Changes in Endothelial Function and Biomarkers in African Americans (AA) With Metabolic Syndrome
Information source: InVasc Therapeutics, Inc.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
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
Summary
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.
Clinical Details
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.
Eligibility
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.
Locations and Contacts
Atlanta Clinical Research Center, Tucker, Georgia 30084, United States
Additional Information
Starting date: April 2010
Last updated: May 4, 2011
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