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
- Registration Number
- NCT00162448
- Lead Sponsor
- Bristol-Myers Squibb
- 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
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A2 Placebo - A1 BMS-394136 -
- Primary Outcome Measures
Name Time Method Effect of BMS-394136 on atrial refractoriness (atrial effective refractory period)
- Secondary Outcome Measures
Name Time Method Assess the safety and tolerability of a single dose of BMS-394136 Effect of BMS-394136 on atrial vs ventricular refractoriness Effect of BMS-394136 on the QTc interval Explore the relationship between plasma concentration of BMS-394136 and refractoriness
Trial Locations
- Locations (1)
Local Institution
🇺🇸Columbus, Ohio, United States