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

NCT ID: NCT00648895

Last Updated: 2010-09-20

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

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.

Detailed Description

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Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Nebivolol

Group Type ACTIVE_COMPARATOR

Nebivolol

Intervention Type DRUG

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

2

Metoprolol ER (TM)

Group Type ACTIVE_COMPARATOR

Metoprolol ER (TM)

Intervention Type DRUG

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

Interventions

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Nebivolol

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

Intervention Type DRUG

Metoprolol ER (TM)

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

Intervention Type DRUG

Other Intervention Names

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Bystolic (TM) Toprol XL (TM)

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Forest Laboratories

INDUSTRY

Sponsor Role lead

Responsible Party

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Forest Research Institute, a subsidiary of Forest Laboratories Inc.

Principal Investigators

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Tatjana Lukic, MD., M.Sc.

Role: STUDY_DIRECTOR

Forest Research Institute, Inc., a Subsidiary of Forest Laboratories, Inc.

Locations

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Forest Investigative Site

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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NEB-MD-08

Identifier Type: -

Identifier Source: org_study_id