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

This study has been completed.
Sponsor:
Information provided by:
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT00648895
First received: March 28, 2008
Last updated: August 30, 2010
Last verified: August 2010
  Purpose

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 Intervention Phase
Hypertension
Drug: Nebivolol
Drug: Metoprolol ER (TM)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Forest Laboratories:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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).


Enrollment: 12
Study Start Date: November 2007
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Nebivolol
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)

  Eligibility

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00648895

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

No publications provided

Responsible Party: John Whalen, MD, Executive Director, Clinical Development, Cardiovascular, Forest Research Institute, a subsidiary of Forest Laboratories Inc.
ClinicalTrials.gov Identifier: NCT00648895     History of Changes
Other Study ID Numbers: NEB-MD-08
Study First Received: March 28, 2008
Results First Received: July 21, 2010
Last Updated: August 30, 2010
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Metoprolol
Nebivolol
Metoprolol succinate
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
Sympatholytics
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

ClinicalTrials.gov processed this record on April 17, 2014