Effectiveness of Avapro in Obese Normotensive/Hypertensive African Americans
Avapro3
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
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 hypertension
Started Apr 2014
Longer than P75 for phase_2 hypertension
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2014
CompletedFirst Submitted
Initial submission to the registry
March 3, 2015
CompletedFirst Posted
Study publicly available on registry
March 11, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2019
CompletedJune 21, 2019
June 1, 2019
5.7 years
March 3, 2015
June 19, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Urinary sodium excretion rate
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.
2 hours
Secondary Outcomes (1)
Hemodynamics
2 hours
Study Arms (2)
Placebo
PLACEBO COMPARATORSugar pill identical to Avapro provided for 7 day prescription
Irbesartan
ACTIVE COMPARATOR150 mg of Avapro once daily for 7 days.
Interventions
Double blind placebo controlled cross over trial to determine effectiveness of an angiotensin receptor blocker in obese hypertensive African American patients.
Eligibility Criteria
You may qualify if:
- of good general health
- not on any prescription medications
- between the ages of 18 and 50
- not pregnant
You may not qualify if:
- not African-American
- pregnant
- taking medications that will affect my blood pressure
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Augusta University
Augusta, Georgia, 30912, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gregory A Harshfield, PhD
Augusta University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director
Study Record Dates
First Submitted
March 3, 2015
First Posted
March 11, 2015
Study Start
April 1, 2014
Primary Completion
November 30, 2019
Study Completion
November 30, 2019
Last Updated
June 21, 2019
Record last verified: 2019-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
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.