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

January 11, 2010
December 18, 2013
December 2009
October 2010   (final data collection date for primary outcome measure)
Difference between AMR101 (ethyl icosapentate) and placebo treatment groups in triglyceride lowering effect [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01047683 on ClinicalTrials.gov Archive Site
Difference between AMR101 (ethyl icosapentate) and placebo treatment groups in other lipid and biomarker levels [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Efficacy and Safety of AMR101 (Ethyl Icosapentate) in Patients With Fasting Triglyceride (Tg) Levels ≥ 500 and ≤ 2000 mg/dL
Evaluation of the Efficacy and Safety of AMR101 (Ethyl Icosapentate) in Patients With Fasting Triglyceride Levels ≥ 500 mg/dL and ≤ 2000 mg/dL

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Hypertriglyceridemia
  • 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)
  • 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 4 capsules/day for 12 weeks (Weeks 1-12), then AMR101 (ethyl icosapentate) for 40 weeks (Weeks 13-52)
  • Drug: Placebo
    Placebo 2 capsules/day for 12 weeks (Weeks 1-12)
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Experimental: AMR101 (ethyl icosapentate) - 2 g/day
    Interventions:
    • Drug: AMR101 (ethyl icosapentate)
    • Drug: Placebo
  • Experimental: AMR101 (ethyl icosapentate) - 4 g/day
    Intervention: Drug: AMR101 (ethyl icosapentate)
Bays HE, Braeckman RA, Ballantyne CM, Kastelein JJ, Otvos JD, Stirtan WG, Soni PN. Icosapent ethyl, a pure EPA omega-3 fatty acid: effects on lipoprotein particle concentration and size in patients with very high triglyceride levels (the MARINE study). J Clin Lipidol. 2012 Nov;6(6):565-72. doi: 10.1016/j.jacl.2012.07.001. Epub 2012 Jul 24.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
229
July 2011
October 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
India,   United States,   Denmark,   Finland,   Germany,   Ukraine,   Italy,   Mexico,   Netherlands,   Russian Federation,   South Africa
 
NCT01047683
AMR-01-01-0016
No
Amarin Pharma Inc.
Amarin Pharma Inc.
Not Provided
Not Provided
Amarin Pharma Inc.
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP