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

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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

This Tabular View shows the required WHO registration data elements as marked by ^†

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 For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm

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.