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.

First Received: September 9, 2005 Last Updated: August 18, 2008 History of Changes

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00162448

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 I

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety Study
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:

MedlinePlus related topics: Heart Diseases

U.S. FDA Resources

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
A1: Experimental	Drug: BMS-394136 Oral Solution, Oral, 100 mg, Single dose, 1 day.
A2: Placebo Comparator	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

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:

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

No publications provided

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

Keywords provided by Bristol-Myers Squibb:

Patients requiring dual-chamber pacemakers or defibrillators

Study placed in the following topic categories:

Heart Diseases

Additional relevant MeSH terms:

Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 11, 2009