Health Condition 1: null- Severe Hypertriglyceridemia
Conditions
Interventions
Intervention1: Epanova® (omefas): orally, in 1-gram polyacrylate-coated soft gelatin capsules
Intervention2: Drug: placebo: 4 capsules (1g) daily for 12 weeks
Intervention3: Drug: omefas: 2 capsules (
Sponsors
Radiant Development
Spectrum Clinical Research Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Men or women, ≥18 years of age. 2. Serum TG values in the range ≥500 mg/dL and 2000 mg/dL (≥5.65 mmol/L and 22.60 mmol/L) for the average of Visits 2 and 3 (Weeks -2 and -1). Repeat of Visit 3 test is allowed (Visit 3a), and the average of Visit 2 (Week -2) + Visit 3 (Week -1) + Visit 3a (repeat visit) is used as the criterion. 3. Body mass index ≥20 kg/m2. 4. Untreated dyslipidemia, or use of a statin or cholesterol absorption inhibitor, or their combination, if stable for 6 weeks at Visit 2 (Week -2) and prior to randomization. 5. Willing to restrict consumption of fish to no more than twice per week during the study. 6. Willingness to maintain current activity level and follow TLC diet.
Exclusion criteria
Exclusion criteria: 1. Allergy or intolerance to omega-3 fatty acids, omega-3-acid ethyl esters, or fish. 2. Known lipoprotein lipase impairment or deficiency or apolipoprotein C-II deficiency or familial dysbetalipoproteinemia. 3. Unable to discontinue use of omega-3 drugs/supplements at Week -8 (Visit 1) 4. 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 Week -4 (Visit 1) 5. Women who are pregnant, lactating, or planning to become pregnant. Women of childbearing potential who are not using acceptable contraceptive methods. A woman is considered of childbearing potential if she is not surgically sterile or is less than 1 year since last menstrual period.Examples of acceptable contraceptive methods include abstinence, intrauterine device (IUD) or double barrier method. Estrogen-containing contraceptives are excluded 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 at Visit 1 or prior to randomization. 8. History of pancreatitis. 9. History of symptomatic gallstone disease, unless treated with cholecystectomy 10. Uncontrolled diabetes (HbA1c ≥9). 11. Uncontrolled hypothyroidism or thyroid stimulating hormone (TSH) 5 mIU/L. 12. History of cancer (other than basal cell carcinoma) in the past 2 years 13. 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 prior six months at Visit 1, or prior to randomization. 14. Use of anticoagulants (e.g. warfarin [Coumadin®], coumarin, heparin, enoxaparin, clopidogrel). 15. Presence of an aortic aneurysm or resection of an aortic aneurysm within prior six months at Visit 1, or prior to randomization 16. Recent history (within prior six months at Visit 1 or prior to randomization) of significant nephrotic syndrome, pulmonary, hepatic, biliary, gastrointestinal or immunologic disease. 17. Poorly controlled hypertension (resting blood pressure ≥160 mm Hg systolic and/or ≥100 mm Hg diastolic) at two consecutive visits prior to randomization at Visit 4 18. Any of the following laboratory criteria: serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) 3x the upper limit of normal (ULN), fasting serum glucose 200 mg/dL, calculated glomerular filtration rate (GFR) 30 ml/min, platelet counts 60 x 109/L, or hemoglobin 10.0 g/dL. 19. Exposure to any investigational product within 4 weeks prior to Visit 1, or prior to randomization. 20. 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 21.Recent history (past 12 months) of drug abuse or alcohol abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy endpoint for each arm is the percent change in TG levels from baselineTimepoint: average of Weeks -2, -1 and 0) to end of treatment (average of Weeks 10 and 12) | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary efficacy endpoint for each arm includes the percent change from baseline in serum non-HDL-C and HDL-C.Timepoint: average of Weeks -2, -1 and 0) to end of treatment (average of Weeks 10 and 12) | — |
Countries
Denmark, Hungary, India, Netherlands, Russian Federation, Ukraine, United States of America
Contacts
Public ContactDr Viral Shah
Spectrum Clinical Research Pvt. Ltd.
Outcome results
None listed