Comparing the Effects of Two Beta Blockers,Metoprolol and Nebivolol,on Ambulatory Blood Pressure and Basal Metabolic Rate

This study is currently recruiting participants.

Verified by University of Mississippi Medical Center, July 2009

First Received: February 2, 2009 Last Updated: July 1, 2009 History of Changes

Sponsored by:	University of Mississippi Medical Center
Information provided by:	University of Mississippi Medical Center
ClinicalTrials.gov Identifier:	NCT00849810

Purpose

The purpose of the study is to compare the effects of nebivolol and metoprolol on 24-hour ambulatory blood pressure characteristics and basal metabolic rates in patients with hypertension.

Condition	Intervention
Hypertension	Drug: Metoprolol

Study Type:	Interventional
Study Design:	Treatment, Open Label, Active Control, Factorial Assignment, Safety/Efficacy Study
Official Title:	Comparative Effects of Nebivolol Versus Metoprolol on 24-Hour Blood Pressures and Basal Metabolic Rate: An Open-Label Study

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 University of Mississippi Medical Center:

Primary Outcome Measures:

Primary outcome is pre- and post-treatment ambulatory blood pressure, basal metabolic rate, and quality of life. [ Time Frame: pre- and post-treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	20
Study Start Date:	January 2009
Estimated Study Completion Date:	January 2010
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Nebivolol: Active Comparator Nebivolol once daily times 4-5 weeks.	Drug: Metoprolol Metoprolol tablets 25-200 mg daily times four weeks. Nebivolol daily for 4-5 weeks
Metoprolol: Active Comparator metoprolol 25-200mg daily for 4 weeks	Drug: Metoprolol Metoprolol tablets 25-200 mg daily times four weeks. Nebivolol daily for 4-5 weeks

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

18 years old or older
currently be treated at a University of MS Medical Center Internal Medicine Clinics
currently taking metoprolol succinate for hypertension
have their hypertension controlled (<140/90).

Exclusion Criteria:

uncontrolled hypertension
severe renal or moderate hepatic impairment
currently taking CYP 2D6 inducers/inhibitors
recent stroke (less than 6 months)
recent myocardial infarction (less than 6 months)
congestive heart failure
diagnosed obstructive sleep apnea
atrial fibrillation
arm circumference >50 cm

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00849810

Contacts

Contact: Cathy Adair, RN, CCRC	601-815-1338	cadair@medicine.umsmed.edu
Contact: Deborah Minor, PharmD	601-984-5770	dminor@medicine.umsmed.edu

Locations

United States, Mississippi
University of Mississippi Medical Center	Recruiting
Jackson, Mississippi, United States, 39216

Sponsors and Collaborators

University of Mississippi Medical Center

Investigators

Principal Investigator:

Deborah Minor, PharmD

University of Mississippi Medical Center

More Information

No publications provided

Responsible Party:	University of Mississippi Medical Center ( Deborah Minor, PharmD )
Study ID Numbers:	2009-0002
Study First Received:	February 2, 2009
Last Updated:	July 1, 2009
ClinicalTrials.gov Identifier:	NCT00849810 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Mississippi Medical Center:

Hypertension
Beta-blockers
Ambulatory blood pressure
Basal metabolic rate
Quality of life

Study placed in the following topic categories:

Vasodilator Agents
Neurotransmitter Agents
Adrenergic Agents
Vascular Diseases
Quality of Life
Nebivolol
Cardiovascular Agents
Metoprolol

Antihypertensive Agents
Metoprolol succinate
Adrenergic beta-Antagonists
Adrenergic Antagonists
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Hypertension

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 August 30, 2009