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

March 18, 2013 updated by: Deborah Minor, University of Mississippi Medical Center

Comparative Effects of Nebivolol Versus Metoprolol on 24-hour Blood Pressures and Basal Metabolic Rate: An Open-Label Study

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Mississippi Medical Center

Investigators

  • Principal Investigator: Deborah Minor, PharmD, University of Mississippi Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (ACTUAL)

November 1, 2010

Study Completion (ACTUAL)

November 1, 2010

Study Registration Dates

First Submitted

February 2, 2009

First Submitted That Met QC Criteria

February 23, 2009

First Posted (ESTIMATE)

February 24, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

March 19, 2013

Last Update Submitted That Met QC Criteria

March 18, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009-0002 (Institutional Review Board)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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