Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
Last Update Posted : January 17, 2014
Sponsor:
Information provided by (Responsible Party):
Amarin Pharma Inc.

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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) Drug: Placebo Phase 3

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Triglycerides

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Placebo
Placebo 4 capsules/day for 12 weeks (Weeks 1-12), then AMR101 (ethyl icosapentate) for 40 weeks (Weeks 13-52)
Experimental: AMR101 (ethyl icosapentate) - 2 g/day Drug: AMR101 (ethyl icosapentate)
AMR101 (ethyl icosapentate) 2 capsules/day for 12 weeks (Weeks 1-12), then AMR101 (ethyl icosapentate) 4 capsules/day for 40 weeks (Weeks 13-52)

Drug: Placebo
Placebo 2 capsules/day for 12 weeks (Weeks 1-12)
Experimental: AMR101 (ethyl icosapentate) - 4 g/day Drug: AMR101 (ethyl icosapentate)
AMR101 (ethyl icosapentate) 4 capsules/day for 12 weeks (Weeks 1-12), then AMR101 (ethyl icosapentate) 4 capsules/day for 40 weeks (Weeks 13-52)


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Difference between AMR101 (ethyl icosapentate) and placebo treatment groups in triglyceride lowering effect [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Difference between AMR101 (ethyl icosapentate) and placebo treatment groups in other lipid and biomarker levels [ Time Frame: 12 weeks ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


  Show 60 Study Locations
Sponsors and Collaborators
Amarin Pharma Inc.
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
Bays HE et al. Eicosapentaenoic acid ethyl ester (AMR101) therapy in patients with very high triglyceride levels (from the MARINE trial). Am J Cardiol. 2011 Sep 1;108(5):682-90. Epub 2011 Jun 16  This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Amarin Pharma Inc.
ClinicalTrials.gov Identifier: NCT01047683     History of Changes
Other Study ID Numbers: AMR-01-01-0016
First Posted: January 13, 2010    Key Record Dates
Last Update Posted: January 17, 2014
Last Verified: December 2013
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
Niaspan
ezetimibe
Zetia
ethyl-EPA
ethyl icosapentate
Crestor
Zocor
Lipitor
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypertriglyceridemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
 Metabolic Diseases
Eicosapentaenoic acid ethyl ester
Platelet Aggregation Inhibitors