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

• Status: Completed
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline

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