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Study of the Effects of BMS-919373 on the Electrical Activity of the Heart Using Pacemakers

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 by Bristol-Myers Squibb
Information provided by (Responsible Party):
Bristol-Myers Squibb Identifier:
First received: May 30, 2014
Last updated: August 23, 2016
Last verified: August 2016
To determine the effect of our compound (BMS-919373) on electrical activity of the heart using pacemakers.

Condition Intervention Phase
Atrial Fibrillation
Drug: BMS-919373
Drug: Sotalol
Drug: Placebo for BMS-919373
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Basic Science
Official Title: A Study of the Effects of BMS-919373 on Atrial Effective Refractory Period in Subjects With a Dual-Chamber Pacemaker

Resource links provided by NLM:

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • The effect of BMS-919373 on Atrial effective refractory period (AERP) in subjects with a dual chamber pacemaker [ Time Frame: At 0.5, 1, 2, and 4 hours following study drug administration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The safety assessments will be based on Adverse event reports, vital sign measurements, Electrocardiogram (ECGs), physical examinations and clinical laboratory tests [ Time Frame: At 1, 2, and 4 hours following study drug administration ] [ Designated as safety issue: Yes ]
  • Safety assessments based on Ventricular Effective Refractory Period (VERP) and change from baseline [ Time Frame: At 2 hour following study drug administration ] [ Designated as safety issue: Yes ]
  • Safety assessments based on Atrioventricular interval (AVI) and change from baseline [ Time Frame: At 1, 2, and 4 hours following study drug administration ] [ Designated as safety issue: Yes ]
  • Safety assessments based on Wenckebach cycle length (WCL) and change from baseline [ Time Frame: At 1, 2, and 4 hours following study drug administration ] [ Designated as safety issue: Yes ]
  • Safety assessments based on Intra-atrial conduction time (IACT) and change from baseline [ Time Frame: At 1, 2, and 4 hours following study drug administration ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: October 2014
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A: BMS-919373
BMS-919373 oral Solution/tablet single dose for one day
Drug: BMS-919373
Other Name: iKUR
Active Comparator: Arm B: Sotalol
Sotalol oral Tablet single dose for one day
Drug: Sotalol
Other Name: Co Sotalol
Placebo Comparator: Arm C: Placebo for BMS-919373
Oral solution/tablet one single dose for one day
Drug: Placebo for BMS-919373


Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

For more information regarding BMS clinical trial participation, please visit

Inclusion Criteria:

  • Age 18 years to 85 years
  • Eligible patients will have a dual-chamber permanent pacemaker
  • Women who are not of childbearing potential

Exclusion Criteria:

  • Patients with a history of Atrial Fibrillation (AF) that is either

    • (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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02153437

Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email:
Contact: First line of the email MUST contain NCT# and Site #.

United States, Texas
Local Institution Not yet recruiting
Austin, Texas, United States, 78705
Contact: Site 0004         
Canada, Alberta
The University Of Calgary Recruiting
Calgary, Alberta, Canada, T2N 4N1
Contact: Satish Raj, Site 0005    403-210-6152      
Canada, Ontario
University Of Ottawa Heart Institute Recruiting
Ottawa, Ontario, Canada, K1Y 4W7
Contact: Girish Nair, Site 0003    613-761-4914      
St. Michael'S Hospital Recruiting
Toronto, Ontario, Canada, M5B 1W8
Contact: Paul Angaran, Site 0001    416-864-6060 ext 2403      
Canada, Quebec
Montreal Heart Institute Recruiting
Montreal, Quebec, Canada, H1T 1C8
Contact: Marc Dubuc, Site 0002    514-376-3330 ext 4058      
Local Institution Recruiting
Montreal, Quebec, Canada, H2W 1T8
Contact: Site 0006         
Sponsors and Collaborators
Bristol-Myers Squibb
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Responsible Party: Bristol-Myers Squibb Identifier: NCT02153437     History of Changes
Other Study ID Numbers: CV205-006 
Study First Received: May 30, 2014
Last Updated: August 23, 2016
Health Authority: Canada: Health Canada
United States: Food and Drug Administration

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Autonomic Agents
Peripheral Nervous System Agents processed this record on October 25, 2016