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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)

Primary Purpose

Severe Hypertriglyceridemia

Status

Completed

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

Epanova

Lovaza

About this trial

This is an interventional treatment trial for Severe Hypertriglyceridemia

Eligibility Criteria

18 Years - 130 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Research Site
Research Site
Research Site
Research Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Arm Label

E4:L4

L4:E4

E2:L4

L4:E2

Arm Description

Crossover Sequence

Outcomes

Primary Outcome Measures

Baseline-adjusted AUC0-24 for Plasma Total EPA + Total DHA

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

Cmax: Maximum measured plasma concentration over the time span specified

Secondary Outcome Measures

Baseline-adjusted AUC0-24 for Plasma Total EPA

Baseline-adjusted Cmax for Plasma Total EPA

Baseline-adjusted AUC0-24 for Plasma Total DHA

Baseline-adjusted Cmax for Plasma Total DHA

Baseline-adjusted AUC0-24 for Plasma Total DPA

Baseline-adjusted Cmax for Plasma Total DPA

Full Information

NCT ID

NCT02189252

First Posted

June 23, 2014

Last Updated

May 11, 2016

Sponsor

AstraZeneca

1. Study Identification

Unique Protocol Identification Number

NCT02189252

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2016

Overall Recruitment Status

Completed

Study Start Date

October 2014 (undefined)

Primary Completion Date

July 2015 (Actual)

Study Completion Date

July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AstraZeneca

4. Oversight

Data Monitoring Committee

5. 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®.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Severe Hypertriglyceridemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

E4:L4

Arm Type

Active Comparator

Arm Description

Crossover Sequence

Arm Title

L4:E4

Arm Type

Active Comparator

Arm Description

Crossover Sequence

Arm Title

E2:L4

Arm Type

Active Comparator

Arm Description

Crossover Sequence

Arm Title

L4:E2

Arm Type

Active Comparator

Arm Description

Crossover Sequence

Intervention Type

Drug

Intervention Name(s)

Epanova

Intervention Type

Drug

Intervention Name(s)

Lovaza

Primary Outcome Measure Information:

Title

Baseline-adjusted AUC0-24 for Plasma Total EPA + Total DHA

Description

AUC0-24: Area under the plasma concentration versus time curve, from time 0 to 24 hours after start of the meal

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.

Title

Baseline-adjusted Cmax for Plasma Total EPA + Total DHA

Description

Cmax: Maximum measured plasma concentration over the time span specified

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.

Secondary Outcome Measure Information:

Title

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.

Title

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.

Title

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.

Title

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.

Title

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.

Title

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

130 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Andrea L Lawless, MD

Organizational Affiliation

Biofortis, Inc Addison IL 60101

Official's Role

Principal Investigator

Facility Information:

Facility Name

Research Site

City

Kansas City

State/Province

Kansas

Country

United States

Facility Name

Research Site

City

Cincinnati

State/Province

Ohio

Country

United States

Facility Name

Research Site

City

Philadelphia

State/Province

Pennsylvania

Country

United States

Facility Name

Research Site

City

Chocoutimi

State/Province

Quebec

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

32473640

Citation

Dunbar RL, Gaudet D, Davidson M, Rensfeldt M, Yang H, Nilsson C, Kvarnstrom 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.

Results Reference

derived

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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

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