Clinical trials: Omega-3 Polyunsaturated Fatty Acids
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
Hypertriglyceridemia
A PK and PD Study of Two Formulations of Omega-3 One Gram Capsules
Comparative bioavailability and pharmacodynamics effects of MAT9001 versus an active omega-3 medication comparator.
- Trial name
- PK/PD (NCT02310022)
- Testing
- Drug Omega 3, Drug Omega-3 Comparator
- Where
- Canada
- Volunteers
- 48 people
- Sponsor
- Matinas Biopharma, Inc
Absorption of Omega-3, Omega-3 Supplementation
A Study in Healthy Adults to Compare the Bioavailability of EPA + DHA From Two Microalgal Sources to One Fish Source and Placebo
This is a randomised, double-blind, parallel, placebo-controlled study in healthy adults to compare the absorption of two microalgal formulations, to a fish oil and a placebo.
- Conditions
- Absorption of Omega-3, Omega-3 Supplementation, Healthy Participants
- Trial name
- GOBO 2 (NCT07241377)
- Testing
- life'sTM omega O1035DS nTG, life'sTM omega O3020DS nTG, MEG-3 3323rTG
- Where
- Australia
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- RDC Clinical Pty Ltd
Attention Deficit Hyperactivity Disorder, Healthy
The Effects of EPA/DHA Supplementation on Cognitive Control in Children With ADHD
Forty children with and 40 children without Attention deficit Hyperactivity Disorder (ADHD) receive Docosahexaenoic Acid (DHA) and Eicosapentaenoic Acid (EPA) or placebo via a dietary intervention.
- Trial name
- NCT01554462
- Testing
- Eicosapentaenoic acid / Docosahexaenoic acid
- Where
- Netherlands
- Volunteers
- 79 people, healthy volunteers welcome
- Sponsor
- Unilever R&D
Hypertriglyceridemia
A Phase 3 STudy of CaPRe in LOwering Very hiGh TriglYcerides (TRILOGY 2)
The primary objective of this study is to determine the efficacy of CaPre 4 g daily, compared to placebo, in lowering fasting TG levels in subjects with fasting TG levels ≥500 mg/dL and ≤1500 mg/dL (≥5.7 mmol/L and ≤17.0 mmol/L)…
- Trial name
- TRILOGY 2 (NCT03361501)
- Testing
- CaPre
- Where
- 68 sites in United States, Canada and 1 more
- Volunteers
- 278 people
- Sponsor
- Grace Therapeutics Inc.
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
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.
Diabetic Foot Ulcer
Omega3 Wound Fish Skin Graft in the Treatment of DFUs
The purpose of this clinical evaluation is to collect patient outcome data on a commercially available 510K FDA-approved product that is derived from minimal processing of Atlantic cod fish skin: KerecisTM Omega3 Wound.
- Trial name
- NCT04133493
- Testing
- Kerecis Omega3 Wound, Fibracol
- Where
- 5 sites in United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Kerecis Ltd.
Hypertriglyceridemia
Efficacy and Safety of AMR101 (Ethyl Icosapentate) in Patients With Fasting Triglyceride (Tg) Levels ≥ 500 and ≤ 2000 mg/dL
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.
- Trial name
- MARINE (NCT01047683)
- Testing
- AMR101 (ethyl icosapentate) - 4 g/day, AMR101 (ethyl icosapentate) - 2 g/day
- Where
- 60 sites in United States, Denmark and 9 more
- Volunteers
- 229 people
- Sponsor
- Amarin Pharma Inc.
Dry Eye Syndromes
Topical Omega-3 Fatty Acids (REMOGEN® OMEGA) in the Treatment of Dry Eye
The primary objective of this study is to evaluate the efficacy of REMOGEN® OMEGA in reducing Dry Eye Syndrome (DES) symptoms.
- Trial name
- REMOTOP (NCT02908282)
- Testing
- REMOGEN OMEGA, Povidone
- Where
- 5 sites in Germany
- Volunteers
- 81 people
- Sponsor
- TRB Chemedica AG
Hypertriglyceridemia
Study to Evaluate the 2-Way Interaction Between Multiple Doses of Epanova™ and a Single Dose of Rosuvastatin (Crestor®)
This study is intended to evaluate the potential 2-way reciprocal interaction between multiple doses of Epanova™ and a single dose of rosuvastatin
- Trial name
- ECLIPSEIII (NCT02859129)
- Testing
- rosuvastatin 40 mg tablet, Epanova™ QD (2 x 1 g capsules), Multiple doses of 4 g Epanova™ with single of rosuvastatin 40 mg dose
- Where
- United States
- Volunteers
- 114 people, healthy volunteers welcome
- 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
Evaluation of MF4637 for Correcting the Omega-3 Nutritional Deficiency in NAFLD Patients
This study is a prospective, randomized, placebo-controlled, double-blind trial to determine the effect of high concentrate omega-3 capsules on the omega-3 status of patients with non-alcoholic fatty liver.
- Trial name
- NCT02923804
- Testing
- Omega-3, Olive oil
- Where
- 7 sites in United States
- Volunteers
- 172 people
- Sponsor
- Pronova BioPharma
Premenstrual Syndrome
Investigation of Krill Oil in Women with Premenstrual Syndrome
In this study the effects of different dosages and preparations of krill oil in comparison to placebo on symptoms of premenstrual syndrome in healthy, female adults will be assessed.
- Trial name
- NCT06584669
- Testing
- Krill oil
- Where
- Germany
- Volunteers
- 179 people, healthy volunteers welcome
- Sponsor
- Aker BioMarine Human Ingredients AS
Healthy Subjects
A Ph 1 Study of Epanova® in Healthy Chineses
The purpose of this study is to explore the safety, tolerability, and PK of single and multiple doses of Epanova in healthy male and female Chinese subjects and to allow comparison of these parameters with the Western population…
- Trial name
- NCT03574142
- Testing
- Epanova
- Where
- China
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Hyperlipidemia, Hypertriglyceridemia
Phase I Drug-drug Interaction of Omega-3 and Atorvastatin
This study evaluates the safety and pharmacokinetic drug-drug interactions of omega-3 and atorvastatin in healthy male volunteers.
- Trial name
- NCT03438955
- Testing
- Omacor, Pritor, Omacor + Pritor
- Where
- South Korea
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- DongKoo Bio & Pharma
Non-Alcoholic Fatty Liver Disease, Non Alcoholic Fatty Liver
Hepaxa Management of Non-alcoholic Fatty Liver Disease
This study measures the steatosis in patients With fatty livers as determined by CAP score from a fibroscan assessment. The study attempts to determine the effect of using the Medical Food Hepaxa in a Clinical setting Close to…
- Conditions
- Non-Alcoholic Fatty Liver Disease, Non Alcoholic Fatty Liver, NASH - Nonalcoholic Steatohepatitis
- Trial name
- NCT03801577
- Testing
- Hepaxa
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- BASF AS
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
Attention Deficit/Hyperactivity Disorder (ADHD)
The Efficacy and Safety of Phosphatidylserine-Omega3 in Children With Attention-Deficit/ Hyperactivity Disorder
The primary objective of this trial is to determine whether an oral administration of Phosphatidylserine-Omega3 would significantly improve the clinical symptoms of children suffering from ADHD.
- Trial name
- NCT00418184
- Testing
- Phosphatidylserine-Omega3, Colored cellulose tainted with fishy odor
- Where
- Israel
- Volunteers
- 200 people
- Sponsor
- Enzymotec
Hypertriglyceridemia
Evaluation of Efficacy and Safety of Combined Omacor (Omega-3-acid Ethyl Esters) and Simvastatin Therapy in Hypertriglyceridemic Subjects
The purpose of OM6 is to evaluate efficacy and safety of Lovaza (omega-3-acid ethyl esters) [formerly known as Omacor] combined with simvastatin for lowering non-high-density lipoprotein cholesterol (non-HDL-C) in subjects with…
- Trial name
- COMBOS (NCT00246701)
- Testing
- Simvastatin, Simvastatin + Lovaza
- Volunteers
- 256 people
- Sponsor
- GlaxoSmithKline