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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amarin Pharma Inc.
ClinicalTrials.gov Identifier:
NCT01047683
First received: January 11, 2010
Last updated: December 18, 2013
Last verified: December 2013
  Purpose

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 Intervention Phase
Hypertriglyceridemia
Drug: AMR101 (ethyl icosapentate)
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Amarin Pharma Inc.:

Primary Outcome Measures:
  • Difference between AMR101 (ethyl icosapentate) and placebo treatment groups in triglyceride lowering effect [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Difference between AMR101 (ethyl icosapentate) and placebo treatment groups in other lipid and biomarker levels [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 229
Study Start Date: December 2009
Study Completion Date: July 2011
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01047683

  Hide Study Locations
Locations
United States, California
Amarin Investigational Site
Sacramento, California, United States, 95823
United States, Colorado
Amarin Investigational Site
Golden, Colorado, United States, 80401
United States, Florida
Amarin Investigational Site
Miami, Florida, United States, 33183
Amarin Investigational Site
Miami, Florida, United States, 33169
Amarin Investigational Site
Ocala, Florida, United States, 34471
United States, Illinois
Amarin Investigational Site
Addison, Illinois, United States, 27106
Amarin Investigational Site
Chicago, Illinois, United States, 60611
United States, Kentucky
Amarin Investigational Site
Louisville, Kentucky, United States, 40213
United States, Montana
Amarin Investigational Site
Butte, Montana, United States, 59701
United States, North Carolina
Amarin Investigational Site
Raleigh, North Carolina, United States, 27527
Amarin Investigational Site
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Amarin Investigational Site
Cincinnati, Ohio, United States, 45219
Amarin Investigational Site
Cincinnati, Ohio, United States, 45212
Amarin Investigational Site
Lynhurst, Ohio, United States, 44124
United States, Oklahoma
Amarin Investigational Site
Tulsa, Oklahoma, United States, 74136
United States, Texas
Amarin Investigational Site
Corpus Christi, Texas, United States, 78404
Amarin Investigational Site
Houston, Texas, United States, 77030
United States, Virginia
Amarin Investigational Site
Richmond, Virginia, United States, 23294
Denmark
Amarin Investigational Site
Aalborg, Denmark, 9000
Amarin Investigational Site
Herlev, Denmark, 2730
Finland
Amarin Investigational Site
Oulu, Finland, FI-90014
Germany
Amarin Investigational Site
Dresden, Germany, 1307
Amarin Investigational Site
Giessen, Germany, 35392
Amarin Investigational Site
Magdeburg, Germany, 39120
Amarin Investigational Site
Muenchen, Germany, 81377
Amarin Investigational Site
Muenchen, Germany, 80336
Amarin Investigational Site
Nuernberg, Germany, 90402
India
Amarin Investigational Site
Ahmedabad, India, 380 015
Amarin Investigational Site
Bangalore, India, 560054
Amarin Investigational Site
Bangalore, India, 560010
Amarin Investigational Site
Bangalore, India, 560003
Amarin Investigational Site
Gopalapuram, India, 600086
Amarin Investigational Site
Indore, India, 452010
Amarin Investigational Site
Mysore, India, 570 020
Italy
Amarin Investigational Site
Genova, Italy, I-16132
Amarin Investigational Site
Palermo, Italy, 90127
Mexico
Amarin Investigational Site
Guadalajara, Jalisco, Mexico, 44600
Amarin Investigational Site
Mexico City, Mexico, 6700
Amarin Investigational Site
Mexico City, Mexico, 11650
Amarin Investigational Site
Monterrey Nuevo Leon, Mexico, 64460
Netherlands
Amarin Investigational Site
Amsterdam, Netherlands, 1105 AZ
Amarin Investigational Site
Groningen, Netherlands, 9711 SG
Amarin Investigational Site
Rotterdam, Netherlands, 3021 HC
Amarin Investigational Site
Rotterdam, Netherlands, 3045 PM
Amarin Investigational Site
Utrecht, Netherlands, 3584 CX
Russian Federation
Amarin Investigational Site
Moscow, Russian Federation, 129090
Amarin Investigational Site
Moscow, Russian Federation, 121552
Amarin Investigational Site
St Petersburg, Russian Federation, 198205
Amarin Investigational Site
St. Petersburg, Russian Federation, 197341
Amarin Investigational Site
St. Petersburg, Russian Federation, 194291
South Africa
Amarin Investigational Site
Bloemfontein, South Africa, 9301
Amarin Investigational Site
Cape Town, South Africa, 7500
Amarin Investigational Site
Johannesburg, South Africa, 2113
Amarin Investigational Site
Parktown, South Africa, 2193
Amarin Investigational Site
Pretoria, South Africa, 157
Amarin Investigational Site
Somerset West, South Africa, 7129
Ukraine
Amarin Investigational Site
Ivano-Frankivsk, Ukraine, 76018
Amarin Investigational Site
Kiev, Ukraine, 3680
Amarin Investigational Site
Kyiv, Ukraine, 4114
Amarin Investigational Site
Odessa, Ukraine, 65059
Sponsors and Collaborators
Amarin Pharma Inc.
  More Information

Additional Information:
No publications provided by Amarin Pharma Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Amarin Pharma Inc.
ClinicalTrials.gov Identifier: NCT01047683     History of Changes
Other Study ID Numbers: AMR-01-01-0016
Study First Received: January 11, 2010
Last Updated: December 18, 2013
Health Authority: United States: Food and Drug Administration
Denmark: Danish Medicines Agency
Finland: Finnish Medicines Agency
Germany: Federal Institute for Drugs and Medical Devices
India: Drugs Controller General of India
Italy: The Italian Medicines Agency
Mexico: Federal Commission for Protection Against Health Risks
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Russia: Ministry of Health of the Russian Federation
South Africa: Medicines Control Council
Ukraine: Ministry of Health

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:
Hypertriglyceridemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Eicosapentaenoic acid ethyl ester
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014