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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02189252
Recruitment Status : Completed
First Posted : July 14, 2014
Results First Posted : June 20, 2016
Last Update Posted : June 20, 2016
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:
This is a randomized, open-label crossover study. The primary objective of this study is to compare the relative bioavailability of eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), docosapentaenoic acid (DPA), and the ethyl esters of EPA and DHA in plasma from a single 2 g or 4 g dose of Epanova® or 4 g Lovaza®.

Condition or disease Intervention/treatment Phase
Severe Hypertriglyceridemia Drug: Epanova Drug: Lovaza Phase 1

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis

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



Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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. ]
  2. 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. ]
  3. 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. ]
  4. 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. ]
  5. 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. ]
  6. 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. ]


Information from the National Library of Medicine

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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
Criteria

Inclusion Criteria:

  1. Male or female, ≥18 years of age;
  2. History of serum TG concentration ≥500 mg/dL within the past 5 years;
  3. Have at least one episode of documented hospitalization for pancreatitis due to hypertriglyceridemia in his/her lifetime;
  4. 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;
  5. 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);
  6. Willing to eat the standardized breakfast, lunch, and dinner meals and snacks before and during Visits 4b and 6b (Weeks 4 and 12);
  7. 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
  8. 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:

  1. 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)
  2. Poorly controlled hypertension (resting blood pressure ≥160 mmHg systolic and/or ≥100 mmHg diastolic) prior to randomization (Visit 3 [Week 0])
  3. A history of cancer (other than basal cell carcinoma) in the last 2 years
  4. 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

Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
AstraZeneca
Investigators
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Principal Investigator: Andrea L Lawless, MD Biofortis, Inc Addison IL 60101
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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
Additional relevant MeSH terms:
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Pancreatitis
Hypertriglyceridemia
Pancreatic Diseases
Digestive System Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases