NCT01522651

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 134 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
DRUG	Ranolazine	Tablets administered orally twice daily.
DRUG	Dronedarone	Capsule administered orally twice daily
DRUG	Ranolazine placebo	Tablets administered orally twice daily.
DRUG	Dronedarone placebo	Capsules administered orally twice daily

Timeline

• Start date: 2012-01-24
• Primary completion: 2014-03-10
• Completion: 2014-03-10
• First posted: 2012-01-31
• Last updated: 2020-11-06
• Results posted: 2020-11-06

Locations

50 sites across 7 countries: United States, Germany, Israel, Italy, Netherlands, Poland, United Kingdom

Regulatory

• FDA-regulated drug study