drugset / Trial / NCT01831856

Efficacy and Safety Study of F373280

NCT01831856 ↗

Phase 2 Completed 135 enrolled Pierre Fabre Laboratories
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to assess the efficacy of F373280 on the maintenance of normal cardiac rhythm after direct electric cardioversion in patients with persistent atrial fibrillation and cardiac failure.

Timeline

Start
2013-04
Primary completion
2017-04-03
Completion
2017-06-21

Outcome

Missed primary endpoint

registry analysis (superiority test); F373280 vs Placebo; p = 0.5749; Hazard Ratio (HR) 1.14 (95% CI 0.71 to 1.85); Log Rank NCT01831856 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject F373280 Unknown 1 g Oral

Indications