Trial record 1 of 11 for:
Reduce-It
A Study of AMR101 to Evaluate Its Ability to Reduce Cardiovascular Events in High Risk Patients With Hypertriglyceridemia and on Statin. The Primary Objective is to Evaluate the Effect of 4 g/Day AMR101 for Preventing the Occurrence of a First Major Cardiovascular Event. (REDUCE-IT)
This study is ongoing, but not recruiting participants.
Sponsor:
Amarin Pharma Inc.
Information provided by (Responsible Party):
Amarin Pharma Inc.
ClinicalTrials.gov Identifier:
NCT01492361
First received: December 13, 2011
Last updated: July 25, 2016
Last verified: July 2016
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Purpose
AMR101 (icosapent ethyl [ethyl-EPA]) is a highly purified ethyl ester of eicosapentaenoic acid (EPA) being developed by Amarin Pharma Inc. for the treatment of hypertriglyceridemia. The purpose of this study is to evaluate whether this drug, combined with a statin therapy, will be superior to the statin therapy alone, when used as a prevention in reducing long-term cardiovascular events in high-risk patients with mixed dyslipidemia.
| Condition | Intervention | Phase |
|---|---|---|
|
Cardiovascular Diseases |
Drug: AMR101 Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention |
| Official Title: | Evaluation of the Effect of AMR101 on Cardiovascular Health and Mortality in Hypertriglyceridemic Patients With Cardiovascular Disease or at High Risk for Cardiovascular Disease: REDUCE-IT (Reduction of Cardiovascular Events With EPA - Intervention Trial) |
Resource links provided by NLM:
Further study details as provided by Amarin Pharma Inc.:
Primary Outcome Measures:
- Composite endpoint of CV death, MI, stroke, coronary revascularization, and hospitalization for unstable angina. [ Time Frame: 4-6 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Incidence of additional cardiovascular events, lipid and lipoprotein levels, subgroup analyses such as: diabetics, etc. [ Time Frame: 4-6 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 8000 |
| Study Start Date: | November 2011 |
| Estimated Primary Completion Date: | December 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: AMR101 |
Drug: AMR101
Parallel Assignment
Other Name: VASCEPA® (icosapent ethyl)
|
| Placebo Comparator: Placebo |
Drug: Placebo
Parallel Assignment
|
Eligibility| Ages Eligible for Study: | 45 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Men and non-pregnant or sterile women ages 45 and older
- Hypertriglyceridemia
- On statin therapy for at least four weeks
- Either having established Cardiovascular Disease or at high risk for Cardiovascular Disease
Exclusion Criteria:
- Severe heart failure
- Any life-threatening disease other than Cardiovascular Disease
- Active severe liver disease
- Hemoglobin A1c >10.0%
- Poorly controlled hypertension
- Planned coronary intervention (such as stent placement or heart bypass) or any non-cardiac major surgical procedure
- Known familial lipoprotein lipase deficiency (Fredrickson Type I), apolipoprotein C-II deficiency, or familial dysbetalipoproteinemia (Fredrickson Type III)
- Known hypersensitivity to the study product, fish and/or shellfish, or placebo
- History of acute or chronic pancreatitis
-
Patients are excluded if using the following medications:
- niacin >200 mg/day or fibrates;
- any omega-3 fatty acid medications ;
- dietary supplements containing omega-3 fatty acids (e.g., flaxseed oil, fish oil, krill oil, or algal oil);
- bile acid sequestrants
Contacts and Locations
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, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01492361
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01492361
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Locations
| United States, Alabama | |
| Amarin Investigational Site | |
| Birmingham, Alabama, United States, 35205 | |
| Amarin Investigational Site | |
| Birmingham, Alabama, United States, 35235 | |
| Amarin Investigational Site | |
| Huntsville, Alabama, United States, 35801 | |
| Amarin Investigational Site | |
| Mobile, Alabama, United States, 36608 | |
| Amarin Investigational Site | |
| Muscle Shoals, Alabama, United States, 35662 | |
| United States, Arizona | |
| Amarin Investigational Site | |
| Mesa, Arizona, United States, 85206 | |
| Amarin Investigational Site | |
| Phoenix, Arizona, United States, 85251 | |
| Amarin Investigational Site | |
| Tucson, Arizona, United States, 85745 | |
| United States, Arkansas | |
| Amarin Investigational Site | |
| Little Rock, Arkansas, United States, 72204 | |
| United States, California | |
| Amarin Investigational Site | |
| Beverly Hills, California, United States, 90211 | |
| Amarin Investigational Site | |
| Chino, California, United States, 91710 | |
| Amarin Investigational Site | |
| Concord, California, United States, 94520 | |
| Amarin Investigational Site | |
| El Cajon, California, United States, 92020 | |
| Amarin Investigational Site | |
| Encino, California, United States, 91436 | |
| Amarin Investigational Site | |
| Fair Oaks, California, United States, 95628 | |
| Amarin Investigational Site | |
| Hawaiian Gardens, California, United States, 90716 | |
| Amarin Investigational Site | |
| Lancaster, California, United States, 93534 | |
| Amarin Investigational Site | |
| Lincoln, California, United States, 95648 | |
| Amarin Investigational Site | |
| Los Angeles, California, United States, 90015 | |
| Amarin Investigational Site | |
| Los Angeles, California, United States, 90017 | |
| Amarin Investigational Site | |
| Los Angeles, California, United States, 90033 | |
| Amarin Investigational Site | |
| National City, California, United States, 91950 | |
| Amarin Investigational Site | |
| Orange, California, United States, 92868 | |
| Amarin Investigational Site | |
| Paramount, California, United States, 90723 | |
| Amarin Investigational Site | |
| Roseville, California, United States, 95661 | |
| Amarin Investigational Site | |
| San Diego, California, United States, 92123 | |
| Amarin Investigational Site | |
| Torrance, California, United States, 90502 | |
| Amarin Investigational Site | |
| Ventura, California, United States, 93003 | |
| Amarin Investigational Site | |
| Walnut Creek, California, United States, 94598 | |
| United States, Colorado | |
| Amarin Investigational Site | |
| Aurora, Colorado, United States, 80012 | |
| Amarin Investigational Site | |
| Colorado Springs, Colorado, United States, 80909 | |
| Amarin Investigational Site | |
| Golden, Colorado, United States, 80401 | |
| United States, Connecticut | |
| Amarin Investigational Site | |
| Guilford, Connecticut, United States, 06437 | |
| Amarin Investigational Site | |
| Hartford, Connecticut, United States, 06102 | |
| United States, Delaware | |
| Amarin Investigational Site | |
| Newark, Delaware, United States, 19718 | |
| Amarin Investigational Site | |
| Wilmington, Delaware, United States, 19803 | |
| United States, District of Columbia | |
| Amarin Investigational Site | |
| Washington, District of Columbia, United States, 20037 | |
| United States, Florida | |
| Amarin Investigational Site | |
| Boynton Beach, Florida, United States, 33437 | |
| Amarin Investigational Site | |
| Bradenton, Florida, United States, 34209 | |
| Amarin Investigational Site | |
| Clearwater, Florida, United States, 33756 | |
| Amarin Investigational Site | |
| Edgewater, Florida, United States, 32132 | |
| Amarin Investigational Site | |
| Fleming Island, Florida, United States, 32003 | |
| Amarin Investigational Site | |
| Fort Lauderdale, Florida, United States, 33308 | |
| Amarin Investigational Site | |
| Fort Lauderdale, Florida, United States, 33312 | |
| Amarin Investigational Site | |
| Inverness, Florida, United States, 34429 | |
| Amarin Investigational Site | |
| Jacksonville, Florida, United States, 32204 | |
| Amarin Investigational Site | |
| Jacksonville, Florida, United States, 32205 | |
| Amarin Investigational Site | |
| Jacksonville, Florida, United States, 32207 | |
| Amarin Investigational Site | |
| Jacksonville, Florida, United States, 32216 | |
| Amarin Investigational Site | |
| Miami Beach, Florida, United States, 33140 | |
| Amarin Investigational Site | |
| Miami Lakes, Florida, United States, 33014 | |
| Amarin Investigational Site | |
| Miami, Florida, United States, 33144 | |
| Amarin Investigational Site | |
| Miami, Florida, United States, 33175 | |
| Amarin Investigational Site | |
| Ocala, Florida, United States, 34471 | |
| Amarin Investigational Site | |
| Orlando, Florida, United States, 32803 | |
| Amarin Investigational Site | |
| Pembroke Pines, Florida, United States, 33026 | |
| Amarin Investigational Site | |
| Plantation, Florida, United States, 33324 | |
| Amarin Investigational Site | |
| Safety Harbor, Florida, United States, 34695 | |
| Amarin Investigational Site | |
| Sarasota, Florida, United States, 34233 | |
| Amarin Investigational Site | |
| St. Petersburg, Florida, United States, 33713 | |
| Amarin Investigational Site | |
| Vero Beach, Florida, United States, 32960 | |
| Amarin Investigational Site | |
| West Palm Beach, Florida, United States, 33401 | |
| United States, Georgia | |
| Amarin Investigational Site | |
| Conyers, Georgia, United States, 30094 | |
| Amarin Investigational Site | |
| Covington, Georgia, United States, 30014 | |
| Amarin Investigational Site | |
| Cumming, Georgia, United States, 30041 | |
| Amarin Investigational Site | |
| Roswell, Georgia, United States, 30076 | |
| United States, Hawaii | |
| Amarin Investigational Site | |
| Honolulu, Hawaii, United States, 96818 | |
| United States, Illinois | |
| Amarin Investigational Site | |
| Addison, Illinois, United States, 60101 | |
| Amarin Investigational Site | |
| Chicago, Illinois, United States, 60611 | |
| Amarin Investigational Site | |
| Norman, Illinois, United States, 61761 | |
| Amarin Investigational Site | |
| North Chicago, Illinois, United States, 60064 | |
| Amarin Investigational Site | |
| Peoria, Illinois, United States, 61636 | |
| Amarin Investigational Site | |
| Winfield, Illinois, United States, 60190 | |
| United States, Indiana | |
| Amarin Investigational Site | |
| Evansville, Indiana, United States, 47713 | |
| United States, Iowa | |
| Amarin Investigational Site | |
| Iowa City, Iowa, United States, 52242 | |
| United States, Kansas | |
| Amarin Investigational Site | |
| Wichita, Kansas, United States, 67203 | |
| Amarin Investigational Site | |
| Wichita, Kansas, United States, 67207 | |
| United States, Kentucky | |
| Amarin Investigational Site | |
| Louisville, Kentucky, United States, 40213 | |
| United States, Louisiana | |
| Amarin Investigational Site | |
| Alexandria, Louisiana, United States, 71301 | |
| Amarin Investigational Site | |
| Eunice, Louisiana, United States, 70535 | |
| Amarin Investigational Site | |
| Marrero, Louisiana, United States, 70072 | |
| United States, Maine | |
| Amarin Investigational Site | |
| Auburn, Maine, United States, 04210 | |
| United States, Maryland | |
| Amarin Investigational Site | |
| Baltimore, Maryland, United States, 21236 | |
| Amarin Investigational Site | |
| Lutherville, Maryland, United States, 21093 | |
| Amarin Investigational Site | |
| Takoma Park, Maryland, United States, 20912 | |
| United States, Massachusetts | |
| Amarin Investigational Site | |
| Boston, Massachusetts, United States, 02118 | |
| Amarin Investigational Site | |
| Boston, Massachusetts, United States, 02215 | |
| Amarin Investigational Site | |
| Fall River, Massachusetts, United States, 02721 | |
| United States, Michigan | |
| Amarin Investigational Site | |
| Lansing, Michigan, United States, 48910 | |
| Amarin Investigational Site | |
| Marquette, Michigan, United States, 49855 | |
| Amarin Investigational Site | |
| Troy, Michigan, United States, 48098 | |
| United States, Minnesota | |
| Amarin Investigational Site | |
| St. Cloud, Minnesota, United States, 56303 | |
| United States, Mississippi | |
| Amarin Investigational Site | |
| Biloxi, Mississippi, United States, 39531 | |
| Amarin Investigational Site | |
| Tupelo, Mississippi, United States, 38801 | |
| United States, Missouri | |
| Amarin Investigational Site | |
| Chesterfield, Missouri, United States, 63141 | |
| Amarin Investigational Site | |
| Florissant, Missouri, United States, 63031 | |
| Amarin Investigational Site | |
| Jefferson City, Missouri, United States, 65109 | |
| Amarin Investigational Site | |
| Kansas City, Missouri, United States, 64114 | |
| Amarin Investigational Site | |
| St. Louis, Missouri, United States, 63110 | |
| Amarin Investigational Site | |
| St. Peters, Missouri, United States, 63303 | |
| United States, Nebraska | |
| Amarin Investigational Site | |
| Hastings, Nebraska, United States, 68901 | |
| Amarin Investigational Site | |
| Omaha, Nebraska, United States, 68114 | |
| Amarin Investigational Site | |
| Omaha, Nebraska, United States, 68154 | |
| United States, Nevada | |
| Amarin Investigational Site | |
| Henderson, Nevada, United States, 89052 | |
| Amarin Investigational Site | |
| Las Vegas, Nevada, United States, 89101 | |
| United States, New Jersey | |
| Amarin Investigational Site | |
| Ocean, New Jersey, United States, 07712 | |
| United States, New Mexico | |
| Amarin Investigational Site | |
| Albuquerque, New Mexico, United States, 87102 | |
| United States, New York | |
| Amarin Investigational Site | |
| Albany, New York, United States, 12206 | |
| Amarin Investigational Site | |
| Brooklyn, New York, United States, 11206 | |
| Amarin Investigational Site | |
| Great Neck, New York, United States, 11023 | |
| Amarin Investigational Site | |
| Liverpool, New York, United States, 13088 | |
| Amarin Investigational Site | |
| New York, New York, United States, 10001 | |
| Amarin Investigational Site | |
| New York, New York, United States, 10016 | |
| Amarin Investigational Site | |
| North Massapequa, New York, United States, 11758 | |
| Amarin Investigational Site | |
| Smithtown, New York, United States, 11787 | |
| Amarin Investigational Site | |
| Vestal, New York, United States, 13850 | |
| Amarin Investigational Site | |
| West Seneca, New York, United States, 14224 | |
| United States, North Carolina | |
| Amarin Investigational Site | |
| Charlotte, North Carolina, United States, 28204 | |
| Amarin Investigational Site | |
| Durham, North Carolina, United States, 27710 | |
| Amarin Investigational Site | |
| Gastonia, North Carolina, United States, 28054 | |
| Amarin Investigational Site | |
| Kernersville, North Carolina, United States, 27284 | |
| Amarin Investigational Site | |
| Raleigh, North Carolina, United States, 27609 | |
| Amarin Investigational Site | |
| Winston-Salem, North Carolina, United States, 27157 | |
| United States, North Dakota | |
| Amarin Investigational Site | |
| Fargo, North Dakota, United States, 58103 | |
| United States, Ohio | |
| Amarin Investigational Site | |
| Cincinnati, Ohio, United States, 45219 | |
| Amarin Investigational Site | |
| Dayton, Ohio, United States, 45419 | |
| Amarin Investigational Site | |
| Lorain, Ohio, United States, 44053 | |
| Amarin Investigational Site | |
| Sandusky, Ohio, United States, 44870 | |
| United States, Oklahoma | |
| Amarin Investigational Site | |
| Tulsa, Oklahoma, United States, 74104 | |
| United States, Oregon | |
| Amarin Investigational Site | |
| Bend, Oregon, United States, 97702 | |
| Amarin Investigational Site | |
| Portland, Oregon, United States, 97239 | |
| United States, Pennsylvania | |
| Amarin Investigational Site | |
| Beaver, Pennsylvania, United States, 15009 | |
| Amarin Investigational Site | |
| Doylestown, Pennsylvania, United States, 18901 | |
| Amarin Investigational Site | |
| Jersey Shore, Pennsylvania, United States, 17740 | |
| Amarin Investigational Site | |
| Newport, Pennsylvania, United States, 17074 | |
| Amarin Investigational Site | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Amarin Investigational Site | |
| Phoenixville, Pennsylvania, United States, 19460 | |
| Amarin Investigational Site | |
| Sellersville, Pennsylvania, United States, 18960 | |
| Amarin Investigational Site | |
| Tipton, Pennsylvania, United States, 16684 | |
| Amarin Investigational Site | |
| Wyomissing, Pennsylvania, United States, 19610 | |
| Amarin Investigational Site | |
| Yardley, Pennsylvania, United States, 19067 | |
| United States, South Carolina | |
| Amarin Investigational Site | |
| Lancaster, South Carolina, United States, 29720 | |
| Amarin Investigational Site | |
| Simpsonville, South Carolina, United States, 29681 | |
| United States, South Dakota | |
| Amarin Investigational Site | |
| Rapid City, South Dakota, United States, 57701 | |
| United States, Tennessee | |
| Amarin Investigational Site | |
| Bristol, Tennessee, United States, 37620 | |
| Amarin Investigational Site | |
| Columbia, Tennessee, United States, 38401 | |
| Amarin Investigational Site | |
| Germantown, Tennessee, United States, 38138 | |
| Amarin Investigational Site | |
| Jackson, Tennessee, United States, 38301 | |
| Amarin Investigational Site | |
| Knoxville, Tennessee, United States, 37917 | |
| Amarin Investigational Site | |
| Smyrna, Tennessee, United States, 37167 | |
| United States, Texas | |
| Amarin Investigational Site | |
| Austin, Texas, United States, 78756 | |
| Amarin Investigational Site | |
| Beaumont, Texas, United States, 77702 | |
| Amarin Investigational Site | |
| Carrollton, Texas, United States, 75007 | |
| Amarin Investigational Site | |
| Dallas, Texas, United States, 75231 | |
| Amarin Investigational Site | |
| Houston, Texas, United States, 77024 | |
| Amarin Investigational Site | |
| Houston, Texas, United States, 77025 | |
| Amarin Investigational Site | |
| Houston, Texas, United States, 77030 | |
| Amarin Investigational Site | |
| Houston, Texas, United States, 77053 | |
| Amarin Investigational Site | |
| Houston, Texas, United States, 77070 | |
| Amarin Investigational Site | |
| Houston, Texas, United States, 77077 | |
| Amarin Investigational Site | |
| Houston, Texas, United States, 77079 | |
| Amarin Investigational Site | |
| Hurst, Texas, United States, 76054 | |
| Amarin Investigational Site | |
| New Braunfels, Texas, United States, 78130 | |
| Amarin Investigational Site | |
| Plano, Texas, United States, 75075 | |
| Amarin Investigational Site | |
| San Antonio, Texas, United States, 78228 | |
| Amarin Investigational Site | |
| San Antonio, Texas, United States, 78238 | |
| Amarin Investigational Site | |
| Splendora, Texas, United States, 77372 | |
| Amarin Investigational Site | |
| Tomball, Texas, United States, 77375 | |
| United States, Utah | |
| Amarin Investigational Site | |
| West Jordan, Utah, United States, 84088 | |
| United States, Virginia | |
| Amarin Investigational Site | |
| Falls Church, Virginia, United States, 22044 | |
| Amarin Investigational Site | |
| Manassas, Virginia, United States, 20109 | |
| Amarin Investigational Site | |
| Midlothian, Virginia, United States, 23114 | |
| Amarin Investigational Site | |
| Newport News, Virginia, United States, 23606 | |
| United States, Washington | |
| Amarin Investigational Site | |
| Burien, Washington, United States, 98166 | |
| Amarin Investigational Site | |
| Tacoma, Washington, United States, 98405 | |
| United States, West Virginia | |
| Amarin Investigational Site | |
| Huntington, West Virginia, United States, 25701 | |
| Australia, New South Wales | |
| Amarin Investigational Site | |
| Camperdown, New South Wales, Australia, 2015 | |
| Amarin Investigational Site | |
| Lismore, New South Wales, Australia, 2480 | |
| Australia, Queensland | |
| Amarin Investigational Site | |
| Brisbane, Queensland, Australia, 4064 | |
| Amarin Investigational Site | |
| Chermside, Queensland, Australia, 4032 | |
| Australia, South Australia | |
| Amarin Investigational Site | |
| Bedford Park, South Australia, Australia, 5042 | |
| Australia, Tasmania | |
| Amarin Investigational Site | |
| Launceston, Tasmania, Australia, 7250 | |
| Australia, Victoria | |
| Amarin Investigational Site | |
| Fitzroy, Victoria, Australia, 3065 | |
| Amarin Investigational Site | |
| Geelong, Victoria, Australia, 3220 | |
| Amarin Investigational Site | |
| Heidelberg Heights, Victoria, Australia, 3081 | |
| Amarin Investigational Site | |
| Melbourne, Victoria, Australia, 3004 | |
| Australia, Western Australia | |
| Amarin Investigational Site | |
| Fremantle, Western Australia, Australia, 6160 | |
| Amarin Investigational Site | |
| Joondalup, Western Australia, Australia, 6027 | |
| Amarin Investigational Site | |
| Murdoch, Western Australia, Australia, 6150 | |
| Amarin Investigational Site | |
| Nedlands, Western Australia, Australia, 6009 | |
| Amarin Investigational Site | |
| Perth, Western Australia, Australia, 6000 | |
| Canada, Alberta | |
| Amarin Investigational Site | |
| Edmonton, Alberta, Canada, T5A 4L8 | |
| Canada, British Columbia | |
| Amarin Investigational Site | |
| Coquitlam, British Columbia, Canada, V3K 3V9 | |
| Amarin Investigational Site | |
| Vancouver, British Columbia, Canada, V5Z 1M9 | |
| Amarin Investigational Site | |
| Vancouver, British Columbia, Canada, V6Z1Y6 | |
| Canada, Ontario | |
| Amarin Investigational Site | |
| Brampton, Ontario, Canada, L6Z 4N5 | |
| Amarin Investigational Site | |
| Collingwood, Ontario, Canada, L9Y 1W3 | |
| Amarin Investigational Site | |
| Corunna, Ontario, Canada, N0N 1G0 | |
| Amarin Investigational Site | |
| Newmarket, Ontario, Canada, L3Y 5G8 | |
| Amarin Investigational Site | |
| Sarnia, Ontario, Canada, N7T 4X3 | |
| Amarin Investigational Site | |
| Strathroy, Ontario, Canada, N7G 1Y7 | |
| Canada, Quebec | |
| Amarin Investigational Site | |
| Laval, Quebec, Canada, H7T 2P5 | |
| Amarin Investigational Site | |
| Montreal, Quebec, Canada, H1T 1C8 | |
| Amarin Investigational Site | |
| Montreal, Quebec, Canada, H3H 1A1 | |
| Amarin Investigational Site | |
| Québec, Quebec, Canada, G1V 4G5 | |
| Amarin Investigational Site | |
| Québec, Quebec, Canada, G1V 4M6 | |
| Amarin Investigational Site | |
| Sherbrooke, Quebec, Canada, J1J 2E3 | |
| Amarin Investigational Site | |
| St. Charles-Borromée, Quebec, Canada, J6E 6J2 | |
| India | |
| Amarin Investigational Site | |
| Hyderabad, Andhra Pradesh, India, 500001 | |
| Amarin Investigational Site | |
| Hyderabad, Andhra Pradesh, India, 500004 | |
| Amarin Investigational Site | |
| Secunderabad, Andhra Pradesh, India, 500003 | |
| Amarin Investigational Site | |
| Visakhapatnam, Andhra Pradesh, India, 530013 | |
| Amarin Investigational Site | |
| New Delhi, Delhi, India, 110025 | |
| Amarin Investigational Site | |
| New Delhi, Delhi, India, 110060 | |
| Amarin Investigational Site | |
| Bangalore, Karnataka, India, 560034 | |
| Amarin Investigational Site | |
| Bangalore, Karnataka, India, 560038 | |
| Amarin Investigational Site | |
| Bangalore, Karnataka, India, 560052 | |
| Amarin Investigational Site | |
| Mysore, Karnataka, India, 570015 | |
| Amarin Investigational Site | |
| Mysore, Karnataka, India, 570020 | |
| Amarin Investigational Site | |
| Kottayam, Kerala, India, 686016 | |
| Amarin Investigational Site | |
| Mumbai, Maharashtra, India, 422055 | |
| Amarin Investigational Site | |
| Nashik, Maharashtra, India, 422005 | |
| Amarin Investigational Site | |
| Pune, Maharashtra, India, 411004 | |
| Amarin Investigational Site | |
| Chennai, Tamil Nadu, India, 600086 | |
| Amarin Investigational Site | |
| Coimbatore, Tamil Nadu, India, 641037 | |
| Netherlands | |
| Amarin Investigational Site | |
| Almelo, Netherlands, 7600 SZ | |
| Amarin Investigational Site | |
| Amersfoort, Netherlands, 3813 TZ | |
| Amarin Investigational Site | |
| Blaricum, Netherlands, 1261 AN | |
| Amarin Investigational Site | |
| Capelle aan den Ijssel, Netherlands, 2906 ZC | |
| Amarin Investigational Site | |
| Den Haag, Netherlands, 2597 AX | |
| Amarin Investigational Site | |
| Den Helder, Netherlands, 1782 GZ | |
| Amarin Investigational Site | |
| Deventer, Netherlands, 7416 SE | |
| Amarin Investigational Site | |
| Ede, Netherlands, 6716 RP | |
| Amarin Investigational Site | |
| Eindhoven, Netherlands, 5611 NV | |
| Amarin Investigational Site | |
| Enschede, Netherlands, 7513 ER | |
| Amarin Investigational Site | |
| Goes, Netherlands, 4462 RA | |
| Amarin Investigational Site | |
| Gorinchem, Netherlands, 4204 AA | |
| Amarin Investigational Site | |
| Gouda, Netherlands, 2803 HH | |
| Amarin Investigational Site | |
| Groningen, Netherlands, 9728 NT | |
| Amarin Investigational Site | |
| Haarlem, Netherlands, 2035 RC | |
| Amarin Investigational Site | |
| Harderwijk, Netherlands, 3844 DG | |
| Amarin Investigational Site | |
| Heerenveen, Netherlands, 8441 PW | |
| Amarin Investigational Site | |
| Heerlen, Netherlands, 6419 PC | |
| Amarin Investigational Site | |
| Hoofddorp, Netherlands, 2134 TM | |
| Amarin Investigational Site | |
| Leeuwarden, Netherlands, 8934 AD | |
| Amarin Investigational Site | |
| Leiderdorp, Netherlands, 2353 GA | |
| Amarin Investigational Site | |
| Nijmegen, Netherlands, 6532 SZ | |
| Amarin Investigational Site | |
| Roosendaal, Netherlands, 4708 AE | |
| Amarin Investigational Site | |
| Rotterdam, Netherlands, 3021 HC | |
| Amarin Investigational Site | |
| Rotterdam, Netherlands, 3045 PM | |
| Amarin Investigational Site | |
| Rotterdam, Netherlands, 3083 AN | |
| Amarin Investigational Site | |
| s'Hertogenbosch, Netherlands, 5223 GV | |
| Amarin Investigational Site | |
| Schiedam, Netherlands, 3118 JH | |
| Amarin Investigational Site | |
| Sneek, Netherlands, 8601 ZK | |
| Amarin Investigational Site | |
| Tilburg, Netherlands, 5022 GC | |
| Amarin Investigational Site | |
| Tilburg, Netherlands, 5042 AD | |
| Amarin Investigational Site | |
| Uden, Netherlands, 5406 PT | |
| Amarin Investigational Site | |
| Veldhoven, Netherlands, 5504 DB | |
| Amarin Investigational Site | |
| Zoetermeer, Netherlands, 2725 NA | |
| Amarin Investigational Site | |
| Zutphen, Netherlands, 7207 AE | |
| New Zealand | |
| Amarin Investigational Site | |
| Takapuna, Auckland, New Zealand, 0622 | |
| Amarin Investigational Site | |
| Christchurch, New Zealand, 8011 | |
| Amarin Investigational Site | |
| Dunedin, New Zealand, 9016 | |
| Amarin Investigational Site | |
| Hamilton, New Zealand, 3240 | |
| Amarin Investigational Site | |
| Hastings, New Zealand, 4120 | |
| Amarin Investigational Site | |
| Nelson, New Zealand, 7010 | |
| Amarin Investigational Site | |
| New Plymouth, New Zealand, 4342 | |
| Amarin Investigational Site | |
| Takapuna, Auckland, New Zealand, 0622 | |
| Amarin Investigational Site | |
| Tauranga, New Zealand, 3112 | |
| Amarin Investigational Site | |
| Whangarei, New Zealand, 0110 | |
| Poland | |
| Amarin Investigational Site | |
| Bialystok, Poland, 15-351 | |
| Amarin Investigational Site | |
| Bialystok, Poland, 15-875 | |
| Amarin Investigational Site | |
| Katowice, Poland, 40-748 | |
| Amarin Investigational Site | |
| Katowice, Poland, 40-772 | |
| Amarin Investigational Site | |
| Kraków, Poland, 31-011 | |
| Amarin Investigational Site | |
| Mikolów, Poland, 43-190 | |
| Amarin Investigational Site | |
| Skierniewice, Poland, 96-100 | |
| Amarin Investigational Site | |
| Tarnów, Poland, 33-100 | |
| Amarin Investigational Site | |
| Warszawa, Poland, 01-231 | |
| Amarin Investigational Site | |
| Warszawa, Poland, 04-628 | |
| Amarin Investigational Site | |
| Warszawska, Poland, 01-192 | |
| Amarin Investigational Site | |
| Wroclaw, Poland, 50-088 | |
| Amarin Investigational Site | |
| Wroclaw, Poland, 50-315 | |
| Amarin Investigational Site | |
| Zgierz, Poland, 95-100 | |
| Romania | |
| Amarin Investigational Site | |
| Argeş, Romania, 110084 | |
| Amarin Investigational Site | |
| Brăila, Romania, 810249 | |
| Amarin Investigational Site | |
| Bucharest, Romania, 010628 | |
| Amarin Investigational Site | |
| Bucharest, Romania, 050098 | |
| Amarin Investigational Site | |
| Bucharest, Romania, 050524 | |
| Amarin Investigational Site | |
| Bucuresti, Romania, 011234 | |
| Amarin Investigational Site | |
| Bucuresti, Romania, 0200054 | |
| Amarin Investigational Site | |
| Bucuresti, Romania, 061098 | |
| Amarin Investigational Site | |
| Cluj-Napoca, Romania, 400006 | |
| Amarin Investigational Site | |
| Constanţa, Romania, 900203 | |
| Amarin Investigational Site | |
| Craiova, Dolj, Romania, 200030 | |
| Amarin Investigational Site | |
| Iaşi, Romania, 700661 | |
| Amarin Investigational Site | |
| Maramureş, Romania, 430123 | |
| Amarin Investigational Site | |
| Mureş, Romania, 540098 | |
| Amarin Investigational Site | |
| Sibiu, Romania, 550245 | |
| Amarin Investigational Site | |
| Timişoara, Romania, 300359 | |
| Amarin Investigational Site | |
| Târgu Mureş, Romania, 540136 | |
| Russian Federation | |
| Amarin Investigational Site | |
| Arkhangelsk, Russian Federation, 163000 | |
| Amarin Investigational Site | |
| Arkhangelsk, Russian Federation, 163001 | |
| Amarin Investigational Site | |
| Arkhangelsk, Russian Federation, 163045 | |
| Amarin Investigational Site | |
| Ekaterinburg, Russian Federation, 620102 | |
| Amarin Investigational Site | |
| Ekaterinburg, Russian Federation, 620109 | |
| Amarin Investigational Site | |
| Kazan, Russian Federation, 420012 | |
| Amarin Investigational Site | |
| Kazan, Russian Federation, 420097 | |
| Amarin Investigational Site | |
| Kemerovo, Russian Federation, 650000 | |
| Amarin Investigational Site | |
| Kemerovo, Russian Federation, 650002 | |
| Amarin Investigational Site | |
| Kirovsk, Leningradskaya region, Russian Federation, 187342 | |
| Amarin Investigational Site | |
| Krasnodar, Russian Federation, 350086 | |
| Amarin Investigational Site | |
| Moscow, Russian Federation, 109240 | |
| Amarin Investigational Site | |
| Moscow, Russian Federation, 111020 | |
| Amarin Investigational Site | |
| Moscow, Russian Federation, 111539 | |
| Amarin Investigational Site | |
| Moscow, Russian Federation, 115093 | |
| Amarin Investigational Site | |
| Moscow, Russian Federation, 117292 | |
| Amarin Investigational Site | |
| Moscow, Russian Federation, 117593 | |
| Amarin Investigational Site | |
| Moscow, Russian Federation, 117630 | |
| Amarin Investigational Site | |
| Moscow, Russian Federation, 117997 | |
| Amarin Investigational Site | |
| Moscow, Russian Federation, 121374 | |
| Amarin Investigational Site | |
| Moscow, Russian Federation, 121552 | |
| Amarin Investigational Site | |
| Moscow, Russian Federation, 124489 | |
| Amarin Investigational Site | |
| Nizhny Novgorod, Russian Federation, 603126 | |
| Amarin Investigational Site | |
| Novosibirsk, Russian Federation, 630008 | |
| Amarin Investigational Site | |
| Novosibirsk, Russian Federation, 630047 | |
| Amarin Investigational Site | |
| Novosibirsk, Russian Federation, 630089 | |
| Amarin Investigational Site | |
| Petrozavodsk, Russian Federation, 185000 | |
| Amarin Investigational Site | |
| Saint-Petersburg, Russian Federation, 190000 | |
| Amarin Investigational Site | |
| Saint-Petersburg, Russian Federation, 190107 | |
| Amarin Investigational Site | |
| Saint-Petersburg, Russian Federation, 192283 | |
| Amarin Investigational Site | |
| Saint-Petersburg, Russian Federation, 194044 | |
| Amarin Investigational Site | |
| Saint-Petersburg, Russian Federation, 194156 | |
| Amarin Investigational Site | |
| Saint-Petersburg, Russian Federation, 194291 | |
| Amarin Investigational Site | |
| Saint-Petersburg, Russian Federation, 194354 | |
| Amarin Investigational Site | |
| Saint-Petersburg, Russian Federation, 196601 | |
| Amarin Investigational Site | |
| Saint-Petersburg, Russian Federation, 197022 | |
| Amarin Investigational Site | |
| Saint-Petersburg, Russian Federation, 197110 | |
| Amarin Investigational Site | |
| Saint-Petersburg, Russian Federation, 197227 | |
| Amarin Investigational Site | |
| Saint-Petersburg, Russian Federation, 197341 | |
| Amarin Investigational Site | |
| Saint-Petersburg, Russian Federation, 197729 | |
| Amarin Investigational Site | |
| Saint-Petersburg, Russian Federation, 198205 | |
| Amarin Investigational Site | |
| Saint-Petersburg, Russian Federation, 199106 | |
| Amarin Investigational Site | |
| Saratov, Russian Federation, 410002 | |
| Amarin Investigational Site | |
| Saratov, Russian Federation, 410028 | |
| Amarin Investigational Site | |
| Sestroretsk, Saint-Petersburg, Russian Federation, 197706 | |
| Amarin Investigational Site | |
| Tomsk, Russian Federation, 634050 | |
| Amarin Investigational Site | |
| Tomsk, Russian Federation, 643012 | |
| Amarin Investigational Site | |
| Volgograd, Russian Federation, 400001 | |
| Amarin Investigational Site | |
| Voronezh, Russian Federation, 394018 | |
| Amarin Investigational Site | |
| Voronezh, Russian Federation, 394065 | |
| Amarin Investigational Site | |
| Yaroslavl, Russian Federation, 150030 | |
| Amarin Investigational Site | |
| Yaroslavl, Russian Federation, 150062 | |
| South Africa | |
| Amarin Investigational Site | |
| Bloemfontein, Freestate, South Africa, 9301 | |
| Amarin Investigational Site | |
| Benoni, Gauteng, South Africa, 1500 | |
| Amarin Investigational Site | |
| Pretorio, Gauteng, South Africa, 0157 | |
| Amarin Investigational Site | |
| Soweto, Gauteng, South Africa, 2013 | |
| Amarin Investigational Site | |
| Witbank, Gauteng, South Africa, 1035 | |
| Amarin Investigational Site | |
| Durban, KwaZulu-Natal, South Africa, 4001 | |
| Amarin Investigational Site | |
| Newlands, KwaZulu-Natal, South Africa, 4037 | |
| Amarin Investigational Site | |
| Bellville, Western Cape, South Africa, 7530 | |
| Amarin Investigational Site | |
| Cape Town, Western Cape, South Africa, 7925 | |
| Amarin Investigational Site | |
| Durbanville, Western Cape, South Africa, 7550 | |
| Amarin Investigational Site | |
| Goodwood, Western Cape, South Africa, 7460 | |
| Amarin Investigational Site | |
| Kraaifontein, Western Cape, South Africa, 7570 | |
| Amarin Investigational Site | |
| Paarl, Western Cape, South Africa, 7646 | |
| Amarin Investigational Site | |
| Panorama, Western Cape, South Africa, 7500 | |
| Amarin Investigational Site | |
| Parow, Western Cape, South Africa, 7500 | |
| Amarin Investigational Site | |
| Pinelands, Western Cape, South Africa, 7405 | |
| Amarin Investigational Site | |
| Somerset West, Western Cape, South Africa, 7130 | |
| Amarin Investigational Site | |
| Worcester, Western Cape, South Africa, 6850 | |
| Ukraine | |
| Amarin Investigational Site | |
| Lutsk, Volyn Region, Ukraine, 43000 | |
| Amarin Investigational Site | |
| Cherkasy, Ukraine, 18009 | |
| Amarin Investigational Site | |
| Chernivtsi, Ukraine, 58002 | |
| Amarin Investigational Site | |
| Dnipropetrovsk, Ukraine, 49006 | |
| Amarin Investigational Site | |
| Dnipropetrovsk, Ukraine, 49023 | |
| Amarin Investigational Site | |
| Dnipropetrovsk, Ukraine, 49027 | |
| Amarin Investigational Site | |
| Donetsk, Ukraine, 83001 | |
| Amarin Investigational Site | |
| Donetsk, Ukraine, 83045 | |
| Amarin Investigational Site | |
| Ivano-Frankivsk, Ukraine, 76005 | |
| Amarin Investigational Site | |
| Ivano-Frankivsk, Ukraine, 76018 | |
| Amarin Investigational Site | |
| Kharkiv, Ukraine, 61002 | |
| Amarin Investigational Site | |
| Kharkiv, Ukraine, 61018 | |
| Amarin Investigational Site | |
| Kharkiv, Ukraine, 61039 | |
| Amarin Investigational Site | |
| Kharkiv, Ukraine, 61176 | |
| Amarin Investigational Site | |
| Kyiv, Ukraine, 01032 | |
| Amarin Investigational Site | |
| Kyiv, Ukraine, 01103 | |
| Amarin Investigational Site | |
| Kyiv, Ukraine, 01151 | |
| Amarin Investigational Site | |
| Kyiv, Ukraine, 01601 | |
| Amarin Investigational Site | |
| Kyiv, Ukraine, 02091 | |
| Amarin Investigational Site | |
| Kyiv, Ukraine, 02660 | |
| Amarin Investigational Site | |
| Kyiv, Ukraine, 03151 | |
| Amarin Investigational Site | |
| Kyiv, Ukraine, 04050 | |
| Amarin Investigational Site | |
| Kyiv, Ukraine, 04114 | |
| Amarin Investigational Site | |
| Luhansk, Ukraine, 91016 | |
| Amarin Investigational Site | |
| Lutsk, Ukraine, 43024 | |
| Amarin Investigational Site | |
| Lviv, Ukraine, 79034 | |
| Amarin Investigational Site | |
| Odesa, Ukraine, 65009 | |
| Amarin Investigational Site | |
| Odesa, Ukraine, 65025 | |
| Amarin Investigational Site | |
| Odesa, Ukraine, 65082 | |
| Amarin Investigational Site | |
| Poltava, Ukraine, 36011 | |
| Amarin Investigational Site | |
| Ternopil, Ukraine, 46003 | |
| Amarin Investigational Site | |
| Uzhgorod, Ukraine, 88000 | |
| Amarin Investigational Site | |
| Uzhgorod, Ukraine, 88014 | |
| Amarin Investigational Site | |
| Vinnytsya, Ukraine, 21018 | |
| Amarin Investigational Site | |
| Vinnytsya, Ukraine, 21029 | |
| Amarin Investigational Site | |
| Zaporizhzhia, Ukraine, 69035 | |
| Amarin Investigational Site | |
| Zaporizhzhia, Ukraine, 69065 | |
| Amarin Investigational Site | |
| Zaporizhzhia, Ukraine, 69106 | |
| Amarin Investigational Site | |
| Zaporizhzhia, Ukraine, 69600 | |
Sponsors and Collaborators
Amarin Pharma Inc.
Investigators
| Principal Investigator: | Deepak L. Bhatt, MD, MPH | Brigham and Women's Hospital, 75 Francis Street, Boston |
More Information
| Responsible Party: | Amarin Pharma Inc. |
| ClinicalTrials.gov Identifier: | NCT01492361 History of Changes |
| Other Study ID Numbers: | AMR-01-01-0019 |
| Study First Received: | December 13, 2011 |
| Last Updated: | July 25, 2016 |
| Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration Canada: Health Canada India: Drugs Controller General of India The Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) New Zealand: Medsafe Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Romania: National Medicines Agency Russia: Ministry of Health of the Russian Federation South Africa: Medicines Control Council Ukraine: Ministry of Health United States: Food and Drug Administration |
| Individual Participant Data | |
| Plan to Share IPD: | Undecided |
Keywords provided by Amarin Pharma Inc.:
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases Acute Coronary Syndrome Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Angina Pectoris Chest Pain Anticholesteremic Agents Hypolipidemic Agents Lipid Regulating Agents hypertriglyceridemia |
omega-3 fatty acids statin triglycerides EPA docosahexaenoic acid fish fatty acids fibrates niacin lipids lipoprotein atorvastatin Lovaza simvastatin lovastatin |
Additional relevant MeSH terms:
|
Cardiovascular Diseases Hypertriglyceridemia Hyperlipidemias Dyslipidemias |
Lipid Metabolism Disorders Metabolic Diseases Eicosapentaenoic acid ethyl ester Platelet Aggregation Inhibitors |
ClinicalTrials.gov processed this record on September 27, 2016