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:
Amarin Pharma Inc.
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
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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 (Adult, Senior) |
| 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01047683
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01047683
Show 60 Study Locations
Sponsors and Collaborators
Amarin Pharma Inc.
More Information
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 |
| 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 |
ClinicalTrials.gov processed this record on September 23, 2016