Status:
COMPLETED
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
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Heart Diseases
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
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
Eligibility Criteria
Inclusion
- Patients with dual-chamber pacemakers or defibrillators
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00162448
Start Date
January 1 2005
Last Update
August 20 2008
Active Locations (3)
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1
Local Institution
Salisbury, Maryland, United States
2
Local Institution
Ann Arbor, Michigan, United States
3
Local Institution
Columbus, Ohio, United States