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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:
Information provided by (Responsible Party):
Deborah Minor, University of Mississippi Medical Center
ClinicalTrials.gov Identifier:
NCT00849810
First received: February 2, 2009
Last updated: March 18, 2013
Last verified: March 2013
History of Changes
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group 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:

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. [ Time Frame: 4 weeks (pre- and post-treatment) ] [ Designated as safety issue: Yes ]

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

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, Professor of Medicine, University of Mississippi Medical Center
ClinicalTrials.gov Identifier: NCT00849810     History of Changes
Other Study ID Numbers: 2009-0002
Study First Received: February 2, 2009
Results First Received: March 18, 2013
Last Updated: March 18, 2013
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 16, 2013