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

Completed · Phase 1 · Has a placebo group

Conditions studied: Heart Diseases

In brief

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

Key facts

Study ID

NCT00162448

Run by

Bristol-Myers Squibb

People needed

36

Starts

2005-01-01

Last updated by the study team

2008-08-20

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with dual-chamber pacemakers or defibrillators

You may not qualify if…

• 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

Where it is running

• Local Institution — Salisbury, Maryland, United States
• Local Institution — Ann Arbor, Michigan, United States
• Local Institution — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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