Chronic Glomerulonephritis, Diabetic Nephropathy
Conditions
Keywords
Chronic Glomerulonephritis, Diabetic Nephropathy, Angiotensin II Receptor Blocker, Urinary Protein
Brief summary
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).
Interventions
DRUGolmesartan medoxomil
olmesartan medoxomil tablets, once daily
Sponsors
Daiichi Sankyo Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* urinary protein/creatinine ratio in the 0.50 g/g to 3.50 g/g creatinine range * normal sitting blood pressure values: systolic blood pressure of 100 mmHg or above but below 140 mmHg; diastolic blood pressure of 50 mmHg or above but less than 90 mmHg
Exclusion criteria
* treatment with corticosteroids or immunosuppressants * treatment with antihypertensives (other than ARBs and ACE inhibitors) * serum potassium level of 5.5 mEq/l or above * serum creatinine level of 2.0 mg/dl or above
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in the urinary protein/creatinine ratio from baseline to the end of treatment. | baseline to 16 weeks |
Secondary
| Measure | Time frame |
|---|---|
| The change of creatinine clearance | baseline to 16 weeks |
Countries
Japan
Outcome results
None listed