drugset / Trial / NCT02156076

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

NCT02156076

Phase 2 Terminated 158 enrolled Bristol-Myers Squibb
RandomizedParallel-groupQuadruple-blindOther

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.

Timeline

Start
2014-07-25
Primary completion
2016-06-01
Completion
2016-06-01

Drugs

EvaluationDrugModalityDoseRoute
Subject BMS-919373 Small molecule 3 mg Oral
Subject BMS-919373 Small molecule 5 mg Oral
Subject BMS-919373 Small molecule 12 mg Oral