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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Heart Diseases

Treatments: Drug: Placebo; Drug: BMS-394136

Study type: Interventional

Funder types: Industry

Identifiers

NCT00162448

CV175-003

Details and patient eligibility

About

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

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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36 participants in 2 patient groups, including a placebo group

A1

Experimental group

Treatment:

Drug: BMS-394136

A2

Placebo Comparator group

Treatment:

Drug: Placebo