Efficacy and Safety of AMR101 (Ethyl Icosapentate) in Patients With Fasting Triglyceride (Tg) Levels ≥ 500 and ≤ 2000 mg/dL

Study Overview
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Brief Summary
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The primary objective is to determine the efficacy of AMR101 (ethyl icosapentate) compared to placebo in lowering fasting triglyceride levels in patients with very high fasting triglyceride levels ≥ 500 and ≤ 2000 mg/dL.

Official Title
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Evaluation of the Efficacy and Safety of AMR101 (Ethyl Icosapentate) in Patients With Fasting Triglyceride Levels ≥ 500 mg/dL and ≤ 2000 mg/dL

Conditions
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Hypertriglyceridemia

Intervention / Treatment
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* Drug: AMR101 (ethyl icosapentate) - 4 g/day
* Drug: AMR101 (ethyl icosapentate) - 2 g/day
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women, ages >18 Fasting triglyceride ≥500 mg/dL and ≤2000 mg/dL Provide written informed consent and authorization for protected health information disclosure Exclusion Criteria: Women who are pregnant or lactating, or planning to become pregnant Use of non-statin lipid-altering drugs which cannot be stopped including fibrates, niacin, fish oil and other products containing omega-3 fatty acids or other dietary supplements with potential lipid-altering effects History of pancreatitis History of bariatric surgery or currently on weight loss drugs Uncontrolled hypertension (BP > 160/100) HIV infection or on treatment with HIV-protease inhibitors, cyclophosphamide,or isotretinoin Consumption of more than 2 alcoholic beverages per day History of cancers (except if been disease free for >5 years OR history was basal or squamous cell skin cancer) Participation in another clinical trial involving an investigational agent in the last 30 days Other parameters will be assessed at the study center to ensure eligibility for this study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo 4 capsules/day for 12 weeks (Weeks 1-12)<br>|
| Experimental: AMR101 (ethyl icosapentate) - 2 g/day<br> | Drug: AMR101 (ethyl icosapentate) - 2 g/day<br>* AMR101 (ethyl icosapentate) 2 capsules/day with placebo 2 capsules/day for 12 weeks (Weeks 1-12)<br>* Other names: VASCEPA® (icosapent ethyl);|
| Experimental: AMR101 (ethyl icosapentate) - 4 g/day<br> | Drug: AMR101 (ethyl icosapentate) - 4 g/day<br>* AMR101 (ethyl icosapentate) 4 capsules/day for 12 weeks (Weeks 1-12)<br>* Other names: VASCEPA® (icosapent ethyl);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Triglyceride Lowering Effect | Median percent change from baseline to Week 12 in fasting serum triglyceride levels following treatment with AMR101 (ethyl icosapentate) 2 g/day or 4 g/day | baseline and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Very Low-density Lipoprotein Cholesterol Levels | Median percent change from baseline to Week 12 in serum very low-density lipoprotein cholesterol levels following treatment with AMR101 (ethyl icosapentate) 2 g/day or 4 g/day | baseline and 12 weeks | 
| Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Lipoprotein-associated Phospholipase A2 Levels | Median percent change from baseline to Week 12 in serum Lipoprotein-associated Phospholipase A2 levels following treatment with AMR101 (ethyl icosapentate) 2 g/day or 4 g/day | baseline and 12 weeks | 
| Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Group in Apolipoprotein B Levels | Median in percent change from baseline to Week 12 in serum Apolipoprotein B levels following treatment with AMR101 (ethyl icosapentate) 2 g/day or 4 g/day | baseline and 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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statin, hypertriglyceridemia, omega-3 fatty acids, triglycerides, lipids, EPA, docosahexaenoic acid, fish, fatty acids, fibrates, niacin, lipid, atorvastatin, Lovaza, simvastatin, lovastatin, pravastatin, fluvastatin, rosuvastatin, Trilipix, Vytorin, Simcor, ezetimibe, Zetia, ethyl-EPA, ethyl icosapentate, Crestor, Zocor, Lipitor, Niaspan, LDL, HDL, cholesterol, dyslipidemia, VASCEPA, icosapent ethyl