Status:
COMPLETED
Evaluation of Efficacy and Safety of Lovaza (Omega-3-Acid Ethyl Esters) in Recurrent, Symptomatic Atrial Fibrillation
Lead Sponsor:
GlaxoSmithKline
Conditions:
Fibrillation, Atrial
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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
- 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
- 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
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
663 Patients enrolled
Trial Details
Trial ID
NCT00402363
Start Date
November 1 2006
End Date
January 1 2010
Last Update
January 30 2017
Active Locations (178)
Enter a location and click search to find clinical trials sorted by distance.
1
GSK Investigational Site
Birmingham, Alabama, United States, 35215
2
GSK Investigational Site
Huntsville, Alabama, United States, 35801
3
GSK Investigational Site
Anchorage, Alaska, United States, 99508
4
GSK Investigational Site
Cottonwood, Arizona, United States, 86326