HypertensionPhase 3NCT01135212
The Clinical Study to Evaluate the Efficacy and Safety of Fimasartan in Patients With Mild to Moderate Essential Hypertension
A Phase 3 study testing Fimasartan 60mg, Fimasartan 120mg and Candesartan cilexetil in people with Hypertension, run by Boryung Pharmaceutical Co., Ltd at 1 site in South Korea.
Trial summary
The purpose of this clinical study is to evaluate and compare the efficacy and safety of Fimasartan (60mg / 120mg) with Candesartan(8mg) in patients with mild to moderate hypertension. Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Fimasartan 60mg, Fimasartan 120mg and Candesartan cilexetil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 290 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2010to May 2011
- 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 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 19 to 75 years
- Mild to moderate essential hypertension subjects who are measured more 90mmHg, less than 110mmHg 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 110mmHg of SiDBP and/or more 180 mmHg of Sitting systolic blood pressure (SiSBP)
- Patients with secondary hypertension
- Patients with significant investigations - abnormal renal function (Creatinine more than upper limit of normal), abnormal liver function (AST, ALT more 2 times than upper normal), moderate fatty lever needed medication
- Patients with hypotension who has sign and symptom
- 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)
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- 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
- 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.
South Korea1 site
KyungPook National University Hospital
Daegu, Daegu, 110-750
About this study
Official title: A Randomized, Double-blind, Candesartan-controlled, Parallel Group Comparison Clinical Study to Evaluate the Antihypertensive Efficacy and Safety of Fimasartan in Patients With Mild to Moderate Essential Hypertension (Phase IIIb)
The purpose of this clinical study is to evaluate and compare the efficacy and safety of Fimasartan (60mg / 120mg) with Candesartan(8mg) in patients with mild to moderate hypertension.
Read the detailed description
A randomized, double-blind, Candesartan controlled, parallel group comparison clinical study to evaluate the antihypertensive efficacy and safety of Fimasartan in patients with mild to moderate hypertension Approximately 288 patients will be enrolled in 10 centers in South Korea. This study has planned 5 visits during 14 weeks (placebo run-in period 2 weeks, treatment period 12 weeks). All of the subjects who agreed to participate in this study and gave the written informed consent voluntary are assessed the exclusion and inclusion criteria and receive the investigational product(placebo) at screening visit.
During more than 14 days of placebo run-in period, subjects have to stop the previous anti-hypertension drug. After 2 weeks, subjects are assessed the final eligibility and randomized into one of 3 groups(Fimasartan 60mg, Fimasartan 120mg, Candesartan 8mg) at baseline visit. Subjects take physical and laboratory tests and receive the investigational products per 4weeks during treatment period (12weeks).
- Conditions
- Hypertension
- Being tested
- Fimasartan 60mg, Fimasartan 120mg, Candesartan cilexetil
- Keywords
- Hypertension, ARB, Fimasartan
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fimasartan 60mgDrug
Fimasartan 60mg for mild to moderate hypertension. Take a tablet(filled in Doubleblind capsule) every morning.
Fimasartan 120mgDrug
Fimasartan 120mg for mild to moderate hypertension. Take a tablet(filled in Doubleblind capsule) every morning.
Candesartan cilexetilDrug
Also called Atacand 8mg
Candesartan 8mg for mild to moderate hypertension. Take a tablet(filled in Doubleblind capsule) every morning.
| Study group | Role | What they receive |
|---|---|---|
| Fimasartan 60mg | Active comparator | Take one tablet of Fimasartan 60mg once a day in the morning Receives: Drug: Fimasartan 60mg |
| Fimasartan 120mg | Active comparator | Take one tablet of Fimasartan 120mg once a day in the morning Receives: Drug: Fimasartan 120mg |
| Candesartan 8mg | Active comparator | Take one tablet of Candesartan 8mg once a day in the morning Receives: Drug: Candesartan cilexetil |
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 12 weeks from baseline visit Fimasartan 60mg with Candesartna 8mg
Measured: 12weeks from baseline visit
Secondary outcomes (4)
Sitting DBP
To compare the difference of Sitting Diastolic Blood Pressure at 12 weeks from baseline visit Fimasartan 120mg with Candesartna 8mg
Measured: at 12weeks from Baseline visit
SittingDBP
To compare the difference of Sitting Diastolic Blood Pressure at 4, 8 weeks from baseline visit Fimasartan 60/120mg with Candesartna 8mg
Measured: at 4, 8 weeks from baseline visit
Sitting Systolic Blood Pressure
To compare the difference of Sitting Systolic Blood Pressure at 4,8,12 weeks from baseline visit Fimasartan 60mg/120mg with Candesartna 8mg
Measured: at 4,8,12 weeks from baseline visit
Responder ratio
To compare the ratio or responder(SiDBP<90mmHg or difference of SiDBP>10mmHg from baseline) at 12 weeks Fimasartan 60mg/120mg with Candesartna 8mg
Measured: at 12weeks 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 2010 (estimated)
- Study startApr 2010
- Primary completionApr 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 290 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boryung Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Kyungpook National University Hospital, Gyeongsang National University Hospital, Keimyung University, Kosin University Gospel Hospital, Daegu Catholic University Medical Center, Dong-A medical center, Pusan National University Yangsan Hospital, Yeungnam University Hospital, Ulsan University Hospital, Inje University, Pusan National University Hospital
- Responsible party
- Sponsor
- Investigators
- ShungChull Chae, Doctor´s degree, Principal investigator, KuyngPook National Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01135212
- Sponsor's protocol ID
- A657-BR-CT-302
- Status last verified
- Aug 2012
- First submitted
- 31 May 2010
- Last updated
- 24 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lee JH, Yang DH, Hwang JY, Hur SH, Cha TJ, Kim KS, Kim MH, Chun KJ, Cha GS, Hong GR, Lee SG, Kim DS, Kim DI, Chae SC. A Randomized, Double-blind, Candesartan-controlled, Parallel Group Comparison Clinical Trial to Evaluate the Antihypertensive Efficacy and Safety of Fimasartan in Patients with Mild to Moderate Essential Hypertension. Clin Ther. 2016 Jun;38(6):1485-1497. doi: 10.1016/j.clinthera.2016.04.005. Epub 2016 May 6.
PubMed 27161546Fimasartan. Am J Cardiovasc Drugs. 2011 Aug 1;11(4):249-52. doi: 10.2165/11533640-000000000-00000.
PubMed 21740078
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Candesartan-controlled, Parallel Group Comparison Clinical Study to Evaluate the Antihypertensive Efficacy and Safety of Fimasartan in Patients With Mild to Moderate Essential Hypertension (Phase IIIb)
- ClinicalTrials.gov ID
- NCT01135212
- Acronym / sponsor ID
- A657-BR-CT-302
- Conditions
- Hypertension
- Keywords
- Hypertension, ARB, Fimasartan
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 290 participants (actual)
- Lead sponsor
- Boryung Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Kyungpook National University Hospital, Gyeongsang National University Hospital, Keimyung University, Kosin University Gospel Hospital, Daegu Catholic University Medical Center, Dong-A medical center, Pusan National University Yangsan Hospital, Yeungnam University Hospital, Ulsan University Hospital, Inje University, Pusan National University Hospital
- Study start
- Apr 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 2 Jun 2010 (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 clinical study is to evaluate and compare the efficacy and safety of Fimasartan (60mg / 120mg) with Candesartan(8mg) in patients with mild to moderate hypertension.
Detailed description
A randomized, double-blind, Candesartan controlled, parallel group comparison clinical study to evaluate the antihypertensive efficacy and safety of Fimasartan in patients with mild to moderate hypertension Approximately 288 patients will be enrolled in 10 centers in South Korea. This study has planned 5 visits during 14 weeks (placebo run-in period 2 weeks, treatment period 12 weeks). All of the subjects who agreed to participate in this study and gave the written informed consent voluntary are assessed the exclusion and inclusion criteria and receive the investigational product(placebo) at screening visit.
During more than 14 days of placebo run-in period, subjects have to stop the previous anti-hypertension drug. After 2 weeks, subjects are assessed the final eligibility and randomized into one of 3 groups(Fimasartan 60mg, Fimasartan 120mg, Candesartan 8mg) at baseline visit. Subjects take physical and laboratory tests and receive the investigational products per 4weeks during treatment period (12weeks).
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 60mg | Active comparator | Drug: Fimasartan 60mgTake one tablet of Fimasartan 60mg once a day in the morning |
| Fimasartan 120mg | Active comparator | Drug: Fimasartan 120mgTake one tablet of Fimasartan 120mg once a day in the morning |
| Candesartan 8mg | Active comparator | Drug: Candesartan cilexetilTake one tablet of Candesartan 8mg once a day in the morning |
Who may qualify
- Ages
- 19 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 19 to 75 years
- Mild to moderate essential hypertension subjects who are measured more 90mmHg, less than 110mmHg 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 (21 listed)
- Severe hypertension patients; more 110mmHg of SiDBP and/or more 180 mmHg of Sitting systolic blood pressure (SiSBP)
- Patients with secondary hypertension
- Patients with significant investigations - abnormal renal function (Creatinine more than upper limit of normal), abnormal liver function (AST, ALT more 2 times than upper normal), moderate fatty lever needed medication
- Patients with hypotension who has sign and symptom
- Patients with surgical and medical disease it is able to be affect to absorption, distribution, metabolism, excretion
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 60mgFimasartan 60mg for mild to moderate hypertension. Take a tablet(filled in Doubleblind capsule) every morning. | Drug | Fimasartan 60mg |
| Fimasartan 120mgFimasartan 120mg for mild to moderate hypertension. Take a tablet(filled in Doubleblind capsule) every morning. | Drug | Fimasartan 120mg |
| Candesartan cilexetilAlso: Atacand 8mgCandesartan 8mg for mild to moderate hypertension. Take a tablet(filled in Doubleblind capsule) every morning. | Drug | Candesartan 8mg |
Primary outcome
Sitting Diastolic Blood Pressure
Time frame: 12weeks from baseline visit
To compare the difference of Sitting Diastolic Blood Pressure at 12 weeks from baseline visit Fimasartan 60mg with Candesartna 8mg
4 secondary outcomes
Sitting DBP
Time frame: at 12weeks from Baseline visit
SittingDBP
Time frame: at 4, 8 weeks from baseline visit
Sitting Systolic Blood Pressure
Time frame: at 4,8,12 weeks from baseline visit
Responder ratio
Time frame: at 12weeks 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 24 Aug 2012.
- Derived from this study: PubMed 27161546Lee JH, Yang DH, Hwang JY, Hur SH, Cha TJ, Kim KS, Kim MH, Chun KJ, Cha GS, Hong GR, Lee SG, Kim DS, Kim DI, Chae SC. A Randomized, Double-blind, Candesartan-controlled, Parallel Group Comparison Clinical Trial to Evaluate the Antihypertensive Efficacy and Safety of Fimasartan in Patients with Mild to Moderate Essential Hypertension. Clin Ther. 2016 Jun;38(6):1485-1497. doi: 10.1016/j.clinthera.2016.04.005. Epub 2016 May 6.
- Derived from this study: PubMed 21740078Fimasartan. Am J Cardiovasc Drugs. 2011 Aug 1;11(4):249-52. doi: 10.2165/11533640-000000000-00000.
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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.
ShungChull Chae, Doctor´s degree principal investigator
KuyngPook National 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 60mg, Fimasartan 120mg and Candesartan cilexetil in people with 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 21 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 24 Aug 2012. 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 Diastolic Blood Pressure (time frame: 12weeks 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 NCT01135212, which also lists 2 linked publications.
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 24 Aug 2012.