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| Name | Class |
|---|---|
| Seoul National University Hospital | OTHER |
| Samsung Medical Center | OTHER |
| Asan Medical Center | OTHER |
| Seoul National University Bundang Hospital |
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The purpose of this study is to evaluate the antihypertensive efficacy and tolerability of 8 week treatment with Fimasartan (BR-A-657-K) 20, 60, 120, 240 mg and placebo in patients with mild to moderate essential hypertension and to determine the adequate antihypertensive dosage for later clinical study.
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, placebo-controlled, parallel grouped, clinical study will be conducted to evaluate the antihypertensive efficacy and tolerability and to determine adequate antihypertensive dosage of Fimasartan(BR-A-657-K) in patients with mild to moderate essential hypertension.
Approximately 182 patients will be enrolled over 12 months in 8 centers nationwide.
After 2 weeks of placebo run-in period, all subjects will be randomized into one of the following 5 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 : Placebo, Group II : Fimasartan 20 mg, Group III: Fimasartan 60 mg, Group IV : Fimasartan 120 mg, Group V : Fimasartan 240 mg,
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | 3 tablets of placebo will be taken 30minutes after breakfast for 8 weeks |
|
| Fimasartan 20mg | Active Comparator | 2 tablets of placebo and 1 tablets of fimasartan 20mg will be taken 30minutes after breakfast for 8 weeks |
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| Fimasartan 60mg | Active Comparator | 3 tablets of fimasartan 20mg will be taken 30minutes after breakfast for 8 weeks |
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| Fimasartan 120mg | Active Comparator | 3 tablets of fimasartan 40mg will be taken 30minutes after breakfast |
|
| Fimasartan 240mg | Active Comparator | 3 tablets of fimasartan 80mg will be taken 30minutes after breakfast for 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fimasartan | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| change from baseline to end of 8 week treatment in sitting diastolic blood pressure | 8 week from baseline |
| Measure | Description | Time Frame |
|---|---|---|
| change from baseline to end of 2,4 week treatment in sitting diastolic blood pressure | 2, 4 week from baseline | |
| change from baseline to end of 2,4,8 week treatment in sitting systolic blood pressure | 2,4,8 week from baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Byung-Hee Oh, Professor | Seoul National University Hospital | Study Chair |
| Jae-Joong Kim, Professor | Asan Medical Center | Principal Investigator |
| Eun-Suk Jeon, Professor | Samsung Medical Center | Principal Investigator |
| Dong-Ju Choi, Professor | Seoul National University Bundang Hospital | Principal Investigator |
| Ki-Bae Seong, Professor | Kangnam ST.Mary's Hospital | Principal Investigator |
| Jong-Won Ha, Professor | Severance Hospital | Principal Investigator |
| Se-Joong Lim, Professor | Yonsei University | Principal Investigator |
| Jeong-Bae Park, Professor | Cheil General Hospital and Women's Healthcare Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22608107 | Derived | Lee H, Yang HM, Lee HY, Kim JJ, Choi DJ, Seung KB, Jeon ES, Ha JW, Rim SJ, Park JB, Shin JH, Oh BH. Efficacy and tolerability of once-daily oral fimasartan 20 to 240 mg/d in Korean Patients with hypertension: findings from Two Phase II, randomized, double-blind, placebo-controlled studies. Clin Ther. 2012 Jun;34(6):1273-89. doi: 10.1016/j.clinthera.2012.04.021. Epub 2012 May 17. |
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| OTHER |
| The Catholic University of Korea | OTHER |
| Severance Hospital | OTHER |
| Yonsei University | OTHER |
| Cheil General Hospital and Women's Healthcare Center | OTHER |
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| responders after end of 8 week treatment(portion of DBP<90mmHg or the difference from baseline and end of 8 week treatment>10mmHg | 8 week from baseline |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C558933 | fimasartan |
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