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This is a study in hypertensive patients with mild to moderate renal impairment. The antihypertensive efficacy of olmesartan medoxomil is compared to losartan.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Olmesartan medoxomil | Experimental | Olmesartan oral tablets 20 mg or 40 mg + losartan placebo. Medications are taken once daily before breakfast with water. |
|
| Losartan | Experimental | Losartan over encapsulated tablets 50 mg and 100 mg plus olmesartan placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olmesartan medoxomil | Drug | Olmesartan oral tablets 20 or 40 mg + losartan placebo. Medications are taken once daily before breakfast with water. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in mean sitting diastolic blood pressure (dBP), assessed by conventional blood pressure measurements after 12 weeks of treatment | Baseline to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in mean sitting diastolic blood pressure, assessed by conventional blood pressure measurements after 1, 2, 3, 8, 18, 24, 30, 36, 44 and 52 weeks of treatment; | Baseline to 1, 2, 3, 8, 18, 24, 30, 36, 44 and 52 weeks | |
| Change in mean sitting systolic blood pressure, assessed by conventional blood pressure measurements after 1, 2, 3, 8, 18, 24, 30, 36, 44 and 52 weeks of treatment; |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| P. U. Witte, MD, PhD | IMFORM GmbH, Darmstadt, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Darmstadt | Germany |
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| ID | Term |
|---|---|
| D000075222 | Essential Hypertension |
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007674 | Kidney Diseases |
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| ID | Term |
|---|---|
| D000068557 | Olmesartan Medoxomil |
| D019808 | Losartan |
| D005665 | Furosemide |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Losartan | Drug | Medications are taken once daily before breakfast with water. |
|
| Furosemide oral tablets | Drug | If its use is necessary, the dose of furosemide allowed is 20 to 120 mg per day at the discretion of the investigator |
|
| Baseline to 1, 2, 3, 8, 18, 24, 30, 36, 44 and 52 weeks |
| Response to treatment after 1, 2, 4, 8, 12, 18, 24, 30, 36, 44 and 52 weeks of treatment; | Response to treatment = mean sitting diastolic blood pressure less than or equal to 90 mmHg or reduction greater than or equal to 10 mmHg | Baseline to 1, 2, 4, 8, 12, 18, 24, 30, 36, 44 and 52 weeks |
| Changes in creatinine clearance after 12 and 52 weeks of treatment, changes in proteinuria after 4, 12, 24, 36 and 52 weeks of treatment; | Baseline to 12 and 52 weeks |
| Changes in serum creatinine after 12 and 52 weeks of treatment | Baseline to 12 and 52 weeks |
| Rate of patients per dose level after 12 and 52 weeks of treatment | Baseline to 12 and 52 weeks |
| Change in proteinuria after 4, 12, 24, 36 and 52 weeks of treatment | Baseline to 4, 12, 24, 36 and 52 weeks |
| D014570 |
| Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D013777 |
| Tetrazoles |
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D013424 | Sulfanilamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |