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Generated: December 10, 2018

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CLINICAL TRIALS PROFILE FOR EPANOVA

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Clinical Trials for Epanova

Trial ID Title Status Sponsor Phase Summary
NCT00074542 An Efficacy and Safety Study of Omega-3 Free Fatty Acids (Epanova™) for the Maintenance of Symptomatic Remission in Subjects With Crohn's Disease Completed Tillotts Pharma AG Phase 3 The purpose of this study is to see if Epanova™ is able to maintain the symptomatic remission in subjects with Crohn's Disease who are responding to steroid induction therapy. Patient safety and quality of life will also be monitored throughout the study.
NCT00613197 EPANOVA in Crohn's Disease, Study 1 Completed Tillotts Pharma AG Phase 3 The primary objective of this study is to assess the ability of EpanovaTM Soft Gelatin Capsules at a total daily dose of 4g (4x 1g capsules) to maintain remission (Crohn's Disease Activity Index CDAI < 150) in CD patients in whom remission, stable for at least three months and no longer than one year, has been induced by corticosteroids, azathioprine/6-MP, methotrexate, 5-ASA or antibiotics. Secondary objectives are to assess the: efficacy of Epanova versus placebo by Crohn's Disease Activity Index (CDAI), Investigator and Subject Global Ratings, employment status and use of CD related medical visits in subjects with CD in remission safety and tolerability of Epanova ability of Epanova to maintain the quality of life of CD patients in remission
NCT01208961 Epanova® Compared to Lovaza® In a Pharmacokinetic, Single-dose, Evaluation Completed Radiant Research Phase 2 The objectives of this study are to compare the relative bioavailabilities of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) in plasma from a single dose of Epanova or Lovaza during periods of high- and low -fat consumption.
NCT01208961 Epanova® Compared to Lovaza® In a Pharmacokinetic, Single-dose, Evaluation Completed AstraZeneca Phase 2 The objectives of this study are to compare the relative bioavailabilities of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) in plasma from a single dose of Epanova or Lovaza during periods of high- and low -fat consumption.
NCT01242527 Epanova® for Lowering Very High Triglycerides Completed AstraZeneca Phase 2/Phase 3 The primary objective of the study is to determine the efficacy of Epanova (omefas) compared to placebo in lowering serum triglycerides in subjects with severe hypertriglyceridemia.
NCT01408303 [E]PANOVA Combined With a [S]TATIN in [P]ATIENTS With HYPERT[R]IGLYCER[I]DEMIA to Reduce Non-HDL CHOLES[T]EROL Completed Medpace, Inc. Phase 3 The primary objective is to evaluate the efficacy of adding Epanova (2 g or 4 g daily) to an optimal statin monotherapy for lowering non-high-density lipoprotein (non-HDL) cholesterol in subjects with persistent hypertriglyceridemia and high risk for cardiovascular disease.
NCT01408303 [E]PANOVA Combined With a [S]TATIN in [P]ATIENTS With HYPERT[R]IGLYCER[I]DEMIA to Reduce Non-HDL CHOLES[T]EROL Completed Omthera Pharmaceuticals, Inc Phase 3 The primary objective is to evaluate the efficacy of adding Epanova (2 g or 4 g daily) to an optimal statin monotherapy for lowering non-high-density lipoprotein (non-HDL) cholesterol in subjects with persistent hypertriglyceridemia and high risk for cardiovascular disease.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Epanova

Condition Name

Condition Name for Epanova
Intervention Trials
Hypertriglyceridemia 7
Severe Hypertriglyceridemia 3
Crohn's Disease 2
Non-alcoholic Fatty Liver Disease (NAFLD 1
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Condition MeSH

Condition MeSH for Epanova
Intervention Trials
Hypertriglyceridemia 11
Cardiovascular Diseases 2
Crohn Disease 2
Atherosclerosis 1
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Clinical Trial Locations for Epanova

Trials by Country

Trials by Country for Epanova
Location Trials
United States 112
Canada 14
India 7
Hungary 4
Denmark 4
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Trials by US State

Trials by US State for Epanova
Location Trials
Ohio 6
Illinois 6
Pennsylvania 5
Kentucky 5
Tennessee 4
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Clinical Trial Progress for Epanova

Clinical Trial Phase

Clinical Trial Phase for Epanova
Clinical Trial Phase Trials
Phase 3 6
Phase 2/Phase 3 1
Phase 2 3
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Clinical Trial Status

Clinical Trial Status for Epanova
Clinical Trial Phase Trials
Completed 14
Recruiting 1
Active, not recruiting 1
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Clinical Trial Sponsors for Epanova

Sponsor Name

Sponsor Name for Epanova
Sponsor Trials
AstraZeneca 14
Tillotts Pharma AG 2
Cleveland Clinic Coordinating Center for Clinical Research (C5R) 1
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Sponsor Type

Sponsor Type for Epanova
Sponsor Trials
Industry 19
Other 2
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Serving hundreds of leading biopharmaceutical companies globally:

Covington
Citi
UBS
Dow
McKinsey
Colorcon
Mallinckrodt
Teva
Baxter

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