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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Brief Summary

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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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Detailed Description

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Conditions

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Heart Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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A1

Group Type EXPERIMENTAL

BMS-394136

Intervention Type DRUG

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

A2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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BMS-394136

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No