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CompletedNCT00999752NASAAUpdated May 5, 2011

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

An interventional study of Nebivolol and Hydrochlorothiazide in Hypertension, sponsored by InVasc Therapeutics, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-05-05.

Sponsored by InVasc Therapeutics, Inc. · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Hypertension

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Keywords

  • Hypertension
  • African Americans
  • Arterial Stiffness
  • Vascular Resistance
03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's enrollment of 40 is below the median of 90 across 4,995 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

InVasc Therapeutics, Inc. is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Known Hypertension by history
  • Self-described African American

Exclusion criteria

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)
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Active comparator
    Arm A

    Nebivolol to reach blood pressure control

    Drug: Nebivolol

  • Active comparator
    Arm B

    Hydrochlorothiazide for blood pressure control

    Drug: Hydrochlorothiazide

Interventions

  • DrugNebivolol

    5mg/day with increase to 10 mg/day to reach blood pressure \<140/90

    Also known as: Bystolic

  • DrugHydrochlorothiazide

    Hydrochlorothiazide 25 mg/day

    Also known as: HCTZ

06

What researchers measure

Primary outcomes

  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 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

    Time frame: At the begining and end of study

07

Study locations

1 site
  • Atlanta Vascular Research Foundation
    Tucker, Georgia 30084, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 5, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00999752
Lead sponsor
InVasc Therapeutics, Inc.
First posted
Oct 22, 2009
Start date
Oct 2009
Primary completion
Feb 2010
Completion
May 2010
Last update
May 5, 2011

Study contacts

Bobby V Khan, MD PhD
principal investigator · InVasc Therapeutics, Inc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2011. You cannot join it, but the record below documents what was studied.

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