Epanova® for Lowering Very High Triglycerides II (EVOLVE II)

• Status: Completed
• Trial end date: 2014-12-23
• Target enrollment: 0
• Participant gender: All

Summary

This is a double-blind, randomized, olive oil-controlled study to investigate the efficacy and safety of Epanova as an adjunct therapy to diet for reduction of TG levels in subjects with severe hypertriglyceridemia. The study consists of an approximately 8-week screening period that includes a diet and lifestyle stabilization and washout period and a 12-week treatment period.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca

Criteria

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 (6 mMol/L) and <2500 mg/dL (28 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; and

6. Willingness to maintain current physical activity level and follow the TLC diet throughout the study.

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 screening;

6. Use of tamoxifen, estrogens, or progestins that has not been stable for >4 weeks at screening or is unstable prior to randomization;

7. Use of oral or injected corticosteroids or anabolic steroids prior to randomization;

8. History of hospitalization for pancreatitis in the last 5 years;

9. Uncontrolled diabetes (hemoglobin A1c [HbA1c] >10%);

10. Uncontrolled hypothyroidism or thyroid-stimulating hormone (TSH) >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);

16. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 × the upper limit of normal (ULN); if ALT/AST is >3 × ULN, the levels have been stable for 3 months and are <5 × ULN;

17. Exposure to any investigational product within 4 weeks of randomization; 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.