Not Signed In -
Pacemakers and Implantable Defibrillators |
Defibrillators, Implantable; Implantable Defibrillators |
Clinical Trial: A Phase I Study to Assess the Electrophysiologic Effects of BMS-394136 on the Atrium and Ventricle in Patients with Dual-Chamber Pacemakers or Difibrillators.
This study is currently recruiting patients.
Verified by Bristol-Myers Squibb September 2005
|
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 |
|---|---|---|
| Patients requiring dual-chamber pacemakers or defibrillators | Drug: BMS-394136 | Phase I |
MedlinePlus consumer health information
Study Type: Interventional
Study Design: Diagnostic, Randomized, Double-Blind, 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
Further Study Details:
Primary Outcomes: Effect of BMS-394136 on atrial refractoriness (atrial effective refractory period)
Secondary Outcomes: 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
Expected Total Enrollment: 36
Secondary Outcomes: 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
Expected Total Enrollment: 36
Study start: January 2005
Eligibility
Ages Eligible for Study: 18 Years - 80 Years, Genders Eligible for Study: Both
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
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00162448
BMS Call Center 1-866-892-1BMS Ext. 193
BMS Call Center Outside the US and Canada 1-215-347-4079 Ext. 193
BMS Call Center Outside the US and Canada 1-215-347-4079 Ext. 193
Maryland
Local Institution, Salisbury, Maryland, United States; Recruiting
Michigan
Local Institution, Ann Arbor, Michigan, United States; Recruiting
Ohio
Local Institution, Columbus, Ohio, United States; Recruiting
More Information
Study ID Numbers: CV175-003; NA
Last Updated: September 12, 2005
Record first received: September 9, 2005
ClinicalTrials.gov Identifier: NCT00162448
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-13
Last Updated: September 12, 2005
Record first received: September 9, 2005
ClinicalTrials.gov Identifier: NCT00162448
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-13
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