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Study to Determine the Effects of Nebivolol and Hydrochlorothiazide in African Americans With Hypertension

Information source: InVasc Therapeutics, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension

Intervention: Nebivolol (Drug); Hydrochlorothiazide (Drug)

Phase: N/A

Status: Completed

Sponsored by: InVasc Therapeutics, Inc.

Official(s) and/or principal investigator(s):
Bobby V Khan, MD PhD, Principal Investigator, Affiliation: InVasc Therapeutics, Inc.


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.

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Primary outcome: Changes in systolic and diastolic blood pressure after treatment with nebivolol and reaching normal blood pressure <140/90

Secondary outcome: 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

Detailed description: Many blood pressure medications are not effective in African American men and women. The two lower chambers of the heart contract to pump blood to the body. The lower chambers have to relax so they can refill with blood to pump out again. Many patients with high blood pressure have stiffness in the lower chambers which prevents the heart from relaxing so it can properly fill with blood. Some patients with the stiffness in the lower chambers of the heart will develop heart failure. The study is to test whether or not Nebivolol (Bystolic)and a diuretic Hydrochlorothiazide (HCTZ) will help the heart relax so the heart can properly fill and prevent stiffness of the lower heart chambers.


Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.


Inclusion Criteria:

- Known Hypertension by history

- Self-described African American

Exclusion Criteria:

- 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)

Locations and Contacts

Atlanta Vascular Research Foundation, Tucker, Georgia 30084, United States
Additional Information

Starting date: October 2009
Last updated: May 4, 2011

Page last updated: August 23, 2015

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