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AzTrials

HypertriglyceridemiaPhase 3ESPRITNCT01408303

[E]PANOVA Combined With a [S]TATIN in [P]ATIENTS With HYPERT[R]IGLYCER[I]DEMIA to Reduce Non-HDL CHOLES[T]EROL

A Phase 3 study testing Olive oil, 4g, omega-3-carboxylic acids, 2g and omega-3-carboxylic acids, 4g in people with Hypertriglyceridemia and Cardiovascular Disease, run by AstraZeneca at 89 sites in United States.

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 is to evaluate the efficacy of adding Epanova (2 g or 4 g daily) to an optimal statin monotherapy for lowering non-high-density lipoprotein (non-HDL) cholesterol in subjects with persistent hypertriglyceridemia and high risk for cardiovascular disease. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hypertriglyceridemia, Cardiovascular Disease
What is being tested?
Olive oil, 4g, omega-3-carboxylic acids, 2g and omega-3-carboxylic acids, 4g
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
646 participants
Where
89 sitesUnited States
Study dates
Aug 2011to Jun 2012
Phase
Phase 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.
  • Fasting triglyceride (TG) level ≥200 mg/dL and <500 mg/dL.
  • The subject is a high risk for a future cardiovascular event.
  • The subject is treated with a statin and at or near LDL-C goal.

Who cannot join

  • Allergy or intolerance to omega-3 fatty acids and omega-3-acid ethyl esters.
  • Use of fibrates, bile acid sequestrants, or niacin or its analogues (greater than 200 mg/d) during screening.
  • Use of simvastatin 80 mg or Vytorin10/80 mg during screening.
  • Use of any eicosapentaenoic acid (EPA) or docosahexaenoic acid (DHA) products.
  • Use of any supplement for the purpose of lowering plasma cholesterol during screening.
  • Use of weight loss drugs or programs during screening.
Show all 23Show fewer
  • Use of erythromycin, telithromycin, clarithromycin, cyclosporine, itraconazole, ketoconazole, protease inhibitors, or nefazodone during screening.
  • Use of anticoagulants during screening.
  • Use of oral or injected corticosteroids during screening.
  • Use of tamoxifen, estrogens, progestins, or testosterone, that has not been stable for >4 weeks at Visit 1, or is unstable during screening.
  • Use of >750 mL/d grapefruit juice during screening.
  • Known lipoprotein lipase impairment or deficiency, or apolipoprotein C-II deficiency or familial dysbetalipoproteinemia.
  • History of pancreatitis.
  • Type I diabetes mellitus, use of insulin, or HbA1c >10% at Visit 1.
  • Poorly controlled hypertension
  • Uncontrolled hypothyroidism, or thyroid stimulating hormone (TSH) >1.5xULN at Visit 2.
  • Recent history or current significant nephrotic syndrome, pulmonary, hepatic, biliary, gastrointestinal or immunologic disease.
  • History of cancer (except non-melanoma skin cancer, or carcinoma in situ of cervix) within the previous two years.
  • Females who are pregnant, planning to be pregnant during the study period, lactating, or women of childbearing potential who are not using an acceptable method of contraception.
  • Creatine kinase >5.0 times upper limit of normal (ULN); aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2.5 times ULN at Visit 2.
  • Current or recent history (past 12 months) of drug or alcohol abuse.
  • Exposure to any investigational agent within 4 weeks prior to Visit 1.
  • 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

89 sites in 1 country.

89 sites in 1 country

United States89 sites

  • Study site

    Addison, Illinois, 60101

  • Study site

    Auburn, Maine, 04210

  • Study site

    Berlin, New Jersey, 08009

  • Study site

    Brandon, Florida, 33511

  • Study site

    Bristol, Tennessee, 37620

  • Study site

    Butte, Montana, 59701

  • Study site

    Cary, North Carolina, 27518

  • Study site

    Chandler, Arizona, 85224

  • Study site

    Charlotte, North Carolina, 28602

  • Study site

    Chesterfield, Missouri, 63017

  • Study site

    Chicago, Illinois, 60654

  • Study site

    Cincinnati, Ohio, 45212

  • Study site

    Cincinnati, Ohio, 45219

  • Study site

    Cincinnati, Ohio, 45242

  • Study site

    Cincinnati, Ohio, 45246

  • Study site

    Clearwater, Florida, 33756

  • Study site

    Colorado Springs, Colorado, 80902

  • Study site

    Columbus, Ohio, 43213

  • Study site

    Coral Gables, Florida, 33134

  • Study site

    Corpus Christi, Texas, 78404

  • Study site

    Denver, Colorado, 80239

  • Study site

    Edina, Minnesota, 55435

  • Study site

    Encinitas, California, 92024

  • Study site

    Endwell, New York, 13760

  • Study site

    Eugene, Oregon, 97404

  • Study site

    Gray, Tennessee, 37615

  • Study site

    Harleysville, Pennsylvania, 19438

  • Study site

    Hialeah, Florida, 33012

  • Study site

    Hickory, North Carolina, 28602

  • Study site

    High Point, North Carolina, 27265

  • Study site

    Houston, Texas, 77074

  • Study site

    Indianapolis, Indiana, 46260

  • Study site

    Jacksonville, Florida, 32205

  • Study site

    Jacksonville, Florida, 32223

  • Study site

    Jersey Shore, Pennsylvania, 17740

  • Study site

    Jupiter, Florida, 33458

  • Study site

    Kansas City, Missouri, 64111

  • Study site

    Katy, Texas, 77450

  • Study site

    Kingsport, Tennessee, 37660

  • Study site

    Lansdale, Pennsylvania, 19446

  • Study site

    Las Vegas, Nevada, 89123

  • Study site

    Little Rock, Arkansas, 72205

  • Study site

    Lomita, California, 90717

  • Study site

    Los Angeles, California, 90057

  • Study site

    Louisville, Kentucky, 40213

  • Study site

    Lyndhurst, Ohio, 44124

  • Study site

    Madisonville, Kentucky, 42431

  • Study site

    Marion, Ohio, 43302

  • Study site

    Melbourne, Florida, 32901

  • Study site

    Miami, Florida, 33014

  • Study site

    Miami, Florida, 33169

  • Study site

    Miami, Florida, 33183

  • Study site

    Mt. Pleasant, South Carolina, 29464

  • Study site

    Murray, Utah, 84123

  • Study site

    Muscle Shoals, Alabama, 35662

  • Study site

    New Port Richey, Florida, 34652

  • Study site

    New Windsor, New York, 12553

  • Study site

    Newton, Kansas, 67114

  • Study site

    Norfolk, Virginia, 23502

  • Study site

    Oakbrook Terrace, Illinois, 60181

  • Study site

    Ocala, Florida, 34471

  • Study site

    Oklahoma City, Oklahoma, 73112

  • Study site

    Olympia, Washington, 98502

  • Study site

    Orlando, Florida, 32806

  • Study site

    Oviedo, Florida, 32765

  • Study site

    Oxon Hill, Maryland, 20745

  • Study site

    Philadelphia, Pennsylvania, 19104

  • Study site

    Phoenix, Arizona, 85020

  • Study site

    Ponte Vedra, Florida, 32081

  • Study site

    Raleigh, North Carolina, 27527

  • Study site

    Raleigh, North Carolina, 27612

  • Study site

    Rapid City, South Dakota, 57702

  • Study site

    Richmond, Virginia, 23294

  • Study site

    Rochester, New York, 14609

  • Study site

    Sacramento, California, 95823

  • Study site

    Salisbury, North Carolina, 28144

  • Study site

    Salt Lake City, Utah, 84107

  • Study site

    San Antonio, Texas, 78205

  • Study site

    San Diego, California, 92117

  • Study site

    Spring Valley, California, 91978

  • Study site

    St Louis, Missouri, 63128

  • Study site

    St. Petersburg, Florida, 33709

  • Study site

    Statesville, North Carolina, 28677

  • Study site

    Troy, Michigan, 48098

  • Study site

    Tulsa, Oklahoma, 74136

  • Study site

    Westlake Village, California, 91361

  • Study site

    Wichita, Kansas, 67205

  • Study site

    Wichita, Kansas, 67207

  • Study site

    Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: A 6-Week, Randomized, Double-Blind, Placebo(Olive Oil)-Controlled Study to Assess the Efficacy and Safety of Add-On Epanova® to Statin Therapy in Subjects With Persistent Hypertriglyceridemia and High Risk for Cardiovascular Disease

The primary objective is to evaluate the efficacy of adding Epanova (2 g or 4 g daily) to an optimal statin monotherapy for lowering non-high-density lipoprotein (non-HDL) cholesterol in subjects with persistent hypertriglyceridemia and high risk for cardiovascular disease.

Read the detailed description

The primary efficacy variable is serum non-HDL cholesterol. The primary endpoints are the differences in mean percent changes from baseline to end-of-treatment in non-HDL cholesterol between placebo and the 2g/day and 4g/day Epanova groups. Baseline is defined as the average of Visits 2, 3 and 4 (Weeks -2, -1 and 0) and end-of-treatment is the average of Visits 5 and 6 (Weeks 5 and 6).

Being tested
Olive oil, 4g, omega-3-carboxylic acids, 2g, omega-3-carboxylic acids, 4g
Keywords
dyslipidemia, hyperlipidemia, cardiovascular risk
Medical subject headings
Hypertriglyceridemia, Cardiovascular Diseases, Dyslipidemias, Hyperlipidemias

What participants receive

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

  • Olive oil, 4gDrug

    Also called Placebo comparator

    Olive oil: 4 x 1 g capsule daily for 6 weeks + prescription statin

  • omega-3-carboxylic acids, 2gDrug

    Also called omega-3-carboxylic acids

    Epanova: 2 x 1 g capsule + olive oil 2 x 1 g capsule daily for 6 weeks + prescription statin

  • omega-3-carboxylic acids, 4gDrug

    Also called omega-3-carboxylic acids

    Epanova: 4 x 1 g capsule daily for 6 weeks + prescription statin

Study groups in NCT01408303
Study groupRoleWhat they receive
Olive OilPlacebo comparatorolive oil: 4 g/day + prescription statin
Receives: Drug: Olive oil, 4g
Epanova, 2 gExperimentalomega-3-carboxylic acids, 2g/day + prescription statin
Receives: Drug: omega-3-carboxylic acids, 2g
Epanova, 4 gExperimentalomega-3-carboxylic acids, 4g/day + prescription statin
Receives: Drug: omega-3-carboxylic acids, 4g

What is being measured

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

  1. Serum Non-HDL Cholesterol

    The primary endpoints are the differences in mean percent changes from baseline to end-of-treatment in non-HDL cholesterol between placebo and the 2g/day and 4g/day Epanova groups.

    Measured: 6 weeks

Timeline

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

  1. First posted3 Aug 2011 (estimated)
  2. Study startAug 2011
  3. Primary completionJun 2012
  4. Study completionJun 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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
646 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01408303
Sponsor's protocol ID
OM-EPA-004
Other IDs
OM-EPA-004, NCT01408303
Acronym
ESPRIT
Status last verified
Nov 2014
First submitted
1 Aug 2011
Last updated
5 Dec 2014
Data monitoring committee
No

Publications

  • Dunbar RL, Nicholls SJ, Maki KC, Roth EM, Orloff DG, Curcio D, Johnson J, Kling D, Davidson MH. Effects of omega-3 carboxylic acids on lipoprotein particles and other cardiovascular risk markers in high-risk statin-treated patients with residual hypertriglyceridemia: a randomized, controlled, double-blind trial. Lipids Health Dis. 2015 Sep 2;14:98. doi: 10.1186/s12944-015-0100-8.

    PubMed 26328624

  • Maki KC, Orloff DG, Nicholls SJ, Dunbar RL, Roth EM, Curcio D, Johnson J, Kling D, Davidson MH. A highly bioavailable omega-3 free fatty acid formulation improves the cardiovascular risk profile in high-risk, statin-treated patients with residual hypertriglyceridemia (the ESPRIT trial). Clin Ther. 2013 Sep;35(9):1400-11.e1-3. doi: 10.1016/j.clinthera.2013.07.420. Epub 2013 Aug 30.

    PubMed 23998969

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Olive oil, 4g, omega-3-carboxylic acids, 2g and omega-3-carboxylic acids, 4g in people with Hypertriglyceridemia and Cardiovascular Disease, run by AstraZeneca at 89 sites in United States.

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 4 inclusion and 23 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 5 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 89 sites in United States. 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 phase mean?

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 5 Dec 2014). 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?

Serum Non-HDL Cholesterol (time frame: 6 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 NCT01408303, which also lists 2 linked publications.

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 5 Dec 2014.

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