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A phase 3 clinical study to evaluate the safety and efficacy of Azilsartan in Chinese hypertension patients
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment-Azilsartan | Experimental | Azilsartan tabelts |
|
| Positive Control-olmesartan medoxomil | Active Comparator | olmesartan medoxomil tablets |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azilsartan tablets | Drug | 20mg/tablet |
| |
| Azilsartan placebo tablets |
| Measure | Description | Time Frame |
|---|---|---|
| Decrease of sitting diastolic blood pressure at week 16 | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Decrease of sitting diastolic blood pressure at week 8 | 8 weeks | |
| Decrease of sitting systolic blood pressure at week 8 | 8 weeks | |
| Decrease of sitting diastolic blood pressure at week 2 |
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Inclusion Criteria:
Exclusion Criteria:
14 patients with malignant tumors. 15. hemodialysis patients or strictly limit salt therapy. 16. Participated in other clinical trials within 30 days.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University First hospiatl | Beijing | 100000 | China |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C521273 | azilsartan |
| D000068557 | Olmesartan Medoxomil |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Drug |
placebo tablet |
|
| Olmesartan medoxomil tablets | Drug | 20mg/tablet |
|
| olmesartan medoxomil placebo tablets | Drug | placebo tablet |
|
| 2 weeks |
| Decrease of sitting diastolic blood pressure at week 4 | 4 weeks |
| Decrease of sitting diastolic blood pressure at week 12 | 12weeks |
| Decrease of sitting systolic blood pressure at week 2 | 2 weeks |
| Decrease of sitting systolic blood pressure at week 4 | 4 weeks |
| Decrease of sitting systolic blood pressure at week 12 | 12 weeks |
| decrease of 24-hour ambulatory blood pressure monitoring at week 16 | do a 24-hour ambulatory blood pressure monitoring at baseline and at week 16, compare the decrease. | 16 week |
| D013777 |
| Tetrazoles |