Conditions: Paroxysmal Atrial Fibrillation
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 158
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the effect of BMS-919373 on atrial fibrillation (AF) through its effect on AF burden (AFB), or the percent of time in AF, in subjects with paroxysmal AF (pAF) when administered orally at a range of doses (2 mg once daily (QD), 5 mg QD, 12 mg QD following a 1-week period of loading doses of 3 mg QD, 8 mg QD and 20 mg QD, respectively) for a total of 4 weeks. It is hypothesized that treatment with BMS-919373 will reduce AF burden as compared to baseline relative to placebo.

Detailed description:
Primary Purpose: Protocol designed to assess, by the use of long term non-invasive beat-to-beat monitoring with the SEEQ Mobile Cardiac Telemetry (MCT) system, the effect of BMS-919373 on the percent change from baseline relative to placebo of atrial fibrillation burden in subjects with paroxysmal atrial fibrillation.

Arms:
arm 1: Placebo (Matching with BMS-919373) 0 mg tablets orally once daily for approximately 28 Days arm 2: BMS-919373 3 mg tablets orally once daily for approximately 28 days arm 3: BMS-919373 5 mg tablets orally once daily for approximately 28 days arm 4: BMS-919373 12 mg tablets orally once daily for approximately 28 days

Interventions: intervention 1: BMS-919373 intervention 2: Placebo (Matching with BMS-919373)
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document: