NCT00162448

Brief 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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 13, 2005

Completed
Last Updated

August 20, 2008

Status Verified

August 1, 2008

First QC Date

September 9, 2005

Last Update Submit

August 18, 2008

Conditions

Heart Diseases

Keywords

Patients requiring dual-chamber pacemakers or defibrillators

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (4)

  • 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

Study Arms (2)

A1

EXPERIMENTAL
Drug: BMS-394136

A2

PLACEBO COMPARATOR
Drug: Placebo

Interventions

BMS-394136DRUG

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

A1
PlaceboDRUG

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

A2

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with dual-chamber pacemakers or defibrillators

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Local Institution

Salisbury, Maryland, United States

Location

Local Institution

Ann Arbor, Michigan, United States

Location

Local Institution

Columbus, Ohio, United States

Location

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 13, 2005

Study Start

January 1, 2005

Last Updated

August 20, 2008

Record last verified: 2008-08

Locations

US(3)