- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00893984
Alternative in Beta Blocker Intolerance: The ABBI Trial (ABBI)
July 29, 2019 updated by: Minneapolis Heart Institute Foundation
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
6
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Minnesota
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Minneapolis, Minnesota, United States, 55407
- Minneapolis Heart Institute at Abbott Northwestern Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
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Bystolic (Nebivolol), 5 mg per day for 30 days, titrated up to 10 mg at 2 weeks if necessary for blood pressure control.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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30 Days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Termination of Bystolic Stratified by Reason
Time Frame: 30 Days
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30 Days
|
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Incidence of Same Symptom Stopping Bystolic as Previous Beta Blocker
Time Frame: 30 Days
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30 Days
|
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Number of Participants With Mild Symptoms
Time Frame: 30 Days
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Mild symptoms include weight gain, edema, and headaches
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30 Days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Graham, Minneapolis Heart Institute Foundation
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2009
Primary Completion (Actual)
June 1, 2012
Study Completion (Actual)
June 1, 2012
Study Registration Dates
First Submitted
May 5, 2009
First Submitted That Met QC Criteria
May 5, 2009
First Posted (Estimate)
May 6, 2009
Study Record Updates
Last Update Posted (Actual)
August 6, 2019
Last Update Submitted That Met QC Criteria
July 29, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Myocardial Ischemia
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Coronary Disease
- Coronary Artery Disease
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Vasodilator Agents
- Adrenergic Agonists
- Adrenergic beta-Agonists
- Adrenergic beta-1 Receptor Agonists
- Nebivolol
Other Study ID Numbers
- PRE001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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