The purpose of the study is to evaluate the effectiveness and safety of olmesartan versus placebo on the progression of diabetic renal disease.

Condition	Intervention	Phase
Diabetic Nephropathy type 2 diabeted mellitus Proteinuria	Drug: olmesartan medoxomil	Phase IV

Further Study Details: 

Primary Outcomes: 1.First occurrence of any of the folllwing events:; Doubling of serum creatinine level; End stage renal disease; Death; 2. Safety
Secondary Outcomes: 1. First occurrence of any of the following:; Cardiovascular death; non-fatal stroke; non-fatal myocardial infarction; hospitalization for unstable angina; hospitalization for heart failure; coronary/carotid/periperal revascularization; lower extremity amputation; 2. change in proteinuria; 3. reciprocal of serum creatinine
Expected Total Enrollment:  400

Ages Eligible for Study:  30 Years   -   70 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• clinical diagnonsis of diabetic nehropathy in patients with type 2 diabetes
• albumin-to-creatinine ratio >= 300 mg/g creatinine in first morning uranalysis
• serum creatinine between 1.0 and 2.5 mg/dL in women and between 1.2 and 2.5 mg/dL in men

Exclusion Criteria:

• type 1 diabetes
• non-diabetic nephropathy
• history of myocardial infarction
• history of cardic bypass grafting within 3 months
• history of percutaneous coronary intervention (PCI)within 6 months
• history of carotid artery or peripheral artery revascularization within 6 months
• stroke or transient ischemic attack (TIA) within 1 year
• unstable angina pectoris
• heart failure of NYHA functional classes III or IV
• rapid progression of kindney disease within 3 months
• severe orthostatic hypotension
• serum potassium level=<3.5 mEq(mmol)/L or =>5.5 mEq(mmol)L
• history of rapid elevation of the serum creatinine level after starting treatment with AII receptor antagonists or ACE inhibitors
• poor glycemic control: HbA1c level =>11%

China
      Hong Kong,  China
Japan
      Tokyo,  Japan

Study chairs or principal investigators

Hirofumi Makino, MD,  Study Chair,  Dept. of Medicine, Okayama University   

Study ID Numbers:  ORIENT
Last Updated:  August 31, 2005
Record first received:  August 31, 2005
ClinicalTrials.gov Identifier:  NCT00141453
Health Authority: Japan: Ministry of Health, Labor and Welfare; Hong Kong: Department of Health
ClinicalTrials.gov processed this record on 2005-09-13