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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.

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.

Condition or disease Intervention/treatment Phase
Hypertension Drug: amlodipine and olmesartan Drug: losartan and HCTZ Phase 4

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : April 2010
Estimated Primary Completion Date : June 2011
Estimated Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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
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
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
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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Blood pressure control [ Time Frame: 25 weeks ]
    Secondary endpoints of percentage of subjects achieving BP goals will be analyzed using Cochran-Mentel-Haenzsel test.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01271374


Locations
United States, Georgia
Atlanta Clinical Research Center
Tucker, Georgia, United States, 30084
Sponsors and Collaborators
InVasc Therapeutics, Inc.
Investigators
Principal Investigator: Bobby V Khan, MD, PhD Director, Atlanta Clinical Research Centers
Study Director: Keith C Ferdinand, MD Atlanta Clinical Research Centers

Responsible Party: Bobby Khan, MD PhD, Atlanta Clinical Research Center
ClinicalTrials.gov Identifier: NCT01271374     History of Changes
Other Study ID Numbers: AVR-2010-001
First Posted: January 6, 2011    Key Record Dates
Last Update Posted: May 5, 2011
Last Verified: May 2011

Keywords provided by InVasc Therapeutics, Inc.:
African American
Hypertension
Cardiometabolic Syndrome

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Olmesartan
Amlodipine
Losartan
Hydrochlorothiazide
Olmesartan Medoxomil
Amlodipine Besylate, Olmesartan Medoxomil Drug Combination
Spironolactone
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Anti-Arrhythmia Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Diuretics, Potassium Sparing