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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:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT02153437
First received: May 30, 2014
Last updated: February 14, 2017
Last verified: February 2017
  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: 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

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
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 ClinicalTrials.gov identifier: 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
Study First Received: May 30, 2014
Last Updated: February 14, 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

ClinicalTrials.gov processed this record on May 25, 2017