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To test the efficacy and safety of olmesartan in patients with essential hypertension.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Placebo Comparator | 2 week placebo run-in |
|
| 2 | Experimental | Olmesartan medoxomil tablets for 8 weeks |
|
| 3 | Experimental | Olmesartan medoxomil tablets, or olmesartan medoxomil tablets + hydrochlorothiazide tablets for 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| placebo | Other | Placebo oral tablets for 2 weeks |
| |
| olmesartan medoxomil |
| Measure | Description | Time Frame |
|---|---|---|
| To compare the efficacy on diastolic blood pressure of 40 mg olmesartan to a combination of 20 mg olmesartan and 12.5 mg hydrochlorothiazide in patients who are not sufficiently responding to treatment with 20 mg olmesartan. | From week 8 to week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the effects on systolic and diastolic blood pressure of 20 mg olmesartan, 40 mg olmesartan and the combination of 20 mg olmesartan with 12.5 mg hydrochlorothiazide at week 2, 4, 8 and 12. | 12 weeks | |
| To detect less frequent adverse drug reactions and assess the safety and tolerability of olmesartan. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Prof. Michael Bohm, MD | Universitatskliniken des Saarlandes, Homburg, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Result Cro | Vienna | 1130 | Austria | |||
| INPUT GmbG |
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| 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 |
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| Drug |
olmesartan medoxomil oral tablets for 8 weeks |
|
| olmesartan medoxomil oral tablets, hydrochlorothiazide oral tablets | Drug | olmesartan medoxomil oral tablets,or olmesartan medoxomil oral tablets + hydrochlorothiazide oral tablets |
|
| 12 weeks |
| Aachen |
| 52074 |
| Germany |
| Biokos Farma s.r.l. | Bologna | 40122 | Italy |
| IMRO TRAMARKO International bv | Berghem | 5352 | Netherlands |
| EUROTRIALS Lda | Lisbon | 1070-274 | Portugal |
| Phidea S.L. | Madrid | 28002 | Spain |
| PFC Pharma Focus Consultants AG | Zurich | Volketswil | 8604 | Switzerland |
| Inveresk Ltd. | Edinburgh | United Kingdom |
| 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 |