Epanova® for Lowering Very High Triglycerides (EVOLVE)

June 24, 2016 updated by: AstraZeneca

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

399

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
      • Gentofte, Denmark, 2820
      • Herlev, Denmark, 2730
      • Viborg, Denmark, 8800
  • Hungary
      • Baja, Hungary, 6500
      • Budapest, Hungary, 1115
      • Budapest, Hungary, 1125
      • Budapest, Hungary, 1062
      • Debrecen, Hungary, 4032
      • Debrecen, Hungary, 4043
      • Satoraljaujhely, Hungary, 3980
      • Szekesfehervar, Hungary, 8000
      • Szikszo, Hungary, 3800
  • India
      • Surat, India, 395007
    • Haryana
      • Karnal, Haryana, India, 132001
    • Karnataka
      • Bangalore, Karnataka, India
      • Bangalore, Karnataka, India, 560003
      • Bangalore, Karnataka, India, 560054
      • Banswada, Karnataka, India, 560043
    • Madhya Pradesh
      • Indore, Madhya Pradesh, India, 452014
    • Maharashtra
      • Pune, Maharashtra, India, 411005
    • Rajasthan
      • Jaipur City, Rajasthan, India, 302015
    • Tamil nadu
      • Chennai, Tamil nadu, India, 600010
  • Netherlands
      • Amsterdam, Netherlands, 1105AZ
      • Groningen, Netherlands, 9711SG
      • Rotterdam, Netherlands, 3004BA
      • Rotterdam, Netherlands, 3021HC
      • Utrecht, Netherlands, 3584CX
  • Russian Federation
      • Moscow, Russian Federation, 129090
      • Novosibirsk, Russian Federation, 630068
      • St Petersburg, Russian Federation, 192288
      • St Petersburg, Russian Federation, 196084
  • Ukraine
      • Kharkiv, Ukraine, 61039
      • Kharkiv, Ukraine, 61176
      • Kharkiv, Ukraine, 61037
      • Kiev, Ukraine, 03115
      • Kiev, Ukraine, 03680
      • Zaporizhzhya, Ukraine, 69118
  • United States
    • California
      • National City, California, United States, 91950
      • Sacramento, California, United States, 95823
    • Connecticut
      • Manchester, Connecticut, United States, 06040
    • Florida
      • Coral Gables, Florida, United States, 33134
      • Hialeah, Florida, United States, 33012
      • Miami, Florida, United States, 33169
      • Ocala, Florida, United States, 34471
      • St Petersburg, Florida, United States, 33709
      • Summerfield, Florida, United States, 34461
    • Georgia
      • Atlanta, Georgia, United States, 30328
    • Illinois
      • Addison, Illinois, United States, 60101
      • Chicago, Illinois, United States, 60654
    • Kentucky
      • Louisville, Kentucky, United States, 40213
    • Maine
      • Auburn, Maine, United States, 04210
    • Mississippi
      • Olive Branch, Mississippi, United States, 38654
    • North Carolina
      • High Point, North Carolina, United States, 27262
      • Salisbury, North Carolina, United States, 28144
    • Ohio
      • Cincinnati, Ohio, United States, 45212
      • Cincinnati, Ohio, United States, 45246
      • Columbus, Ohio, United States, 43213
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
      • Philadelphia, Pennsylvania, United States, 19446
    • Tennessee
      • Bristol, Tennessee, United States, 37620
      • Johnson City, Tennessee, United States, 37604
      • Kingsport, Tennessee, United States, 37660
    • Texas
      • San Antonio, Texas, United States, 78215
    • Virginia
      • Norfolk, Virginia, United States, 23502
      • Richmond, Virginia, United States, 23294
    • Washington
      • Olympia, Washington, United States, 98502

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.
  • Uncontrolled hypothyroidism or thyroid stimulating hormone (TSH).
  • History of cancer (other than basal cell carcinoma) in the past 2 years.
  • Cardiovascular event (i.e., myocardial infarction, acute coronary syndrome, new onset angina, stroke, transient ischemic attack, unstable congestive heart failure requiring a change in treatment) or revascularization procedure within six months prior to Visit 1.
  • Use of anticoagulants (e.g. warfarin [Coumadin®], coumarin, heparin, enoxaparin, clopidogrel).
  • Presence of an aortic aneurysm or resection of an aortic aneurysm within six months prior to Visit 1.
  • Recent history (within six months prior to Visit 1) or current significant nephrotic syndrome, pulmonary, hepatic, biliary, gastrointestinal or immunologic disease.
  • Poorly controlled hypertension.
  • Any of the following laboratory criteria: serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST), glucose, glomerular filtration rate (GFR), platelet count,or hemoglobin outside of study range.
  • Recent history (past 12 months) of drug abuse or alcohol abuse.
  • Exposure to any investigational product, within 4 weeks prior to Visit 1.
  • Presence of any other condition the Investigator believes would interfere with the subject's ability to provide informed consent, comply with study instructions, or which might confound the interpretation of the study results or put the subject at undue risk

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
Drug: placebo
4 capsules (1g) daily for 12 weeks
Experimental: Epanova 2 g
Drug: omefas
2 capsules (1g) + 2 placebo daily for 12 weeks
Drug: omefas
3 capsules (1g) + 1 placebo daily for 12 weeks
Drug: omefas
4 capsules (1g)daily for 12 weeks
Experimental: Epanova 3 g
Drug: omefas
2 capsules (1g) + 2 placebo daily for 12 weeks
Drug: omefas
3 capsules (1g) + 1 placebo daily for 12 weeks
Drug: omefas
4 capsules (1g)daily for 12 weeks
Experimental: Epanova 4 g
Drug: omefas
2 capsules (1g) + 2 placebo daily for 12 weeks
Drug: omefas
3 capsules (1g) + 1 placebo daily for 12 weeks
Drug: omefas
4 capsules (1g)daily for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fasting Serum Triglycerides
Time Frame: 12 weeks
The primary endpoints are the differences in mean percent changes from baseline to end-of-treatment in triglycerides between placebo and the 2g/day, 3g/day and 4g/day Epanova groups
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

November 15, 2010

First Submitted That Met QC Criteria

November 15, 2010

First Posted (Estimate)

November 17, 2010

Study Record Updates

Last Update Posted (Estimate)

August 4, 2016

Last Update Submitted That Met QC Criteria

June 24, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OM-EPA-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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