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US Department of Justice
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Generated: October 16, 2018

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CLINICAL TRIALS PROFILE FOR OMEGA-3-ACID ETHYL ESTERS

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Clinical Trials for OMEGA-3-ACID ETHYL ESTERS

Trial ID Title Status Sponsor Phase Summary
NCT00000473 Do Fish Oils Prevent Restenosis Post-Coronary Angioplasty? Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 3 To determine whether a dietary supplement of n-3 polyunsaturated fatty acids (PUFAs) derived from fish oil would decrease the restenosis rate in patients undergoing percutaneous transluminal coronary angioplasty (PTCA).
NCT00001146 Omega-3 Fatty Acids in the Treatment of Bipolar Disorder: A Double-Blind, Placebo-Controlled Trial Completed National Institute of Mental Health (NIMH) Phase 2 This study will examine the effectiveness of omega-3 fatty acids, compounds found in plants and fish, in treating bipolar disorder. Some studies have indicated that omega-3 fatty acids may be effective in treating mood disorders. For example, one investigator has shown a correlation between the prevalence of major depression and the amount of fish consumed per capita worldwide. Others have found decreased amounts of EPA (one of the active ingredients in omega-3 fatty acids) in the red blood cells of patients with major depression. And a recent small study of patients with bipolar illness indicated that omega-3 fatty acids prevented relapses, especially of depression, in patients. Patients with bipolar disorder who are not benefiting satisfactorily on their current medications are eligible to participate in this study. Candidates will be screened with a psychiatric evaluation, routine blood tests, a urine test and other tests needed to monitor medications. Participants will be randomly assigned to one of two groups: one group will receive 6 grams of omega-3 fatty acid every day for 16 weeks; the second will receive a placebo (inactive capsule). In addition, patients in both groups will continue to take their previous medications. Every 2 weeks, all patients will have their vital signs checked and be evaluated for side effects and mood changes. At the end of the 16-week study period, all patients will be given the opportunity to continue in the study for another 8 months and receive active drug (omega-3 fatty acid). Patients who continue will be evaluated once a month and will have blood drawn on the last visit for routine tests.
NCT00074542 An Efficacy and Safety Study of Omega-3 Free Fatty Acids (Epanova™) for the Maintenance of Symptomatic Remission in Subjects With Crohn's Disease Completed Tillotts Pharma AG Phase 3 The purpose of this study is to see if Epanova™ is able to maintain the symptomatic remission in subjects with Crohn's Disease who are responding to steroid induction therapy. Patient safety and quality of life will also be monitored throughout the study.
NCT00246636 Evaluation of Efficacy and Safety of Omacor (Omega-3-acid Ethyl Esters) as Add-on Therapy in Hypertriglyceridemic Subjects Treated With Antara (Fenofibrate) Followed by an 8-week Extension Completed GlaxoSmithKline Phase 4 The purpose of OM5/LOV111859 was to evaluate efficacy and safety of Omacor (omega-3-acid ethyl esters) as add-on therapy to Antara (fenofibrate) and diet for the treatment of patients with very high triglycerides. The purpose of both OM5X/LOV111860 was to assess the continued efficacy and safety of adjunctive Lovaza (omega-3-acid ethyl esters) therapy in hypertriglyceridemic subjects treated with fenofibrate in lowering serum triglyceride (TG) levels.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for OMEGA-3-ACID ETHYL ESTERS

Condition Name

Condition Name for OMEGA-3-ACID ETHYL ESTERS
Intervention Trials
Hypertriglyceridemia 10
Hyperlipidemia 4
Psoriasis 3
Breast Cancer 3
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Condition MeSH

Condition MeSH for OMEGA-3-ACID ETHYL ESTERS
Intervention Trials
Hypertriglyceridemia 14
Psoriasis 6
Hyperlipidemias 4
Diabetes Mellitus 4
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Clinical Trial Locations for OMEGA-3-ACID ETHYL ESTERS

Trials by Country

Trials by Country for OMEGA-3-ACID ETHYL ESTERS
Location Trials
United States 108
Canada 8
Germany 6
Brazil 3
Japan 3
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Trials by US State

Trials by US State for OMEGA-3-ACID ETHYL ESTERS
Location Trials
California 6
Pennsylvania 5
Ohio 5
Illinois 5
Texas 5
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Clinical Trial Progress for OMEGA-3-ACID ETHYL ESTERS

Clinical Trial Phase

Clinical Trial Phase for OMEGA-3-ACID ETHYL ESTERS
Clinical Trial Phase Trials
Phase 4 16
Phase 3 13
Phase 2/Phase 3 2
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Clinical Trial Status

Clinical Trial Status for OMEGA-3-ACID ETHYL ESTERS
Clinical Trial Phase Trials
Completed 37
Not yet recruiting 5
Recruiting 5
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Clinical Trial Sponsors for OMEGA-3-ACID ETHYL ESTERS

Sponsor Name

Sponsor Name for OMEGA-3-ACID ETHYL ESTERS
Sponsor Trials
GlaxoSmithKline 11
Takeda 4
AstraZeneca 3
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Sponsor Type

Sponsor Type for OMEGA-3-ACID ETHYL ESTERS
Sponsor Trials
Other 43
Industry 34
NIH 4
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Serving hundreds of leading biopharmaceutical companies globally:

Cipla
Johnson and Johnson
Chubb
US Army
McKesson
Teva
Covington
Boehringer Ingelheim
Chinese Patent Office

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