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| Name | Class |
|---|---|
| Severance Hospital | OTHER |
The purpose of this study is to evaluate the antihypertensive efficacy and changes of neurohormonal markers of fimasartan and atenolol with exaggerated blood pressure response during exercise in essential hypertensive patients.
After subjects have signed informed consent voluntarily, when they are taking hypertension medication, they go through screening period for 7 days including wash-out period.
After screening and wash-out period, subjects take the placebo for 14 days (Maximum 21 days), and evaluate their suitability to Inclusion and Exclusion criteria.
Patients, who evaluated the proper subject for this clinical trial, are allocated to experimental group (Fimasartan 60mg) or Control group (Atenolol 50mg) randomly at a ratio 1:1 and their investigational drugs will be administered daily for the study period (8 weeks). Subjects visit their investigators twice during treatment period, when they take their investigational drugs for 4 weeks, and 8 weeks.
The placebo period will be single-blinded and the treatment allocation in this study will be double-blinded.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fimasartan 60mg | Experimental | 60mg/day of Fimasartan will be oral administered for the study period (8 weeks) |
|
| Atenolol 50mg | Active Comparator | 50mg/day of Atenolol will be oral administered for the study period (8 weeks) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fimasartan | Drug | Fimasartan 60mg |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| The difference of sitting Systolic Blood Pressure(SiSBP) between at the peak compared to at resting | To compare the difference of sitting Systolic Blood Pressure(SiSBP) at the peak compared to at resting between Fimasartan 60mg group and Atenolol 50mg group | After 8 weeks from baseline visit |
| Measure | Description | Time Frame |
|---|---|---|
| The difference of sitting Diastolic Blood Pressure(SiDBP) at the peak compared to at resting | To compare the difference of sitting Diastolic Blood Pressure(SiDBP), Heart Rate, Neurohormonal markers at the peak compared to at resting between Fimasartan 60mg group and Atenolol 50mg group | After 8 weeks from baseline visit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jong Won Ha, PhD | Yonsei University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hallym University Medical Center | Anyang | South Korea | ||||
| Gachon University Gil Hospital |
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| Atenolol | Drug | Atenolol 50mg |
|
|
| The difference of sitting Systolic Blood Pressure(SiSBP) at each exercising stage compared to at resting |
To compare the difference of sitting Systolic Blood Pressure(SiSBP), sitting Diastolic Blood Pressure(SiDBP), Heart Rate at each exercising stage and at recovery compared to at resting between Fimasartan 60mg group and Atenolol 50mg group |
| After 8 weeks from baseline visit |
| The difference of sitting Systolic Blood Pressure(SiSBP) among at resting, each exercising stage and recovery | To compare the difference of sitting Systolic Blood Pressure(SiSBP), sitting Diastolic Blood Pressure(SiDBP), Heart Rate, neurohormonal markers among at resting, each exercising stage and recovery between Fimasartan 60mg group and Atenolol 50mg group | After 8 weeks from baseline visit |
| Incheon |
| South Korea |
| Severance Hospital | Seoul | 120-752 | South Korea |
| Kangnam Severance Hospital | Seoul | South Korea |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| C558933 | fimasartan |
| D001262 | Atenolol |
| ID | Term |
|---|---|
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
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