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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)

Interaction of Epanova on Warfarin Pharmacokinetic and Anticoagulant Activity and Comparison of the Effects of Epanova and Lovaza on Eicosapentaenoic Acid (EPA) and Docosahexaenoic Acid (DHA) After Low-fat Meals

Phase 1
Completed
Conditions
Hypertriglyceridemia
Interventions
First Posted Date
2011-09-09
Last Posted Date
2015-04-24
Lead Sponsor
AstraZeneca
Target Recruit Count
52
Registration Number
NCT01431690

Efficacy Study to Treat Subjects With Severe Hypertriglyceridemia

Phase 3
Conditions
Severe Hypertriglyceridemia
Interventions
First Posted Date
2010-10-27
Last Posted Date
2011-11-24
Lead Sponsor
Trygg Pharma, Inc.
Target Recruit Count
240
Registration Number
NCT01229566
Locations
🇺🇸

Illinois Recruiting, Chicago, Illinois, United States

Epanova® Compared to Lovaza® In a Pharmacokinetic, Single-dose, Evaluation

Phase 2
Completed
Conditions
Severe Hypertriglyceridemia
Interventions
Drug: Epanova (4 g) and Lovaza (4 g)
First Posted Date
2010-09-24
Last Posted Date
2015-07-15
Lead Sponsor
AstraZeneca
Target Recruit Count
54
Registration Number
NCT01208961
Locations
🇺🇸

Radiant Research, Chicago, Illinois, United States

Investigational Study of Oral Fish Oil in Treating Parenteral Nutrition Associated Liver Disease

Phase 1
Withdrawn
Conditions
Liver Disease
Short Bowel Syndrome
Interventions
Dietary Supplement: Corn oil
First Posted Date
2010-08-30
Last Posted Date
2017-06-22
Lead Sponsor
Boston Children's Hospital
Registration Number
NCT01191177
Locations
🇺🇸

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

Effects of Lovaza on High Density Lipoprotein (HDL) Composition and Function in Hypertriglyceridemia

Phase 4
Withdrawn
Conditions
Hypertriglyceridemia
Interventions
First Posted Date
2010-08-12
Last Posted Date
2016-02-08
Lead Sponsor
University of Utah
Registration Number
NCT01180764
Locations
🇺🇸

University of Utah, Salt Lake City, Utah, United States

Parenteral Nutrition Associated Liver Disease: Early Markers and Therapy Wih Enteral Omega-3 Supplementation

Not Applicable
Conditions
Parenteral Nutrition Associated Liver Disease
Interventions
First Posted Date
2010-07-07
Last Posted Date
2011-06-17
Lead Sponsor
University of Tennessee
Target Recruit Count
100
Registration Number
NCT01157780
Locations
🇺🇸

Le Bonheur Children's Medical Center, Memphis, Tennessee, United States

The Effects of Lovaza® in Acute Myocardial Infarction

Phase 1
Terminated
Conditions
Myocardial Infarction
Interventions
Drug: The placebo contained 1 gram of corn oil in each capsule.
First Posted Date
2010-07-01
Last Posted Date
2017-11-06
Lead Sponsor
University of Rochester
Target Recruit Count
4
Registration Number
NCT01155336
Locations
🇺🇸

University or Rochester, Rochester, New York, United States

Oral Omega-3 Fatty Acids in the Treatment of Dry Eye Syndrome

Not Applicable
Completed
Conditions
Dry Eye Syndrome
Interventions
Drug: Placebo corn oil capsule
First Posted Date
2010-04-21
Last Posted Date
2017-12-22
Lead Sponsor
Milton S. Hershey Medical Center
Target Recruit Count
27
Registration Number
NCT01107964
Locations
🇺🇸

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

Fenofibrate and Omega-3 Fatty Acid Modulation of Endotoxemia

Not Applicable
Completed
Conditions
Cardiovascular Disease
Interventions
First Posted Date
2010-01-13
Last Posted Date
2016-02-19
Lead Sponsor
University of Pennsylvania
Target Recruit Count
100
Registration Number
NCT01048502
Locations
🇺🇸

Clinical and Translational Research Center (CTRC); Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, United States

Pilot Study of Lovaza (Omega 3 Fatty Acids) to Improve Cardiac Antioxidant/Anti-inflammatory Profile Before Cardiac Surgery

Phase 4
Conditions
Left Atrium Dilatation and Hypertrophy
Cardiomyocyte Apoptosis
Cardiac Inflammation
Mitochondrial Dysfunction in the Heart
Mitral Valve Regurgitation
Interventions
First Posted Date
2010-01-12
Last Posted Date
2013-09-10
Lead Sponsor
East Carolina University
Target Recruit Count
24
Registration Number
NCT01046604
Locations
🇺🇸

Brody School of Medicine, Greenville, North Carolina, United States

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