search
Back to results

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

Primary Purpose

Hypertension

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Metoprolol
Nebivolol
Sponsored by
University of Mississippi Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring Hypertension, Beta-blockers, Ambulatory blood pressure, Basal metabolic rate, Quality of life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Mississippi Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Metoprolol to nebivolol

Arm Description

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.

Outcomes

Primary Outcome Measures

Primary Outcome is Pre- and Post-treatment Ambulatory Blood Pressure.

Secondary Outcome Measures

Full Information

First Posted
February 2, 2009
Last Updated
March 18, 2013
Sponsor
University of Mississippi Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT00849810
Brief Title
Comparing the Effects of Two Beta Blockers,Metoprolol and Nebivolol,on Ambulatory Blood Pressure and Basal Metabolic Rate
Official Title
Comparative Effects of Nebivolol Versus Metoprolol on 24-hour Blood Pressures and Basal Metabolic Rate: An Open-Label Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Terminated
Why Stopped
Difficulty with recruiting willing participants.
Study Start Date
January 2009 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Mississippi Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
Hypertension, Beta-blockers, Ambulatory blood pressure, Basal metabolic rate, Quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Metoprolol to nebivolol
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Metoprolol
Other Intervention Name(s)
Nebivolol is bystolic, Metoprolol is lopressor
Intervention Description
Metoprolol tablets 25-200 mg daily times four weeks. Nebivolol daily for 4-5 weeks
Intervention Type
Drug
Intervention Name(s)
Nebivolol
Intervention Description
5 - 20 mg daily, at a stable dose for 4 to 5 weeks
Primary Outcome Measure Information:
Title
Primary Outcome is Pre- and Post-treatment Ambulatory Blood Pressure.
Time Frame
4 weeks (pre- and post-treatment)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deborah Minor, PharmD
Organizational Affiliation
University of Mississippi Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs