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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by InVasc Therapeutics, Inc..
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
InVasc Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01271374
First received: January 5, 2011
Last updated: May 4, 2011
Last verified: May 2011
History of Changes
  Purpose

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 Intervention Phase
Hypertension
 Drug: amlodipine and olmesartan
Drug: losartan and HCTZ
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by InVasc Therapeutics, Inc.:

Primary Outcome Measures:
  • Change in Central Aortic Pressure (CAP) [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
    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:
  • Blood pressure control [ Time Frame: 25 weeks ] [ Designated as safety issue: No ]
    Secondary endpoints of percentage of subjects achieving BP goals will be analyzed using Cochran-Mentel-Haenzsel test.


Estimated Enrollment: 80
Study Start Date: April 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Bobby Khan, MD PhD, Atlanta Clinical Research Center
ClinicalTrials.gov Identifier: NCT01271374     History of Changes
Other Study ID Numbers: AVR-2010-001
Study First Received: January 5, 2011
Last Updated: May 4, 2011
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Hydrochlorothiazide
Spironolactone
Olmesartan medoxomil
Amlodipine
Losartan
Olmesartan
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Sodium Chloride Symporter Inhibitors
 Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Aldosterone Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Calcium Channel Blockers
Vasodilator Agents
Anti-Arrhythmia Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on May 19, 2013