Status:
TERMINATED
Alternative in Beta Blocker Intolerance: The ABBI Trial
Lead Sponsor:
Minneapolis Heart Institute Foundation
Collaborating Sponsors:
Forest Laboratories
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
21+ years
Phase:
PHASE4
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 trac...
Detailed Description
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 t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00893984
Start Date
May 1 2009
End Date
June 1 2012
Last Update
August 6 2019
Active Locations (1)
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1
Minneapolis Heart Institute at Abbott Northwestern Hospital
Minneapolis, Minnesota, United States, 55407