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The aim of present study is to evaluate the efficacy and safety of two dose combination of S-Amlodipine/Telmisartan (2.5/40mg amd 2.5/80mg) compared with S-Amlodipine monotherapy (2.5mg) in hypertensive patients inadequately controlled by S-Amlodipine monotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CKD-828 2.5/40mg | Experimental | CKD-828 2.5/40mg |
|
| CKD-828 2.5/80mg | Experimental | CKD-828 2.5/80mg |
|
| S-Amlodipine 2.5mg | Active Comparator | S-Amlodipine 2.5mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CKD-828 2.5/40mg | Drug | fixed dose combination of S-Amlodipine 2.5mg and Telmisartan 40mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Sitting Diastolic Blood Pressure (MSDBP) | After 8 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Sitting Diastolic Blood Pressure (MSDBP) | After 4 weeks of treatment | |
| Mean Sitting Systolic Blood Pressure (MSSBP) | After 4 weeks and 8 weeks of treatment | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ho-Joong Yoon, Ph.D | Seoul St. Mary's hospital, The catholic university of Korea | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul St. Mary's hospital, The catholic university of Korea | Seoul | South Korea |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D000075222 | Essential Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C542574 | levamlodipine |
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| CKD-828 2.5/80mg | Drug | Fixed dose combination of S-Amlodipine 2.5 and Telmisartan 80mg |
|
| S-Amlodipine 2.5mg | Drug | S-Amlodipine 2.5mg monotherapy |
|
|
| Control Rate |
SBP<140mmHg, DBP<90mmHg |
| After 8 weeks of treatment |
| Response Rate | Reduction of SBP≥20mmHg, DBP≥10mmHg | After 8 weeks of treatment |