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

This study has been completed.
Sponsor:
Collaborators:
Omthera Pharmaceuticals, Inc
Medpace, Inc.
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01408303
First received: August 1, 2011
Last updated: November 27, 2014
Last verified: November 2014
  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
Hypertriglyceridemia
Cardiovascular Disease
Drug: Olive oil, 4g
Drug: omega-3-carboxylic acids, 2g
Drug: omega-3-carboxylic acids, 4g
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(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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

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: 646
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: 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 Name: 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 Name: 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 Name: omega-3-carboxylic acids

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).
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
AstraZeneca
Omthera Pharmaceuticals, Inc
Medpace, Inc.
Investigators
Study Director: Michael H Davidson, MD, FACC Omthera Pharmaceuticals, Inc
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01408303     History of Changes
Other Study ID Numbers: OM-EPA-004  OM-EPA-004 
Study First Received: August 1, 2011
Results First Received: June 21, 2013
Last Updated: November 27, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
dyslipidemia
hyperlipidemia
cardiovascular risk

Additional relevant MeSH terms:
Cardiovascular Diseases
Hypertriglyceridemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents

ClinicalTrials.gov processed this record on September 23, 2016