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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

NCT ID: NCT00162448

Last Updated: 2008-08-20

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

Detailed Description

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Conditions

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Heart Diseases

Keywords

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Patients requiring dual-chamber pacemakers or defibrillators

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

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Locations

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Local Institution

Salisbury, Maryland, United States

Site Status

Local Institution

Ann Arbor, Michigan, United States

Site Status

Local Institution

Columbus, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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CV175-003

Identifier Type: -

Identifier Source: org_study_id