrial fibrillation, atrial flutter or other significant arrhythmia
- Patients with hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, hemodynamically significant aortic valve or mitral valve disease
- Patients with severe cerebrovascular disease
- Patients with wasting disease, autoimmune disease, connective tissue disease at present and/or previous.
- Patients with known severe or malignancy retinopathy
- Patients with hepatitis B or C or HIV positive reaction
- Patients who have a story or evidence of alcohol or drug abuse within 2years
- Patients who are measured the mean difference of mean blood pressure of both arm under SiDBP 10mmHg or SiSBP 20mmHg at screening and baseline visit
- Patients with history of allergic reaction to any angiotensin II antagonist
- Patients with any chronic inflammation disease needed to chronic inflammation therapy
- Patients with the medical histories of malignant tumor within 5years, except local basal cell carcinoma of the skin
- Childbearing and breast-feeding women
- Female who plan to become pregnancy or have a possibility of pregnancy but don't prevent conception with acknowledged methods
- Patients who took medicine within 12 weeks from screening visit or is going on the progress of other clinical trial
- Subject who are judged unsuitable to participate in this study by investigator
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the antihypertensive efficacy and safety of Fimasartan
- Conditions
- Hypertension
- Being tested
- Fimasartan , Amlodipine, Placebo
- Keywords
- Fimasartan, Amlodipine, antihypertension
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fimasartan , Amlodipine, PlaceboDrug
Also called Kanarb, Norvasc
Fimasartan 60mg, Fimasartan 30mg, Amlodipine 5mg, Amlodipine 10mg, Placebo, Fimasartan 60mg/Amlodipine 5mg combination, Fimasartan 60mg/Amlodipine 10mg combination, Fimasartan 30mg/Amlodipine 5mg combination, Fimasartan 30mg/Amlodipine 10mg combination
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Take one double-blind capsule filled with a placebo tablet in the every morning Receives: Drug: Fimasartan , Amlodipine, Placebo |
| Fimasartan 60mg | Active comparator | Take one double-blind capsule filled with of Fimasartan 60mg in the every morning Receives: Drug: Fimasartan , Amlodipine, Placebo |
| Fimasartan 30mg | Active comparator | Take one double-blind capsule filled with Fimasartan 30mg in the every morning Receives: Drug: Fimasartan , Amlodipine, Placebo |
| Amlodipine 5mg | Active comparator | Take one double-blind capsule filled with Amlodipine 5mg in the every morning Receives: Drug: Fimasartan , Amlodipine, Placebo |
| Amlodipine 10mg | Active comparator | Take one double-blind capsule filled with Amlodipine 10mg in the every morning Receives: Drug: Fimasartan , Amlodipine, Placebo |
| Fimasartan 60mg/ Amlodipine 5mg | Experimental | Take one double-blind capsule filled with Fimasartan 60mg and Amlodipine 5mg in the every morning Receives: Drug: Fimasartan , Amlodipine, Placebo |
| Fimasartan 60mg/Amlodipine 10mg | Experimental | Take one double-blind capsule filled with Fimasartan 60mg and Amlodipine 10mg in the every morning Receives: Drug: Fimasartan , Amlodipine, Placebo |
| Fimasartan 30mg/Amlodipine 5mg | Experimental | Take one double-blind capsule filled with Fimasartan 30mg and Amlodipine 5mg in the every morning Receives: Drug: Fimasartan , Amlodipine, Placebo |
| Fimasartan 30mg/Amlodipine 10mg | Experimental | Take one double-blind capsule filled with Fimasartan 30mg and Amlodipine 10mg in the every morning Receives: Drug: Fimasartan , Amlodipine, Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sitting Diastolic Blood Pressure
To compare the difference of Sitting Diastolic Blood Pressure at 8 weeks from baseline visit
Measured: 8weeks from baseline visit
Secondary outcomes (3)
Sitting Systolic Blood Pressure
To compare the difference of Sitting Systolic Blood Pressure at 4,8 weeks from baseline visit
Measured: at 4 and 8 weeks from Baseline visit
Sitting Diastolic Blood Pressure
To compare the difference of Sitting Diastolic Blood Pressure at 4 weeks from baseline visit
Measured: 4weeks from baseline visit
Responder ratio
To compare the ratio or responder(SiDBP<90mmHg or difference of SiDBP>10mmHg from baseline) at 8 weeks
Measured: at 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 posted26 Jan 2012 (estimated)
- Study startAug 2011
- Primary completionOct 2013
- Study completionNov 2013
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 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 420 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, Kyungpook National University Hospital, Daegu Catholic University Medical Center, Wonkwang University Hospital, Wonju Severance Christian Hospital, Korea University Guro Hospital, DongGuk University, Yeungnam University Hospital, Chonnam National University Hospital, Cheil General Hospital and Women's Healthcare Center, Chungnam National University, Asan Medical Center, Seoul National University Bundang Hospital, Inha University Hospital, Seoul National University Hospital, Inje University, Samsung Medical Center, Pusan National University Yangsan Hospital, Soon Chun Hyang University, Catholic University of Korea Saint Paul's Hospital, Hallym University Kangnam Sacred Heart Hospital, Jeju National University Hospital, Hanyang University Seoul Hospital, Kangbuk Samsung Hospital
- Responsible party
- Sponsor
- Investigators
- Young Kwan Jeon, Medical Director, Study director, Boryung Pharmaceutical Co., Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01518998
- Sponsor's protocol ID
- BR-FAC-CT-201
- Status last verified
- Jun 2016
- First submitted
- 24 Jan 2012
- Last updated
- 1 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lee HY, Kim YJ, Ahn T, Youn HJ, Chull Chae S, Seog Seo H, Kim KS, Rhee MY, Choi DJ, Kim JJ, Chun KJ, Yoo BS, Park JS, Oh SK, Kim DS, Kwan J, Ahn Y, Bae Park J, Jeong JO, Hyon MS, Cho EJ, Han KR, Kim DI, Joo SJ, Shin JH, Sung KC, Jeon ES. A Randomized, Multicenter, Double-blind, Placebo-controlled, 3 x 3 Factorial Design, Phase II Study to Evaluate the Efficacy and Safety of the Combination of Fimasartan/Amlodipine in Patients With Essential Hypertension. Clin Ther. 2015 Nov 1;37(11):2581-2596.e3. doi: 10.1016/j.clinthera.2015.02.019. Epub 2015 Apr 4.
PubMed 25850881
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, 3x3 Factorial Design, Phase II Study to Evaluate the Antihypertensive Efficacy and Safety of Combination of Fimasartan and Amlodipine in Patients With Essential Hypertension
- ClinicalTrials.gov ID
- NCT01518998
- Acronym / sponsor ID
- BR-FAC-CT-201
- Conditions
- Hypertension
- Keywords
- Fimasartan, Amlodipine, antihypertension
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 420 participants (actual)
- Lead sponsor
- Boryung Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Gachon University Gil Medical Center, The Catholic University of Korea, Kyungpook National University Hospital, Daegu Catholic University Medical Center, Wonkwang University Hospital, Wonju Severance Christian Hospital, Korea University Guro Hospital, DongGuk University, Yeungnam University Hospital, Chonnam National University Hospital, Cheil General Hospital and Women's Healthcare Center, Chungnam National University, Asan Medical Center, Seoul National University Bundang Hospital, Inha University Hospital, Seoul National University Hospital, Inje University, Samsung Medical Center, Pusan National University Yangsan Hospital, Soon Chun Hyang University, Catholic University of Korea Saint Paul's Hospital, Hallym University Kangnam Sacred Heart Hospital, Jeju National University Hospital, Hanyang University Seoul Hospital, Kangbuk Samsung Hospital
- Study start
- Aug 2011
- Primary completion
- Oct 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 26 Jan 2012 (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 purpose of this study is to evaluate the antihypertensive efficacy and safety of Fimasartan
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Fimasartan , Amlodipine, PlaceboTake one double-blind capsule filled with a placebo tablet in the every morning |
| Fimasartan 60mg | Active comparator | Drug: Fimasartan , Amlodipine, PlaceboTake one double-blind capsule filled with of Fimasartan 60mg in the every morning |
| Fimasartan 30mg | Active comparator | Drug: Fimasartan , Amlodipine, PlaceboTake one double-blind capsule filled with Fimasartan 30mg in the every morning |
| Amlodipine 5mg | Active comparator | Drug: Fimasartan , Amlodipine, PlaceboTake one double-blind capsule filled with Amlodipine 5mg in the every morning |
| Amlodipine 10mg | Active comparator | Drug: Fimasartan , Amlodipine, PlaceboTake one double-blind capsule filled with Amlodipine 10mg in the every morning |
| Fimasartan 60mg/ Amlodipine 5mg | Experimental | Drug: Fimasartan , Amlodipine, PlaceboTake one double-blind capsule filled with Fimasartan 60mg and Amlodipine 5mg in the every morning |
| Fimasartan 60mg/Amlodipine 10mg | Experimental | Drug: Fimasartan , Amlodipine, PlaceboTake one double-blind capsule filled with Fimasartan 60mg and Amlodipine 10mg in the every morning |
| Fimasartan 30mg/Amlodipine 5mg | Experimental | Drug: Fimasartan , Amlodipine, PlaceboTake one double-blind capsule filled with Fimasartan 30mg and Amlodipine 5mg in the every morning |
| Fimasartan 30mg/Amlodipine 10mg | Experimental | Drug: Fimasartan , Amlodipine, PlaceboTake one double-blind capsule filled with Fimasartan 30mg and Amlodipine 10mg in the every morning |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects who agreed to participate in this study and submitted the written informed consent
- Subjects aged 20 to 75 years
- Essential hypertension subjects who are measured more 90mmHg, less than 114mmHg of sitting diastolic blood pressure (SiDBP) at baseline(day 0).
- Subjects who considered to understand this study , be cooperative, and able to be followed-up whole of the study period.
Key exclusion criteria (24 listed)
- Severe hypertension patients; more 115mmHg of SiDBP and/or more 185 mmHg of Sitting systolic blood pressure (SiSBP)
- Patients with secondary hypertension
- Patients with significant investigations - abnormal renal function (Creatinine more 1.5 times than upper limit of normal), abnormal liver function (AST, ALT more 2 times than upper normal), moderate fatty lever needed medication
- Patients with significant investigations - Hypokalemia(Less than 3.5mmol/L), Hyperkalemia(exceeded 5.5mmol/L)
- Patients with sodium ion or body fluid is depleted and not able to correct
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, PlaceboAlso: Kanarb, NorvascFimasartan 60mg, Fimasartan 30mg, Amlodipine 5mg, Amlodipine 10mg, Placebo, Fimasartan 60mg/Amlodipine 5mg combination, Fimasartan 60mg/Amlodipine 10mg combination, Fimasartan 30mg/Amlodipine 5mg combination, Fimasartan 30mg/Amlodipine 10mg combination | Drug | Amlodipine 10mg, Amlodipine 5mg, Fimasartan 30mg, Fimasartan 30mg/Amlodipine 10mg, Fimasartan 30mg/Amlodipine 5mg, Fimasartan 60mg, Fimasartan 60mg/ Amlodipine 5mg, Fimasartan 60mg/Amlodipine 10mg, Placebo |
Primary outcome
Sitting Diastolic Blood Pressure
Time frame: 8weeks from baseline visit
To compare the difference of Sitting Diastolic Blood Pressure at 8 weeks from baseline visit
3 secondary outcomes
Sitting Systolic Blood Pressure
Time frame: at 4 and 8 weeks from Baseline visit
Sitting Diastolic Blood Pressure
Time frame: 4weeks from baseline visit
Responder ratio
Time frame: at 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 1 Jul 2016.
- Derived from this study: PubMed 25850881Lee HY, Kim YJ, Ahn T, Youn HJ, Chull Chae S, Seog Seo H, Kim KS, Rhee MY, Choi DJ, Kim JJ, Chun KJ, Yoo BS, Park JS, Oh SK, Kim DS, Kwan J, Ahn Y, Bae Park J, Jeong JO, Hyon MS, Cho EJ, Han KR, Kim DI, Joo SJ, Shin JH, Sung KC, Jeon ES. A Randomized, Multicenter, Double-blind, Placebo-controlled, 3 x 3 Factorial Design, Phase II Study to Evaluate the Efficacy and Safety of the Combination of Fimasartan/Amlodipine in Patients With Essential Hypertension. Clin Ther. 2015 Nov 1;37(11):2581-2596.e3. doi: 10.1016/j.clinthera.2015.02.019. Epub 2015 Apr 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.
Young Kwan Jeon, Medical Director study director
Boryung Pharmaceutical Co., Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study of 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 4 inclusion and 24 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 1 Jul 2016. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Diastolic 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 NCT01518998, 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 1 Jul 2016.