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

Completed · Phase 3 · Has a placebo group

Conditions studied: Fibrillation, Atrial

In brief

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.

Key facts

Study ID

NCT00402363

Run by

GlaxoSmithKline

People needed

663

Starts

2006-11-01

Expected to finish

2010-01-01

Last updated by the study team

2017-01-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• GSK Investigational Site — Huntsville, Alabama, United States
• GSK Investigational Site — Anchorage, Alaska, United States
• GSK Investigational Site — Cottonwood, Arizona, United States
• GSK Investigational Site — Mesa, Arizona, United States
• GSK Investigational Site — Phoenix, Arizona, United States
• GSK Investigational Site — Phoenix, Arizona, United States
• GSK Investigational Site — Phoenix, Arizona, United States
• GSK Investigational Site — Tucson, Arizona, United States
• GSK Investigational Site — Fort Smith, Arkansas, United States
• GSK Investigational Site — Hot Springs, Arkansas, United States
• GSK Investigational Site — Alamada, California, United States
• GSK Investigational Site — Bakersfield, California, United States
• GSK Investigational Site — Bakersfield, California, United States
• GSK Investigational Site — Beverly Hills, California, United States
• GSK Investigational Site — Carmichael, California, United States
• GSK Investigational Site — Fair Oaks, California, United States
• GSK Investigational Site — Fountain Valley, California, United States
• GSK Investigational Site — Loma Linda, California, United States
• GSK Investigational Site — Los Angeles, California, United States
• GSK Investigational Site — Los Angeles, California, United States
• GSK Investigational Site — Los Angeles, California, United States
• GSK Investigational Site — Los Angeles, California, United States
• GSK Investigational Site — Merced, California, United States
• GSK Investigational Site — Palm Springs, California, United States
• GSK Investigational Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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