Essential HypertensionPhase 2NCT00922441
A Therapeutic Exploratory Clinical Study to Evaluate the Antihypertensive Efficacy of Fimasartan (BR-A-657•K) During 24 Hours in Patients With Mild to Moderate Essential Hypertension
A Phase 2 study testing Fimasartan 60 mg group, Fimasartan 120 mg group and Reference (Valsartan 80 mg) group in people with Essential Hypertension, run by Boryung Pharmaceutical Co., Ltd.
Trial summary
The purpose of this study is to evaluate the antihypertensive efficacy and safety of Fimasartan (BR-A-657•K) during 24 hours by dose in patients with mild to moderate essential hypertension. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Essential Hypertension
- What is being tested?
- Fimasartan 60 mg group, Fimasartan 120 mg group and Reference (Valsartan 80 mg) group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- No sites listed yet
- Study dates
- Dec 2008to Aug 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mild to moderate essential hypertension : sitting diastolic blood pressure measured at Placebo visit and Baseline are 90~109mmHg inclusive and the difference between sitting diastolic blood pressures measured at Placebo visit and Baseline(Day0) is under 7mmHg.
- Subjects who agree to participate in this sudy and give written informed consent
- Subjects considered to understand the study, be cooperative, and able to be followed-up until the end of the study
Who cannot join
- The sitting DBP is less than 89mmHg or more than 110mmHg or severe hypertensive patient with sitting systolic blood pressure over 200mmHg Patients with secondary hypertension
- Patients with severe renal(Creatinine more 1.5mg/dl), gastrointestinal, hematological or hepatic(AST, ALT more 2 twice more than upper limit of normal)disease etc. which might affect absorption, disposition, metabolism or excretion of the drug
- Patients with postural hypotension
- Patients with sever insulin dependent diabetes mellitus or uncontrolled diabetes mellitus(HbA1c>9%, regimen change of oral hypoglycemic agents within 12weeks, treated insulin before screening)
- Patients with a history of myocardial infarction, severe coronary artery disease or clinically significant heart failure or valvular defect in last 6 months
- Patients with consumptive disease, autoimmune disease, connective tissue disease
Show all 14Show fewer
- Patients with a history of type B or C hepatitis
- Patients with HIV or hepatitis
- Patients with clinically significant laboratory abnormality
- Patients receiving any drugs known to affect blood pressure or medical treatments that can influence the blood pressure
- Patients with allergy or contraindication to any angiotensin II receptor antagonists
- Female of childbearing potential who does not undergo hysterectomy or is not post-menopausal
- Patients judged to have a history of alcohol or drug abuse by the investigator
- Patients participated other clinical trial 12 weeks before Screening Patients judged to be inappropriate for this study by the investigator with other reasons
About this study
Official title: A Randomized, Double-blind, Valsartan-Referenced, Parallel Grouped, Therapeutic Exploratory Clinical Study to Evaluate the Antihypertensive Efficacy of Fimasartan(BR-A-657•K) During 24hours by Dose in Patients With Mild to Moderate Essential Hypertension
The purpose of this study is to evaluate the antihypertensive efficacy and safety of Fimasartan (BR-A-657•K) during 24 hours by dose in patients with mild to moderate essential hypertension.
Read the detailed description
Fimasartan(BR-A-657-K), a selective blocker of AT1 receptor subtype, showed the rapid and potent antihypertensive effect in many hypertensive models. Phase I study, Fimasartan(BR-A-657-K) 20mg ~ 480mg single dosing with healthy subjects, demonstrated that the Fimasartan(BR-A-657-K) was very safe and well tolerated. Another phase I study, Fimasartan(BR-A-657-K) 120mg and 360mg dosing for 7 days, also showed that Fimasartan(BR-A-657-K) was safe and tolerable though one temporal adverse event was observed in high dose.
A Randomized, Double-blind, Valsartan-referenced, Parallel Grouped, Therapeutic Exploratory Clinical Study to Evaluate the Antihypertensive Efficacy of Fimasartan(BR-A-657•K) during 24hoursby dose in Patients with Mild to Moderate Essential Hypertension.
Approximately 90 patients will be enrolled over 12 months in 5 centers nationwide.
After 2 weeks of placebo run-in period, all subjects will be randomized into one of the following 3 groups. Subjects will take test/control drug for 8 weeks of treatment period.
If subjects take any antihypertensive medications before screening, the subjects will have 1 week of wash-out period.
Group I : Fimasartan 60mg group. Group II : Fimasartan 120mg group Group III : Valsartan 80mg group
- Conditions
- Essential Hypertension
- Being tested
- Fimasartan 60 mg group, Fimasartan 120 mg group, Reference (Valsartan 80 mg) group
- Keywords
- Fimasartan, Essential Hypertension, 24hour ABPM, Population PK
- 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 60 mg groupDrug
Also called BR-A-657.K
Fimasartan 60 mg
Fimasartan 120 mg groupDrug
Also called BR-A-657.K
Fimasartan 120 mg
Reference (Valsartan 80 mg) groupDrug
Also called Diovan
Reference (Valsartan 80 mg)
| Study group | Role | What they receive |
|---|---|---|
| Fimasartan 1 | Experimental | Fimasartan 60 mg group Receives: Drug: Fimasartan 60 mg group |
| Fimasartan 2 | Experimental | Fimasartan 120 mg group Receives: Drug: Fimasartan 120 mg group |
| Valsartan | Active comparator | Reference (Valsartan 80 mg) group Receives: Drug: Reference (Valsartan 80 mg) group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change of Diastolic Blood Pressure
24hr Mean change of DBP on Week 8, from Baseline
Measured: baseline and 8 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2009 (estimated)
- Study startDec 2008
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boryung Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Seoul National University Hospital, Kyungpook National University Hospital, Catholic Medical Center, Inje University, Chonnam National University Hospital
- Responsible party
- Sponsor
- Investigators
- Byung-He Oh, Professor, Study chair, Seoul National University HospitalDong-Soo Kim, Professor, Principal investigator, Inje UniversitySung Chul Chae, Professor, Principal investigator, Kyungpook National University HospitalGi-Sik Kim, professor, Principal investigator, Daegu Catholic University Medical CenterMyung-Ho Jung, Professor, Principal investigator, Connam National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00922441
- Sponsor's protocol ID
- A657-BR-CT-203
- Status last verified
- Feb 2018
- First submitted
- 16 Jun 2009
- Last updated
- 15 Mar 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Lee H, Kim KS, Chae SC, Jeong MH, Kim DS, Oh BH. Ambulatory blood pressure response to once-daily fimasartan: an 8-week, multicenter, randomized, double-blind, active-comparator, parallel-group study in Korean patients with mild to moderate essential hypertension. Clin Ther. 2013 Sep;35(9):1337-49. doi: 10.1016/j.clinthera.2013.06.021. Epub 2013 Aug 7.
PubMed 23932463
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Valsartan-Referenced, Parallel Grouped, Therapeutic Exploratory Clinical Study to Evaluate the Antihypertensive Efficacy of Fimasartan(BR-A-657•K) During 24hours by Dose in Patients With Mild to Moderate Essential Hypertension
- ClinicalTrials.gov ID
- NCT00922441
- Acronym / sponsor ID
- A657-BR-CT-203
- Conditions
- Essential Hypertension
- Keywords
- Fimasartan, Essential Hypertension, 24hour ABPM, Population PK
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Boryung Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Seoul National University Hospital, Kyungpook National University Hospital, Catholic Medical Center, Inje University, Chonnam National University Hospital
- Study start
- Dec 2008
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 17 Jun 2009 (estimated)
- Results
- Posted 13 Feb 2018
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 (BR-A-657•K) during 24 hours by dose in patients with mild to moderate essential hypertension.
Detailed description
Fimasartan(BR-A-657-K), a selective blocker of AT1 receptor subtype, showed the rapid and potent antihypertensive effect in many hypertensive models. Phase I study, Fimasartan(BR-A-657-K) 20mg ~ 480mg single dosing with healthy subjects, demonstrated that the Fimasartan(BR-A-657-K) was very safe and well tolerated. Another phase I study, Fimasartan(BR-A-657-K) 120mg and 360mg dosing for 7 days, also showed that Fimasartan(BR-A-657-K) was safe and tolerable though one temporal adverse event was observed in high dose.
A Randomized, Double-blind, Valsartan-referenced, Parallel Grouped, Therapeutic Exploratory Clinical Study to Evaluate the Antihypertensive Efficacy of Fimasartan(BR-A-657•K) during 24hoursby dose in Patients with Mild to Moderate Essential Hypertension.
Approximately 90 patients will be enrolled over 12 months in 5 centers nationwide.
After 2 weeks of placebo run-in period, all subjects will be randomized into one of the following 3 groups. Subjects will take test/control drug for 8 weeks of treatment period.
If subjects take any antihypertensive medications before screening, the subjects will have 1 week of wash-out period.
Group I : Fimasartan 60mg group. Group II : Fimasartan 120mg group Group III : Valsartan 80mg group
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fimasartan 1 | Experimental | Drug: Fimasartan 60 mg groupFimasartan 60 mg group |
| Fimasartan 2 | Experimental | Drug: Fimasartan 120 mg groupFimasartan 120 mg group |
| Valsartan | Active comparator | Drug: Reference (Valsartan 80 mg) groupReference (Valsartan 80 mg) group |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Mild to moderate essential hypertension : sitting diastolic blood pressure measured at Placebo visit and Baseline are 90~109mmHg inclusive and the difference between sitting diastolic blood pressures measured at Placebo visit and Baseline(Day0) is under 7mmHg.
- Subjects who agree to participate in this sudy and give written informed consent
- Subjects considered to understand the study, be cooperative, and able to be followed-up until the end of the study
Key exclusion criteria (14 listed)
- The sitting DBP is less than 89mmHg or more than 110mmHg or severe hypertensive patient with sitting systolic blood pressure over 200mmHg Patients with secondary hypertension
- Patients with severe renal(Creatinine more 1.5mg/dl), gastrointestinal, hematological or hepatic(AST, ALT more 2 twice more than upper limit of normal)disease etc. which might affect absorption, disposition, metabolism or excretion of the drug
- Patients with postural hypotension
- Patients with sever insulin dependent diabetes mellitus or uncontrolled diabetes mellitus(HbA1c>9%, regimen change of oral hypoglycemic agents within 12weeks, treated insulin before screening)
- Patients with a history of myocardial infarction, severe coronary artery disease or clinically significant heart failure or valvular defect in last 6 months
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 60 mg groupAlso: BR-A-657.KFimasartan 60 mg | Drug | Fimasartan 1 |
| Fimasartan 120 mg groupAlso: BR-A-657.KFimasartan 120 mg | Drug | Fimasartan 2 |
| Reference (Valsartan 80 mg) groupAlso: DiovanReference (Valsartan 80 mg) | Drug | Valsartan |
Primary outcome
Mean Change of Diastolic Blood Pressure
Time frame: baseline and 8 Weeks
24hr Mean change of DBP on Week 8, from Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23932463Lee H, Kim KS, Chae SC, Jeong MH, Kim DS, Oh BH. Ambulatory blood pressure response to once-daily fimasartan: an 8-week, multicenter, randomized, double-blind, active-comparator, parallel-group study in Korean patients with mild to moderate essential hypertension. Clin Ther. 2013 Sep;35(9):1337-49. doi: 10.1016/j.clinthera.2013.06.021. Epub 2013 Aug 7.
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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.
Byung-He Oh, Professor study chair
Seoul National University Hospital
Dong-Soo Kim, Professor principal investigator
Inje University
Sung Chul Chae, Professor principal investigator
Kyungpook National University Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fimasartan 60 mg group, Fimasartan 120 mg group and Reference (Valsartan 80 mg) group in people with Essential Hypertension, run by Boryung Pharmaceutical Co., Ltd.
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 3 inclusion and 14 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 15 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
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 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?
Yes. Results are posted in the registry (first posted 13 Feb 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Change of Diastolic Blood Pressure (time frame: baseline and 8 Weeks). 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 NCT00922441, 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 15 Mar 2018.