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

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).

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Key information

Conditions

Chronic Glomerulonephritis Diabetes Complications Diabetes Mellitus Diabetic Nephropathies Diabetic Nephropathy Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Urogenital Diseases Urologic Diseases

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Tokyo, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

olmesartan medoxomil

Drug

olmesartan medoxomil tablets, once daily

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

Sponsors and collaborators

Lead sponsor

Daiichi Sankyo Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start: 2005
Primary completion: 2006
Study completion: 2006
First posted: Jun 5, 2009
Registry last updated: Sep 29, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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