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

Diabetic Nephropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00914524
• Other study ID #: CS0866-C-J201
• Status: Completed
• Phase: Phase 2
• First received: June 3, 2009
• Last updated: September 28, 2010
• Start date: January 2005
• Est. completion date: October 2006

Study information

• 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

Clinical Trial 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).

Recruitment information / eligibility

• 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Disease
• Chronic Glomerulonephritis
• Diabetic Nephropathies
• Diabetic Nephropathy
• Glomerulonephritis
• Kidney Diseases

Intervention

Drug:
• olmesartan medoxomil
olmesartan medoxomil tablets, once daily

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Daiichi Sankyo Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

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