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

This study has been terminated.
(Insufficient enrollment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT02153437
First Posted: June 3, 2014
Last Update Posted: February 15, 2017
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.
Information provided by (Responsible Party):
Bristol-Myers Squibb
  Purpose
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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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 ]

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 ]
  • Safety assessments based on Ventricular Effective Refractory Period (VERP) and change from baseline [ Time Frame: At 2 hour following study drug administration ]
  • Safety assessments based on Atrioventricular interval (AVI) and change from baseline [ Time Frame: At 1, 2, and 4 hours following study drug administration ]
  • Safety assessments based on Wenckebach cycle length (WCL) and change from baseline [ Time Frame: At 1, 2, and 4 hours following study drug administration ]
  • 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 ]

Enrollment: 7
Study Start Date: October 2014
Study Completion Date: October 2016
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

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
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 ClinicalTrials.gov identifier (NCT number): NCT02153437


Locations
United States, Texas
Local Institution
Austin, Texas, United States, 78705
Canada, Alberta
The University Of Calgary
Calgary, Alberta, Canada, T2N 4N1
Canada, Ontario
University Of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4W7
St. Michael'S Hospital
Toronto, Ontario, Canada, M5B 1W8
Canada, Quebec
Montreal Heart Institute
Montreal, Quebec, Canada, H1T 1C8
Local Institution
Montreal, Quebec, Canada, H2W 1T8
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02153437     History of Changes
Other Study ID Numbers: CV205-006
First Submitted: May 30, 2014
First Posted: June 3, 2014
Last Update Posted: February 15, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Sotalol
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents