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| Name | Class |
|---|---|
| Seoul National University Hospital | OTHER |
| Kyungpook National University Hospital | OTHER |
| Catholic Medical Center | OTHER |
| Inje University |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fimasartan 1 | Experimental | Fimasartan 60 mg group |
|
| Fimasartan 2 | Experimental | Fimasartan 120 mg group |
|
| Valsartan | Active Comparator | Reference (Valsartan 80 mg) group |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fimasartan 60 mg group | Drug | Fimasartan 60 mg |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean Change of Diastolic Blood Pressure | 24hr Mean change of DBP on Week 8, from Baseline | baseline and 8 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Byung-He Oh, Professor | Seoul National University Hospital | Study Chair |
| Dong-Soo Kim, Professor | Inje University | Principal Investigator |
| Sung Chul Chae, Professor | Kyungpook National University Hospital | Principal Investigator |
| Gi-Sik Kim, professor | Daegu Catholic University Medical Center | Principal Investigator |
| Myung-Ho Jung, Professor | Connam National University Hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23932463 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Fimasartan 1 | Fimasartan 60 mg group Fimasartan 60 mg daily, po |
| FG001 | Fimasartan 2 | Fimasartan 120 mg group Fimasartan 120 mg daily, po |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| OTHER |
| Chonnam National University Hospital | OTHER |
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| Fimasartan 120 mg group | Drug | Fimasartan 120 mg |
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| Reference (Valsartan 80 mg) group | Drug | Reference (Valsartan 80 mg) |
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| FG002 | Valsartan: Control | Reference (Valsartan 80 mg) group Valsartan 80 mg daily, po |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Fimasartan 1 | Fimasartan 60 mg group Fimasartan 60 mg daily, po |
| BG001 | Fimasartan 2 | Fimasartan 120 mg group Fimasartan 120 mg daily, po |
| BG002 | Valsartan: Control | Reference (Valsartan 80 mg) group Valsartan 80 mg daily, po |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Change of Diastolic Blood Pressure | 24hr Mean change of DBP on Week 8, from Baseline | Posted | Mean | Standard Deviation | mmHg | baseline and 8 Weeks |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fimasartan 1 | Fimasartan 60 mg group Fimasartan 60 mg daily, po | 0 | 30 | 4 | 30 | ||
| EG001 | Fimasartan 2 | Fimasartan 120 mg group Fimasartan 120 mg daily, po | 0 | 30 | 5 | 30 | ||
| EG002 | Valsartan: Control | Reference (Valsartan 80 mg) group Valsartan 80 mg daily, po | 0 | 32 | 2 | 32 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders | Systematic Assessment |
| ||
| Headache | Nervous system disorders | Systematic Assessment |
| ||
| Nasopharyngitis | Infections and infestations | Systematic Assessment |
| ||
| ALT Increased | Investigations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Manager of Clinical Research | Boryung Pharmaceutical | +82-2-708-8069 | rainbowleo@boryung.co.kr |
| ID | Term |
|---|---|
| D000075222 | Essential Hypertension |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C558933 | fimasartan |
| D044382 | Population Groups |
| D000068756 | Valsartan |
| ID | Term |
|---|---|
| D003710 | Demography |
| D011154 | Population Characteristics |
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D014633 | Valine |
| D000597 | Amino Acids, Branched-Chain |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000601 | Amino Acids, Essential |
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| Male |
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