Study of the Effects of BMS-919373 on the Electrical Activity of the Heart Using Pacemakers
NCT ID: NCT02153437
Last Updated: 2023-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
7 participants
INTERVENTIONAL
2014-10-30
2016-10-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
TRIPLE
Study Groups
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Arm A: BMS-919373
BMS-919373 oral Solution/tablet single dose for one day
BMS-919373
Arm B: Sotalol
Sotalol oral Tablet single dose for one day
Sotalol
Arm C: Placebo for BMS-919373
Oral solution/tablet one single dose for one day
Placebo for BMS-919373
Interventions
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BMS-919373
Sotalol
Placebo for BMS-919373
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Eligible patients will have a dual-chamber permanent pacemaker.
* Women who are not of childbearing potential.
Exclusion Criteria
i) Permanent (i.e. patients are only in AF and never in sinus rhythm) or.
ii) Persistent (i.e. patients who's episodes of AF are longer than 7 days and require medical intervention, such as electrical or medical cardioversion, to return to sinus rhythm), are excluded.
* History of Transient Ischemic Attack (TIA) or stroke in the last 12 months.
* History of clinically significant ventricular arrhythmia (not including isolated monomorphic Premature Ventricular Contractions (PVCs)). Such arrhythmias are marked by loss of consciousness, emergent cardioversion or defibrillation or unstable vital signs requiring medical intervention.
* Complete heart block.
* Planned surgery, endovascular intervention or cardioversion within the study period.
* History of atrial fibrillation.
18 Years
85 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution
Austin, Texas, United States
The University Of Calgary
Calgary, Alberta, Canada
University Of Ottawa Heart Institute
Ottawa, Ontario, Canada
Local Institution - 0001
Toronto, Ontario, Canada
Local Institution - 0002
Montreal, Quebec, Canada
Local Institution
Montreal, Quebec, Canada
Countries
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Related Links
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FDA Safety Alerts and Recalls
BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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CV205-006
Identifier Type: -
Identifier Source: org_study_id