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

NCT ID: NCT01271374

Last Updated: 2011-05-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2011-12-31

Brief Summary

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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

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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.

Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Hyzaar-Treatment Arm B

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

Group Type ACTIVE_COMPARATOR

losartan and HCTZ

Intervention Type DRUG

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

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

Group Type ACTIVE_COMPARATOR

amlodipine and olmesartan

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

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

Intervention Type DRUG

Other Intervention Names

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Azor Hydrochlorothiazide Spironoloactone Hyzaar Azor Hydrochlorothiazide Spironolactone

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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InVasc Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Atlanta Clinical Research Center

Principal Investigators

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Bobby V Khan, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Director, Atlanta Clinical Research Centers

Keith C Ferdinand, MD

Role: STUDY_DIRECTOR

Atlanta Clinical Research Centers

Locations

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Atlanta Clinical Research Center

Tucker, Georgia, United States

Site Status

Countries

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United States

Other Identifiers

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AVR-2010-001

Identifier Type: -

Identifier Source: org_study_id

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