Status:
COMPLETED
Study of Olmesartan Medoxomil (CS-866) in Patients With Chronic Glomerulonephritis or Diabetic Nephropathy
Lead Sponsor:
Daiichi Sankyo Co., Ltd.
Conditions:
Chronic Glomerulonephritis
Diabetic Nephropathy
Eligibility:
All Genders
20-70 years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2006
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT00914524
Start Date
January 1 2005
End Date
October 1 2006
Last Update
September 29 2010
Active Locations (1)
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1
Tokyo, Japan