Back to resultsStudy of Olmesartan Medoxomil (CS-866) in Patients With Chronic Glomerulonephritis or Diabetic Nephropathy
Primary Purpose
Chronic Glomerulonephritis, Diabetic Nephropathy
Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
olmesartan medoxomil
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Glomerulonephritis focused on measuring Chronic Glomerulonephritis, Diabetic Nephropathy, Angiotensin II Receptor Blocker, Urinary Protein
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment
Arm Description
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.
Outcomes
Primary Outcome Measures
The change in the urinary protein/creatinine ratio from baseline to the end of treatment.
Secondary Outcome Measures
The change of creatinine clearance
Full Information
NCT ID
NCT00914524
First Posted
June 3, 2009
Last Updated
September 28, 2010
Sponsor
Daiichi Sankyo Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT00914524
Brief Title
Study of Olmesartan Medoxomil (CS-866) in Patients With Chronic Glomerulonephritis or Diabetic Nephropathy
Official Title
An Open-label Study of Olmesartan Medoxomil (CS-866) in Normotensive Patients With Chronic Glomerulonephritis or Diabetic Nephropathy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
April 2006 (Actual)
Study Completion Date
October 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Daiichi Sankyo Co., Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Glomerulonephritis, Diabetic Nephropathy
Keywords
Chronic Glomerulonephritis, Diabetic Nephropathy, Angiotensin II Receptor Blocker, Urinary Protein
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
olmesartan medoxomil
Intervention Description
olmesartan medoxomil tablets, once daily
Primary Outcome Measure Information:
Title
The change in the urinary protein/creatinine ratio from baseline to the end of treatment.
Time Frame
baseline to 16 weeks
Secondary Outcome Measure Information:
Title
The change of creatinine clearance
Time Frame
baseline to 16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
City
Tokyo
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Study of Olmesartan Medoxomil (CS-866) in Patients With Chronic Glomerulonephritis or Diabetic Nephropathy
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