EUCTR2013-004682-14-HUActive, not recruitingNot Applicable
A 12-Week, Randomized, Double-Blind, Olive Oil-Controlled Phase 3 Study to Assess the Efficacy and Safety of EPANOVA™ in Subjects With Severe Hypertriglyceridemia (EVOLVE II)
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 116
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. Understanding of the study procedures, willingness to adhere to the study schedule, and agreement to participate in the study by giving written informed consent prior to screening;
- •2. Willing to use an appropriate and effective method of contraception;
- •3. Qualifying (average of Visit 1 or 1a + Visit 2 + Visit 2a [repeat measurement]) serum TG =500 mg/dL (5.65 mMol/L) and <2500 mg/dL (28.25 mMol/L);
- •4. Body mass index =20 kg/m2;
- •5. Untreated dyslipidemia or dyslipidemia treated with a statin, CAI, or statin-CAI combination that has been stable for 6 weeks prior to randomization;
- •6. Willingness to maintain current physical activity level and follow the TLC diet throughout the study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 98
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 18
Exclusion Criteria
- •1. Allergy or intolerance to omega-3 fatty acids, omega-3-acid ethyl esters, or fish;
- •2. Known lipoprotein lipase impairment;
- •3. Known non-responder to omega-3 or fenofibrate therapy;
- •4. Use of any prescription medications containing EPA and/or DHA (eg, Lovaza® or Vascepa®) within 8 weeks prior to randomization. Up to 1 g capsule/day of an omega-3 dietary supplement will be permitted;
- •5. 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 including but not limited to dietary fiber supplements, red rice yeast supplements, garlic supplements, soy isoflavone supplements, sterol/stanol products, or policosanols at Visit 1;
- •6. Use of tamoxifen, estrogens, or progestins that has not been stable for >4 weeks at Visit 1 or is unstable prior to randomization;
- •7. Use of oral or injected corticosteroids or anabolic steroids in the 4 weeks prior to Visit 1;
- •8. History of hospitalization for pancreatitis in the last 5 years;
- •9. Uncontrolled diabetes (hemoglobin A1c >10%);
- •10. Uncontrolled hypothyroidism or thyroid-stimulating hormone >5 mIU/L;
- •11. History of cancer (other than basal cell carcinoma) in the past 2 years;
- •12. Cardiovascular event (ie, myocardial infarction, acute coronary syndrome, new onset angina, stroke, transient heart attack, unstable congestive heart failure requiring a change in treatment), revascularization procedure or vascular surgery within 6 months of randomization;
- •13. Use of simvastatin 80 mg or Vytorin 10/80 mg;
- •14. Recent history (within 6 months of randomization) of significant nephrotic syndrome, pulmonary, hepatic, biliary, gastrointestinal, or immunologic disease;
- •15. Poorly controlled hypertension (systolic blood pressure =180 mmHg and/or diastolic blood pressure =110 mmHg) at two consecutive visits prior to randomization at Visit 3;
- •16. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 × the upper limit of normal;
- •17. Exposure to any investigational product within 4 weeks of Visit 1; or
- •18. Any condition or therapy which, in the opinion of the Investigator, might pose a risk to the subject or make participation in the study not in the subject’s best interest.
Investigators
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