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

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ClinicalTrials.gov Identifier: NCT01271374
Recruitment Status : Unknown
Verified May 2011 by InVasc Therapeutics, Inc..
Recruitment status was:  Active, not recruiting
First Posted : January 6, 2011
Last Update Posted : May 5, 2011
Sponsor:
Information provided by:
InVasc Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE January 5, 2011
First Posted Date  ICMJE January 6, 2011
Last Update Posted Date May 5, 2011
Study Start Date  ICMJE April 2010
Estimated Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 5, 2011)
Change in Central Aortic Pressure (CAP) [ Time Frame: 14 weeks ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01271374 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 5, 2011)
Blood pressure control [ Time Frame: 25 weeks ]
Secondary endpoints of percentage of subjects achieving BP goals will be analyzed using Cochran-Mentel-Haenzsel test.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Changes in Endothelial Function and Biomarkers in African Americans (AA) With Metabolic Syndrome
Official Title  ICMJE Changes in Central Aortic Pressure, Endothelial Function and Biomarkers in African Americans With Cardiometabolic Syndrome: Comparison of Amlodipine/Olmesartan Versus Hydrochlorothiazide/Losartan
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hypertension
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: 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
    Intervention: Drug: losartan and HCTZ
  • Active Comparator: 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
    Intervention: Drug: amlodipine and olmesartan
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 5, 2011)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2011
Estimated Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01271374
Other Study ID Numbers  ICMJE AVR-2010-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bobby Khan, MD PhD, Atlanta Clinical Research Center
Study Sponsor  ICMJE InVasc Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Bobby V Khan, MD, PhD Director, Atlanta Clinical Research Centers
Study Director: Keith C Ferdinand, MD Atlanta Clinical Research Centers
PRS Account InVasc Therapeutics, Inc.
Verification Date May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP