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| Name | Class |
|---|---|
| Seoul National University Hospital | OTHER |
| Asan Medical Center | OTHER |
| Seoul National University Bundang Hospital | OTHER |
| Kyungpook National University Hospital |
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The purpose of this study is to Evaluate the Antihypertensive efficacy of Fimasartan 30 mg during 24 hours in Patients with Mild to Moderate Essential Hypertension
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fimasartan 30 mg | Experimental | Take one capsule filled with a Fimasartan 30 mg in the every morning |
|
| Valsartan 80 mg | Active Comparator | Take one capsule filled with a Valsartan 80 mg in the every morning |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fimasartan | Drug | Fimasartan 30 mg |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Systolic Blood Pressure during 24 hours | To compare the difference of Mean Systolic Blood Pressure during 24 hours at 8 weeks from baseline visit | 8 weeks from baseline visit |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Diastolic Blood Pressure during 24 hours | To compare the difference of Mean Diastolic Blood Pressure during 24 hours at 8 weeks from baseline visit | 8 weeks from baseline visit |
| Mean Diastolic Blood pressure and Systolic Blood pressure during daytime or nighttime |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Adverse evnt(AE)s are collected as a safety measure. All AEs are arranged based on severity, relevance to the investigational drug and serious adverse event each. | about 10~11weeks from placebo run-in visit |
| Adverse changes in laboratory test results |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Byung-He Oh, professor | Seoul National University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | Seoul | 110-744 | South Korea |
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| OTHER |
| Chonnam National University Hospital | OTHER |
| Inje University | OTHER |
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| Valsartan | Drug | Valsartan 80 mg |
|
|
To compare the difference of Diastolic Blood pressure and Systolic Blood pressure during daytime or nighttime at 8 weeks from baseline visit |
| 8 weeks from baseline visit |
| Sitting Diastolic Blood pressure and Systolic Blood pressure | To compare the difference of Sitting Diastolic Blood pressure and Systolic Blood pressure at 8 weeks from baseline visit | 8 weeks from baseline visit |
| Trough-to-peak ratio | Trough-to-peak ratio of systolic blood pressure and diastolic blood pressure measured by ABP(Ambulatory Blood Pressure) monitor | 8 weeks from baseline visit |
| Smoothness index | Smoothness index of systolic blood pressure and diastolic blood pressure measured by ABP monitor | 8 weeks from baseline visit |
Adverse changes in laboratory test results are collected as a safety measure. As a continuous data group for each test visit, adverse changes in laboratory test results present descriptive statistics (mean, standard deviation, minimum, maximum, etc.) |
| about 10~11weeks from screening visit |
| Adverse changes in electrocardiography(ECG) | Adverse changes in ECG are collected as a safety measure. As a categorical data, adverse changes in ECG present frequency and percentage for each category. | about 10~11weeks from screening visit |
| ID | Term |
|---|---|
| D000075222 | Essential Hypertension |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C558933 | fimasartan |
| D000068756 | Valsartan |
| ID | Term |
|---|---|
| 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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