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Alternative in Beta Blocker Intolerance: The ABBI Trial (ABBI)

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

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.

Condition Intervention Phase
Coronary Artery Disease
Drug: Nebivolol
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Alternative in Beta Blocker Intolerance; the ABBI Trial

Resource links provided by NLM:

Further study details as provided by Minneapolis Heart Institute Foundation:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Reason for termination of Bystolic [ Time Frame: 30 Days ]
  • Incidence of same symptom stopping Bystolic as previous beta blocker [ Time Frame: 30 Days ]
  • Symptom severity [ Time Frame: 30 Days ]

Enrollment: 6
Study Start Date: May 2009
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nebivolol 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

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 tolerated. Side effects will be tracked and compared to previous.

Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00893984

United States, Minnesota
Minneapolis Heart Institute at Abbott Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
Sponsors and Collaborators
Minneapolis Heart Institute Foundation
Forest Laboratories
Principal Investigator: Graham Minneapolis Heart Institute Foundation
  More Information

Additional Information:
Responsible Party: Minneapolis Heart Institute Foundation Identifier: NCT00893984     History of Changes
Other Study ID Numbers: pre001
Study First Received: May 5, 2009
Last Updated: December 6, 2013

Keywords provided by Minneapolis Heart Institute Foundation:
Beta blocker

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antihypertensive Agents
Vasodilator Agents
Adrenergic beta-1 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists processed this record on April 24, 2017