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

Primary Purpose

Hypertension

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
amlodipine and olmesartan
losartan and HCTZ
Sponsored by
InVasc Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring African American, Hypertension, Cardiometabolic Syndrome

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • Atlanta Clinical Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Hyzaar-Treatment Arm B

Azor-Treatment A

Arm 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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
January 5, 2011
Last Updated
May 4, 2011
Sponsor
InVasc Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01271374
Brief Title
Changes in Endothelial Function and Biomarkers in African Americans (AA) With Metabolic Syndrome
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Unknown status
Study Start Date
April 2010 (undefined)
Primary Completion Date
June 2011 (Anticipated)
Study Completion Date
December 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
InVasc Therapeutics, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
African American, Hypertension, Cardiometabolic Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hyzaar-Treatment Arm B
Arm Type
Active Comparator
Arm 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
Arm Title
Azor-Treatment A
Arm Type
Active Comparator
Arm 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
Intervention Type
Drug
Intervention Name(s)
amlodipine and olmesartan
Other Intervention Name(s)
Azor, Hydrochlorothiazide, Spironoloactone
Intervention 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
Intervention Type
Drug
Intervention Name(s)
losartan and HCTZ
Other Intervention Name(s)
Hyzaar, Azor, Hydrochlorothiazide, Spironolactone
Intervention 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
Primary Outcome Measure Information:
Title
Change in Central Aortic Pressure (CAP)
Description
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.
Time Frame
14 weeks
Secondary Outcome Measure Information:
Title
Blood pressure control
Description
Secondary endpoints of percentage of subjects achieving BP goals will be analyzed using Cochran-Mentel-Haenzsel test.
Time Frame
25 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bobby V Khan, MD, PhD
Organizational Affiliation
Director, Atlanta Clinical Research Centers
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Keith C Ferdinand, MD
Organizational Affiliation
Atlanta Clinical Research Centers
Official's Role
Study Director
Facility Information:
Facility Name
Atlanta Clinical Research Center
City
Tucker
State/Province
Georgia
ZIP/Postal Code
30084
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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