Status:
COMPLETED
ORIENT: Olmesartan Reducing Incidence of End Stage Renal Disease in Diabetic Nephropathy Trial
Lead Sponsor:
Daiichi Sankyo Co., Ltd.
Conditions:
Diabetic Nephropathy
Type 2 Diabetes Mellitus
Eligibility:
All Genders
30-70 years
Phase:
PHASE3
Brief Summary
The purpose of the study is to evaluate the effectiveness and safety of olmesartan versus placebo on the progression of diabetic renal disease.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
577 Patients enrolled
Trial Details
Trial ID
NCT00141453
Start Date
April 1 2003
End Date
January 1 2009
Last Update
May 10 2011
Active Locations (2)
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1
Hong Kong, China
2
Tokyo, Japan