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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.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00849810
First Posted: February 24, 2009
Last Update Posted: March 19, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Deborah Minor, University of Mississippi Medical Center
  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 Drug: Nebivolol

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (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:


Further study details as provided by Deborah Minor, University of Mississippi Medical Center:

Primary Outcome Measures:
  • Primary Outcome is Pre- and Post-treatment Ambulatory Blood Pressure. [ Time Frame: 4 weeks (pre- and post-treatment) ]

Enrollment: 1
Study Start Date: January 2009
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Metoprolol to nebivolol
metoprolol 25-200mg at a stable daily dose for 4 weeks, then change to nebivolol at a comparable stable dose (5-20 mg) for 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
Drug: Nebivolol
5 - 20 mg daily, at a stable dose for 4 to 5 weeks

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Deborah Minor, Professor of Medicine, University of Mississippi Medical Center
ClinicalTrials.gov Identifier: NCT00849810     History of Changes
Other Study ID Numbers: 2009-0002
First Submitted: February 2, 2009
First Posted: February 24, 2009
Results First Submitted: March 18, 2013
Results First Posted: March 19, 2013
Last Update Posted: March 19, 2013
Last Verified: March 2013

Keywords provided by Deborah Minor, 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
Metoprolol
Nebivolol
Adrenergic beta-Antagonists
Anti-Arrhythmia Agents
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Adrenergic beta-1 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists