NCT00914524

Study of Olmesartan Medoxomil (CS-866) in Patients With Chronic Glomerulonephritis or Diabetic Nephropathy

An Open-label Study of Olmesartan Medoxomil (CS-866) in Normotensive Patients With Chronic Glomerulonephritis or Diabetic Nephropathy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Daiichi Sankyo Co., Ltd. · Industry
• Sex: All
• Age: 20 Years – 70 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Chronic Glomerulonephritis
• Diabetic Nephropathy

Interventions

Type	Name	Description
DRUG	olmesartan medoxomil	olmesartan medoxomil tablets, once daily

Timeline

• Start date: 2005-01-01
• Primary completion: 2006-04-01
• Completion: 2006-10-01
• First posted: 2009-06-05
• Last updated: 2010-09-29

Locations

1 site across 1 country: Japan