AzTrials
AzTrials

Severe HypertriglyceridemiaPhase 2/3EVOLVENCT01242527

Epanova® for Lowering Very High Triglycerides

A Phase 2/3 study testing omefas in people with Severe Hypertriglyceridemia, run by AstraZeneca at 68 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Severe Hypertriglyceridemia
What is being tested?
omefas
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
399 participants
Where
68 sitesin 7 countries
Study dates
Jan 2011to Apr 2012
Phase
Phase 2/3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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.
Show all 21Show fewer
  • 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

Trial locations and contacts

68 sites in 7 countries.

68 sites in 7 countries

United States30 sites

  • Study site

    Addison, Illinois, 60101

  • Study site

    Atlanta, Georgia, 30328

  • Study site

    Auburn, Maine, 04210

  • Study site

    Bristol, Tennessee, 37620

  • Study site

    Chicago, Illinois, 60654

  • Study site

    Cincinnati, Ohio, 45212

  • Study site

    Cincinnati, Ohio, 45246

  • Study site

    Columbus, Ohio, 43213

  • Study site

    Coral Gables, Florida, 33134

  • Study site

    Hialeah, Florida, 33012

  • Study site

    High Point, North Carolina, 27262

  • Study site

    Johnson City, Tennessee, 37604

  • Study site

    Kingsport, Tennessee, 37660

  • Study site

    Louisville, Kentucky, 40213

  • Study site

    Manchester, Connecticut, 06040

  • Study site

    Miami, Florida, 33169

  • Study site

    National City, California, 91950

  • Study site

    Norfolk, Virginia, 23502

  • Study site

    Ocala, Florida, 34471

  • Study site

    Oklahoma City, Oklahoma, 73103

  • Study site

    Olive Branch, Mississippi, 38654

  • Study site

    Olympia, Washington, 98502

  • Study site

    Philadelphia, Pennsylvania, 19104

  • Study site

    Philadelphia, Pennsylvania, 19446

  • Study site

    Richmond, Virginia, 23294

  • Study site

    Sacramento, California, 95823

  • Study site

    Salisbury, North Carolina, 28144

  • Study site

    San Antonio, Texas, 78215

  • Study site

    St. Petersburg, Florida, 33709

  • Study site

    Summerfield, Florida, 34461

Other trials in United States

India10 sites

  • Study site

    Bangalore, Karnataka, 560003

  • Study site

    Bangalore, Karnataka, 560054

  • Study site

    Bangalore, Karnataka

  • Study site

    Banswada, Karnataka, 560043

  • Study site

    Chennai, Tamil Nadu, 600010

  • Study site

    Indore, Madhya Pradesh, 452014

  • Study site

    Jaipur, Rajasthan, 302015

  • Study site

    Karnāl, Haryana, 132001

  • Study site

    Pune, Maharashtra, 411005

  • Study site

    Surat, 395007

Other trials in India

Hungary9 sites

  • Study site

    Baja, 6500

  • Study site

    Budapest, 1062

  • Study site

    Budapest, 1115

  • Study site

    Budapest, 1125

  • Study site

    Debrecen, 4032

  • Study site

    Debrecen, 4043

  • Study site

    Sátoraljaújhely, 3980

  • Study site

    Székesfehérvár, 8000

  • Study site

    Szikszó, 3800

Other trials in Hungary

Ukraine6 sites

  • Study site

    Kharkiv, 61037

  • Study site

    Kharkiv, 61039

  • Study site

    Kharkiv, 61176

  • Study site

    Kiev, 03115

  • Study site

    Kiev, 03680

  • Study site

    Zaporizhzhya, 69118

Other trials in Ukraine

Netherlands5 sites

  • Study site

    Amsterdam, 1105AZ

  • Study site

    Groningen, 9711SG

  • Study site

    Rotterdam, 3004BA

  • Study site

    Rotterdam, 3021HC

  • Study site

    Utrecht, 3584CX

Other trials in Netherlands

Denmark4 sites

  • Study site

    Copenhagen, 2100

  • Study site

    Gentofte Municipality, 2820

  • Study site

    Herlev, 2730

  • Study site

    Viborg, 8800

Other trials in Denmark

Russia4 sites

  • Study site

    Moscow, 129090

  • Study site

    Novosibirsk, 630068

  • Study site

    Saint Petersburg, 192288

  • Study site

    Saint Petersburg, 196084

Other trials in Russia

About this study

Official title: 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.

Being tested
placebo, omefas
Keywords
dyslipidemia, hyperlipidemia, omega-3 carboxylic acid
Medical subject headings
Hypertriglyceridemia, Dyslipidemias, Hyperlipidemias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • placeboDrug

    4 capsules (1g) daily for 12 weeks

  • omefasDrug

    2 capsules (1g) + 2 placebo daily for 12 weeks

  • omefasDrug

    3 capsules (1g) + 1 placebo daily for 12 weeks

  • omefasDrug

    4 capsules (1g)daily for 12 weeks

Study groups in NCT01242527
Study groupRoleWhat they receive
placeboPlacebo comparatorNot described
Receives: Drug: placebo
Epanova 2 gExperimentalNot described
Receives: Drug: omefas
Epanova 3 gExperimentalNot described
Receives: Drug: omefas
Epanova 4 gExperimentalNot described
Receives: Drug: omefas

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fasting Serum Triglycerides

    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

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Nov 2010 (estimated)
  2. Study startJan 2011
  3. Primary completionMar 2012
  4. Study completionApr 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
399 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01242527
Sponsor's protocol ID
OM-EPA-003
Acronym
EVOLVE
Status last verified
Jun 2016
First submitted
15 Nov 2010
Last updated
4 Aug 2016
Data monitoring committee
No

Publications

  • Kastelein JJ, Maki KC, Susekov A, Ezhov M, Nordestgaard BG, Machielse BN, Kling D, Davidson MH. Omega-3 free fatty acids for the treatment of severe hypertriglyceridemia: the EpanoVa fOr Lowering Very high triglyceridEs (EVOLVE) trial. J Clin Lipidol. 2014 Jan-Feb;8(1):94-106. doi: 10.1016/j.jacl.2013.10.003. Epub 2013 Oct 14.

    PubMed 24528690

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing omefas in people with Severe Hypertriglyceridemia, run by AstraZeneca at 68 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 68 sites in United States, India, Hungary, Ukraine, Netherlands and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Sep 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fasting Serum Triglycerides (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01242527, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2016.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in