A Study of the Effect of Nebivolol to Evaluate Its Vasodilatory Effects in Hypertensive Patients

The study is designed to compare the effects of nebivolol (10, 20, 40mg/day) with another beta blocker, extended-release metoprolol, at a range of doses. Its purpose is to study the mechanism of action of nebivolol on forearm blood flow, nitric oxide availability and other biomarkers.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Forest Investigative Site

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Male or female, ambulatory outpatients 18-79 years old at screening
Minimum 2-year history of Stage I/II hypertension
Qualifying blood pressure criteria for study entry and for randomization
Willing to adhere to the dietary compliance and undergo protocol procedures
Have a lifestyle that will permit him/her to attend all evaluations, including those conducted on consecutive days

Exclusion criteria

Have any form of secondary hypertension
Have clinically significant respiratory or cardiovascular disease
Presence/history of coronary artery disease or peripheral vascular disease
Have diabetes mellitus, Type I or II
Have a history of hypersensitivity to nebivolol, metoprolol, or any beta-blocker

Treatment and study plan

nebivolol

Drug

nebivolol 10mg, 20mg, 40mg daily dosage, oral administration

Other names: Bystolic (TM)

Metoprolol ER (TM)

Drug

Metoprolol ER 100mg, 200mg, 400mg, daily dosage, oral administration

Other names: Toprol XL (TM)

Primary outcomes

Percentage Change From Baseline to End of Treatment for the Difference Between the Post-ischemia and Pre-ischemia Forearm Vascular Resistance (FVR).

Time frame: Before treatment and after 10 weeks

Pre-and post-ischemia forearm vascular resistance (FVR), calculated by forearm blood flow (FBF) and systolic blood pressure (SBP), and assessed at the trough/pre-meal time point (used for percentage change analysis between baseline and postbaseline). Measurements occured at baseline (visit 5) and end of treatment (week 10).

Sponsors and collaborators

Lead sponsor

Forest Laboratories

Industry

Registry information

Official study title

Effect of Nebivolol on Forearm Vasodilation, Nitric Oxide Bioavailability, and Oxidative Stress in Patients With Stage 1/2 Hypertension

Important dates

Study start: 2007
Primary completion: 2009
First posted: Apr 1, 2008
Registry last updated: Sep 20, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed