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

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ClinicalTrials.gov Identifier: NCT00999752
Recruitment Status : Completed
First Posted : October 22, 2009
Last Update Posted : May 5, 2011
Sponsor:
Information provided by:
InVasc Therapeutics, Inc.

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.

Condition or disease Intervention/treatment Phase
Hypertension Drug: Nebivolol Drug: Hydrochlorothiazide Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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 Start Date : October 2009
Actual Primary Completion Date : February 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Arm A
Nebivolol to reach blood pressure control
Drug: Nebivolol
5mg/day with increase to 10 mg/day to reach blood pressure <140/90
Other Name: Bystolic

Active Comparator: Arm B
Hydrochlorothiazide for blood pressure control
Drug: Hydrochlorothiazide
Hydrochlorothiazide 25 mg/day
Other Name: HCTZ




Primary Outcome Measures :
  1. Changes in systolic and diastolic blood pressure after treatment with nebivolol and reaching normal blood pressure <140/90 [ Time Frame: Every visit for 25 weeks (9 study visits) ]

Secondary Outcome Measures :
  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 [ Time Frame: At the begining and end of study ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

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): NCT00999752


Locations
United States, Georgia
Atlanta Vascular Research Foundation
Tucker, Georgia, United States, 30084
Sponsors and Collaborators
InVasc Therapeutics, Inc.
Investigators
Principal Investigator: Bobby V Khan, MD PhD InVasc Therapeutics, Inc.

Responsible Party: Bobby V. Khan, MD PhD, InVasc Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT00999752     History of Changes
Other Study ID Numbers: AVR-2009-02 (BYS-MD-27)
First Posted: October 22, 2009    Key Record Dates
Last Update Posted: May 5, 2011
Last Verified: May 2011

Keywords provided by InVasc Therapeutics, Inc.:
Hypertension
African Americans
Arterial Stiffness
Vascular Resistance

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Hydrochlorothiazide
Nebivolol
Antihypertensive Agents
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Adrenergic beta-1 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents