NCT02189252

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®.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Oct 2014

Geographic Reach
2 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 23, 2014

Completed
21 days until next milestone

First Posted

Study publicly available on registry

July 14, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
12 months until next milestone

Results Posted

Study results publicly available

June 20, 2016

Completed
Last Updated

June 20, 2016

Status Verified

May 1, 2016

Enrollment Period

9 months

First QC Date

June 23, 2014

Results QC Date

March 29, 2016

Last Update Submit

May 11, 2016

Conditions

Severe Hypertriglyceridemia

Outcome Measures

Primary Outcomes (2)

  • 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

    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 + Total DHA

    Cmax: Maximum measured plasma concentration over the time span specified

    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 Outcomes (6)

  • Baseline-adjusted AUC0-24 for Plasma Total EPA

    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

    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

    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

    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

    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.

  • +1 more secondary outcomes

Study Arms (4)

E4:L4

ACTIVE COMPARATOR

Crossover Sequence

Drug: EpanovaDrug: Lovaza

L4:E4

ACTIVE COMPARATOR

Crossover Sequence

Drug: EpanovaDrug: Lovaza

E2:L4

ACTIVE COMPARATOR

Crossover Sequence

Drug: EpanovaDrug: Lovaza

L4:E2

ACTIVE COMPARATOR

Crossover Sequence

Drug: EpanovaDrug: Lovaza

Interventions

EpanovaDRUG
E2:L4E4:L4L4:E2L4:E4
LovazaDRUG
E2:L4E4:L4L4:E2L4:E4

Eligibility Criteria

Age18 Years - 130 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Research Site

Kansas City, Kansas, United States

Location

Research Site

Cincinnati, Ohio, United States

Location

Research Site

Philadelphia, Pennsylvania, United States

Location

Research Site

Chocoutimi, Quebec, Canada

Location

Related Publications (1)

  • 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.

    PMID: 32473640DERIVED

MeSH Terms

Conditions

Hypertriglyceridemia

Interventions

Omacor

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Results Point of Contact

Title
Hong Yang, Study Statistician
Organization
AstraZeneca AB
hong.yang1@astrazeneca.com
+46-(0)317762397

Study Officials

  • Andrea L Lawless, MD

    Biofortis, Inc Addison IL 60101

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2014

First Posted

July 14, 2014

Study Start

October 1, 2014

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

June 20, 2016

Results First Posted

June 20, 2016

Record last verified: 2016-05

Locations

CA(1)US(3)