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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb

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