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

This study has been completed.
Sponsor:
Information provided by:
InVasc Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT00999752
First received: October 21, 2009
Last updated: May 4, 2011
Last verified: May 2011
History of Changes

October 21, 2009
May 4, 2011
October 2009
February 2010   (final data collection date for primary outcome measure)
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) ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00999752 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study to Determine the Effects of Nebivolol and Hydrochlorothiazide in African Americans With Hypertension
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

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.

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Hypertension
  • Drug: Nebivolol
    5mg/day with increase to 10 mg/day to reach blood pressure <140/90
    Other Name: Bystolic
  • Drug: Hydrochlorothiazide
    Hydrochlorothiazide 25 mg/day
    Other Name: HCTZ
  • Active Comparator: Arm A
    Nebivolol to reach blood pressure control
    Intervention: Drug: Nebivolol
  • Active Comparator: Arm B
    Hydrochlorothiazide for blood pressure control
    Intervention: Drug: Hydrochlorothiazide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
May 2010
February 2010   (final data collection date for primary outcome measure)

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)
Both
18 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00999752
AVR-2009-02 (BYS-MD-27)
No
Bobby V. Khan, MD PhD, InVasc Therapeutics, Inc.
InVasc Therapeutics, Inc.
Not Provided
Principal Investigator: Bobby V Khan, MD PhD InVasc Therapeutics, Inc.
InVasc Therapeutics, Inc.
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP