Changes in Endothelial Function and Biomarkers in African Americans (AA) With Metabolic Syndrome

Condition(s) targeted: Hypertension

Intervention: amlodipine and olmesartan (Drug); losartan and HCTZ (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: InVasc Therapeutics, Inc.

Official(s) and/or principal investigator(s):
Bobby V Khan, MD, PhD, Principal Investigator, Affiliation: Director, Atlanta Clinical Research Centers
Keith C Ferdinand, MD, Study Director, Affiliation: Atlanta Clinical Research Centers

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.

Official title: Changes in Central Aortic Pressure, Endothelial Function and Biomarkers in African Americans With Cardiometabolic Syndrome: Comparison of Amlodipine/Olmesartan Versus Hydrochlorothiazide/Losartan

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Change in Central Aortic Pressure (CAP)

Secondary outcome: Blood pressure control

Detailed 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.

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

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.

Atlanta Clinical Research Center, Tucker, Georgia 30084, United States

Starting date: April 2010
Last updated: May 4, 2011