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

InVasc Therapeutics

Status: Completed

Conditions: Hypertension

Treatments: Drug: Hydrochlorothiazide; Drug: Nebivolol

Study type: Interventional

Funder types: Industry

Identifiers

NCT00999752

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

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Arm A

Active Comparator group

Description:

Nebivolol to reach blood pressure control

Treatment:

Drug: Nebivolol

Arm B

Active Comparator group

Description:

Hydrochlorothiazide for blood pressure control

Treatment:

Drug: Hydrochlorothiazide