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| Name | Class |
|---|---|
| Shanghai Sankyo Pharmaceuticals Co., Ltd. | UNKNOWN |
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This study is designed to evaluate the additional efficacy and safety of olmesartan medoxomil/hydrochlorothiazide in the treatment of Chinese patients with mild to moderate essential hypertension, who fail to attain the blood pressure goals with olmesartan medoxomil monotherapy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Olmesartan medoxomil and hydrochlorothiazide |
|
| 2 | Active Comparator | olmesartan medoxomil |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| olmesartan medoxomil + hydrochlorothiazide | Drug | olmesartan medoxomil 20mg oral tablets, once daily for 4 weeks then olmesartan medoxomil 20mg oral tablets + hydrochlorothiazide 12.5 mg oral tablets, once daily for up to 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change of trough seated diastolic blood pressure from baseline to Week 12 between the two treatment groups. | Baseline to12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The mean change of trough seated systolic blood pressure from Week 5 to Week 12 between the two treatment groups | 8 weeks (week 5 to week 12) | |
| The mean change of trough seated diastolic blood pressure and seated systolic blood pressure from Week 5 to Week 9 between the two treatment groups |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Naotaka Ikegami, VP | Shanghai Sankyo Pharmaceuticals Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing | China | |||||
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| olmesartan medoxomil | Drug | olmesartan medoxomil 20mg oral tablets, once daily for 4 weeks then olmesartan medoxomil 40mg oral tablets, once daily for up to 8 weeks |
|
| 5 weeks (Week 5 to week 9) |
| The response rate in the two treatment groups from baseline to Week 9 | Baseline to 9 weeks |
| The response rate in the two treatment groups from baseline to Week 12 | Baseline to 12 weeks |
| Chengdu |
| China |
| Chongqing | China |
| Guangzhou | China |
| Hangzhou | China |
| Nanjing | China |
| Shanghai | China |
| Wuhan | China |
| ID | Term |
|---|---|
| D000075222 | Essential Hypertension |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000068557 | Olmesartan Medoxomil |
| D006852 | Hydrochlorothiazide |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013777 | Tetrazoles |
| D002740 | Chlorothiazide |
| D001581 | Benzothiadiazines |
| D013449 | Sulfonamides |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D049971 | Thiazides |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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