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Completed

NCT Number: NCT00162448

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

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

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Key information

Conditions

Heart Diseases Cardiovascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution, Salisbury, Maryland, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BMS-394136

Drug

Oral Solution, Oral, 100 mg, Single dose, 1 day.

Placebo

Drug

Oral Solution, Oral, 0 mg, Single dose, 1 day.

Primary outcomes

  1. Effect of BMS-394136 on atrial refractoriness (atrial effective refractory period)

Secondary outcomes

  1. Effect of BMS-394136 on atrial vs ventricular refractoriness

  2. Effect of BMS-394136 on the QTc interval

  3. Assess the safety and tolerability of a single dose of BMS-394136

  4. Explore the relationship between plasma concentration of BMS-394136 and refractoriness

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Important dates

Study start
2005
First posted
Sep 13, 2005
Registry last updated
Aug 20, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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