Diabetic Nephropathy Clinical Trial
Official title:
An Open-label Study of Olmesartan Medoxomil (CS-866) in Normotensive Patients With Chronic Glomerulonephritis or Diabetic Nephropathy
Verified date | September 2010 |
Source | Daiichi Sankyo Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | Japan: Ministry of Health, Labor and Welfare |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 49 |
Est. completion date | October 2006 |
Est. primary completion date | April 2006 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years to 70 Years |
Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Daiichi Sankyo Co., Ltd. |
Japan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The change in the urinary protein/creatinine ratio from baseline to the end of treatment. | baseline to 16 weeks | No | |
Secondary | The change of creatinine clearance | baseline to 16 weeks | No |
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