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

Daiichi Sankyo

Status and phase: Completed; Phase 3

Conditions: Diabetic Nephropathy; Proteinuria; Type 2 Diabetes Mellitus

Treatments: Drug: olmesartan medoxomil; Drug: Placebo Tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT00141453

ORIENT

Details and patient eligibility

About

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

Enrollment: 577 patients

Sex: All

Ages: 30 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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577 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

Olmesartan medoxomil tablets 10mg to 40 mg

Treatment:

Drug: olmesartan medoxomil

2

Placebo Comparator group

Description:

Matching placebo tablets

Treatment:

Drug: Placebo Tablets