Phase 3 N=663 Randomized Double-blind Treatment

Evaluation of Efficacy and Safety of Lovaza (Omega-3-Acid Ethyl Esters) in Recurrent, Symptomatic Atrial Fibrillation

Fibrillation, Atrial

Bottom Line

View on ClinicalTrials.gov: NCT00402363 ↗

Enrolled (actual)

663

Serious AEs

6.8%

Results posted

Oct 2010

Primary outcome: Primary: Number of Participants With Paroxysmal AF With an Event of Documented Symptomatic Atrial Fibrillation (AF)/Flutter — 129; 135; 140; 123 participants — p=0.263

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: omega-3-acid ethyl esters (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: GlaxoSmithKline
Primary completion: Jan 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Paroxysmal AF With an Event of Documented Symptomatic Atrial Fibrillation (AF)/Flutter	129; 135; 140; 123	0.263
SECONDARY Number of Participants With Persistent AF and in Both AF Subgroups Combined With an Event of Documented Symptomatic AF/Flutter	18; 32; 147; 167; 36; 32	0.089
SECONDARY Number of Participants With Paroxysmal AF or Persistent AF With an Event of Documented Symptomatic AF (Exclusive of Atrial Flutter)	126; 133; 18; 30; 143; 125	0.213
SECONDARY Number of Participants in Both AF Subgroups Combined With an Event of Documented Symptomatic AF (Exclusive of Atrial Flutter)	144; 163; 179; 159	0.082
SECONDARY Number Participants With Paroxysmal or Persistent AF With an Event of Documented Symptomatic or Asymptomatic AF/Flutter	149; 153; 27; 40; 120; 105	0.331
SECONDARY Number of Participants in Both AF Subgroups Combined With an Event of Documented Symptomatic or Asymptomatic AF/Flutter	176; 193; 147; 129	0.168
SECONDARY Number of Participants With Paroxysmal or Persistent AF With an Event of Documented Symptomatic or Asymptomatic AF (Exclusive of Flutter)	146; 151; 27; 38; 123; 107	0.270
SECONDARY Number of Participants in Both AF Subgroups Combined With an Event of Documented Symptomatic or Asymptomatic AF (Exclusive of Flutter)	173; 189; 150; 133	0.167
SECONDARY Number of Participants With Paroxysmal or Persistent AF With an Event After Completion of Day 7 to the Occurrence of Symptomatic AF/Flutter	88; 87; 15; 27; 136; 118	0.565
SECONDARY Number of Participants in the Combined AF Subgroups With an Event After Completion of Day 7 to the Occurrence of Symptomatic AF/Flutter	103; 114; 170; 148	0.185
SECONDARY Number of Participants With Paroxysmal or Persistent AF With an Event That Occurred After Completion of Day 7 to the Occurrence of Symptomatic AF (Exclusive of Flutter)	86; 86; 15; 25; 139; 120	0.461
SECONDARY Number of Participants in the Combined AF Subgroups With an Event That Occurred After Completion of Day 7 to the Occurrence of Symptomatic AF (Exclusive of Flutter)	101; 111; 173; 152	0.188
SECONDARY Annualized Number of AF/Flutter Rescue Episodes During the Treatment Period	2.44; 4.17; 2.17; 2.24; 2.19; 4.01	0.290
SECONDARY Annualized Cumulative Frequency of Symptomatic AF/Flutter Recurrences During the Treatment Period	6.81; 8.32; 4.22; 4.35; 6.48; 6.52	0.218
SECONDARY Annualized Cumulative Frequency of Symptomatic AF Recurrences During the Treatment Period	6.91; 8.30; 4.22; 4.35; 6.48; 6.52	0.239

Summary

The purpose of this study is to evaluate efficacy and safety of Omacor (omega-3-acid ethyl esters) in patients with recurrent, symptomatic atrial fibrillation.

Eligibility Criteria

Inclusion Criteria

Men and women age 18 years or older
History of symptomatic atrial fibrillation (either paroxysmal or persistent)
Provide written informed consent and authorization for protected health information disclosure

Exclusion Criteria

Permanent (chronic) atrial fibrillation
Antiarrhythmic drug therapy which cannot be stopped
Use of amiodarone with prior 6 months
History of unsuccessful cardioversion
History of certain cardiovascular conditions or cardiac surgery within prior 6 months
History of stroke within prior 6 months
Implanted cardio-defibrillator
Certain circulatory, thyroid, pulmonary, liver, kidney, musculoskeletal or metabolic conditions, or cancer (except non-melanoma skin cancer)
Poorly controlled diabetes

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Data sourced from ClinicalTrials.gov (NCT00402363). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.