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

Phase 4

• Conditions: Hypertension
• Interventions: Drug: losartan and HCTZ; Drug: amlodipine and olmesartan

• Registration Number: NCT01271374
• Lead Sponsor: InVasc Therapeutics, Inc.

Brief 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.

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.

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2011-01-05
• Study First Submitted QC: 2011-01-05
• Study First Posted: 2011-01-06
• Status Verified: 2011-05
• Last Update Submitted: 2011-05-04
• Last Update Posted: 2011-05-05
• Primary Completion: 2011-06
• Study Completion: 2011-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

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Exclusion Criteria

• History of Heart failure
• use of insulin
• non-dominant arm circ > 50 cm.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hyzaar-Treatment Arm B	losartan and HCTZ	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
Azor-Treatment A	amlodipine and olmesartan	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

Primary Outcome Measures

Name	Time	Method
Change in Central Aortic Pressure (CAP)	14 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Blood pressure control	25 weeks	Secondary endpoints of percentage of subjects achieving BP goals will be analyzed using Cochran-Mentel-Haenzsel test.

Trial Locations

Locations (1)

Atlanta Clinical Research Center; 🇺🇸 Tucker, Georgia, United States