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

Daiichi Sankyo Co., Ltd.49 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Glomerulonephritis Diabetic Nephropathy

Interventions

olmesartan medoxomilDRUG

olmesartan medoxomil tablets, once daily

Eligibility

Sex: ALLMin age: 20 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Tokyo, Japan

Outcomes

Primary Outcomes

The change in the urinary protein/creatinine ratio from baseline to the end of treatment.

Time frame: baseline to 16 weeks

Secondary Outcomes

The change of creatinine clearance

Time frame: baseline to 16 weeks

Data from ClinicalTrials.gov

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