ORIENT: Olmesartan Reducing Incidence of End Stage Renal Disease in Diabetic Nephropathy Trial

• Status: Completed
• Trial end date: 2009-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daiichi Sankyo Co., Ltd.
• Treatments: Olmesartan; Olmesartan Medoxomil

Criteria

Inclusion Criteria:

• clinical diagnosis of diabetic nephropathy in patients with type 2 diabetes

• albumin-to-creatinine ratio >= 300 mg/g creatinine in first morning urinalysis

• 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 cardiac 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 kidney 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%

• history of myocardial infarction (MI) or coronary artery bypass grafting (CABG) within 3 months