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The purpose of this study is to compare in patients with primary hypertension, the non-blood pressure lowering effects of one-year therapy with olmesartan medoxomil vs. those of atenolol on changes in the vascular structure and function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | olmesartan medoxomil tablets with added doses of hydrochlorothiazide, amlodipine, or hydralazine, if required to maintain target blood pressure |
|
| 2 | Active Comparator | Atenolol tablets with added doses of hydrochlorothiazide, amlodipine, or hydralazine, if required to maintain target blood pressure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| olmesartan medoxomil + hydrochlorothiazide + amlodipine + hydralazine if necessary to control blood pressure | Drug | Tablets and capsules for oral administration once or twice daily for up to 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Subcutaneous gluteal fat arteriole measurements prior to and after 52 weeks of therapy | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Results of vascular function tests | 12 weeks | |
| Results of vascular function tests | 28 weeks | |
| Results of vascular function tests |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Baptist Medical Center | Winston-Salem | North Carolina | 27157 | United States |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000068557 | Olmesartan Medoxomil |
| D006852 | Hydrochlorothiazide |
| D017311 | Amlodipine |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| atenolol+ hydrochlorothiazide + amlodipine + hydralazine if necessary to control blood pressure | Drug | Tablets and capsules for oral administration once or twice daily for up to 52 weeks |
|
| 52 weeks |
| Measurement of serum lipid and markers of atherosclerosis | 12 weeks |
| Measurement of serum lipid and markers of atherosclerosis | 28 weeks |
| Measurement of serum lipid and markers of atherosclerosis | 52 weeks |
| Retinal arteriole measurements | 52 weeks |
| Calculation of insulin sensitivity measurement | 12 Weeks |
| Calculation of insulin sensitivity measurement | 28 weeks |
| Calculation of insulin sensitivity measurement | 52 weeks |
| 24 hour urine creatinine and thromboxane B2 measurements | 12 weeks |
| Calculation of albumin-to-creatinine ratio and sodium-to-creatinine ratio | 12 weeks |
| Calculation of albumin-to-creatinine ratio and sodium-to-creatinine ratio | 28 weeks |
| Calculation of albumin-to-creatinine ratio and sodium-to-creatinine ratio | 52 weeks |
| 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 |
| D004095 | Dihydropyridines |
| D011725 | Pyridines |