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

This study has been terminated.

( Difficulty with recruiting willing participants. )

First Received on February 2, 2009. Last Updated on April 6, 2011 History of Changes

Sponsor:	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:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Treatment
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 Nebivolol Hydrochloride

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 ]

Enrollment:	1
Study Start Date:	January 2009
Estimated Study Completion Date:	January 2012
Estimated Primary Completion Date:	January 2012 (Final data collection date for primary outcome measure)

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

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

Locations

United States, Mississippi
University of Mississippi Medical Center
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:	Deborah Minor, PharmD, University of Mississippi Medical Center
ClinicalTrials.gov Identifier:	NCT00849810 History of Changes
Other Study ID Numbers:	2009-0002
Study First Received:	February 2, 2009
Last Updated:	April 6, 2011
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

Additional relevant MeSH terms:

Hypertension
Vascular Diseases
Cardiovascular Diseases
Adrenergic beta-Antagonists
Metoprolol
Metoprolol succinate
Nebivolol
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

Pharmacologic Actions
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic beta-1 Receptor Antagonists
Vasodilator Agents

ClinicalTrials.gov processed this record on May 23, 2012