Efficacy and Safety of Add-on Epanova® to Statin in Subjects With Persistent Hypertriglyceridemia and High Risk for Cardiovascular Disease (ESPRIT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Omthera Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:
NCT01408303
First received: August 1, 2011
Last updated: June 26, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Persistent Hypertriglyceridemia
High Risk for Cardiovascular Disease
Drug: placebo
Drug: omefas + placebo
Drug: omefas
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 6-Week, Randomized, Double-Blind, Placebo-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

Resource links provided by NLM:


Further study details as provided by Omthera Pharmaceuticals, Inc:

Primary Outcome Measures:
  • Serum non-HDL cholesterol [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 647
Study Start Date: August 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
placebo, 1 g capsule
Drug: placebo
4 x 1 g capsule daily for 6 weeks
Experimental: Epanova, 2 g
omefas, 1 g capsule
Drug: omefas + placebo
omefas 2 x 1 g capsule + placebo 2 x 1 g capsule daily for 6 weeks
Experimental: Epanova, 4 g
omefas, 1 g capsule
Drug: omefas
omefas 4 x 1 g capsule daily for 6 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01408303

  Show 90 Study Locations
Sponsors and Collaborators
Omthera Pharmaceuticals, Inc
Investigators
Study Director: Michael H Davidson, MD, FACC Omthera Pharmaceuticals, Inc
  More Information

No publications provided by Omthera Pharmaceuticals, Inc

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Omthera Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT01408303     History of Changes
Other Study ID Numbers: OM-EPA-004
Study First Received: August 1, 2011
Last Updated: June 26, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Omthera Pharmaceuticals, Inc:
dyslipidemia
hyperlipidemia

Additional relevant MeSH terms:
Cardiovascular Diseases
Hypertriglyceridemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on August 20, 2014