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

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00162448
First received: September 9, 2005
Last updated: August 18, 2008
Last verified: August 2008
  Purpose

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


Condition Intervention Phase
Heart Diseases
Drug: BMS-394136
Drug: Placebo
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Effect of BMS-394136 on atrial refractoriness (atrial effective refractory period)

Secondary Outcome Measures:
  • Effect of BMS-394136 on atrial vs ventricular refractoriness
  • Effect of BMS-394136 on the QTc interval
  • Assess the safety and tolerability of a single dose of BMS-394136
  • Explore the relationship between plasma concentration of BMS-394136 and refractoriness

Estimated Enrollment: 36
Study Start Date: January 2005
Arms Assigned Interventions
Experimental: A1 Drug: BMS-394136
Oral Solution, Oral, 100 mg, Single dose, 1 day.
Placebo Comparator: A2 Drug: Placebo
Oral Solution, Oral, 0 mg, Single dose, 1 day.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00162448

Locations
United States, Maryland
Local Institution
Salisbury, Maryland, United States
United States, Michigan
Local Institution
Ann Arbor, Michigan, United States
United States, Ohio
Local Institution
Columbus, Ohio, United States
Sponsors and Collaborators
Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00162448     History of Changes
Other Study ID Numbers: CV175-003
Study First Received: September 9, 2005
Last Updated: August 18, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:
Patients requiring dual-chamber pacemakers or defibrillators

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 26, 2014