Alternative in Beta Blocker Intolerance: The ABBI Trial

This study has been terminated.
(Lack of patient recruitment)
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Minneapolis Heart Institute Foundation
ClinicalTrials.gov Identifier:
NCT00893984
First received: May 5, 2009
Last updated: December 6, 2013
Last verified: December 2013

May 5, 2009
December 6, 2013
May 2009
June 2012   (final data collection date for primary outcome measure)
Incidence of intolerance of Bystolic, measured by side effect(s) that lead to discontinuance of Bystolic by the patient and/or the physician [ Time Frame: 30 Days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00893984 on ClinicalTrials.gov Archive Site
  • Reason for termination of Bystolic [ Time Frame: 30 Days ] [ Designated as safety issue: No ]
  • Incidence of same symptom stopping Bystolic as previous beta blocker [ Time Frame: 30 Days ] [ Designated as safety issue: No ]
  • Symptom severity [ Time Frame: 30 Days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Alternative in Beta Blocker Intolerance: The ABBI Trial
Alternative in Beta Blocker Intolerance; the ABBI Trial

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.

Patients who have been prescribed standard beta blockers but were unable to tolerate them due to side effects will be studied. They will take a new beta blocker, Nebivolol (Bystolic) for 30 days, if tolerated. Side effects will be tracked and compared to previous.

Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Coronary Artery Disease
Drug: Nebivolol
Bystolic (Nebivolol), 5 mg per day for 30 days, titrated up to 10 mg at 2 weeks if necessary for blood pressure control.
Other Name: Bystolic
Experimental: Nebivolol
Intervention: Drug: Nebivolol

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
6
June 2012
June 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00893984
pre001
No
Minneapolis Heart Institute Foundation
Minneapolis Heart Institute Foundation
Forest Laboratories
Principal Investigator: Graham Minneapolis Heart Institute Foundation
Minneapolis Heart Institute Foundation
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP