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

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01271374

Acronym

AMORE

Enrollment

Registered

2011-01-06

Start date

2010-04-30

Completion date

2011-12-31

Last updated

2011-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

African American, Hypertension, Cardiometabolic Syndrome

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.

Interventions

DRUGamlodipine 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

DRUGlosartan 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026