CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 241 enrolled
Drug / intervention
Ranolazine +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01534962
NCT01534962Phase 2Completed

A Randomised, Double-blind, Double-dummy, Placebo-controlled, Dose-ranging Phase II Study Assessing Ranolazine in the Maintenance of Sinus Rhythm After Electrical Cardioversion in Patients With Non-permanent Atrial Fibrillation.

Menarini Group·interventional·Posted Feb 17, 2012·Updated Aug 19, 2014

In Brief

A Phase 2 clinical trial evaluating Ranolazine and Placebo for Persistent Atrial Fibrillation. Completed, enrolled 241 participants across 4 sites in 4 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesGermany, Italy, Spain, United Kingdom
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedFeb 17, 2012
Enrollment StartJan 1, 2012
Primary CompletionOct 1, 2013
Study CompletionMar 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 14.4 years ago

Interventions

Ranolazinedrug

Oral administration, BID; for a maximum of 112 days.

Ranolazinedrug

Oral administration, BID; for a maximum of 112 days.

Ranolazinedrug

Oral administration, BID; for a maximum of 112 days.

Placebodrug

Oral administration, BID; for a maximum of 112 days.