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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 16, 2014