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A Phase I Study to Assess the Electrophysiologic Effects of BMS-394136 on the Atrium and Ventricle in Patients With Dual-Chamber Pacemakers or Defibrillators

This study has been completed.
Study NCT00162448.   Last updated on August 18, 2008.   Information provided by Bristol-Myers Squibb

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Descriptive Information Fields
Brief Title  A Phase I Study to Assess the Electrophysiologic Effects of BMS-394136 on the Atrium and Ventricle in Patients With Dual-Chamber Pacemakers or Defibrillators
Official Title  Double-Blind, Randomized, Single-Dose Study to Evaluate the Atrial Selectivity and Safety of BMS-394136 in Patients With Implanted Dual-Chamber Pacemakers or Defibrillators
Brief Summary

Double-Blind, Randomized, Single-Dose Study to Evaluate the Atrial Selectivity and Safety of BMS-394136 in Subjects with Implanted Dual-Chamber Pacemakers or Defibrillators

Detailed Description
Study Phase Phase I
Study Type  Interventional
Study Design  Diagnostic, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety Study
Primary Outcome Measure  Effect of BMS-394136 on atrial refractoriness (atrial effective refractory period)
Secondary Outcome Measure  Effect of BMS-394136 on atrial vs ventricular refractoriness
Effect of BMS-394136 on the QTc interval
Assess the safety and tolerability of a single dose of BMS-394136
Explore the relationship between plasma concentration of BMS-394136 and refractoriness
Condition  Heart Diseases
Intervention  Drug: BMS-394136
Drug: Placebo
MEDLINE PMIDs
Links BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Completed
Enrollment  36
Start Date  January 2005
Completion Date
Eligibility Criteria 

Inclusion Criteria:

  • Patients with dual-chamber pacemakers or defibrillators

Exclusion Criteria:

  • Recent acute ischemic events
  • Recent atrial or ventricular arrhythmias
  • Uncompensated heart failure
  • Amiodarone use within last year
  • Women of childbearing potential
  • QTc <430 msec males
  • QTc <450 msec females
Gender Both
Ages 18 Years to 80 Years
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00162448
Organization ID CV175-003
Secondary IDs ††
Study Sponsor  Bristol-Myers Squibb
Collaborators ††
Investigators 
Information Provided By Bristol-Myers Squibb
Verification Date August 2008
First Received Date  September 9, 2005
Last Updated Date August 18, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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