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)

• 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: AstraZeneca
• Information provided by (Responsible Party): AstraZeneca

Study Description

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

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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. ]

Eligibility Criteria

• 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

Contacts and Locations

Locations

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

• Principal Investigator: Andrea L Lawless, MD; Biofortis, Inc Addison IL 60101

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Dunbar RL, Gaudet D, Davidson M, Rensfeldt M, Yang H, Nilsson C, Kvarnström M, Oscarsson J. Omega-3 fatty acid exposure with a low-fat diet in patients with past hypertriglyceridemia-induced acute pancreatitis; an exploratory, randomized, open-label crossover study. Lipids Health Dis. 2020 May 30;19(1):117. doi: 10.1186/s12944-020-01295-7.

• Responsible Party: AstraZeneca
• ClinicalTrials.gov Identifier: NCT02189252
• Other Study ID Numbers: D5880C00003; OM-EPA-013 ( Other Identifier: Omthera )
• First Posted: July 14, 2014
• Results First Posted: June 20, 2016
• Last Update Posted: June 20, 2016
• Last Verified: May 2016

Additional relevant MeSH terms:

Pancreatitis; Hypertriglyceridemia; Pancreatic Diseases; Digestive System Diseases; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases