Trial | NCT01271374  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    80
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.
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.
Study Started
Apr 30
2010
Primary Completion
Jun 30
2011
Anticipated
Study Completion
Dec 31
2011
Anticipated
Last Update
May 05
2011
Estimate

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

  • Other names: Azor, Hydrochlorothiazide, Spironoloactone

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

  • Other names: Hyzaar, Azor, Hydrochlorothiazide, Spironolactone

Hyzaar-Treatment Arm B Active Comparator

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 Active Comparator

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

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.
No Results Posted