Study to Determine the Effects of Nebivolol and Hydrochlorothiazide in African Americans With Hypertension
NASAA
A 25 Week, Open Label Study to Determine the Effects of Nebivolol When Added to Hydrochlorothiazide on Diastolic Function and Arterial Stiffness in African Americans With Hypertension
1 other identifier
interventional
40
1 country
1
Brief Summary
The main purpose of this study is to evaluate the effects of Nebivolol and Hydrochlorothiazide on blood pressure in African Americans with high blood pressure.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable hypertension
Started Oct 2009
Shorter than P25 for not_applicable 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
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
October 21, 2009
CompletedFirst Posted
Study publicly available on registry
October 22, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2010
CompletedMay 5, 2011
May 1, 2011
4 months
October 21, 2009
May 4, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes in systolic and diastolic blood pressure after treatment with nebivolol and reaching normal blood pressure <140/90
Every visit for 25 weeks (9 study visits)
Secondary Outcomes (1)
Differences after nebivolol treatment on diastolic function as measured by tissue doppler imaging (ECHO), arterial compliance and stiffness and vascular nitric oxide availability determined by neutrophil function
At the begining and end of study
Study Arms (2)
Arm A
ACTIVE COMPARATORNebivolol to reach blood pressure control
Arm B
ACTIVE COMPARATORHydrochlorothiazide for blood pressure control
Interventions
5mg/day with increase to 10 mg/day to reach blood pressure \<140/90
Eligibility Criteria
You may qualify if:
- Known Hypertension by history
- Self-described African American
You may not qualify if:
- Uncontrolled Diabetes Mellitus (HbA1C\>10)
- Known CAD, Cerebrovascular Disease, PVD or Renovascular Disease
- Liver disease
- Chronic Renal Disease
- Uncontrolled Hypertension (\>199 systolic and/or \>115)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Atlanta Vascular Research Foundation
Tucker, Georgia, 30084, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bobby V Khan, MD PhD
InVasc Therapeutics, Inc.
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 21, 2009
First Posted
October 22, 2009
Study Start
October 1, 2009
Primary Completion
February 1, 2010
Study Completion
May 1, 2010
Last Updated
May 5, 2011
Record last verified: 2011-05