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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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Cardiovascular Diseases
Vascular Diseases
Adrenergic beta-Antagonists
Metoprolol
Metoprolol succinate
Nebivolol
Adrenergic Agents
Adrenergic Antagonists
Adrenergic beta-1 Receptor Antagonists
Anti-Arrhythmia Agents
Antihypertensive Agents
Autonomic Agents
Cardiovascular Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sympatholytics
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on November 27, 2014