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

November 27, 2014 updated by: AstraZeneca

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
646

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • Alabama
      • Muscle Shoals, Alabama, United States, 35662
    • Arizona
      • Chandler, Arizona, United States, 85224
      • Phoenix, Arizona, United States, 85020
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
    • California
      • Encinitas, California, United States, 92024
      • Lomita, California, United States, 90717
      • Los Angeles, California, United States, 90057
      • Sacramento, California, United States, 95823
      • San Diego, California, United States, 92117
      • Spring Valley, California, United States, 91978
      • Westlake Village, California, United States, 91361
    • Colorado
      • Colorado Springs, Colorado, United States, 80902
      • Denver, Colorado, United States, 80239
    • Florida
      • Brandon, Florida, United States, 33511
      • Clearwater, Florida, United States, 33756
      • Coral Gables, Florida, United States, 33134
      • Hialeah, Florida, United States, 33012
      • Jacksonville, Florida, United States, 32205
      • Jacksonville, Florida, United States, 32223
      • Jupiter, Florida, United States, 33458
      • Melbourne, Florida, United States, 32901
      • Miami, Florida, United States, 33169
      • Miami, Florida, United States, 33014
      • Miami, Florida, United States, 33183
      • New Port Richey, Florida, United States, 34652
      • Ocala, Florida, United States, 34471
      • Orlando, Florida, United States, 32806
      • Oviedo, Florida, United States, 32765
      • Ponte Vedra, Florida, United States, 32081
      • St. Petersburg, Florida, United States, 33709
    • Illinois
      • Addison, Illinois, United States, 60101
      • Chicago, Illinois, United States, 60654
      • Oakbrook Terrace, Illinois, United States, 60181
    • Indiana
      • Indianapolis, Indiana, United States, 46260
    • Kansas
      • Newton, Kansas, United States, 67114
      • Wichita, Kansas, United States, 67207
      • Wichita, Kansas, United States, 67205
    • Kentucky
      • Louisville, Kentucky, United States, 40213
      • Madisonville, Kentucky, United States, 42431
    • Maine
      • Auburn, Maine, United States, 04210
    • Maryland
      • Oxon Hill, Maryland, United States, 20745
    • Michigan
      • Troy, Michigan, United States, 48098
    • Minnesota
      • Edina, Minnesota, United States, 55435
    • Missouri
      • Chesterfield, Missouri, United States, 63017
      • Kansas City, Missouri, United States, 64111
      • St. Louis, Missouri, United States, 63128
    • Montana
      • Butte, Montana, United States, 59701
    • Nevada
      • Las Vegas, Nevada, United States, 89123
    • New Jersey
      • Berlin, New Jersey, United States, 08009
    • New York
      • Endwell, New York, United States, 13760
      • New Windsor, New York, United States, 12553
      • Rochester, New York, United States, 14609
    • North Carolina
      • Cary, North Carolina, United States, 27518
      • Charlotte, North Carolina, United States, 28602
      • Hickory, North Carolina, United States, 28602
      • High Point, North Carolina, United States, 27265
      • Raleigh, North Carolina, United States, 27612
      • Raleigh, North Carolina, United States, 27527
      • Salisbury, North Carolina, United States, 28144
      • Statesville, North Carolina, United States, 28677
      • Winston-Salem, North Carolina, United States, 27103
    • Ohio
      • Cincinnati, Ohio, United States, 45242
      • Cincinnati, Ohio, United States, 45212
      • Cincinnati, Ohio, United States, 45219
      • Cincinnati, Ohio, United States, 45246
      • Columbus, Ohio, United States, 43213
      • Lyndhurst, Ohio, United States, 44124
      • Marion, Ohio, United States, 43302
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
      • Tulsa, Oklahoma, United States, 74136
    • Oregon
      • Eugene, Oregon, United States, 97404
    • Pennsylvania
      • Harleysville, Pennsylvania, United States, 19438
      • Jersey Shore, Pennsylvania, United States, 17740
      • Lansdale, Pennsylvania, United States, 19446
      • Philadelphia, Pennsylvania, United States, 19104
    • South Carolina
      • Mount Pleasant, South Carolina, United States, 29464
      • Mt Pleasant, South Carolina, United States, 29464
    • South Dakota
      • Rapid City, South Dakota, United States, 57702
    • Tennessee
      • Bristol, Tennessee, United States, 37620
      • Gray, Tennessee, United States, 37615
      • Kingsport, Tennessee, United States, 37660
    • Texas
      • Corpus Christi, Texas, United States, 78404
      • Houston, Texas, United States, 77074
      • Katy, Texas, United States, 77450
      • San Antonio, Texas, United States, 78205
    • Utah
      • Murray, Utah, United States, 84123
      • Salt Lake City, Utah, United States, 84107
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Men or women, ≥18 years of age.
  2. Fasting triglyceride (TG) level ≥200 mg/dL and <500 mg/dL.
  3. The subject is a high risk for a future cardiovascular event.
  4. The subject is treated with a statin and at or near LDL-C goal.

Exclusion Criteria:

  1. Allergy or intolerance to omega-3 fatty acids and omega-3-acid ethyl esters.
  2. Use of fibrates, bile acid sequestrants, or niacin or its analogues (greater than 200 mg/d) during screening.
  3. Use of simvastatin 80 mg or Vytorin10/80 mg during screening.
  4. Use of any eicosapentaenoic acid (EPA) or docosahexaenoic acid (DHA) products.
  5. Use of any supplement for the purpose of lowering plasma cholesterol during screening.
  6. Use of weight loss drugs or programs during screening.
  7. Use of erythromycin, telithromycin, clarithromycin, cyclosporine, itraconazole, ketoconazole, protease inhibitors, or nefazodone during screening.
  8. Use of anticoagulants during screening.
  9. Use of oral or injected corticosteroids during screening.
  10. Use of tamoxifen, estrogens, progestins, or testosterone, that has not been stable for >4 weeks at Visit 1, or is unstable during screening.
  11. Use of >750 mL/d grapefruit juice during screening.
  12. Known lipoprotein lipase impairment or deficiency, or apolipoprotein C-II deficiency or familial dysbetalipoproteinemia.
  13. History of pancreatitis.
  14. Type I diabetes mellitus, use of insulin, or HbA1c >10% at Visit 1.
  15. Poorly controlled hypertension
  16. Uncontrolled hypothyroidism, or thyroid stimulating hormone (TSH) >1.5xULN at Visit 2.
  17. Recent history or current significant nephrotic syndrome, pulmonary, hepatic, biliary, gastrointestinal or immunologic disease.
  18. History of cancer (except non-melanoma skin cancer, or carcinoma in situ of cervix) within the previous two years.
  19. 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.
  20. Creatine kinase >5.0 times upper limit of normal (ULN); aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2.5 times ULN at Visit 2.
  21. Current or recent history (past 12 months) of drug or alcohol abuse.
  22. Exposure to any investigational agent within 4 weeks prior to Visit 1.
  23. 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
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
PLACEBO_COMPARATOR: Olive Oil
olive oil: 4 g/day + prescription statin
Drug: Olive oil, 4g
Olive oil: 4 x 1 g capsule daily for 6 weeks + prescription statin
Other Names:
  • Placebo comparator
EXPERIMENTAL: Epanova, 2 g
omega-3-carboxylic acids, 2g/day + prescription statin
Drug: omega-3-carboxylic acids, 2g
Epanova: 2 x 1 g capsule + olive oil 2 x 1 g capsule daily for 6 weeks + prescription statin
Other Names:
  • omega-3-carboxylic acids
EXPERIMENTAL: Epanova, 4 g
omega-3-carboxylic acids, 4g/day + prescription statin
Drug: omega-3-carboxylic acids, 4g
Epanova: 4 x 1 g capsule daily for 6 weeks + prescription statin
Other Names:
  • omega-3-carboxylic acids

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Serum Non-HDL Cholesterol
Time Frame: 6 weeks
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.
6 weeks

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Medpace, Inc.
Omthera Pharmaceuticals, Inc

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2011

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2012

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 1, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 2, 2011

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 3, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 5, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 27, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • OM-EPA-004 (OTHER: Omthera Pharmaceuticals, Inc.)
  • NCT01408303 (OTHER: ClinicalTrials.gov Identifier)

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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