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The aim of the present study is to evaluate the efficacy and safety of two dose combination of Telmisartan/S-Amlodipine (40/2.5mg and 40/5mg) compared with telmisartan monotherapy (80mg) in hypertensive patients inadequately controlled by telmisartan monotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CKD-828 40/2.5mg | Experimental |
| |
| CKD-828 40/5mg | Experimental |
| |
| Telmisartan 80mg | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CKD-828 40/2.5mg | Drug | Fixed dose combination of Telmisartan 40mg and S-Amlodipine 2.5mg |
|
| 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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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kandong Sacred Heart Hospital | Anyang | South Korea | ||||
| Daegu Catholic University Medical Center |
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| CKD-828 40/5mg | Drug | Fixed dose combination of Telmisartan 40mg and S-Amlidioine 5mg |
|
| Telmisartan 80mg | Drug | Telmisartan 80mg monotherapy |
|
| Response rate |
Reduction of SBP ≥ 20mmHg, DBP ≥ 10mmHg |
| After 4 weeks and 8 weeks of treatment |
| Control rate | Reduction SBP < 140mmHg, DBP < 90mmHg | After 4 weeks and 8 weeks of treatment |
| Daegu |
| South Korea |
| Keimyung University Dongsan Medical Center | Daegu | South Korea |
| DonGuk University Ilsan Hospital | Goyang | South Korea |
| National Health Insurance Corporation Ilsan Hospital | Goyang | South Korea |
| Gachon University Gil Medical Center | Inchon | South Korea |
| Chonbuk National University Hospital | Jeonju | South Korea |
| Seoul National University Bundang Hospital | Seongnam | South Korea |
| Bundang Cha Medical Center | Seoul | South Korea |
| Ewha Womans University Hospital | Seoul | South Korea |
| Gangnam Severance Hospital | Seoul | South Korea |
| Inje University Ilsan Paik Hospital | Seoul | South Korea |
| Korea University Guro Hospital | Seoul | South Korea |
| Kyung Hee University Medical Center | Seoul | South Korea |
| Severance Hospital | Seoul | South Korea |
| Soon Chun Hyang University Hospital | Seoul | South Korea |
| St. Paul's Hospital, The catholic University of Korea | Seoul | South Korea |
| Ajou University Hospital | Suwon | South Korea |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D000075222 | Essential Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000077333 | Telmisartan |
| ID | Term |
|---|---|
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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