Nebivolol and the Endothelin (ET)-1 System

Summary

The investigators hypothesize that nebivolol will reduce ET-1-mediated vasoconstrictor tone in adult humans with elevated blood pressure to a greater extent than either metoprolol or placebo.

Conditions

• Prehypertension
• Hypertension

Interventions

DRUG

Nebivolol

5 mg tablet to be taken by mouth once per day for 12 weeks

DRUG

Metoprolol

100 mg tablet to be taken by mouth once per day for 12 weeks

DRUG

Placebo

gelatin capsule to be taken by mouth once per day for 12 weeks

OTHER

Forearm Blood Flow (FBF) response to BQ-123 (100 mol/min)

The forearm blood flow response to the endothelin (ET) -1 A receptor blocker BQ-123 (100 nmol/min) for 60 minutes at baseline and at 12 weeks.

OTHER

FBF response to BQ-123 (100 nmol/min)+BQ-788(50 nmol/min)

The FBF response to the nonselective endothelin (ET) -1 receptor blockade BQ-123 (100 nmol/min) + BQ-788 (50 nmol/min)for 60 minutes at baseline and at 12 weeks.

OTHER

FBF response to Acetylcholine

The FBF response to the endothelium-dependent vasodilator ACh (4, 8 and 16 ug/100 mL tissue/min) at baseline and at 12 weeks.

OTHER

FBF response to Sodium Nitroprusside

The FBF response to the endothelium independent vasodilator NTP (1,2 and 4 ug/100 mL tissue/min) at baseline and at 12 weeks.

OTHER

FBF response to BQ-123+BQ-788+ACh

The FBF response to the nonselective endothelin (ET) -1 receptor blockade BQ-123 (100 nmol/min) + BQ-788 (50 nmol/min)for 60 minutes at baseline and at 12 weeks.

Sponsors & Collaborators

• Forest Laboratories

  collaborator INDUSTRY

• University of Colorado, Boulder

  lead OTHER

Principal Investigators

• Christopher A DeSouza, Ph.D. · University of Colorado at Boulder

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

45 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2011-05-31

Primary Completion

2016-11-30

Completion

2016-12-31

Countries

• United States

Study Locations