NCT01051947

Brief Summary

A randomized, cross-over, single-blind study to compare the effects of nebivolol and metoprolol on central aortic pressure and peripheral brachial pressure in patients with stable cardiovascular disease.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

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

December 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 19, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 20, 2010

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

August 1, 2011

Status Verified

July 1, 2011

Enrollment Period

5 months

First QC Date

January 19, 2010

Last Update Submit

July 29, 2011

Conditions

Central Aortic Pressure

Keywords

NebivololMetoprololcentral aortic pressurehypertension

Outcome Measures

Primary Outcomes (1)

  • Stable blood pressure

    Subjects will be randomized to nebivolol or metoprolol. Their medication will be titrated so that their blood pressure is within 10% of their initial reading.

    6 months

Study Arms (2)

Nebivolol

EXPERIMENTAL

Nebivolol therapy for 2-6 weeks depending on blood pressure readings

Drug: Nebivolol

Metoprolol

EXPERIMENTAL

Metoprolol therapy for 2-6 weeks depending on blood pressure readings

Drug: Metoprolol

Interventions

NebivololDRUG

10 mg by mouth daily for 2 weeks 20 mg by mouth daily for 2 weeks 40 mg by mouth daily for 2 weeks

Nebivolol
MetoprololDRUG

dosage prescribed prior to starting on study

Metoprolol

Eligibility Criteria

Age45 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects with history of hypertension
  • Subjects who have received metoprolol for a minimum of 3 months

You may not qualify if:

  • Patients who have had an acute myocardial infarction, coronary revascularization or who have been hospitalized for heart failure or cardiac arrhythmia in the past 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Cardiac Center at Creighton University

Omaha, Nebraska, 68131, United States

Location

MeSH Terms

Conditions

Hypertension

Interventions

NebivololMetoprolol

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingPhenoxypropanolaminesPropanolaminesPropanols

Study Officials

  • Jennifer Campbell, PharmD

    Creighton University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 19, 2010

First Posted

January 20, 2010

Study Start

December 1, 2009

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

August 1, 2011

Record last verified: 2011-07

Locations

US(1)