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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01047683
Recruitment Status : Completed
First Posted : January 13, 2010
Results First Posted : April 25, 2022
Last Update Posted : April 25, 2022
Sponsor:
Information provided by (Responsible Party):
Amarin Pharma Inc.

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hypertriglyceridemia Drug: AMR101 (ethyl icosapentate) - 4 g/day Drug: AMR101 (ethyl icosapentate) - 2 g/day Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 229 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of the Efficacy and Safety of AMR101 (Ethyl Icosapentate) in Patients With Fasting Triglyceride Levels ≥ 500 mg/dL and ≤ 2000 mg/dL
Study Start Date : December 2009
Actual Primary Completion Date : October 2010
Actual Study Completion Date : July 2011

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Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Placebo
Placebo 4 capsules/day for 12 weeks (Weeks 1-12)
Experimental: AMR101 (ethyl icosapentate) - 2 g/day Drug: AMR101 (ethyl icosapentate) - 2 g/day
AMR101 (ethyl icosapentate) 2 capsules/day with placebo 2 capsules/day for 12 weeks (Weeks 1-12)
Other Name: VASCEPA® (icosapent ethyl)
Experimental: AMR101 (ethyl icosapentate) - 4 g/day Drug: AMR101 (ethyl icosapentate) - 4 g/day
AMR101 (ethyl icosapentate) 4 capsules/day for 12 weeks (Weeks 1-12)
Other Name: VASCEPA® (icosapent ethyl)


Outcome Measures
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Primary Outcome Measures :
  1. Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Triglyceride Lowering Effect [ Time Frame: baseline and 12 weeks ]
    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


Secondary Outcome Measures :
  1. Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Very Low-density Lipoprotein Cholesterol Levels [ Time Frame: baseline and 12 weeks ]
    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

  2. Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Lipoprotein-associated Phospholipase A2 Levels [ Time Frame: baseline and 12 weeks ]
    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

  3. Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Group in Apolipoprotein B Levels [ Time Frame: baseline and 12 weeks ]
    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


Other Outcome Measures:
  1. Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Low-density Lipoprotein Cholesterol Levels [ Time Frame: baseline and 12 weeks ]
    Median percent change from baseline to Week 12 in serum low density lipoprotein cholesterol levels following treatment with AMR101 (ethyl icosapentate) 2 g/day or 4 g/day

  2. Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Non-High-Density Lipoprotein Cholesterol Levels [ Time Frame: baseline and 12 weeks ]
    Median percent change from baseline to Week 12 in serum non-high density lipoprotein cholesterol levels following treatment with AMR101 (ethyl icosapentate) 2 g/day or 4 g/day


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01047683


Locations
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Sponsors and Collaborators
Amarin Pharma Inc.
More Information
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Publications of Results:

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Responsible Party: Amarin Pharma Inc.
ClinicalTrials.gov Identifier: NCT01047683    
Other Study ID Numbers: AMR-01-01-0016
The MARINE Study ( Other Identifier: Amarin Pharma Inc. )
First Posted: January 13, 2010    Key Record Dates
Results First Posted: April 25, 2022
Last Update Posted: April 25, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Amarin Pharma Inc.:
hypertriglyceridemia
omega-3 fatty acids
statin
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
Additional relevant MeSH terms:
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Hypertriglyceridemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
 Metabolic Diseases
Eicosapentaenoic acid ethyl ester
Platelet Aggregation Inhibitors
Lipid Regulating Agents