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

Pre- and Post-ischemia forearm vascular resistance (FVR) [ Time Frame: Before treatment and after 10 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Pre- and Post-ischemia forearm blood flow (FBF) [ Time Frame: Two times, one before treatment and one after 10 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	March 2008
Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Nebivolol	Drug: Nebivolol nebivolol 10mg, 20mg, 40mg daily dosage, oral administration
2: Active Comparator Metoprolol ER (TM)	Drug: Metoprolol ER (TM) Metoprolol ER 100mg, 200mg, 400mg, daily dosage, oral administration

Detailed Description:

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.

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:

David Bharucha, MD, PhD

Forest Laboratories

More Information

No publications provided

Responsible Party:	Forest Research Institute, a subsidiary of Forest Laboratories Inc. ( Carol Satler MD, PhD Vice President, Clinical Development, Cardiovascular & Respiratory )
Study ID Numbers:	NEB-MD-08
Study First Received:	March 28, 2008
Last Updated:	December 31, 2009
ClinicalTrials.gov Identifier:	NCT00648895 History of Changes
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:

Vasodilator Agents
Sympatholytics
Neurotransmitter Agents
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Vascular Diseases
Nebivolol
Cardiovascular Agents
Antihypertensive Agents
Metoprolol

Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Metoprolol succinate
Adrenergic beta-Antagonists
Cardiovascular Diseases
Adrenergic Antagonists
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Hypertension

ClinicalTrials.gov processed this record on February 08, 2010