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

Study Overview
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Brief Summary
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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.

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

Conditions
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Hypertension

Intervention / Treatment
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* Drug: Nebivolol
* Drug: Metoprolol ER (TM)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Nebivolol | Drug: Nebivolol<br>* nebivolol 10mg, 20mg, 40mg daily dosage, oral administration<br>* Other names: Bystolic (TM);|
| Active Comparator: 2<br>Metoprolol ER (TM) | Drug: Metoprolol ER (TM)<br>* Metoprolol ER 100mg, 200mg, 400mg, daily dosage, oral administration<br>* Other names: Toprol XL (TM);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage Change From Baseline to End of Treatment for the Difference Between the Post-ischemia and Pre-ischemia Forearm Vascular Resistance (FVR). | 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). | Before treatment and after 10 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertension, Blood pressure, Nebivolol, Bystolic (TM), Metoprolol ER (TM)