CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 134 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/NCT01522651
NCT01522651Phase 2Completed
CompareCT.gov

A Phase 2, Proof of Concept, Randomized, Placebo-Controlled, Parallel Group Study to Evaluate the Effect of Ranolazine and Dronedarone When Given Alone and in Combination on Atrial Fibrillation Burden in Subjects With Paroxysmal Atrial Fibrillation

Gilead Sciences·interventional·Posted Jan 31, 2012·Updated Nov 6, 2020

In Brief

A Phase 2 clinical trial evaluating Ranolazine, Dronedarone, and 2 other interventions for Atrial Fibrillation. Completed, enrolled 134 participants across 50 sites in 7 countries.

Detailed Summary

The primary objective of this study is to evaluate the effect of ranolazine and of low-dose dronedarone when given alone and in combination at different dose levels on atrial fibrillation burden (AFB) over 12 weeks of treatment. AFB is defined as the total time a participant is in atrial tachycardia/atrial fibrillation (AT/AF) expressed as a percentage of total recording time.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtrial Fibrillation
CountriesGermany, Israel, Italy, Netherlands, Poland, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJan 31, 2012
Enrollment StartJan 24, 2012
Primary CompletionMar 10, 2014
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 14.4 years ago

Interventions

Ranolazinedrug

Tablets administered orally twice daily.

Dronedaronedrug

Capsule administered orally twice daily

Ranolazine placebodrug

Tablets administered orally twice daily.

Dronedarone placebodrug

Capsules administered orally twice daily