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

NCT01522651 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 134

Last updated 2020-11-06

Study results available
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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

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Gilead Study Director · Gilead Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-24
Primary Completion
2014-03-10
Completion
2014-03-10
FDA Drug
Yes

Countries

  • United States
  • Germany
  • Israel
  • Italy
  • Netherlands
  • Poland
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01522651 on ClinicalTrials.gov