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| Name | Class |
|---|---|
| Eisai Co., Ltd. | INDUSTRY |
The purpose of this study is to investigate the efficacy and safety of Bunazosin with Valsartin compared to Doxazosin with Valsartin for patients with mild to moderate essential hypertension accompanied by metabolic syndrome.
This clinical study will comprise a 1 to 2-week washout period, a 5-week mono therapy period with Angiotensinâ…¡antagonist, and an 8-week alpha blocker add-on treatment period. Total study period will be 15 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bunazosin | Drug | Patients will be randomized to the add-on treatment with Bunazosin (Detantol-R) 3 mg once-daily after breakfast for a total of eight weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Blood Pressure | Week 0, Week 4, Week 9, Week 13. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability. | Week 4, Week 9, Week 13. |
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Inclusion Criteria:
Subjects with mild to moderate essential hypertension, with the following criteria:
Washout period (Week -2)
Angiotensin II antagonist mono-therapy period (week 0)
Angiotensin II antagonist with add-on Bunazosin or Doxazosin treatment period (Week 5)
Exclusion Criteria:
Subjects with the following conditions are not eligible for participation:
a) Washout period (Week -1 or -2)
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| Name | Affiliation | Role |
|---|---|---|
| Ya-hui Cheng | Medical Affairs Department , Eisai Taiwan Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital. | Taipei | Taiwan |
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| Doxazosin | Drug | Patients will be randomized to the add-on treatment with Doxazosin (Doxaben XL) 4 mg once-daily after breakfast for a total of eight weeks. |
|
|
| Valsartin | Drug | After wash-out period, the eligible subjects will be treated with Valsartin (Diovan) 80 mg as the mono therapy for 5 weeks. If the blood pressures are inadequately responded, then the patients will be randomized to either Bunazosin (Detantol-R) or Doxazosin (Doxaben XL) along with Valsartin as the add-on treatment for 8 weeks. |
|
|
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C018176 | bunazosin |
| D017292 | Doxazosin |
| D000068756 | Valsartan |
| ID | Term |
|---|---|
| D011224 | Prazosin |
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D014633 | Valine |
| D000597 | Amino Acids, Branched-Chain |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000601 | Amino Acids, Essential |
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