Epanova® for Lowering Very High Triglycerides (EVOLVE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Omthera Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:
NCT01242527
First received: November 15, 2010
Last updated: June 27, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Severe Hypertriglyceridemia
Drug: placebo
Drug: omefas
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Epanova® (Omefas) in Severe Hypertriglyceridemia

Resource links provided by NLM:


Further study details as provided by Omthera Pharmaceuticals, Inc:

Primary Outcome Measures:
  • Fasting Serum Triglycerides [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 399
Study Start Date: January 2011
Study Completion Date: April 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: placebo Drug: placebo
4 capsules (1g) daily for 12 weeks
Experimental: Epanova 2 g Drug: omefas
2 capsules (1g) + 2 placebo daily for 12 weeks
Experimental: Epanova 3 g Drug: omefas
3 capsules (1g) + 1 placebo daily for 12 weeks
Experimental: Epanova 4 g Drug: omefas
4 capsules (1g)daily for 12 weeks

  Eligibility

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

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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.
  • 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
  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: NCT01242527

  Show 68 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: NCT01242527     History of Changes
Other Study ID Numbers: OM-EPA-003
Study First Received: November 15, 2010
Results First Received: June 26, 2013
Last Updated: June 27, 2013
Health Authority: United States: Food and Drug Administration
Hungary: National Institute of Pharmacy
Denmark: Ethics Committee
Netherlands: Medical Ethics Review Committee (METC)
Russia: Ministry of Health of the Russian Federation
India: Drugs Controller General of India

Keywords provided by Omthera Pharmaceuticals, Inc:
dyslipidemia
hyperlipidemia

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

ClinicalTrials.gov processed this record on July 23, 2014