NCT01356914
Completed
Phase 2
Randomized, Double-Blind, Placebo-Controlled, 4-Way Crossover Study to Evaluate the Safety, Tolerability and Effect on Atrial Fibrillation Burden of BMS-914392 in Patients With Paroxysmal Atrial Fibrillation and Permanent Pacemaker
Overview
- Phase
- Phase 2
- Intervention
- BMS-914392
- Conditions
- Atrial Fibrillation
- Sponsor
- Bristol-Myers Squibb
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Atrial Fibrillation Burden
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
The purpose of the study is to determine whether treatment with BMS-914392 is safe, well tolerated and associated with a reduction of atrial fibrillation burden in patients with paroxysmal atrial fibrillation and permanent pacemaker.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Paroxysmal atrial fibrillation (AF)
- •Programmable dual chamber pacemaker with appropriate arrhythmia diagnostics.
- •1-50% AF burden on pacemaker interrogation at screening.
- •Women of childbearing potential (WOCBP) and men must be using an acceptable method of contraception to avoid pregnancy.
Exclusion Criteria
- •Persistent or permanent AF.
- •AF Burden \<1% or \> 50%.
- •Current or history of neurological diseases and mental disorders.
- •Ejection Fraction \< 45%.
- •Severe mitral or aortic valve dysfunction.
- •TIA (Transient Ischemic Attack) within last 12 months.
- •Acute coronary syndrome in the last 2 months.
- •Previous AF ablation.
- •Cardioversion in last 3 months.
- •Current kidney or liver disease, or current cancer.
Arms & Interventions
Treatment A: BMS-914392
Intervention: BMS-914392
Treatment B: BMS-914392
Intervention: BMS-914392
Treatment C: BMS-914392
Intervention: BMS-914392
Treatment D: Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Atrial Fibrillation Burden
Time Frame: On Day 22 of each cross-over period
Secondary Outcomes
- Number of participants with adverse events and type of adverse events(At Day 22 of each cross-over period)
- Number of Atrial fibrillation (AF) episodes(At Day 1 of each cross-over period)
- Number of AF episodes(At Day 22 of each cross-over period)
- Duration of AF episodes(At Day 22 of each cross-over period)
- Heart Rate(At Day 22 of each cross-over period)
- Severity of AF (SAF) scale score at the end of each study period(At Day 22 of each cross-over period)
- Electrocardiogram (ECG) intervals (PR, QRS, RR, QT, QTc)(At Day 22 of each cross-over period)
- BMS-914392 plasma concentrations and exposures during each study period(At Days 1, 8 and 22 of each cross-over period)
Study Sites (1)
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