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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   Information provided by Bristol-Myers Squibb
First Received: September 9, 2005   Last Updated: August 18, 2008   History of Changes

September 9, 2005
August 18, 2008
January 2005
 
Effect of BMS-394136 on atrial refractoriness (atrial effective refractory period)
Same as current
Complete list of historical versions of study NCT00162448 on ClinicalTrials.gov Archive Site
  • 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
Same as current
 
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
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

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

 
Phase I
Interventional
Diagnostic, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety Study
Heart Diseases
  • Drug: BMS-394136
  • Drug: Placebo
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
36
 
 

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00162448
 
CV175-003
Bristol-Myers Squibb
 
 
Bristol-Myers Squibb
August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP