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The aim of this trial is to determine the best dose combination of S-Amlodipine and Telmisartan as compared to monotherapy by assessing the blood pressure lowering effects of a once daily regimen of various combinations of S-Amlodipine and Telmisartan, compared to their monotherapy components and placebo, in patients with stage I or II essential hypertension(a mean seated cuff diastolic blood pressure >=95 and <=115 mmHg).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| S-Amlodipine 2.5mg + Telmisartan 40mg | Experimental |
| |
| S-Amlodipine 2.5mg + Telmisartan 80mg | Experimental |
| |
| S-Amlodipine 5mg + Telmisartan 40mg | Experimental |
| |
| S-Amlodipine 5mg + Telmisartan 80mg | Experimental |
| |
| S-Amlodipine 2.5mg | Active Comparator |
| |
| S-Amlodipine 5mg | Active Comparator |
| |
| Telmisartan 40mg | Active Comparator |
| |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| S-Amlodipine, Telmisartan | Drug |
|
| 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 |
|---|---|---|---|---|---|---|
| Hallym University Sacred Heart Hospital | Anyang | South Korea | ||||
| Soonchunhyang University Hospital in Bucheon |
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| Telmisartan 80mg |
| Active Comparator |
|
| Placebo | Placebo Comparator |
|
| S-Amlodipine | Drug |
|
| Telmisartan | Drug |
|
| Placebo | Drug |
|
| 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 |
| Bucheon-si |
| South Korea |
| Kosin University Gospel Hospital | Busan | South Korea |
| Chungbuk National Uiversity Hospital | Cheongju-si | South Korea |
| Daegu Catholic University Medical Center | Daegu | South Korea |
| Keimyung University Dongsan Medical Center | Daegu | South Korea |
| DonGuk University International Hospital | Goyang | South Korea |
| National Health Insurance Corporation Ilsan Hospital | Goyang | South Korea |
| Chonnam National University Hospital | Gwangju | South Korea |
| Gachon University Gil Medical Center | Inchon | South Korea |
| Chonbuk National University Hospital | Jeonju | South Korea |
| Pusan National University Hospital | Pusan | South Korea |
| Seoul National University Bundang Hospital | Seongnam | South Korea |
| Ewha Womans University Hospital | Seoul | South Korea |
| Gangnam Severance Hospital | Seoul | South Korea |
| Kandong Sacred Heart Hospital | Seoul | South Korea |
| Korea University Guro Hospital | Seoul | South Korea |
| Kyung Hee University Medical Center | Seoul | South Korea |
| Seoul St. Mary's Hospital, The catholic University of Korea | Seoul | South Korea |
| Severance Hospital | Seoul | South Korea |
| SMG-SNU Boramae Medical Center | 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 |
| Uijeongbu St. Mary's Hospital, The catholic University of Korea | Uijeongbu-si | South Korea |
| Wonju Christian Hospital | Wŏnju | South Korea |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D000075222 | Essential Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C542574 | levamlodipine |
| 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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