drugset / Trial / NCT01534962

Ranolazine in Atrial Fibrillation Following An ELectricaL CardiOversion

NCT01534962

Phase 2 Completed 241 enrolled Menarini Group
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Dose-ranging Phase II study testing the efficacy and safety of 3 doses of Ranolazine (low, intermediate and high, given BID) versus placebo in maintaining sinus rhythm after successful electrical cardioversion in patients with persistent atrial fibrillation (AFib). After successful cardioversion and subsequent randomisation, patients report trans-telephonic EGCs on a daily basis to a central core ECG facility. Maximum treatment duration is 112 days (16 weeks).

Timeline

Start
2012-01
Primary completion
2013-10
Completion
2014-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Ranolazine Small molecule 375 mg Oral
Subject Ranolazine Small molecule 500 mg Oral
Subject Ranolazine Small molecule 750 mg Oral