Primary Objective: To evaluate the effect of irbesartan/atorvastatin fixed-dose combination comparing to each irbesartan and atorvastatin on flow mediated dilation change in type 2 diabetic patients diagnosed with hyperlipidemia, hypertension. Secondary Objective: To evaluate efficacy of blood pressure and hyperlipidemic factors of irbesartan/atorvastatin fixed-dose combination in type 2 diabetic patients diagnosed with hyperlipidemia and hypertension, with adequately controlled blood glucose levels in groups.
The total study duration per patient is up to maximum of 7 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
11
Pharmaceutical form:Tablet Route of administration: Oral
Pharmaceutical form:Tablet Route of administration: Oral
Pharmaceutical form:Tablet Route of administration: Oral
Korea
Seoul, South Korea
Change from baseline in flow mediated dilatation
Time frame: 4 weeks, up to maximum 5 weeks
Rate of change from baseline in nytrotyrosine marker
Time frame: 4 weeks, up to maximum 5 weeks
Rate of change from baseline in Intercellular Adhesion Molecule-1
Time frame: 4 weeks, up to maximum 5 weeks
Rate of change from baseline in Interleukin-6
Time frame: 4 weeks, up to maximum 5 weeks
Rate of change from baseline in C-reactive protein
Time frame: 4 weeks, up to maximum 5 weeks
Change from baseline in blood pressure (irbesartan/atorvastatin fixed-dose combination group and irbesartan group)
Time frame: 4 weeks, up to maximum 5 weeks
Change from baseline in low density lipoprotein-C (irbesartan/atorvastatin fixed-dose combination group and atorvastatin group)
Time frame: 4 weeks, up to maximum 5 weeks
Change from baseline in total cholesterol (irbesartan/atorvastatin fixed-dose combination group and atorvastatin group)
Time frame: 4 weeks, up to maximum 5 weeks
Change from baseline in high density lipoprotein-C (irbesartan/atorvastatin fixed-dose combination group and atorvastatin group)
Time frame: 4 weeks, up to maximum 5 weeks
Change from baseline in triglycerides (irbesartan/atorvastatin fixed-dose combination group and atorvastatin group)
Time frame: 4 weeks, up to maximum 5 weeks
Change from baseline in apolipoprotein-A1 (irbesartan/atorvastatin fixed-dose combination group and atorvastatin group)
Time frame: 4 weeks, up to maximum 5 weeks
Change from baseline in apolipoprotein-B (irbesartan/atorvastatin fixed-dose combination group and atorvastatin group) - Time Frame: 4 weeks, up to maximum 5 weeks
Time frame: 4 weeks, up to maximum 5 weeks
Percentage of participants with decreased level of blood pressure (irbesartan/atorvastatin fixed-dose combination group and irbesartan group)
Time frame: 4 weeks, up to maximum 5 weeks
Rate of change from baseline in immunosenescence T cell fractionation
Time frame: 4 weeks, up to maximum 5 weeks
Rate of change from baseline in T-cell induced inflammatory factors
Time frame: 4 weeks, up to maximum 5 weeks
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