Changes in Endothelial Function and Biomarkers in African Americans (AA) With Metabolic Syndrome
This trial is active, not recruiting.
|Treatments||amlodipine and olmesartan, losartan and hctz|
|Sponsor||InVasc Therapeutics, Inc.|
|Start date||April 2010|
|End date||June 2011|
|Trial size||80 participants|
|Trial identifier||NCT01271374, AVR-2010-001|
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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
Change in Central Aortic Pressure (CAP)
time frame: 14 weeks
Blood pressure control
time frame: 25 weeks
Male or female participants from 18 years up to 75 years old.
Inclusion Criteria: - African American - Hypertension and one of the following: - Fasting glucose > 100 mg/dl - HgA1C> 6.0 % - Plasma triglycerides >150 - HDL cholesterol < 40 mg/dl in men or < 50 mg/dl in women Exclusion Criteria: - History of Heart failure - use of insulin - non-dominant arm circ > 50 cm.
|Official title||Changes in Central Aortic Pressure, Endothelial Function and Biomarkers in African Americans With Cardiometabolic Syndrome: Comparison of Amlodipine/Olmesartan Versus Hydrochlorothiazide/Losartan|
|Principal investigator||Bobby V Khan, MD, PhD|
|Description||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.|
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