NCT00893984

Brief Summary

In this study the investigators will assess the tolerance of Nebivolol (Bystolic) in cardiovascular patients who are not able to tolerate conventional beta blockers. A side effect profile will be tracked and compared with previous beta blocker use. The investigators hypothesize that Bystolic will be tolerated by many patients who are intolerant of conventional blockers.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for phase_4 coronary-artery-disease

Timeline
Completed

Started May 2009

Typical duration for phase_4 coronary-artery-disease

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

May 1, 2009

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

May 5, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 6, 2009

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
7.1 years until next milestone

Results Posted

Study results publicly available

July 17, 2019

Completed
Last Updated

August 6, 2019

Status Verified

July 1, 2019

Enrollment Period

3.1 years

First QC Date

May 5, 2009

Results QC Date

June 26, 2019

Last Update Submit

July 29, 2019

Conditions

Coronary Artery Disease

Keywords

IntoleranceBeta blocker

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Intolerance of Bystolic, Measured by Side Effect(s) That Lead to Discontinuance of Bystolic by the Patient and/or the Physician

    30 Days

Secondary Outcomes (3)

  • Number of Participants With Termination of Bystolic Stratified by Reason

    30 Days

  • Incidence of Same Symptom Stopping Bystolic as Previous Beta Blocker

    30 Days

  • Number of Participants With Mild Symptoms

    30 Days

Study Arms (1)

Nebivolol

EXPERIMENTAL

Bystolic (Nebivolol), 5 mg per day for 30 days, titrated up to 10 mg at 2 weeks if necessary for blood pressure control.

Drug: Nebivolol

Interventions

NebivololDRUG

Bystolic (Nebivolol), 5 mg per day for 30 days, titrated up to 10 mg at 2 weeks if necessary for blood pressure control.

Also known as: Bystolic
Nebivolol

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 21
  • Male or female who is post-menopausal or not pregnant and using an approved contraceptive regimen
  • Previous beta blocker use and intolerant of beta blocker

You may not qualify if:

  • Systolic blood pressure \< 100 mmHg unless another blood pressure medication is stopped at the time of study entry
  • Hospitalized for heart failure within the past 4 weeks
  • Bradycardia with a heart rate \< 60
  • Heart block greater than first degree
  • History of sick sinus syndrome (unless a permanent pacemaker is in place)
  • History of severe hepatic or renal dysfunction; serum Creatinine \> 2.0 or Amylase \> 3x normal
  • Use of CYP2D6 inhibitors (quinidine, propafenone, fluoxetine, paroxetine, etc.)
  • Ingestion of investigational drug within the past 30 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Minneapolis Heart Institute at Abbott Northwestern Hospital

Minneapolis, Minnesota, 55407, United States

Location

Related Publications (3)

  • Wojciechowski D, Papademetriou V. Beta-blockers in the management of hypertension: focus on nebivolol. Expert Rev Cardiovasc Ther. 2008 Apr;6(4):471-9. doi: 10.1586/14779072.6.4.471.

    PMID: 18402537BACKGROUND

  • Weber MA. The role of the new beta-blockers in treating cardiovascular disease. Am J Hypertens. 2005 Dec;18(12 Pt 2):169S-176S. doi: 10.1016/j.amjhyper.2005.09.009.

    PMID: 16373195BACKGROUND

  • Kramer JM, Hammill B, Anstrom KJ, Fetterolf D, Snyder R, Charde JP, Hoffman BS, Allen LaPointe N, Peterson E. National evaluation of adherence to beta-blocker therapy for 1 year after acute myocardial infarction in patients with commercial health insurance. Am Heart J. 2006 Sep;152(3):454.e1-8. doi: 10.1016/j.ahj.2006.02.030.

    PMID: 16923412BACKGROUND

Related Links

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Nebivolol

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

Title
Chief Medical Officer
Organization
Minneapolis Heart Institute Foundation
scott.sharkey@allina.com
612-863-3900

Study Officials

  • Graham

    Minneapolis Heart Institute Foundation

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2009

First Posted

May 6, 2009

Study Start

May 1, 2009

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

August 6, 2019

Results First Posted

July 17, 2019

Record last verified: 2019-07

Locations

US(1)