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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
134
Tablets administered orally twice daily.
Capsule administered orally twice daily
Tablets administered orally twice daily.
Atrial Fibrillation Burden (AFB) at Baseline
AFB was defined as the total time a participant was in atrial tachycardia (AT)/atrial fibrillation (AF) expressed as a percentage of total recording time. Geometric mean is the mean of log-transformed AFB exponentiated.
Time frame: Baseline
Percent Change From Baseline in Atrial Fibrillation Burden (AFB) by Week 12
AFB was defined as the total time a participant was in atrial tachycardia (AT)/atrial fibrillation (AF) expressed as a percentage of total recording time. Data are presented for baseline-adjusted AFB over 12 weeks of treatment. Geometric mean is the mean of log-transformed AFB exponentiated.
Time frame: Baseline; Week 12
Absolute Change From Baseline in AFB by Week 12
AFB is defined as the total time a participant is in AT/AF expressed as a percentage of total recording time. Data are presented for baseline-adjusted AFB over 12 weeks of treatment.
Time frame: Baseline; Week 12
Percentage of Participants Who Had ≥ 30%, ≥ 50%, or ≥ 70% Reduction From Baseline in AFB
AFB was defined as the total time a participant was in AT/AF expressed as a percentage of total recording time.
Time frame: Week 12
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Capsules administered orally twice daily
Investigational Site
Beverly Hills, California, United States
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Newport Beach, California, United States
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Takoma Park, Maryland, United States
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Utica, New York, United States
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Cleveland, Ohio, United States
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