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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00893984
Recruitment Status : Terminated (Lack of patient recruitment)
First Posted : May 6, 2009
Results First Posted : July 17, 2019
Last Update Posted : August 6, 2019
Forest Laboratories
Information provided by (Responsible Party):
Minneapolis Heart Institute Foundation

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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Drug: Nebivolol Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Alternative in Beta Blocker Intolerance; the ABBI Trial
Study Start Date : May 2009
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Nebivolol
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
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

Primary Outcome Measures :
  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 [ Time Frame: 30 Days ]

Secondary Outcome Measures :
  1. Number of Participants With Termination of Bystolic Stratified by Reason [ Time Frame: 30 Days ]
  2. Incidence of Same Symptom Stopping Bystolic as Previous Beta Blocker [ Time Frame: 30 Days ]
  3. Number of Participants With Mild Symptoms [ Time Frame: 30 Days ]
    Mild symptoms include weight gain, edema, and headaches

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00893984

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United States, Minnesota
Minneapolis Heart Institute at Abbott Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
Sponsors and Collaborators
Minneapolis Heart Institute Foundation
Forest Laboratories
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Principal Investigator: Graham Minneapolis Heart Institute Foundation
Additional Information:
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Responsible Party: Minneapolis Heart Institute Foundation Identifier: NCT00893984    
Other Study ID Numbers: pre001
First Posted: May 6, 2009    Key Record Dates
Results First Posted: July 17, 2019
Last Update Posted: August 6, 2019
Last Verified: July 2019
Keywords provided by Minneapolis Heart Institute Foundation:
Beta blocker
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Antihypertensive Agents
Vasodilator Agents
Adrenergic beta-1 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs