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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00648895
Recruitment Status : Completed
First Posted : April 1, 2008
Results First Posted : September 20, 2010
Last Update Posted : September 20, 2010
Information provided by:
Forest Laboratories

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hypertension Drug: Nebivolol Drug: Metoprolol ER (TM) Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Nebivolol on Forearm Vasodilation, Nitric Oxide Bioavailability, and Oxidative Stress in Patients With Stage 1/2 Hypertension
Study Start Date : November 2007
Primary Completion Date : July 2009

Arm Intervention/treatment
Active Comparator: 1
Drug: Nebivolol
nebivolol 10mg, 20mg, 40mg daily dosage, oral administration
Other Name: Bystolic (TM)
Active Comparator: 2
Metoprolol ER (TM)
Drug: Metoprolol ER (TM)
Metoprolol ER 100mg, 200mg, 400mg, daily dosage, oral administration
Other Name: Toprol XL (TM)

Primary Outcome Measures :
  1. 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).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00648895

United States, Texas
Forest Investigative Site
Houston, Texas, United States, 77030
Sponsors and Collaborators
Forest Laboratories
Study Director: Tatjana Lukic, MD., M.Sc. Forest Research Institute, Inc., a Subsidiary of Forest Laboratories, Inc.

Responsible Party: John Whalen, MD, Executive Director, Clinical Development, Cardiovascular, Forest Research Institute, a subsidiary of Forest Laboratories Inc. Identifier: NCT00648895     History of Changes
Other Study ID Numbers: NEB-MD-08
First Posted: April 1, 2008    Key Record Dates
Results First Posted: September 20, 2010
Last Update Posted: September 20, 2010
Last Verified: August 2010

Keywords provided by Forest Laboratories:
Blood pressure
Bystolic (TM)
Metoprolol ER (TM)

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
Anti-Arrhythmia Agents
Antihypertensive Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Adrenergic beta-1 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists