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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Fibrillation, Atrial

Treatments: Drug: Placebo; Drug: omega-3-acid ethyl esters

Study type: Interventional

Funder types: Industry

Identifiers

NCT00402363

OM8 Afib

Details and patient eligibility

About

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.

Enrollment: 663 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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663 participants in 2 patient groups, including a placebo group

omega-3-acid ethyl esters

Experimental group

Treatment:

Drug: omega-3-acid ethyl esters

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo