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Epanova® for Lowering Very High Triglycerides | Clinical Trials | Clareo Health

COMPLETEDPHASE2/PHASE3

Epanova® for Lowering Very High Triglycerides

Efficacy and Safety of Epanova® (Omefas) in Severe Hypertriglyceridemia

NCT01242527•AstraZeneca

Summary

The primary objective of the study is to determine the efficacy of Epanova (omefas) compared to placebo in lowering serum triglycerides in subjects with severe hypertriglyceridemia.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Men or women, \>=18 years of age.
•Very high serum TG values in the range \>=500 mg/dL and \<2000 mg/dL (\>=5.65 mmol/L and \<22.60 mmol/L)

Exclusion Criteria

•Allergy or intolerance to omega-3 fatty acids, omega-3-acid ethyl esters, or fish.
•Known lipoprotein lipase impairment or deficiency or apolipoprotein C-II deficiency or familial dysbetalipoproteinemia.
•Unable to discontinue use of omega-3 drugs/supplements.
•Unable to discontinue use of bile acid sequestrants, fibrates or niacin (other than niacin-containing vitamins \<200 mg), or any supplement used to alter lipid metabolism.
•Women who are pregnant, lactating, or planning to become pregnant. Women of childbearing potential who are not using acceptable contraceptive methods.
•Use of tamoxifen, estrogens or progestins that has not been stable for \>4 weeks prior to Visit 1.
•Use of oral or injected corticosteroids or anabolic steroids.
•History of pancreatitis.
•History of symptomatic gallstone disease, unless treated with cholecystectomy.
•Uncontrolled diabetes.
+11 more criteria

Locations (68)

National City, California, United States

Sacramento, California, United States

Manchester, Connecticut, United States

Coral Gables, Florida, United States

Hialeah, Florida, United States

Miami, Florida, United States

Ocala, Florida, United States

St. Petersburg, Florida, United States

Summerfield, Florida, United States

Atlanta, Georgia, United States

Key Dates

Start Date

January 1, 2011

Primary Completion Date

March 1, 2012

Completion Date

April 1, 2012

Last Updated

August 4, 2016

Enrollment

399

ACTUAL participants

Conditions

Severe Hypertriglyceridemia

Interventions

placebo

DRUG

omefas

DRUG

omefas

DRUG

omefas

DRUG

A Study of Olezarsen Administered Subcutaneously to Participants With Severe Hypertriglyceridemia

NCT05552326

Severe Hypertriglyceridemia

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COMPLETEDPHASE2

Safety and Efficacy Following Repeat-Dose of Evinacumab (Anti-ANGPTL3) in Patients With Severe Hypertriglyceridemia (sHTG) at Risk for Acute Pancreatitis

NCT03452228

Severe Hypertriglyceridemia (sHTG)

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WITHDRAWNPHASE3

The Efficacy of EPA+DHA (SC401B) for Lowering Triglyceride Levels (≥ 500 mg/dL)

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 4, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Epanova® for Lowering Very High Triglycerides

Inclusion Criteria

Exclusion Criteria

A Study of Olezarsen Administered Subcutaneously to Participants With Severe Hypertriglyceridemia

Safety and Efficacy Following Repeat-Dose of Evinacumab (Anti-ANGPTL3) in Patients With Severe Hypertriglyceridemia (sHTG) at Risk for Acute Pancreatitis

The Efficacy of EPA+DHA (SC401B) for Lowering Triglyceride Levels (≥ 500 mg/dL)

Efficacy Study to Treat Subjects With Severe Hypertriglyceridemia