drugset / Trial / NCT01522651

Study to Evaluate the Effect of Ranolazine and Dronedarone When Given Alone and in Combination in Patients With Paroxysmal Atrial Fibrillation

NCT01522651

Phase 2 Completed 134 enrolled Gilead Sciences
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2012-01-24
Primary completion
2014-03-10
Completion
2014-03-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Dronedarone Small molecule 150 mg Oral
Subject Dronedarone Small molecule 225 mg Oral
Subject Ranolazine Small molecule 750 mg Oral

Indications