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To investigate the efficacy and safety of azilsartan compared to olmesartan medoxomil in patients with grade I or II essential hypertension
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| azilsartan group | Experimental | Once-daily oral administration of 20 or 40 mg tablet before or after breakfast |
|
| olmesartan medoxomil group | Active Comparator | Once-daily oral administration of 20 or 40 mg tablet before or after breakfast |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| azilsartan | Drug |
| ||
| Olmesartan medoxomil |
| Measure | Description | Time Frame |
|---|---|---|
| Trough sitting diastolic blood pressure (change from end of the run-in period to end of the treatment period) | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Trough sitting systolic blood pressure (change from end of the run-in period to end of the treatment period) | 16 weeks | |
| Trough sitting diastolic and systolic blood pressure (change from end of the run-in period to Week 8 of the treatment period) | 8 weeks |
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Inclusion Criteria:
Both sexes. eighteen years or older and no more than 70 years at the time of informed consent
Grade I or II essential hypertension
Both sitting systolic and diastolic blood pressures at Week 0 during the run-in period meet the following criteria:
Sitting systolic blood pressure: greater than or equal to 150 mmHg and less than 180 mmHg
Sitting diastolic blood pressure: greater than or equal to 95 mmHg and less than 110 mmHg
Able to understand the content of the study and comply with the study and to give informed consent in writing before participating in the study
Exclusion Criteria:
(1) Cardiac disease: angina pectoris; valvular stenosis; atrial fibrillation; the following diseases requiring medication: congestive heart failure or arrhythmia; (2) Cerebrovascular disorder: cerebral infarction, cerebral hemorrhage (onset within 24 weeks before start of the screening period), transient ischemic attack (onset of an attack within 24 weeks before start of the screening period); (3) Vascular disease: arteriosclerosis obliterans with symptoms of intermittent claudication; (4) Progressive hypertensive retinopathy: hemorrhage, exudation, or papilledema (observed within 24 weeks after start of the screening period)
3. Decrease in sitting diastolic blood pressure by 8 mmHg or more at the end of the run-in period (Week 0) compared to the start of the screening period
4. Day/night reversal, e.g., nightshift worker
5. Unilateral or bilateral renal artery stenosis
6. Clinically apparent hepatic and renal impairment (e.g., with AST and ALT values of 2.5 x upper limit of normal or higher, with serum creatinine value of 1.5 x upper limit of normal or higher during the screening period)
7. Hyperkalemia (with a laboratory value of 5.5 mEq/L or higher during the run-in period)
8. Malignant tumor
9. Compliance with the study drug of less than 80% during the run-in period
10. Poorly-controlled diabetes mellitus (fasting plasma glucose greater than 11mmol/L),and/or complications (kidney disease, peripheral neuropathy) at Screening.
11. History of hypersensitivity or allergy to olmesartan medoxomil tablets and related drugs (ARB, ACE inhibitors, and renin inhibitors)
12. History of drug abuse (defined as illegal drug use) or alcohol dependency within 2 years before start of the screening period
13. Requirement of the excluded treatment
14. Pregnant or lactating women
15. Participation in another clinical trial or post-marketing clinical trial within 30 days before start of the screening period
16. Dangerous machinery operator such as aerial worker,motor vehicle driver
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing ANZHEN Hospital | Recruiting | Beijing | 100029 | China |
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|
| Trough sitting diastolic and systolic blood pressures at each evaluation | 2 weeks |
| responder rate; rate of patients with normalized blood pressure | Responder is defined as a ≥20mmHg decrease in sitting trough SBP and a ≥10mmHg decrease in sitting trough DBP,or a sitting trough SBP of <140mmHg and a sitting trough DBP of <90mmHg;normalized blood pressure is defined as a sitting trough SBP of <140mmHg and a sitting trough DBP of <90mmHg. | 8 weeks and 16 weeks |
| evaluation by ABPM (1: 24-hour mean change in diastolic and systolic blood pressures, 2: Trough/Peak ratio of diastolic and systolic blood pressures)(change from end of the run-in period to Week 14 of the treatment period) | 14 weeks |
| ID | Term |
|---|---|
| D000075222 | Essential Hypertension |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| 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 |
| D013777 | Tetrazoles |
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