Efficacy and Safety of AMR101 (Ethyl Icosapentate) in Patients With Fasting Triglyceride (Tg) Levels ≥ 500 and ≤ 2000 mg/dL (MARINE)
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| ClinicalTrials.gov Identifier: NCT01047683 |
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Recruitment Status :
Completed
First Posted : January 13, 2010
Last Update Posted : January 17, 2014
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Sponsor:
Amarin Pharma Inc.
Information provided by (Responsible Party):
Amarin Pharma Inc.
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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) Drug: Placebo | Phase 3 |
| 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
| 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) |
Primary Outcome Measures :
- Difference between AMR101 (ethyl icosapentate) and placebo treatment groups in triglyceride lowering effect [ Time Frame: 12 weeks ]
Secondary Outcome Measures :
- Difference between AMR101 (ethyl icosapentate) and placebo treatment groups in other lipid and biomarker levels [ Time Frame: 12 weeks ]
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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.
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
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Sponsors and Collaborators
Amarin Pharma Inc.
Additional Information:
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 |
| First Posted: | January 13, 2010 Key Record Dates |
| Last Update Posted: | January 17, 2014 |
| Last Verified: | December 2013 |
Keywords provided by Amarin Pharma Inc.:
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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:
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Hypertriglyceridemia Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders |
Metabolic Diseases Eicosapentaenoic acid ethyl ester Platelet Aggregation Inhibitors |