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

Severe Hypertriglyceridemia Clinical Trial

— ECLIPSEIV  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02189252
• Other study ID #: D5880C00003
• Secondary ID: OM-EPA-013
• Status: Completed
• Phase: Phase 1
• First received: June 23, 2014
• Last updated: July 29, 2015
• Start date: October 2014
• Est. completion date: July 2015

Study information

• Verified date: July 2015
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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®.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertriglyceridemia
• Pancreatitis
• Severe Hypertriglyceridemia

Intervention

Drug:
• Epanova

• Lovaza

Locations

Country	Name	City	State
Canada	Research Site	Chocoutimi	Quebec
United States	Research Site	Addison	Illinois
United States	Research Site	Cincinnati	Ohio
United States	Research Site	Kansas City	Kansas
United States	Research Site	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the plasma concentration vs. time curve (AUC0-t)		0 to 24 hours (AUC0-24)	No