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| Name | Class |
|---|---|
| Gachon University Gil Medical Center | OTHER |
| The Catholic University of Korea | OTHER |
| Kangbuk Samsung Hospital | OTHER |
| Kyungpook National University Hospital |
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The aim of this study is to ensure the superiority of Fimasartan/Amlodipine combination in hypotensive effect after 8 weeks of treatment over Fimasartan monotherapy in patients with hypertension who have no response to Fimasartan 60mg monotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fimasartan and Amlodipine | Experimental | Combination of Fimasartan and Amlodipine |
|
| Fimasartan | Active Comparator | Fimasartan Monotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fimasartan and Amlodipine | Drug |
| ||
| Fimasartan |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Sitting Systolic Blood Pressure(SiSBP) at week 8 of Investigational Product(IP) Administration from the Baseline | To compare the difference of Mean Systolic Blood Pressure at 8 weeks from baseline visit | 8 weeks from Baseline Visit |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Sitting Systolic Blood Pressure(SiSBP) at week 4 of Investigational Product(IP) Administration from the Baseline | 4 weeks from Baseline Visit | |
| Changes of Sitting Diastolic Blood Pressure(SiDBP) at week 4 and 8 of Investigational Product(IP) Administration from the Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | 12 weeks from Screening Visit | |
| Adverse Changes in Laboratory Test Results | 12 weeks from Screening Visit | |
| Adverse Changes in Electrocardiography (ECG) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cheol Ho Kim, Ph.D. | Seoul National University Bundang Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Bundang | Gyeonggi-do | 463-707 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27502326 | Derived | Kim KI, Shin MS, Ihm SH, Youn HJ, Sung KC, Chae SC, Nam CW, Seo HS, Park SM, Rhee MY, Kim MH, Cha KS, Kim YJ, Kim JJ, Chun KJ, Yoo BS, Park S, Shin ES, Kim DS, Il Kim D, Kim KH, Joo SJ, Jeong JO, Shin J, Kim CH. A Randomized, Double-blind, Multicenter, Phase III Study to Evaluate the Efficacy and Safety of Fimasartan/Amlodipine Combined Therapy Versus Fimasartan Monotherapy in Patients With Essential Hypertension Unresponsive to Fimasartan Monotherapy. Clin Ther. 2016 Oct;38(10):2159-2170. doi: 10.1016/j.clinthera.2016.07.008. Epub 2016 Aug 5. |
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| ID | Term |
|---|---|
| D000075222 | Essential Hypertension |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C558933 | fimasartan |
| D017311 | Amlodipine |
| ID | Term |
|---|---|
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| OTHER |
| Keimyung University Dongsan Medical Center | OTHER |
| Korea University Guro Hospital | OTHER |
| Korea University Anam Hospital | OTHER |
| DongGuk University | OTHER |
| Dong-A University Hospital | OTHER |
| Pusan National University Hospital | OTHER |
| Seoul National University Bundang Hospital | OTHER |
| Seoul National University Hospital | OTHER |
| Asan Medical Center | OTHER |
| Pusan National University Yangsan Hospital | OTHER |
| Wonju Severance Christian Hospital | OTHER |
| Gangnam Severance Hospital | OTHER |
| Severance Hospital | OTHER |
| Ulsan University Hospital | OTHER |
| Inje University | OTHER |
| Inje University Haeundae Paik Hospital | OTHER |
| Chonnam National University Hospital | OTHER |
| Jeju National University Hospital | OTHER |
| Chungnam National University | OTHER |
| Hanyang University Seoul Hospital | OTHER |
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|
| 4 and 8 weeks from Baseline Visit |
| Response rate of the Blood Pressure at week 8 of Investigational Product(IP) Administration | 8 weeks from Baseline Visit |
| The Normalization ratio of Blood Pressure at week 8 of Investigational Product(IP) Administration | 8 weeks from Baseline Visit |
| 12 weeks from Screening Visit |