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
  Purpose

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 Intervention
Hypertension
Drug: Nebivolol
Drug: Hydrochlorothiazide

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by InVasc Therapeutics, Inc.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 40
Study Start Date: October 2009
Study Completion Date: May 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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.
  More Information

No publications provided

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)
Study First Received: October 21, 2009
Last Updated: May 4, 2011
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on October 23, 2014