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To evaluate the efficacy of long-term treatment of individually optimized doses of olmesartan medoxomil compared to nitrendipine in elderly and very elderly patients with isolated systolic hypertension. The study hypothesis is non-inferiority of olmesartan medoxomil compared to nitrendipine in lowering mean sitting systolic blood pressure after 12 weeks of treatment compared to baseline. The study duration is up to 32 weeks, including a 24-week treatment period. After 12 weeks hydrochlorothiazide may be added to control blood pressure. Efficacy and safety measurements are carried out at up to 15 visits during the trial period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | oral olmesartan medoxomil tablets 20 mg or 40 mg once daily for 24 weeks + oral hydrochlorothiazide tablets 12.5 or 25 mg once daily after 12 weeks, if needed to controll BP |
|
| 2 | Active Comparator | oral nitrendipine tablets 10 or 20 mg taken twice daily for 24 weeks + oral hydrochlorothiazide tablets 12.5 or 25 mg once daily after 12 weeks, if needed to control BP |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| olmesartan medoxomil + hydrochlorothiazide, if necessary | Drug | oral olmesartan medoxomil tablets 20 mg or 40 mg once daily for 24 weeks + oral hydrochlorothiazide tablets 12.5 or 25 mg once daily after 12 weeks, if needed to control BP |
| Measure | Description | Time Frame |
|---|---|---|
| Change in mean sitting systolic blood pressure as assessed by conventional BP measurements | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in mean sitting systolic blood pressure assessed by conventional BP measurements | After 1, 2, 4, 8, 12, 16, 20, and 24 weeks | |
| Change in mean standing systolic BP, mean sitting diastolic BP and mean standing diastolic BP | after 1, 2, 4, 8, 12, 16, 20, and 24 weeks of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter U Witte, MD, Ph.D. | IMFORM GmbH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Munich | Germany |
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| ID | Term |
|---|---|
| D000092244 | Isolated Systolic Hypertension |
| ID | Term |
|---|---|
| D000075222 | Essential Hypertension |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000068557 | Olmesartan Medoxomil |
| D006852 | Hydrochlorothiazide |
| D009568 | Nitrendipine |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| nitrendipine + hydrochlorothiazide, if necessary | Drug | oral nitrendipine tablets 10 or 20 mg taken twice daily for 24 weeks + oral hydrochlorothiazide tablets 12.5 or 25 mg once daily after 12 weeks, if needed to control BP |
|
| 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 |