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A multi-center, randomized, double-blind, phase IV clinical trial to compare the efficacy and safety of OROSARTAN® tablet 5/160mg versus CODIOVAN® tablet 160/12.5mg in patients with essential hypertension uncontrolled with valsartan 160mg monotherapy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amlodipine orotate & Valsartan | Experimental | Amlodipine orotate 6.91mg (5mg as amlodipine) and Valsartan 160 mg, tablet, once a day for 8 weeks |
|
| Valsartan & Hydrochlorothiazide | Active Comparator | Valsartan 160mg and Hydrochlorothiazide 12.5mg, tablet, once a day for 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OROSARTAN® 5/160mg | Drug |
| ||
| CODIOVAN® 160/12.5mg |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) | Baseline, Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in MSDBP | Baseline, Week 4 | |
| Change from baseline in Mean Sitting Systolic Blood Pressure (MSSBP) | Baseline, Week 4 and 8 | |
| Control rate in blood pressure |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gachon University Gil Hospital | Incheon | South Korea |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Drug |
|
Rate of patients who achieved target blood pressure(MSDBP<90mmHg and MSSBP<140mmHg) |
| Baseline, Week 8 |
| Responder rate in blood pressure | Rate of patients who achieved MSDBP≥10mmHg and MSSBP≥20mmHg decrease compared to baseline | Baseline, Week 8 |