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

InVasc Therapeutics

Status and phase: Unknown; Phase 4

Conditions: Hypertension

Treatments: Drug: losartan and HCTZ; Drug: amlodipine and olmesartan

Study type: Interventional

Funder types: Industry

Identifiers

NCT01271374

AVR-2010-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Hyzaar-Treatment Arm B

Active Comparator group

Description:

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

Treatment:

Drug: losartan and HCTZ

Azor-Treatment A

Active Comparator group

Description:

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

Treatment:

Drug: amlodipine and olmesartan