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 - Tabular View

Tracking Information
First Received Date ^ICMJE	September 9, 2005
Last Updated Date	August 18, 2008
Start Date ^ICMJE	January 2005
Primary Completion Date
Current Primary Outcome Measures ^ICMJE (submitted: September 11, 2005)	Effect of BMS-394136 on atrial refractoriness (atrial effective refractory period)
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00162448 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: September 11, 2005)	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
Original Secondary Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	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 ^ICMJE	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 ^ICMJE	Interventional
Study Design ^ICMJE	Diagnostic, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety Study
Condition ^ICMJE	Heart Diseases
Intervention ^ICMJE	Drug: BMS-394136 Drug: Placebo
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	36
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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 ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00162448
Responsible Party
Study ID Numbers ^ICMJE	CV175-003
Study Sponsor ^ICMJE	Bristol-Myers Squibb
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Bristol-Myers Squibb
Verification Date	August 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP