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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

CS-866DM Phase 3 Clinical Study: A Double-Blind Controlled Trial in Patients With Diabetic Nephropathy and Overt Proteinuria Secondary to Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00141453
• Other study ID #: ORIENT
• Status: Completed
• Phase: Phase 3
• First received: August 31, 2005
• Last updated: May 9, 2011
• Start date: April 2003
• Est. completion date: January 2009

Study information

• Verified date: May 2011
• Source: Daiichi Sankyo Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and WelfareHong Kong: Department of Health
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 577
• Est. completion date: January 2009
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetic Nephropathies
• Diabetic Nephropathy
• Kidney Diseases
• Kidney Failure, Chronic
• Proteinuria
• Type 2 Diabetes Mellitus

Intervention

Drug:
• olmesartan medoxomil
Tablets 10, 20, or 40 mg
• Placebo Tablets
Matching placebo tablets

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Daiichi Sankyo Co., Ltd.

Countries where clinical trial is conducted

China,  Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Renal Composite Outcomes	first occurrence of any of the following events: Doubling of serum creatinine level; Death; End stage renal disease	Randomization to 5 years	No
Secondary	Number of Participants Experiencing Cardiovascular Composite Outcomes	Number of participants experiencing the first occurence of any of the following: Cardiovascular death; non-fatal stroke; non-fatal myocardial infarction; hospitalization for unstable angina; lower extremity amputation; coronary/carotid/peripheral revascularization.	Within 5 years	No
Secondary	The Change in Proteinuria	The median percentage change from baseline value in urinary protein:creatinine ratio	Randomization to 5 years	No
Secondary	Reciprocal (1/Serum Creatinine) of Serum Creatinine	The amount of serum creatinine was determined by blood tests periodically during the study. The amount of creatinine is an indication of kidney function. The reciprocal of serum creatinine is used in an equation to determine the change in kidney function from baseline. The reciprocal of the serum creatinine was monitored to detect kidney function changes over duration of the study.	Randomization to 5 years	No