NCT02156076

A Blinded Study to Evaluate Effect on Atrial Fibrillation Burden in Patients With Paroxysmal Atrial Fibrillation

A Randomized, Double-Blind, Placebo-Controlled Parallel Arm Study to Evaluate the Safety, Tolerability, and Effect on Atrial Fibrillation Burden of BMS-919373 in Patients With Paroxysmal Atrial Fibrillation

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 158 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Paroxysmal Atrial Fibrillation

Interventions

Type	Name	Description
DRUG	BMS-919373
DRUG	Placebo (Matching with BMS-919373)

Timeline

• Start date: 2014-07-25
• Primary completion: 2016-06-01
• Completion: 2016-06-01
• First posted: 2014-06-05
• Last updated: 2019-07-31
• Results posted: 2019-05-22

Locations

35 sites across 2 countries: United States, Canada