Clinical trials: Omega-3 Fatty Acids
Steatohepatitis
Double-Blind, Placebo-Controlled Study of Two Doses of EPA-E in Patients With Non Alcoholic Steatohepatitis (NASH)
This is a controlled study to determine the effectiveness and safety of ethyl icosapentate (EPA-E) in the treatment of adult patients with non-alcoholic steatohepatitis (NASH).
- Trial name
- NCT01154985
- Testing
- EPA-E 300 mg capsule
- Where
- 34 sites in United States, Puerto Rico
- Volunteers
- 243 people
- Sponsor
- Mochida Pharmaceutical Company, Ltd.
Severe Hypertriglyceridemia
Epanova® Compared to Lovaza® In a Pharmacokinetic, Single-dose, Evaluation
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…
- Trial name
- ECLIPSE (NCT01208961)
- Testing
- Epanova (4 g) and Lovaza (4 g), Lovaza (4 g) and Epanova (4 g)
- Where
- United States
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Patients Requiring Home Parenteral Nutrition
The HOME Study (HPN With OMEGA-3)
The aim of the trial is to investigate safety and tolerability of an Omega-3-FA-enriched lipid emulsion in adult patients with chronic intestinal failure in need of long-term HPN.
- Trial name
- HOME (NCT03282955)
- Testing
- Lipidem, Lipofundin MCT 20%
- Where
- 9 sites in France, Italy and 3 more
- Volunteers
- 74 people
- Sponsor
- B. Braun Melsungen AG
History of Myocardial Infarction, Hypertriglyceridemia
A Prospective Observational Program Using Digital Technology Tools to Enhance Patient Adherence to Omacor Therapy
A prospective observational program using digital technology tools to enhance patient adherence to Omacor therapy
- Trial name
- DIAPAsOn (NCT03415152)
- Testing
- Omacor (Omega-3-acid ethyl esters)
- Where
- 93 sites in Russia
- Volunteers
- 3,000 people
- Sponsor
- Abbott
Memory Impairment
The Efficacy of Phosphatidylserine-Omega3 in Elderly Subjects With Memory Impairment
The primary objective of this trial is to assess the ability of Phosphatidylserine-Omega3 to improve cognitive performance in elderly subjects with memory impairment.
- Trial name
- NCT00736034
- Testing
- Phosphatidylserine-Omega3 (SharpPS™-Gold)
- Where
- Israel
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Enzymotec
Preterm Infants, Parenteral Nutrition n-3 Fatty Acids
Comparison of Two Different Lipid Emulsions for Parenteral Nutrition in Preterm Infants
The study shall provide evidence for the save and efficient use of a fish oil containing lipid emulsion in parenteral nutrition of preterm infants.Safety will be assessed by monitoring hepatological and hematological laboratory…
- Trial name
- NCT00497289
- Testing
- Lipofundin MCT/LCT 20 %, Lipidem 20%
- Where
- 2 sites in Germany
- Volunteers
- 48 people
- Sponsor
- B. Braun Melsungen AG
Severe Hypertriglyceridemia
Epanova® for Lowering Very High Triglycerides
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.
- Trial name
- EVOLVE (NCT01242527)
- Testing
- omefas
- Where
- 68 sites in United States, Denmark and 5 more
- Volunteers
- 399 people
- Sponsor
- AstraZeneca
Hypertriglyceridemia
Pharmacodynamic Effects of a Free-Fatty Acid Formulation of Omega-3 Pentaenoic Acid in Adults With Hypertriglyceridemia
Pharmacodynamic effects of MAT9001 compared to Vascepa in adults with hypertriglyceridemia
- Trial name
- ENHANCE-IT (NCT04177680)
- Testing
- Omega 3 pentaenoic acid, icosapent ethyl
- Where
- 8 sites in United States
- Volunteers
- 100 people
- Sponsor
- Matinas BioPharma Nanotechnologies, Inc.
Non-alcoholic Fatty Liver Disease (NAFLD, Hypertriglyceridemia
A Double-blind Randomized Placebo-controlled Study Comparing Epanova and Fenofibrate on Liver Fat in Overweight Subjects.
This study is a double-blind randomized, placebo-controlled, parallel-group, 12 week study performed in 2 centres in Sweden to assess the effect of Omega-3 carboxylic acids and fenofibrate on liver fat measured with magnetic…
- Trial name
- NCT02354976
- Testing
- Omega-3 carboxylic acid, Fenofibrate 200mg
- Where
- 4 sites in Sweden
- Volunteers
- 78 people
- Sponsor
- AstraZeneca
Eligible Men or Women Considered High Risk for Atherosclerotic Cardiovascular Disease (CVD)
Outcomes Study to Assess STatin Residual Risk Reduction With EpaNova in HiGh CV Risk PatienTs With Hypertriglyceridemia
The study is a randomized, double-blind, placebo-controlled (corn oil), parallel group design that will enroll approximately 13,000 patients with hypertriglyceridemia and low HDL and high risk for CVD to be randomized 1:1 to…
- Trial name
- STRENGTH (NCT02104817)
- Testing
- Epanova® (omega-3 carboxylic acids), corn oil control
- Where
- 684 sites in United States, Australia and 20 more
- Volunteers
- 13,078 people
- Sponsor
- AstraZeneca
Growth and Development
Study Comparing Blood Levels of Fatty Acids After Consuming Two Forms of Cod Liver Oil
This study is designed to compare the incremental area under the curve from 0 to 24h (iAUC0-24h) of plasma levels of n-3 fatty acids (sum of total and free eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)) after…
- Trial name
- NCT02428699
- Testing
- Emulsified cod liver oil product, Non-emulsified cod liver oil product
- Where
- United Kingdom
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hypertriglyceridemia
Evaluation of Efficacy and Safety of Omacor, Co-Administered With Atorvastatin, in Subjects With Hypertriglyceridemia
The purpose of this study is to evaluate the efficacy and safety of Omacor (omega-3-acid ethyl esters) combined with atorvastatin for lowering non-high-density lipoprotein cholesterol (non-HDL-C) in hypertriglyceridemic subjects.
- Trial name
- NCT00435045
- Testing
- Lovaza (omega-3-acid ethyl esters) [formerly known as Omacor] plus atorvastatin, atorvastatin
- Volunteers
- 245 people
- Sponsor
- GlaxoSmithKline
Hyperlipidemia
Specified Drug-use Survey of the Granular Capsule Formulation of Omega-3 Fatty Acid Ethyl Esters: OCEAN3
The purpose of this survey is to determine the incidence rate of cardiovascular (CV) events associated with long-term treatment with and without omega-3 fatty acid ethyl esters (Lotriga Granular Capsules) in high-risk…
- Trial name
- NCT02285166
- Testing
- Omega-3 fatty acid ethyl esters, Standard antihyperlipidemic therapy other than administration of omega-3 fatty acid ethyl esters (Lotriga).
- Where
- 2 sites in Japan
- Volunteers
- 15,330 people
- Sponsor
- Takeda
Cystic Fibrosis
Absorption and Safety With Sustained Use of RELiZORB Evaluation (ASSURE) Study
Protocol 0000498: Multicenter, open label study to evaluate the effect of sustained RELiZORB (immobilized lipase) cartridge use during enteral feeding on fat absorption, as well as safety and tolerability of sustained RELiZORB…
- Trial name
- ASSURE (NCT02750501)
- Testing
- RELiZORB (immobilized lipase) cartridge, Impact Peptide 1.5
- Where
- 10 sites in United States
- Volunteers
- 49 people
- Sponsor
- Alcresta Therapeutics, Inc.
Fibrillation, Atrial
Evaluation of Efficacy and Safety of Lovaza (Omega-3-Acid Ethyl Esters) in Recurrent, Symptomatic Atrial Fibrillation
The purpose of this study is to evaluate efficacy and safety of Omacor (omega-3-acid ethyl esters) in patients with recurrent, symptomatic atrial fibrillation.
- Trial name
- NCT00402363
- Testing
- omega-3-acid ethyl esters
- Where
- 178 sites in United States
- Volunteers
- 663 people
- Sponsor
- GlaxoSmithKline
T2 Diabetes and Fatty Liver Disease (Non-alcoholic Origin)
A Study to Investigate Effects of Omega-3 Carboxylic Acids and Dapagliflozin on Liver Fat Content in Diabetic Patients
This study is a double-blind randomized, placebo-controlled, parallel-group, 12 week study performed in up to 5 centres in Sweden to assess the effect of Omega-3 carboxylic acids and dapagliflozin on liver fat in patients with…
- Trial name
- EFFECTII (NCT02279407)
- Testing
- Omega-3 carboxylic acids, Dapagliflozin
- Where
- 5 sites in Sweden
- Volunteers
- 223 people
- Sponsor
- AstraZeneca
Hyperlipidemia
Evaluation of the Safety and Efficacy of Long-term Use of Omega-3 Fatty Acid Ethyl Esters
The purpose of this study is to evaluate the safety and efficacy of long-term use of granular capsule formulation of omega-3 fatty acid ethyl esters (Lotriga Granular Capsules) in patients with hyperlipidemia in daily medical…
- Trial name
- NCT02153073
- Testing
- Omega-3 fatty acid ethyl esters
- Where
- 2 sites in Japan
- Volunteers
- 3,084 people
- Sponsor
- Takeda
Hyperlipidemia
Exploratory Study of the Effect of Omega-3-acid Ethyl Esters (TAK-085) on Vascular Endothelial Function in Patients With Hyperlipidemia by Flow Mediated Dilation
The purpose of this study is to explore the effects of omega-3-acid ethyl esters (TAK-085) on vascular endothelial function when administered for 8 weeks, as measured by FMD, in patients with hyperlipidemia.
- Trial name
- Oasis Flow (NCT02824432)
- Testing
- TAK-085
- Where
- 4 sites in Japan
- Volunteers
- 37 people
- Sponsor
- Takeda
Cardiovascular Diseases
A Study of AMR101 to Evaluate Its Ability to Reduce Cardiovascular Events in High-Risk Patients With Hypertriglyceridemia and on Statin
AMR101 (icosapent ethyl [ethyl-EPA]) is a highly purified ethyl ester of eicosapentaenoic acid (EPA) developed by Amarin Pharma Inc.
- Trial name
- REDUCE-IT (NCT01492361)
- Testing
- AMR101, Statin therapy
- Where
- 410 sites in United States, Australia and 9 more
- Volunteers
- 8,179 people
- Sponsor
- Amarin Pharma Inc.
Diabetes Mellitus, Non-Insulin-Dependent
The ORIGIN Trial (Outcome Reduction With Initial Glargine Intervention)
The primary objectives of the ORIGIN study were: To determine whether insulin glargine-mediated normoglycemia can reduce cardiovascular morbidity and/or mortality in people at high risk for vascular disease with either Impaired…
- Trial name
- ORIGIN (NCT00069784)
- Testing
- insulin glargine (HOE901), omega-3 polyunsaturated fatty acids (PUFA), reusable pen device for insulin injection
- Where
- 40 sites in United States, Argentina and 38 more
- Volunteers
- 12,537 people
- Sponsor
- Sanofi