A Study of the Effect of Nebivolol to Evaluate Its Vasodilatory Effects in Hypertensive Patients - Full Text View

Sponsor:	Forest Laboratories
Information provided by:	Forest Laboratories
ClinicalTrials.gov Identifier:	NCT00648895

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 III

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:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Metoprolol Metoprolol Tartrate Metoprolol succinate Nebivolol Metoprolol fumarate

U.S. FDA Resources

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 February 09, 2012