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

Hypertension Clinical Trial

— AMORE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01271374
• Other study ID #: AVR-2010-001
• Status: Active, not recruiting
• Phase: Phase 4
• First received: January 5, 2011
• Last updated: May 4, 2011
• Start date: April 2010
• Est. completion date: December 2011

Study information

• Verified date: May 2011
• Source: InVasc Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: December 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• 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
• 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

Locations

Country	Name	City	State
United States	Atlanta Clinical Research Center	Tucker	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
InVasc Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Central Aortic Pressure (CAP)	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.	14 weeks	No
Secondary	Blood pressure control	Secondary endpoints of percentage of subjects achieving BP goals will be analyzed using Cochran-Mentel-Haenzsel test.	25 weeks	No