Study of Olmesartan Medoxomil (CS-866) in Patients With Chronic Glomerulonephritis or Diabetic Nephropathy
Phase 2
Completed
- Conditions
- Chronic GlomerulonephritisDiabetic Nephropathy
- Interventions
- Registration Number
- NCT00914524
- Lead Sponsor
- Daiichi Sankyo Co., Ltd.
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 49
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment olmesartan medoxomil 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.
- Primary Outcome Measures
Name Time Method The change in the urinary protein/creatinine ratio from baseline to the end of treatment. baseline to 16 weeks
- Secondary Outcome Measures
Name Time Method The change of creatinine clearance baseline to 16 weeks