Clinical trials: Omega-3
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
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
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.
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.
Diabetes Mellitus, Type 2, Exocrine Pancreatic Insufficiency
A Study to Investigate How Common Pancreatic Exocrine Insufficiency (PEI) is in Patients With Type 2 Diabetes and Also to Investigate the Uptake of a Single Dose of EPANOVA® or OMACOR® in Patients With Different Degrees of PEI
This study is a 2-part open-label, randomized, crossover, multicenter, non-therapeutic Phase II study to investigate the presence of pancreatic exocrine insufficiency (PEI) in patients with Type 2 diabetes mellitus (T2DM), and to…
- Trial name
- PRECISE (NCT02370537)
- Testing
- Epanova® (omega-3 carboxylic acids), Omacor® (omega-3-acid ethyl esters)
- Where
- 22 sites in Denmark, Hungary and 4 more
- Volunteers
- 490 people
- Sponsor
- AstraZeneca
Relative Bioavailability, AUC
Study in Healthy Subjects to Compare the Concentrations of the Omega-3 Fatty Acids EPA and DHA in Blood When Delivered as Three New Capsules in Relation to the Epanova® Capsule Under Fasting and Fed Conditions
This study is a randomized, open-label, cross-over study in healthy subjects performed at a single study center. The study is divided into two parts, Part 1 and Part 2.
- Conditions
- Relative Bioavailability, AUC, Cmax, Pharmacokinetics
- Trial name
- NCT02359045
- Testing
- D1400147, D14000136, D14000137
- Where
- United States
- Volunteers
- 137 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
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
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.
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
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.
Hypertriglyceridemia
Open-Label Extension of a Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Lovaza® and Simvastatin Therapy in Hypertriglyceridemic Subjects
In a previous trial (LOV111858/OM6), subjects received in a double-blind fashion either 4 g/day of Lovaza® (omega-3-ethyl esters) [formerly known as Omacor] co-administered with simvastatin 40 mg/day or placebo co-administered…
- Trial name
- NCT00903409
- Testing
- Simvastatin + Lovaza® (omega-3-acid ethyl esters)
- Where
- 40 sites in United States
- Volunteers
- 188 people
- Sponsor
- GlaxoSmithKline
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
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
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
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
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
Healthy
A Ph1 Study in Healthy Male Japanese and Caucasian After Single and Multiple Doses of D5884(Omega-3-carboxylic Acids)
The purpose of this study is to assess safety, tolerability and pharmacokinetics of D5884 following administration of single and multiple doses in healthy male Japanese subjects.
- Trial name
- NCT02209766
- Testing
- D5884
- Where
- Japan
- Volunteers
- 86 people, healthy volunteers welcome
- 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
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.
Hypertriglyceridemia
A Second Open-Label Extension of a Double-Blind, Parallel, Phase IV Study to Assess the Efficacy and Safety of Adjunctive Lovaza® (Formerly Known as Omacor®) Therapy in Hypertriglyceridemic Subjects Treated With Antara™
This was a 24-month, open-label extension study that followed an 8-week double-blind study (Study LOV111859/OM5) and an 8-week, open-label extension study (LOV111860/OM5X).
- Trial name
- NCT00891293
- Testing
- Antara (fenofibrate) + Lovaza (omega-3-acid ethyl esters)
- Where
- 32 sites in United States
- Volunteers
- 93 people
- Sponsor
- GlaxoSmithKline