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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:
Sponsor: Daiichi Sankyo Co., Ltd.

Current Primary Outcome: The change in the urinary protein/creatinine ratio from baseline to the end of treatment. [ Time Frame: baseline to 16 weeks ]

Original Primary Outcome: The change in the urinary protein/creatinine ratio from baseline to the end of treatment. [ Time Frame: 16 weeks ]

Current Secondary Outcome: The change of creatinine clearance [ Time Frame: baseline to 16 weeks ]

Original Secondary Outcome: The change of creatinine clearance [ Time Frame: 4, 8, and 16 weeks ]

Information By: Daiichi Sankyo Inc.

Dates:
Date Received: June 3, 2009
Date Started: January 2005
Date Completion:
Last Updated: September 28, 2010
Last Verified: September 2010