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Omega-3-carboxylic acids

Generic Name
Omega-3-carboxylic acids
Drug Type
Small Molecule
Unique Ingredient Identifier
F85N2YHE4E
Background

The omega-3 carboxylic acid (OM3-CA) is a new formulation of omega-3 fatty acids that present an enhanced bioavailability in the treatment of dyslipidemia. The increased bioavailability is explained because OM3-CA is found in a form of polyunsaturated free fatty acids as opposed to other products whose form is as ethyl esters. It is a complex mixture of the free fatty acids form containing eicosapentaenoic acid and docosahexaenoic acid as the most abundant species found in a proportion of 55% and 20% respectively. The rest of the concentration is represented by docosapentaenoic acid and traces of some other components such as alpha-tocopherol, gelatin, glycerol, sorbitol and purified water. It was developed by AstraZeneca Pharmaceuticals and firstly approved by the FDA on May 05, 2014.

Indication

OM3-CA is indicated as an adjunct to diet to reduce triglycerides levels in adults patients with severe hypertriglyceridemia (>500 mg/dL). The patients involved in this treatment should be laced with an appropriate lipid-lowering diet.

Hypertriglyceridemia is defined as an elevated plasma triglyceride concentration. It is usually correlated to other secondary conditions such as poor diet, alcohol use, obesity, metabolic syndrome and type 2 diabetes.

Associated Conditions
Hypertriglyceridemias

A Ph 1 Study of Epanova® in Healthy Chineses

Phase 1
Completed
Conditions
Healthy Subjects
Interventions
First Posted Date
2018-06-29
Last Posted Date
2018-07-05
Lead Sponsor
AstraZeneca
Target Recruit Count
14
Registration Number
NCT03574142
Locations
🇨🇳

Research Site, Beijing, China

AZD0585 Phase III Long-term Study in Japan

Phase 3
Completed
Conditions
Hypertriglyceridemia
Interventions
Drug: AZD0585 placebo
First Posted Date
2015-06-04
Last Posted Date
2018-10-01
Lead Sponsor
AstraZeneca
Target Recruit Count
383
Registration Number
NCT02463071
Locations
🇯🇵

Research Site, Urasoe-shi, Japan

A Study to Investigate the Effect of Food on Pharmacokinetics of Total EPA and Total DHA of AZD0585 in Healthy Male Japanese Subjects

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2015-02-26
Last Posted Date
2016-05-16
Lead Sponsor
AstraZeneca
Target Recruit Count
72
Registration Number
NCT02372344
Locations
🇯🇵

Research Site, Fukuoka-shi, Japan

A Ph1 Study in Healthy Male Japanese and Caucasian After Single and Multiple Doses of D5884(Omega-3-carboxylic Acids)

Phase 1
Completed
Conditions
Healthy
Interventions
Drug: Placebo
First Posted Date
2014-08-06
Last Posted Date
2016-05-17
Lead Sponsor
AstraZeneca
Target Recruit Count
86
Registration Number
NCT02209766
Locations
🇯🇵

CPC Clinical Trial Hospital, Kagoshima, Japan

An Open-Label Crossover Study to Compare the Relative Bioavailability, Efficacy and Safety of Epanova® and Lovaza® in Men and Women With a History of Pancreatitis

Phase 1
Completed
Conditions
Severe Hypertriglyceridemia
Interventions
First Posted Date
2014-07-14
Last Posted Date
2016-06-20
Lead Sponsor
AstraZeneca
Target Recruit Count
30
Registration Number
NCT02189252
Locations
🇨🇦

Research Site, Chocoutimi, Quebec, Canada

Epanova® for Lowering Very High Triglycerides II (EVOLVE II)

Phase 3
Completed
Conditions
Hypertriglyceridemia
Interventions
First Posted Date
2013-12-12
Last Posted Date
2019-09-10
Lead Sponsor
AstraZeneca
Target Recruit Count
379
Registration Number
NCT02009865
Locations
🇷🇺

Research Site, Tomsk, Russian Federation

EPANOVA in Crohn's Disease, Study 1

Phase 3
Completed
Conditions
Crohn's Disease
Interventions
First Posted Date
2008-02-12
Last Posted Date
2013-04-04
Lead Sponsor
Tillotts Pharma AG
Target Recruit Count
384
Registration Number
NCT00613197
Locations
🇧🇪

University of Leuven, Leuven, Belgium

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