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A Multicenter, Randomized, Double-blind, Phase 3 Study to Evaluate the Efficacy and Safety of HGP2102 in patients with Essential Hypertension
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental1 | Experimental | Take HGP2102-1 once daily for 4 weeks orally, and then take HGP2102-2 once daily for 6 weeks orally. |
|
| Experimental2 | Experimental | Take HGP2102-1 once daily for 10 weeks orally. |
|
| Active Comparator | Active Comparator | Take RLD2209-1 once daily for 4 weeks orally, and then take RLD2209-2 once daily for 6 weeks orally. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HGP2102-1 | Drug | Test drug |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in 24 hours ambulatory systolic blood pressure | baseline, 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in 24 hours ambulatory systolic blood pressure | baseline, 4 weeks | |
| Change from baseline in 24 hours ambulatory diastolic blood pressure | baseline, 4 weeks, 10 weeks | |
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Inclusion Criteria:
Subjects whose clinic blood pressure measured in visit 1 corresponds to the following conditions
Subjects whose clinic and ambulatory blood pressure measured in visit 2 corresponds to the following conditions
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sevrance hosptal | Seodaemun-gu | Seoul | 03722 | South Korea |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| HGP2102-2 |
| Drug |
Test drug |
|
| RLD2209-1 | Drug | Control drug |
|
| RLD2209-2 | Drug | Control drug |
|
| Change from baseline in 24 hours ambulatory pulse pressure |
| baseline, 4 weeks, 10 weeks |
| Change from baseline in diurnal ambulatory systolic blood pressure | baseline, 4 weeks, 10 weeks |
| Change from baseline in diurnal ambulatory diastolic blood pressure | baseline, 4 weeks, 10 weeks |
| Change from baseline in diurnal ambulatory pulse pressure | baseline, 4 weeks, 10 weeks |
| Change from baseline in nocturnal ambulatory systolic blood pressure | baseline, 4 weeks, 10 weeks |
| Change from baseline in nocturnal ambulatory diastolic blood pressure | baseline, 4 weeks, 10 weeks |
| Change from baseline in nocturnal ambulatory pulse pressure | baseline, 4 weeks, 10 weeks |
| Change from baseline in sitting systolic blood pressure | baseline, 4 weeks, 10 weeks |
| Change from baseline in sitting diastolic blood pressure | baseline, 4 weeks, 10 weeks |
| Change from baseline in sitting pulse pressure | baseline, 4 weeks, 10 weeks |
| Proportion of subjects achieving blood pressure control | baseline, 4 weeks, 10 weeks |
| Blood pressure response rate | baseline, 4 weeks, 10 weeks |