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OMEGA-3-ACID ETHYL ESTERS 90

OMEGA-3-ACID ETHYL ESTERS 90 is a prescription omega‑3 fatty acid medicine studied in several clinical trials. Researchers mainly tested it for high triglycerides (a type of blood fat) and for heart and blood vessel risks in specific patient groups, such as people living with HIV on HAART and people on chronic hemodialysis.

Table of Contents

What OMEGA-3-ACID ETHYL ESTERS 90 is (and names used in trials)

OMEGA-3-ACID ETHYL ESTERS 90 is an omega‑3 fatty acid medicine tested in multiple clinical trials. In the provided trial data, it appears under several names, including Omacor, LOVAZA, and TAK-085.

In the hypertriglyceridemia trials that used the name TAK-085, the capsule content is described as omega‑3 fatty acid ethyl esters mainly made of ethyl eicosapentaenoate (EPA-E) and ethyl docosahexaenoic acid (DHA-E).

Some trials specifically refer to Omega-3-Acid Ethyl Esters 90 Soft Capsules (1 g soft gel capsules), taken as four capsules once daily with breakfast for 12 weeks.

[1][2][3][4]

How the drug was studied (trial designs and comparisons)

Across the provided studies, researchers used different trial designs to compare omega‑3 treatment with other options.

  • Randomized designs: participants were assigned by chance to different study groups. This helps make the comparison fairer.

  • Double-blind studies: neither participants nor study staff knew which treatment was given during the study. This reduces bias when judging outcomes.

  • Open-label study: the long-term hypertriglyceridemia study was open-label, meaning treatment was known.

  • Different comparators were used, including placebo, corn oil control capsules, and an active comparator, ethyl eicosapentaenoate (EPA-E).

The treatment duration also varied widely, from 12 weeks in several trials to 52 weeks in a long-term hypertriglyceridemia study, and 2 years in a hemodialysis study.

[2][1][3][5]

Trials in hypertriglyceridemia (high triglycerides)

Several trials focused on hypertriglyceridemia, meaning high triglycerides in the blood.

Key ways these trials measured benefit were based on how much fasting triglycerides changed from baseline (the start of treatment) to later study visits.

  • Phase 3, double-blind 12-week study (TAK-085): This study compared TAK-085 2 g once daily or 2 g twice daily with EPA-E 0.6 g three times daily. The main outcome was the percent change from baseline in triglyceride level at the final visit. The study also followed cholesterol measures over time (LDL-C, HDL-C, total cholesterol, and non-HDL-C) and tracked treatment-emergent side effects.

  • Phase 3, open-label long-term study (TAK-085, 52 weeks): This study primarily focused on safety over 52 weeks, counting participants with treatment-emergent adverse events (TEAEs), including those linked with abnormal vital signs, body weight changes, ECG findings, and lab test abnormalities (chemistry, hematology, urinalysis). It also measured lipid changes such as triglycerides and cholesterol values at multiple time points through week 52.

  • Phase 3, double-blind corn oil-controlled study (12 weeks) in severe hypertriglyceridemia: This study enrolled people with fasting triglycerides at or above 500 mg/dL and below 2000 mg/dL. Participants took four 1 g soft capsules once daily with breakfast for 12 weeks. The primary outcome was end-of-treatment fasting triglycerides percent change from baseline. Secondary outcomes included non-HDL-C, total cholesterol, VLDL-C, HDL-C, LDL-C, the LDL-C/HDL-C ratio, and apolipoproteins (Apo A5 and Apo C3).

[2][1][3]

Trial in HIV patients on HAART: cardiovascular risk factors

One trial studied Omacor (omega‑3‑acid ethyl ester 90) in people living with Human Immunodeficiency Virus (HIV) who were receiving HAART (Highly Active Antiviral Therapy).

The trial rationale described that more incidents of Ischemic Heart Disease (IHD) had been seen among patients on HAART. The trial discussion highlighted several possible contributors, including effects of HIV on the immune system, higher rates of risk behaviors (like smoking), and HAART-related increases in cholesterol and triglycerides linked with HIV-related lipodystrophy (metabolic and body-fat changes).

Design details in the provided data included about 50 participants randomized to Omacor 4 g/day or placebo for 12 weeks.

  • Primary outcome: change in plasma triglycerides from baseline to week 12.

  • Secondary outcomes: blood vessel stiffness and function measured by pulse wave velocity and flow mediated vasodilation; cholesterol measures (HDL, LDL, total cholesterol); inflammatory and vascular-related blood markers such as ICAM, VCAM, sensitive CRP; and multiple other laboratory markers listed in the trial, plus safety parameters.

[4]

Trial in chronic hemodialysis: preventing cardiovascular events

Another study tested OMACOR in people with chronic kidney failure who were undergoing chronic hemodialysis and had previously experienced a cardiovascular event.

This was described as a prospective, randomized, placebo-controlled study with a 2-year treatment period. The main goal was to see whether OMACOR affected the incidence of cardiovascular events and mortality in this high-risk group.

The primary outcome was a composite endpoint, meaning the study counted whether a participant had any of several serious events, including:

  • Acute myocardial infarction (heart attack)

  • Angina pectoris leading to coronary investigation or intervention

  • Transient cerebral ischemia (TCI)

  • Apoplexia cerebri (stroke)

  • Peripheral vascular disease with new or worsening symptoms

Secondary outcomes included lab measures (lipids and other markers, including adhesion molecules and an LDL-related size variable), fatty acid profiles in phospholipids, diet registration and “fish score,” thrombosis/stenosis of dialysis graft, and a substudy on heart rate variability (baseline and after three months) in 50 patients.

[5]

Trial in early psychosis: Omacor as part of personalised care

One trial record from a European registry described Omacor 1000 mg soft capsules (active substance omega‑3‑acid ethyl esters 90) as part of a broader “composite personalised care” approach in adolescents and young adults (15 to 30 years) who were Ultra High Risk of psychosis or experiencing a First Episode Psychosis in the first year after diagnosis and care.

The design was described as a phase III prospective randomized open, blinded end-point (PROBE) trial. The main objective was to compare different personalised-care strategies against treatment as usual on global functioning measured by the Personal and Social Performance (PSP) Scale over about 3 to 4 months after the beginning (as described in the record).

[6]

Safety monitoring used across trials

Safety was tracked in multiple ways across the provided trials, especially in the hypertriglyceridemia studies.

  • Treatment-emergent adverse events (TEAEs): how many participants had side effects or new medical issues after starting the study drug.

  • Vital signs: trials counted TEAEs linked with abnormal vital sign changes.

  • Body weight: one long-term study counted TEAEs associated with abnormal body weight changes.

  • Electrocardiogram (ECG): trials tracked clinically significant abnormal ECG findings after taking the study drug.

  • Laboratory tests: some trials grouped abnormal lab findings (chemistry, hematology, urinalysis) as safety-related TEAEs.

[1][2]

What outcomes and tests were used (plain-language guide)

The provided trials used several types of measurements. Understanding these can help you follow what researchers were trying to learn.

  • Fasting triglycerides: triglycerides measured after not eating for a period of time. Trials often reported the percent change from baseline to show improvement or worsening.

  • Cholesterol panel measures: LDL-C (“bad cholesterol”), HDL-C (“good cholesterol”), total cholesterol, and non-HDL-C (total cholesterol minus HDL-C). Some trials also measured VLDL-C.

  • Blood vessel tests: pulse wave velocity (artery stiffness) and flow mediated vasodilation (how well a vessel widens in response to blood flow, related to endothelial function).

  • Composite cardiovascular endpoint: a combined outcome that counts if any serious cardiovascular event happens (for example heart attack, stroke, or angina requiring testing/procedures).

  • Functioning scales in psychiatry: the PSP Scale measures day-to-day personal and social functioning in early psychosis research.

[4][3][5][6]
Topic What the clinical trials studied
Drug names in trials OMEGA-3-ACID ETHYL ESTERS 90, Omacor, LOVAZA, TAK-085; also studied as “Omega-3-Acid Ethyl Esters 90 Soft Capsules.”
Main health focus Lowering triglycerides in hypertriglyceridemia (including severe cases); improving lipid-related cardiovascular risk factors in special populations.
Special populations studied People with HIV on HAART; people with chronic kidney failure on hemodialysis with prior cardiovascular events; people with early psychosis (as part of a broader care package).
Common study designs Randomized trials, including double-blind placebo-controlled and corn oil-controlled studies; one open-label long-term study; one PROBE design in psychiatry.
Typical dosing & duration Often 4 g/day for 12 weeks; also 2 g once daily or 2 g twice daily up to 52 weeks; a hemodialysis study planned 2 years of treatment.
Key outcomes measured Triglyceride change from baseline; cholesterol measures (LDL-C, HDL-C, total cholesterol, non-HDL-C, VLDL-C); blood vessel function/stiffness; cardiovascular events; safety outcomes including TEAEs and ECG findings.

FAQ

  • What is OMEGA-3-ACID ETHYL ESTERS 90 and what are its other names in trials? It is an omega‑3 fatty acid ethyl ester medicine. In the trials, it appears under names such as Omacor, LOVAZA, and TAK-085. It is given as capsules (often 1 g capsules) taken daily.
  • What conditions were studied with this drug in the provided trials? The trials studied severe hypertriglyceridemia (very high triglycerides), hypertriglyceridemia during lifestyle changes, cardiovascular risk factors in people with HIV using HAART, prevention of cardiovascular events in people on chronic hemodialysis with previous heart or vascular events, and a trial in early psychosis where Omacor is part of a broader “personalised care” approach.
  • How was the drug taken in these studies? Several studies used 4 grams per day (for example, 1000 mg capsules taken four times daily, or four 1 g soft capsules taken once daily with breakfast). Other studies tested 2 g once daily or 2 g twice daily. Treatment lasted from 12 weeks in some studies to 52 weeks in a long-term study, and up to 2 years in a hemodialysis study.
  • What outcomes did researchers measure most often? Many trials focused on triglyceride changes (often percent change from baseline). They also measured cholesterol-related values (LDL-C, HDL-C, total cholesterol, non-HDL-C, VLDL-C), and some studies measured blood vessel function and stiffness (such as pulse wave velocity and flow-mediated vasodilation). Safety was tracked by recording adverse events, vital signs, lab tests, and ECG (heart rhythm test) findings.
  • What did trials use as comparisons or control groups? Depending on the study, the drug was compared against placebo, corn oil capsules, or another omega‑3 type product like ethyl eicosapentaenoate (EPA-E). Some studies were double-blind (participants and researchers did not know the assigned group), while one long-term study was open-label.

Ongoing Clinical Trials on OMEGA-3-ACID ETHYL ESTERS 90

  • Study on the Effectiveness of Calcium Folinate, Omega-3-Acid Ethyl Esters, and Cyanocobalamin for Patients at High Risk of Psychosis or Experiencing First Episode Psychosis

    Not yet recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    France

Glossary

  • OMEGA-3-ACID ETHYL ESTERS 90: A prescription omega‑3 fatty acid medicine made of omega‑3 fats in an 'ethyl ester' form. It was studied for lowering triglycerides and for heart and blood vessel risk factors in certain groups.
  • Omacor: A brand name used in trials for omega‑3‑acid ethyl esters 90, commonly given as 1000 mg capsules.
  • LOVAZA: Another name listed in the trial data for omega‑3‑acid ethyl esters 90 (TAK-085).
  • TAK-085: A study name for omega‑3‑acid ethyl esters 90. In the trial description, it contains mainly ethyl eicosapentaenoate (EPA-E) and ethyl docosahexaenoic acid (DHA-E).
  • Hypertriglyceridemia: High levels of triglycerides (a type of fat) in the blood. Some studies focused on severe hypertriglyceridemia with fasting triglycerides at or above 500 mg/dL.
  • Triglycerides (TGs): A type of fat found in blood. High triglycerides can be a risk factor for health problems. Many trials measured how much triglycerides changed from the start of the study (baseline) to the end of treatment.
  • Baseline: The starting measurement taken before the study treatment begins. Later results are compared to this starting point.
  • Percent change from baseline: How much a number (like triglycerides) goes up or down compared with the starting value, shown as a percentage.
  • LDL-C (Low-Density Lipoprotein Cholesterol): Often called 'bad cholesterol.' Trials measured how LDL-C changed with treatment.
  • HDL-C (High-Density Lipoprotein Cholesterol): Often called 'good cholesterol.' Trials measured changes in HDL-C.
  • Non-HDL-C: A cholesterol value calculated as total cholesterol minus HDL-C. It includes several cholesterol types linked with risk.
  • VLDL-C (Very Low-Density Lipoprotein Cholesterol): A cholesterol measure related to triglyceride-rich particles. One study measured VLDL-C changes at end of treatment.
  • Apolipoproteins (Apo A, Apo B, Apo A5, Apo C3): Proteins attached to fats (lipids) in the blood that help transport them. Some trials measured these to better understand lipid changes.
  • Randomized: Participants are assigned by chance to different groups (for example, the omega‑3 medicine or placebo) to make comparisons fairer.
  • Double-blind: Neither the participant nor the study team knows which treatment the participant is receiving during the trial, to reduce bias.
  • Placebo: A look-alike treatment that does not contain the active drug. It helps researchers see whether changes are due to the drug.
  • Corn oil-controlled: A type of comparison where corn oil capsules are used as the control product instead of an inactive pill.
  • Open-label: A study design where participants and researchers know what treatment is being given.
  • Treatment-emergent adverse event (TEAE): A side effect or medical issue that happens after starting the study drug. Trials counted how many participants experienced TEAEs.
  • Vital signs: Basic body measurements such as blood pressure and pulse. Some trials tracked abnormal changes as safety outcomes.
  • Electrocardiogram (ECG): A test that records the heart’s electrical activity. Trials tracked clinically significant ECG changes.
  • HAART (Highly Active Antiviral Therapy): A combination treatment for HIV. In the trial data, HAART was linked with higher cholesterol and triglycerides in some patients.
  • Lipodystrophy (HIV related): Changes in body fat distribution and metabolism that can occur in people with HIV, noted in the trial rationale along with increased blood lipids.
  • Ischemic Heart Disease (IHD): Heart problems caused by reduced blood flow to the heart muscle, often related to narrowed arteries.
  • Atherosclerosis (arteriosclerosis in the trial text): Hardening and narrowing of arteries over time. The HIV/HAART trial discussed factors that may influence this process.
  • Endothelial function: How well the inner lining of blood vessels works. One trial measured this because it relates to blood vessel health.
  • Flow-mediated vasodilation: A test of how a blood vessel widens in response to blood flow. It is used as a measure of endothelial function.
  • Pulse wave velocity: A measure of how fast blood pressure waves move through the arteries. Faster values can suggest stiffer arteries.
  • Chronic hemodialysis: A long-term treatment for kidney failure where a machine filters the blood. One trial tested omega‑3 treatment for preventing cardiovascular events in this group.
  • Composite endpoint: A combined outcome made of several different events. The hemodialysis study combined events like heart attack, angina needing procedures, TCI, stroke, and peripheral vascular disease.
  • Acute myocardial infarction: A heart attack. It was one of the events included in the hemodialysis study’s composite endpoint.
  • Angina pectoris: Chest pain due to reduced blood flow to the heart. In the trial, it counted when it led to coronary investigation or intervention.
  • Transient cerebral ischemia (TCI): A brief period of reduced blood flow to the brain, sometimes similar to a 'mini-stroke.' It was included in the composite endpoint.
  • Apoplexia cerebri (stroke): A stroke, meaning sudden brain injury due to disrupted blood supply. It was part of the composite endpoint.
  • Peripheral vascular disease: Reduced blood flow in blood vessels outside the heart and brain, often in the legs. It was part of the composite endpoint.
  • Heart rate variability: A measure of variation in time between heartbeats. A substudy in the hemodialysis trial measured this at baseline and after three months.
  • Lifestyle modification: Changes in daily habits (often diet and activity) used to help improve triglycerides and other risk factors. Hypertriglyceridemia trials studied the drug while participants were undergoing lifestyle modification.
  • PROBE trial (Prospective Randomised Open, Blinded End-point): A study design where treatment is open (known), but the people judging the main outcome are blinded (do not know group assignment). This was described in the early psychosis trial.
  • Personal and Social Performance (PSP) Scale: A scale used to measure how well someone functions in daily life and social roles. It was the main outcome in the early psychosis trial.
  • Ultra High Risk (UHR) of psychosis and First Episode Psychosis (FEP): UHR refers to people with signs suggesting a high chance of developing psychosis. FEP means the first time a person experiences psychosis. These were the populations in the psychiatry trial.

References

  1. https://clinicaltrials.gov/study/NCT01350999
  2. https://clinicaltrials.gov/study/NCT01350973
  3. https://clinicaltrials.gov/study/NCT02625870
  4. https://clinicaltrials.gov/study/NCT00296153
  5. https://clinicaltrials.gov/study/NCT00257283
  6. https://clinicaltrials.eu/trial/study-on-the-effectiveness-of-calcium-folinate-omega-3-acid-ethyl-esters-and-cyanocobalamin-for-patients-at-high-risk-of-psychosis-or-experiencing-first-episode-psychosis/