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Omega-3-acid ethyl esters

Generic Name
Omega-3-acid ethyl esters
Brand Names
Lovaza, Omtryg
Drug Type
Small Molecule
CAS Number
308081-97-2
Unique Ingredient Identifier
D87YGH4Z0Q
Background

Omega-3-acid ethyl esters are prescription drugs that contain eicosapentaenoic acid-ethyl ester (EPA) and docosahexaenoic acid-ethyl ester (DHA) that are used in combination with changes in diet to lower triglyceride levels in adults with severe (≥ 500 mg/dL) hypertriglyceridemia. Omega-3-acid ethyl esters are currently marketed in the US, EU, and many other regions under the brand name Lovaza.

Indication

Omega-3-Acid Ethyl Esters capsules, USP are indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia (HTG).

Associated Conditions
Severe Hypertriglyceridemia (sHTG)

Human Immunodeficiency Virus (HIV), Arterial Dysfunction, Lipids, Lovaza (HALO) Trial

Phase 4
Completed
Conditions
Cardiovascular Disease
HIV Infection
Interventions
Drug: Placebo
First Posted Date
2008-11-21
Last Posted Date
2019-09-11
Lead Sponsor
Tufts University
Target Recruit Count
41
Registration Number
NCT00795717
Locations
🇺🇸

Tufts University School of Medicine, Boston, Massachusetts, United States

Effects of Fish Oil on Post Ablation Arrhythmias

Phase 4
Terminated
Conditions
Atrial Fibrillation
Interventions
First Posted Date
2008-11-14
Last Posted Date
2017-09-12
Lead Sponsor
University of Michigan
Target Recruit Count
12
Registration Number
NCT00791089
Locations
🇺🇸

University of Michigan Cardiovascular Center, Ann Arbor, Michigan, United States

The Effects of Omega-3 Fatty Acids on Aspirin Resistance

Phase 1
Completed
Conditions
Increased Drug Resistance
Interventions
Drug: Both Aspirin and Lovaza
Other: Placebo
First Posted Date
2008-10-15
Last Posted Date
2012-11-06
Lead Sponsor
University of Rochester
Target Recruit Count
27
Registration Number
NCT00771914
Locations
🇺🇸

University of Rochester School of Medicine and Dentistry, Rochester, New York, United States

Women With Chest Pain and Normal Coronary Arteries Study

Not Applicable
Terminated
Conditions
Chest Pain
Interventions
Behavioral: Therapeutic Lifestyle Changes
First Posted Date
2008-08-28
Last Posted Date
2023-12-12
Lead Sponsor
Northwestern University
Target Recruit Count
3
Registration Number
NCT00743197
Locations
🇺🇸

Northwestern University, Chicago, Illinois, United States

Nutritional Supplements and Hormonal Manipulations for Breast Cancer Prevention

Not Applicable
Completed
Conditions
Breast Cancer
Interventions
First Posted Date
2008-07-28
Last Posted Date
2018-11-01
Lead Sponsor
Milton S. Hershey Medical Center
Target Recruit Count
266
Registration Number
NCT00723398
Locations
🇺🇸

Penn State Hershey Medical Center, Hershey, Pennsylvania, United States

Study of Fish Oil to Reduce ALT Levels in Adolescents

Phase 1
Terminated
Conditions
Non-alcoholic Fatty Liver Disease
Fatty Liver
Interventions
First Posted Date
2008-06-10
Last Posted Date
2016-01-29
Lead Sponsor
Boston University
Target Recruit Count
3
Registration Number
NCT00694746
Locations
🇺🇸

Boston University Medical Center, Boston, Massachusetts, United States

Trial of Lovaza in Adolescents With Mild to Moderately Elevated Triglycerides

Phase 2
Terminated
Conditions
Hypertriglyceridemia
Interventions
Drug: Placebo
First Posted Date
2008-05-06
Last Posted Date
2013-05-29
Lead Sponsor
Boston Children's Hospital
Target Recruit Count
25
Registration Number
NCT00672633
Locations
🇺🇸

Children's Hospital Boston, Boston, Massachusetts, United States

Effects of Fatty Acid Delivery on Heart Metabolism and Function in Type 2 Diabetes (T2DM

Not Applicable
Completed
Conditions
Diabetes Mellitus, Type II
Interventions
First Posted Date
2007-12-20
Last Posted Date
2018-08-31
Lead Sponsor
Washington University School of Medicine
Target Recruit Count
78
Registration Number
NCT00577590
Locations
🇺🇸

Washington University in St. Louis, Saint Louis, Missouri, United States

Lovaza Therapy of Peripheral Arterial Disease

Not Applicable
Withdrawn
Conditions
Peripheral Artery Disease
Interventions
Drug: placebo
First Posted Date
2007-12-07
Last Posted Date
2018-05-07
Lead Sponsor
University of Virginia
Registration Number
NCT00569686
Locations
🇺🇸

University of Virginia Health System, Charlottesville, Virginia, United States

Lovaza's Effect on the Activation of Platelets

Phase 2
Completed
Conditions
Cardiovascular Disease
Bleeding
Interventions
First Posted Date
2007-08-13
Last Posted Date
2013-07-09
Lead Sponsor
Invitrox
Target Recruit Count
43
Registration Number
NCT00515541
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