The purpose of the study is to evaluate the effectiveness and safety of olmesartan versus placebo on the progression of diabetic renal disease.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
577
Tablets 10, 20, or 40 mg
Matching placebo tablets
Unnamed facility
Hong Kong, China
Unnamed facility
Tokyo, Japan
Renal Composite Outcomes
first occurrence of any of the following events: Doubling of serum creatinine level; Death; End stage renal disease
Time frame: Randomization to 5 years
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.
Time frame: Within 5 years
The Change in Proteinuria
The median percentage change from baseline value in urinary protein:creatinine ratio
Time frame: Randomization to 5 years
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.
Time frame: Randomization to 5 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.