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

Heart Diseases Clinical Trial

Official title:

Double-Blind, Randomized, Single-Dose Study to Evaluate the Atrial Selectivity and Safety of BMS-394136 in Patients With Implanted Dual-Chamber Pacemakers or Defibrillators

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00162448
• Other study ID #: CV175-003
• Status: Completed
• Phase: Phase 1
• First received: September 9, 2005
• Last updated: August 18, 2008
• Start date: January 2005

Study information

• Verified date: August 2008
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Heart Diseases

Intervention

Drug:
• BMS-394136
Oral Solution, Oral, 100 mg, Single dose, 1 day.
• Placebo
Oral Solution, Oral, 0 mg, Single dose, 1 day.

Locations

Country	Name	City	State
United States	Local Institution	Ann Arbor	Michigan
United States	Local Institution	Columbus	Ohio
United States	Local Institution	Salisbury	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of BMS-394136 on atrial refractoriness (atrial effective refractory period)
Secondary	Effect of BMS-394136 on atrial vs ventricular refractoriness
Secondary	Effect of BMS-394136 on the QTc interval
Secondary	Assess the safety and tolerability of a single dose of BMS-394136
Secondary	Explore the relationship between plasma concentration of BMS-394136 and refractoriness

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm