The purpose of the study is to compare the effects of Azor (a combination of amlodipine and olmesartan) with Hyzaar ( a combination of losartan and hydrochlorothiazide) on the thin lining on the inside of blood vessels. These cells help keep blood vessels healthy and blood pressure normal.
Participants must be 18-75 years of age, African American, and have a combination of high blood pressure, insulin resistance (Type 2 Diabetes), low HDL cholesterol levels or obesity.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Weeks 1-2: Azor® 5/20 Weeks 3-14: Azor® 10/40 Weeks 15-18: Azor® 10/40+HCTZ 25 Weeks 19-20: Azor® 10/40+HCTZ 25 + spironolactone 25 once daily
Weeks 1-2: Hyzaar® 50/12.5 Weeks 3-14: Hyzaar® 100/25 Weeks 15-18: Azor® 10/40+HCTZ 25 Weeks 19-20: Azor® 10/40+HCTZ 25 + spironolactone 25 once daily
Atlanta Clinical Research Center
Tucker, Georgia, United States
Change in Central Aortic Pressure (CAP)
The primary efficacy endpoints, defined as the change from baseline of Central Aortic Systolic Pressure (CAP) and the change in brachial artery reactivity (BART) via ultrasound testing, will be compared at the end of 14 weeks of randomized treatment.
Time frame: 14 weeks
Blood pressure control
Secondary endpoints of percentage of subjects achieving BP goals will be analyzed using Cochran-Mentel-Haenzsel test.
Time frame: 25 weeks
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