An Open-Label Crossover Study to Compare the Relative Bioavailability, Efficacy and Safety of Epanova® and Lovaza® in Men and Women With a History of Pancreatitis (ECLIPSEIV)
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ClinicalTrials.gov Identifier: NCT02189252 |
Recruitment Status :
Completed
First Posted : July 14, 2014
Results First Posted : June 20, 2016
Last Update Posted : June 20, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Severe Hypertriglyceridemia | Drug: Epanova Drug: Lovaza | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 30 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Randomized, Open-Label Crossover Study to Compare the Relative Bioavailability, Efficacy, and Safety of Epanova® and Lovaza® in Men and Women With a History of Pancreatitis |
Study Start Date : | October 2014 |
Actual Primary Completion Date : | July 2015 |
Actual Study Completion Date : | July 2015 |

Arm | Intervention/treatment |
---|---|
Active Comparator: E4:L4
Crossover Sequence
|
Drug: Epanova Drug: Lovaza |
Active Comparator: L4:E4
Crossover Sequence
|
Drug: Epanova Drug: Lovaza |
Active Comparator: E2:L4
Crossover Sequence
|
Drug: Epanova Drug: Lovaza |
Active Comparator: L4:E2
Crossover Sequence
|
Drug: Epanova Drug: Lovaza |
- Baseline-adjusted AUC0-24 for Plasma Total EPA + Total DHA [ Time Frame: participants were followed for the duration of study, up to 12 weeks, each treatment having a 4-week duration and a 4-week wash off period in between. ]AUC0-24: Area under the plasma concentration versus time curve, from time 0 to 24 hours after start of the meal
- Baseline-adjusted Cmax for Plasma Total EPA + Total DHA [ Time Frame: participants were followed for the duration of study, up to 12 weeks, each treatment having a 4-week duration and a 4-week wash off period in between. ]Cmax: Maximum measured plasma concentration over the time span specified
- Baseline-adjusted AUC0-24 for Plasma Total EPA [ Time Frame: participants were followed for the duration of study, up to 12 weeks, each treatment having a 4-week duration and a 4-week wash off period in between. ]
- Baseline-adjusted Cmax for Plasma Total EPA [ Time Frame: participants were followed for the duration of study, up to 12 weeks, each treatment having a 4-week duration and a 4-week wash off period in between. ]
- Baseline-adjusted AUC0-24 for Plasma Total DHA [ Time Frame: participants were followed for the duration of study, up to 12 weeks, each treatment having a 4-week duration and a 4-week wash off period in between. ]
- Baseline-adjusted Cmax for Plasma Total DHA [ Time Frame: This is a crossover study with two treatment periods. The estimated treatment effects were based on the within-subject comparison between the two treatments, each having a 4-week duration and a 4-week wash off period in between. ]
- Baseline-adjusted AUC0-24 for Plasma Total DPA [ Time Frame: participants were followed for the duration of study, up to 12 weeks, each treatment having a 4-week duration and a 4-week wash off period in between. ]
- Baseline-adjusted Cmax for Plasma Total DPA [ Time Frame: participants were followed for the duration of study, up to 12 weeks, each treatment having a 4-week duration and a 4-week wash off period in between. ]

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Ages Eligible for Study: | 18 Years to 130 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male or female, ≥18 years of age;
- History of serum TG concentration ≥500 mg/dL within the past 5 years;
- Have at least one episode of documented hospitalization for pancreatitis due to hypertriglyceridemia in his/her lifetime;
- Have no health conditions that would prevent him/her from fulfilling the study requirements as judged by the Investigator on the basis of physical examination, ECG, medical history, and routine laboratory test results;
- Willing to maintain his/her current activity level and to follow either the NCEP TLC diet with a caloric target for weight maintenance or a prescribed low-fat diet during the screening, treatment, and washout periods (Visits 1 through 6b; Weeks -4 through 12);
- Willing to eat the standardized breakfast, lunch, and dinner meals and snacks before and during Visits 4b and 6b (Weeks 4 and 12);
- Willing to abstain from alcohol consumption and avoid vigorous physical activity for 48 hours prior to Visits 3 through 6b (Weeks 0 through 12); and
- Subject understands the study procedures and is willing and able to sign the informed consent form to participate in the study and the Health Insurance Portability and Accountability Act authorization for release of relevant protected health information to the Investigators and study personnel.
Exclusion Criteria:
- An allergy or intolerance to omega-3 fatty acids, omega-3-acid ethyl esters, fish, or any of the components of the standardized breakfast, lunch, or dinner meals or snacks (as described to them by study staff)
- Poorly controlled hypertension (resting blood pressure ≥160 mmHg systolic and/or ≥100 mmHg diastolic) prior to randomization (Visit 3 [Week 0])
- A history of cancer (other than basal cell carcinoma) in the last 2 years
- A recent cardiovascular event (i.e., myocardial infarction, acute coronary syndrome, new onset angina, stroke, transient ischemic attack, unstable congestive heart failure requiring a change in treatment), aortic aneurysm or resection, carotid endarterectomy, or revascularization procedure within the 6 months prior to Visit 1

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02189252
United States, Kansas | |
Research Site | |
Kansas City, Kansas, United States | |
United States, Ohio | |
Research Site | |
Cincinnati, Ohio, United States | |
United States, Pennsylvania | |
Research Site | |
Philadelphia, Pennsylvania, United States | |
Canada, Quebec | |
Research Site | |
Chocoutimi, Quebec, Canada |
Principal Investigator: | Andrea L Lawless, MD | Biofortis, Inc Addison IL 60101 |
Responsible Party: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT02189252 |
Other Study ID Numbers: |
D5880C00003 OM-EPA-013 ( Other Identifier: Omthera ) |
First Posted: | July 14, 2014 Key Record Dates |
Results First Posted: | June 20, 2016 |
Last Update Posted: | June 20, 2016 |
Last Verified: | May 2016 |
Pancreatitis Hypertriglyceridemia Pancreatic Diseases Digestive System Diseases |
Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases |