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

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: October 2008

This study is double blind (neither the patient nor the physician will know when which drug is being administered). It is being conducted at one research center in the United States.

The study consists of 14 study visits over about 4 months.

During all of these visits, patients will undergo routine health exams. At two of the visits, patients will complete special tests on three consecutive days, one before the administration of study drug and one after the administration of the study drug that the patient had been receiving for the prior ten weeks.

Intervention(s) in this Clinical Trial

• Drug: Nebivolol
  • nebivolol 10mg, 20mg, 40mg daily dosage, oral administration
• Drug: Metoprolol ER (TM)
  • Metoprolol ER 100mg, 200mg, 400mg, daily dosage, oral administration

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Nebivolol
• Active Comparator: 2
  • Metoprolol ER (TM)

Primary Measures

• Pre- and Post-ischemia forearm vascular resistance (FVR)
  • Time Frame: Before treatment and after 10 weeks
    Safety Issue?: No

Secondary Measures

• Pre- and Post-ischemia forearm blood flow (FBF)
  • Time Frame: Two times, one before treatment and one after 10 weeks
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 79 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Forest Laboratories

Overall Clinical Trial Officials and Contacts

David Bharucha, MD, PhD Study Director Forest Laboratories  

Overall Contact: Sandy Beaird 1-800-678-1605 info@forestpharm.com

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00648895

Study ID Number: NEB-MD-08

ClinicalTrials.gov Identifier: NCT00648895

Health Authority: United States: Food and Drug Administration