NCT00849810

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for not_applicable hypertension

Timeline
Completed

Started Jan 2009

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 2, 2009

Completed
22 days until next milestone

First Posted

Study publicly available on registry

February 24, 2009

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

March 19, 2013

Completed
Last Updated

March 19, 2013

Status Verified

March 1, 2013

Enrollment Period

1.8 years

First QC Date

February 2, 2009

Results QC Date

March 18, 2013

Last Update Submit

March 18, 2013

Conditions

Keywords

HypertensionBeta-blockersAmbulatory blood pressureBasal metabolic rateQuality of life

Outcome Measures

Primary Outcomes (1)

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

    4 weeks (pre- and post-treatment)

Study Arms (1)

Metoprolol to nebivolol

EXPERIMENTAL

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: MetoprololDrug: Nebivolol

Interventions

Metoprolol tablets 25-200 mg daily times four weeks. Nebivolol daily for 4-5 weeks

Also known as: Nebivolol is bystolic, Metoprolol is lopressor
Metoprolol to nebivolol

5 - 20 mg daily, at a stable dose for 4 to 5 weeks

Metoprolol to nebivolol

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

MeSH Terms

Conditions

Hypertension

Interventions

MetoprololNebivolol

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

PhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesEthanolaminesBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Results Point of Contact

Title
Professor of Medicine
Organization
University of Mississippi Medical Center

Study Officials

  • Deborah Minor, PharmD

    University of Mississippi Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

February 2, 2009

First Posted

February 24, 2009

Study Start

January 1, 2009

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

March 19, 2013

Results First Posted

March 19, 2013

Record last verified: 2013-03

Locations