NCT02625870

Brief Summary

The trial was a double-blind, randomized, parallel-group study comparing Omega-3-Acid Ethyl Esters 90 Soft Capsules and placebo. The primary objective of the present study was to evaluate the efficacy and safety of Omega-3-Acid Ethyl Esters 90 Soft Capsules in subjects with severe hypertriglyceridemia (TGs ≥500 mg/dL but \<2000 mg/dL).

Trial Health

50
Monitor

Trial Health Score

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

Enrollment
240

participants targeted

Target at P50-P75 for phase_3

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

December 7, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 9, 2015

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Last Updated

December 9, 2015

Status Verified

December 1, 2015

Enrollment Period

1 year

First QC Date

December 7, 2015

Last Update Submit

December 7, 2015

Conditions

Hypertriglyceridemia

Outcome Measures

Primary Outcomes (1)

  • End-of-treatment Serum Triglycerides percentage change from baseline under fasting conditions

    12 weeks

Secondary Outcomes (8)

  • End-of-treatment non-HDL-C percentage change from baseline under fasting conditions

    12 weeks

  • End-of-treatment TC percentage change from baseline under fasting conditions

    12 weeks

  • End-of-treatment VLDL-C percentage change from baseline under fasting conditions

    12 weeks

  • End-of-treatment HDL-C percentage change from baseline under fasting conditions

    12 weeks

  • End-of-treatment LDL-C percentage change from baseline under fasting conditions

    12 weeks

  • +3 more secondary outcomes

Study Arms (2)

Omega-3-Acid Ethyl Esters 90 Soft Capsules

EXPERIMENTAL
Drug: Omega-3-Acid Ethyl Esters 90 Soft Capsules

Corn Oil

PLACEBO COMPARATOR
Drug: Corn Oil

Interventions

Omega-3-Acid Ethyl Esters 90 Soft CapsulesDRUG

Omega-3-Acid Ethyl Esters 90 Soft Capsules will be provided in 1 g polyacrylate-coated soft gel capsules.Four capsules will be taken with breakfast once per day, for 12 weeks.

Omega-3-Acid Ethyl Esters 90 Soft Capsules
Corn OilDRUG

Corn Oil will be provided in 1 g polyacrylate-coated soft gel capsules.Four capsules will be taken with breakfast once per day, for 12 weeks.

Corn Oil

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • At least 2 times of fasting serum TG concentrations≥500 mg/dL but\<2000 mg/dL at screening (2and 1 and 0 weeks before random assignment).
  • Two times qualified High Triglycerides Dietary Assessment Table at 2 and 0 weeks before random assignment according to the "prevention and treatment of dyslipidemia in Chinese adults Guide ".

You may not qualify if:

  • Unable to discontinue use of other omega-3 fatty acid-containing products, bile acid sequestrants, fibrates ,niacin or any supplement used to alter lipid metabolism throughout the entire study.
  • Patients taking bile acid sequestrants, fibrate, niacin or any supplement used to alter lipid metabolism more than 6 weeks before entering the study dietary phase.
  • Subjects consuming omega-3 fatty acid-containing products such as cod liver oil, or lipid-decreasing fibers at least 4 weeks before beginning the study.
  • Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST)\>3 times the upper limit of normal.
  • Serum creatinine \>176μmol/L. 6.Platelet counts\<60×109/L，hemoglobin \<100 g/L. 7.Poorly controlled hypertension(resting blood pressure ≥160 mm Hg systolic or ≥100 mm Hg diastolic) 8.Uncontrolled type II diabetes(fasting blood sugar \>11.1mmol/L). 9.Type II diabetes, nephrotic syndrome, hypothyroidism. 10.Atrial fibrillation. 11.History of pancreatitis and symptomatic gallstone disease, unless treated with cholecystectomy.
  • History of cancer (other than basal cell carcinoma) in the past 2 years. 13.Allergy or intolerance to omega-3 fatty acids, omega-3-acid ethyl esters, or fish.
  • Exposure to any investigational product, within 30 days prior to Visit. 16.Presence of any other condition the Investigator believes would interfere the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hypertriglyceridemia

Interventions

Corn Oil

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats, UnsaturatedDietary FatsFatsLipidsFats, UnsaturatedPlant OilsOilsPlant PreparationsBiological ProductsComplex MixturesFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Central Study Contacts

Liang Ni, Graduate

CONTACT

18036618765niliang@hrs.com.cn

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 7, 2015

First Posted

December 9, 2015

Study Start

December 1, 2015

Primary Completion

December 1, 2016

Last Updated

December 9, 2015

Record last verified: 2015-12