Changes in Endothelial Function and Biomarkers in African Americans (AA) With Metabolic Syndrome
NCT ID: NCT01271374
Last Updated: 2011-05-05
Study Results
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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UNKNOWN
PHASE4
80 participants
INTERVENTIONAL
2010-04-30
2011-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
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
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
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
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
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
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* use of insulin
* non-dominant arm circ \> 50 cm.
18 Years
75 Years
ALL
Yes
Sponsors
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InVasc Therapeutics, Inc.
INDUSTRY
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
Countries
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Other Identifiers
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AVR-2010-001
Identifier Type: -
Identifier Source: org_study_id
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