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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: May 9, 2013
Last verified: May 2013
History of Changes
  Purpose

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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00893984

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

Additional Information:
Minneapolis Heart Institute  This link exits the ClinicalTrials.gov site
Minneapolis Heart Institute Foundation  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Minneapolis Heart Institute Foundation
ClinicalTrials.gov Identifier: NCT00893984     History of Changes
Other Study ID Numbers: pre001
Study First Received: May 5, 2009
Last Updated: May 9, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Minneapolis Heart Institute Foundation:
Intolerance
Beta blocker

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Adrenergic beta-Antagonists
Nebivolol
Adrenergic Antagonists
 Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents
Adrenergic beta-1 Receptor Antagonists

ClinicalTrials.gov processed this record on May 22, 2013