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The treatment period was 16 weeks, the initial dose, 5 mg, was unforcedly titrated to 10 mg, 20 mg and 40 mg after confirming tolerance at weeks 4, 8 and 12. The primary endpoint for efficacy was the change in the urinary protein/creatinine ratio from baseline to the end of treatment. The secondary endpoint was creatinine clearance (Ccr).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | 16 weeks of treatment starting with 5 mg of olmesartan medoxomil. If tolerated, the dose was increased to the next higher dose at weeks 4, 8, and 12. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| olmesartan medoxomil | Drug | olmesartan medoxomil tablets, once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| The change in the urinary protein/creatinine ratio from baseline to the end of treatment. | baseline to 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The change of creatinine clearance | baseline to 16 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tokyo | Japan |
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| ID | Term |
|---|---|
| D003928 | Diabetic Nephropathies |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D000068557 | Olmesartan Medoxomil |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D013777 |
| Tetrazoles |