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

NCT ID: NCT00999752

Last Updated: 2011-05-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2010-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Arm A

Nebivolol to reach blood pressure control

Group Type ACTIVE_COMPARATOR

Nebivolol

Intervention Type DRUG

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

Arm B

Hydrochlorothiazide for blood pressure control

Group Type ACTIVE_COMPARATOR

Hydrochlorothiazide

Intervention Type DRUG

Hydrochlorothiazide 25 mg/day

Interventions

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Nebivolol

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

Intervention Type DRUG

Hydrochlorothiazide

Hydrochlorothiazide 25 mg/day

Intervention Type DRUG

Other Intervention Names

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Bystolic HCTZ

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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InVasc Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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InVasc Therapeutics, Inc.

Principal Investigators

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Bobby V Khan, MD PhD

Role: PRINCIPAL_INVESTIGATOR

InVasc Therapeutics, Inc.

Locations

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Atlanta Vascular Research Foundation

Tucker, Georgia, United States

Site Status

Countries

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United States

Other Identifiers

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AVR-2009-02 (BYS-MD-27)

Identifier Type: -

Identifier Source: org_study_id

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