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The purpose of this study is to evaluate the efficacy and safety of Candesartan/Amlodipine combined or alone and select better dose of CKD-330 in essential hypertension patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Candesartan 8mg + Amlodipine 5mg | Experimental | Candesartan 8mg + Amlodipine 5mg, po, q.d. |
|
| Candesartan 8mg + Amlodipine 10mg | Experimental | Candesartan 8mg + Amlodipine 10mg, po, q.d. |
|
| Candesartan 16mg + Amlodipine 5mg | Experimental | Candesartan 16mg + Amlodipine 5mg, po, q.d. |
|
| Candesartan 16mg + Amlodipine 10mg | Experimental | Candesartan 16mg + Amlodipine 10mg, po, q.d. |
|
| Candesartan 8mg | Active Comparator | Candesartan 8mg, po, q.d. |
|
| Candesartan 16mg | Active Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Candesartan 8mg | Drug | Once a day, 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| The mean change of sitDBP (sitting diastolic blood pressure) | From baseline at week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| The mean change of sitDBP | From baseline at week 4 and week 8 | |
| The mean change of sitSBP | From baseline at week 4 and 8 | |
| Responder rate: The change of sitDBP > 10mmHg, sitSBP > 20mmHg |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| HyunKyung Oh | Contact | 82-2-2194-0469 | hkoh@ckdpharm.com |
| Name | Affiliation | Role |
|---|---|---|
| Cheol-Ho Kim, M.D., Ph.D. | Seoul National University Bundang Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Recruiting | Seongnam | South Korea |
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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 |
|---|---|
| C081643 | candesartan |
| D017311 | Amlodipine |
| ID | Term |
|---|---|
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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Candesartan 16mg, po, q.d.
|
| Amlodipine 5mg | Active Comparator | Amlodipine 5mg, po, q.d. |
|
| Amlodipine 10mg | Active Comparator | Amlodipine 10mg, po, q.d. |
|
| Candesartan 16mg | Drug | Once a day, 8 weeks |
|
| Amlodipine 5mg | Drug | Once a day, 8 weeks |
|
| Amlodipine 10mg | Drug | Once a day, 8 weeks |
|
| From baseline at week 4 and 8 |
| Control rate: Patient achieving sitDBP < 90mmHg and sitSBP < 140mmHg | At week 4 and 8 |