NCT02009865

Brief Summary

This is a double-blind, randomized, olive oil-controlled study to investigate the efficacy and safety of Epanova as an adjunct therapy to diet for reduction of TG levels in subjects with severe hypertriglyceridemia. The study consists of an approximately 8-week screening period that includes a diet and lifestyle stabilization and washout period and a 12-week treatment period.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
379

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Dec 2013

Shorter than P25 for phase_3

Geographic Reach
7 countries

40 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

December 9, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 12, 2013

Completed
4 days until next milestone

Study Start

First participant enrolled

December 16, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 23, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 23, 2014

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

January 15, 2016

Completed
Last Updated

September 10, 2019

Status Verified

August 1, 2019

Enrollment Period

1 year

First QC Date

December 9, 2013

Results QC Date

December 11, 2015

Last Update Submit

September 2, 2019

Conditions

Hypertriglyceridemia

Keywords

HypertriglyceridemiaDyslipidemiaEicosapentaenoic acidEPADocosahexaenoic acidDHA

Outcome Measures

Primary Outcomes (1)

  • Percent Change in Triglyceride for All Subjects

    This primary endpoint was tested in parallel together with the first of the secondary endpoints, each at 0.025 Type I error rate.

    From Baseline to Week 12 Endpoint

Secondary Outcomes (4)

  • Percent Change in Triglycerides for Subjects With at Least 1 Qualifying Triglyceride >885 mg/dL

    From Baseline to Week 12 Endpoint

  • Percent Change in Non-High-Density Lipoprotein Cholesterol (mg/dL)

    From Baseline to Week 12 Endpoint

  • Percent Change in High-Density Lipoprotein Cholesterol (mg/dL)

    From Baseline to Week 12 Endpoint

  • Percent Change in Triglyceride(mg/dL) in Subjects With Biochemically Defined Fredrickson Type V (Triglyceride/Very-Low-Density Lipoprotein Cholesterol ≥6)

    From Baseline to Week 12 Endpoint

Study Arms (2)

Epanova 2 g/day

EXPERIMENTAL

Arm 1

Drug: Epanova

Olive Oil 2 g/day

PLACEBO COMPARATOR

Arm 2

Drug: Olive Oil

Interventions

EpanovaDRUG

Epanova will be provided in 1 g polyacrylate-coated soft gel capsules. Two capsules will be taken once per day, without regard to meals, for 12 weeks. At clinic visits, study drug will be administered at the clinic after fasting blood draws are complete.

Also known as: omega-3 free fatty acids
Epanova 2 g/day
Olive OilDRUG

Olive oil will be provided in 1 g polyacrylate-coated soft gel capsules. Two capsules will be taken once per day, without regard to meals, for 12 weeks. At clinic visits, study drug will be administered at the clinic after fasting blood draws are complete.

Also known as: placebo comparator
Olive Oil 2 g/day

Eligibility Criteria

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

You may qualify if:

  • Understanding of the study procedures, willingness to adhere to the study schedule, and agreement to participate in the study by giving written informed consent prior to screening;
  • Willing to use an appropriate and effective method of contraception;
  • Qualifying (average of Visit 1 or 1a + Visit 2 + Visit 2a \[repeat measurement\]) serum TG ≥500 mg/dL (6 mMol/L) and \<2500 mg/dL (28 mMol/L);
  • Body mass index ≥20 kg/m2;
  • Untreated dyslipidemia or dyslipidemia treated with a statin, CAI, or statin-CAI combination that has been stable for 6 weeks prior to randomization; and
  • Willingness to maintain current physical activity level and follow the TLC diet throughout the study.

You may not qualify if:

  • Allergy or intolerance to omega-3 fatty acids, omega-3-acid ethyl esters, or fish;
  • Known lipoprotein lipase impairment;
  • Known non-responder to omega-3 or fenofibrate therapy;
  • Use of any prescription medications containing EPA and/or DHA (eg, Lovaza® or Vascepa®) within 8 weeks prior to randomization. Up to 1 g capsule/day of an omega-3 dietary supplement will be permitted;
  • Unable to discontinue use of bile acid sequestrants, fibrates or niacin (other than niacin-containing vitamins \<200 mg), or any supplement used to alter lipid metabolism including but not limited to dietary fiber supplements, red rice yeast supplements, garlic supplements, soy isoflavone supplements, sterol/stanol products, or policosanols at screening;
  • Use of tamoxifen, estrogens, or progestins that has not been stable for \>4 weeks at screening or is unstable prior to randomization;
  • Use of oral or injected corticosteroids or anabolic steroids prior to randomization;
  • History of hospitalization for pancreatitis in the last 5 years;
  • Uncontrolled diabetes (hemoglobin A1c \[HbA1c\] \>10%);
  • Uncontrolled hypothyroidism or thyroid-stimulating hormone (TSH) \>5 mIU/L;
  • History of cancer (other than basal cell carcinoma) in the past 2 years;
  • Cardiovascular event (ie, myocardial infarction, acute coronary syndrome, new onset angina, stroke, transient heart attack, unstable congestive heart failure requiring a change in treatment), revascularization procedure or vascular surgery within 6 months of randomization;
  • Use of simvastatin 80 mg or Vytorin 10/80 mg;
  • Recent history (within 6 months of randomization) of significant nephrotic syndrome, pulmonary, hepatic, biliary, gastrointestinal, or immunologic disease;
  • Poorly controlled hypertension (systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥110 mmHg);
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (40)

Research Site

Los Angeles, California, 90057, United States

Location

Research Site

St. Petersburg, Florida, 33709, United States

Location

Research Site

Addison, Illinois, 60101, United States

Location

Research Site

Louisville, Kentucky, 40213, United States

Location

Research Site

Cincinnati, Ohio, 45227, United States

Location

Research Site

Cincinnati, Ohio, 45246, United States

Location

Research Site

Columbus, Ohio, 43213, United States

Location

Research Site

Kettering, Ohio, 45429, United States

Location

Research Site

Lyndhurst, Ohio, 44124, United States

Location

Research Site

Oklahoma City, Oklahoma, 73103, United States

Location

Research Site

Philadelphia, Pennsylvania, 19104, United States

Location

Research Site

Orangeburg, South Carolina, 29118, United States

Location

Research Site

Bristol, Tennessee, 37620, United States

Location

Research Site

Houston, Texas, 77074, United States

Location

Research Site

Katy, Texas, 77450, United States

Location

Research Site

Chicoutimi, Quebec, G7H 7K9, Canada

Location

Research Site

Hradec Kralova, 50005, Czechia

Location

Research Site

Trutnov, 541 21, Czechia

Location

Research Site

Zlín, 76275, Czechia

Location

Research Site

Esbjerg, 6700, Denmark

Location

Research Site

Gentofte Municipality, 2820, Denmark

Location

Research Site

Herlev, 2730, Denmark

Location

Research Site

Viborg, 8800, Denmark

Location

Research Site

Baja, 6500, Hungary

Location

Research Site

Balatonfüred, 8230, Hungary

Location

Research Site

Budapest, 1062, Hungary

Location

Research Site

Debrecen, 4031, Hungary

Location

Research Site

Debrecen, 4032, Hungary

Location

Research Site

Sátoraljaújhely, 3980, Hungary

Location

Research Site

Székesfehérvár, 8000, Hungary

Location

Research Site

Szikszó, 3800, Hungary

Location

Research Site

Alkmaar, 1815JD, Netherlands

Location

Research Site

Amsterdam, 1105 AZ, Netherlands

Location

Research Site

Barnaul, 656055, Russia

Location

Research Site

Kemerovo, 650002, Russia

Location

Research Site

Moscow, 121551, Russia

Location

Research Site

Moscow, 121552, Russia

Location

Research Site

Saint Petersburg, 196601, Russia

Location

Research Site

Tomsk, 634012, Russia

Location

Research Site

Yekaterinburg, 620219, Russia

Location

MeSH Terms

Conditions

HypertriglyceridemiaDyslipidemias

Interventions

Olive Oil

Condition Hierarchy (Ancestors)

HyperlipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats, UnsaturatedDietary FatsFatsLipidsFats, UnsaturatedPlant OilsOilsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Results Point of Contact

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

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2013

First Posted

December 12, 2013

Study Start

December 16, 2013

Primary Completion

December 23, 2014

Study Completion

December 23, 2014

Last Updated

September 10, 2019

Results First Posted

January 15, 2016

Record last verified: 2019-08

Locations

HU(8)RU(7)US(15)CZ(3)NL(2)CA(1)DK(4)