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Effectiveness of Avapro in Obese Normotensive/Hypertensive African Americans (Avapro3)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02386293
Recruitment Status : Unknown
Verified June 2019 by Gregory Harshfield, Augusta University.
Recruitment status was:  Recruiting
First Posted : March 11, 2015
Last Update Posted : June 21, 2019
Sponsor:
Information provided by (Responsible Party):
Gregory Harshfield, Augusta University

Brief Summary:
The purpose of this study is to test the hypothesis that hypertension increases the anti-natriuretic effects of an angiotensin receptor antagonist during mental stress in overweight/obese African-American's who retain sodium during mental stress.

Condition or disease Intervention/treatment Phase
Hypertension Obesity Stress, Psychological Blood Pressure Drug: Irbesartan Other: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effectiveness of Avapro in the Treatment of Salt Sensitivity in Both Normotensive and Untreated Hypertensive Obese African Americans: A Randomized Double Blind Placebo Controlled Trial
Actual Study Start Date : April 2014
Estimated Primary Completion Date : November 30, 2019
Estimated Study Completion Date : November 30, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Irbesartan

Arm Intervention/treatment
Placebo Comparator: Placebo
Sugar pill identical to Avapro provided for 7 day prescription
Other: Placebo
Sugar pill made to look identical to irbesartan intervention.

Active Comparator: Irbesartan
150 mg of Avapro once daily for 7 days.
Drug: Irbesartan
Double blind placebo controlled cross over trial to determine effectiveness of an angiotensin receptor blocker in obese hypertensive African American patients.
Other Name: Avapro




Primary Outcome Measures :
  1. Urinary sodium excretion rate [ Time Frame: 2 hours ]
    primary variable of interest is the difference in stress induced changes in sodium excretion between placebo and treatment conditions in obese normotensives versus non-obese hypertensives.


Secondary Outcome Measures :
  1. Hemodynamics [ Time Frame: 2 hours ]
    measures of change in systolic blood pressure compared to changes in sodium excretion in treatment versus placebo in obese normotensives versus non-obese hypertensives.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • of good general health
  • not on any prescription medications
  • between the ages of 18 and 50
  • not pregnant

Exclusion Criteria:

  • not African-American
  • pregnant
  • taking medications that will affect my blood pressure

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): NCT02386293


Contacts
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Contact: Sandra Young-Mayes, BS 7067217698 syoungmayes@augusta.edu
Contact: Michelle Brown, MS 7067219893 mibrown1@augusta.edu

Locations
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United States, Georgia
Augusta University Recruiting
Augusta, Georgia, United States, 30912
Contact: Sandra Young-Mayes, BS    706-721-7698    syoungmayes@augusta.edu   
Contact: Michelle Brown, MS    7067219893    mibrown1@augusta.edu   
Principal Investigator: Gregory A Harshfield, PhD         
Sub-Investigator: Ryan A Harris, PhD         
Sub-Investigator: Yanbin Dong, MD, PhD         
Sponsors and Collaborators
Augusta University
Investigators
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Principal Investigator: Gregory A Harshfield, PhD Augusta University
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Responsible Party: Gregory Harshfield, Director, Augusta University
ClinicalTrials.gov Identifier: NCT02386293    
Other Study ID Numbers: 611881
First Posted: March 11, 2015    Key Record Dates
Last Update Posted: June 21, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Dissemination will be carried out in a variety of ways that will be accessible to other scientists studying psychosocial stress, hypertension, and the control of fluid-electrolyte balance and blood pressure. These include publications made available through PubMed-cited journals and presentations at scientific meetings and various organizations.
Supporting Materials: Study Protocol
Additional relevant MeSH terms:
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Stress, Psychological
Behavioral Symptoms
Irbesartan
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action