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Omega-3-Acid Ethyl Esters 90 Soft Capsules for Lowering Very High Triglycerides (OMEELVHT)

Primary Purpose

Hypertriglyceridemia

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Omega-3-Acid Ethyl Esters 90 Soft Capsules
Corn Oil
Sponsored by
Jiangsu HengRui Medicine Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertriglyceridemia

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

-1.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).

2.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 ".

Exclusion Criteria:

  • 1.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.

    2.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.

    3.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.

    4.Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST)>3 times the upper limit of normal.

    5.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.

    12.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.

    14.History in the past 12 months of drug abuse or alcohol abuse (.14 drinks per week; 1 drink was equivalent to 12 oz beer, 5 oz wine, or 1.5 oz hard liquor) was also exclusionary.

    15.Exposure to any investigational product, within 30 days prior to Visit. 16.Presence of any other condition the Investigator believes would interfere the study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Omega-3-Acid Ethyl Esters 90 Soft Capsules

    Corn Oil

    Arm Description

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    End-of-treatment non-HDL-C percentage change from baseline under fasting conditions
    End-of-treatment TC percentage change from baseline under fasting conditions
    End-of-treatment VLDL-C percentage change from baseline under fasting conditions
    End-of-treatment HDL-C percentage change from baseline under fasting conditions
    End-of-treatment LDL-C percentage change from baseline under fasting conditions
    End-of-treatment LDL-C/HDL-C percentage change from baseline under fasting conditions
    End-of-treatment Apo A5 percentage change from baseline under fasting conditions
    End-of-treatment Apo C3 percentage change from baseline under fasting conditions

    Full Information

    First Posted
    December 7, 2015
    Last Updated
    December 7, 2015
    Sponsor
    Jiangsu HengRui Medicine Co., Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02625870
    Brief Title
    Omega-3-Acid Ethyl Esters 90 Soft Capsules for Lowering Very High Triglycerides
    Acronym
    OMEELVHT
    Official Title
    A 12-Week, Randomized, Double-Blind, Corn Oil-Controlled Phase 3 Study to Assess the Efficacy and Safety of Omega-3-Acid Ethyl Esters 90 Soft Capsules in Subjects With Severe Hypertriglyceridemia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 2015 (undefined)
    Primary Completion Date
    December 2016 (Anticipated)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Jiangsu HengRui Medicine Co., Ltd.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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).

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    240 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Omega-3-Acid Ethyl Esters 90 Soft Capsules
    Arm Type
    Experimental
    Arm Title
    Corn Oil
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Omega-3-Acid Ethyl Esters 90 Soft Capsules
    Intervention Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Corn Oil
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    End-of-treatment Serum Triglycerides percentage change from baseline under fasting conditions
    Time Frame
    12 weeks
    Secondary Outcome Measure Information:
    Title
    End-of-treatment non-HDL-C percentage change from baseline under fasting conditions
    Time Frame
    12 weeks
    Title
    End-of-treatment TC percentage change from baseline under fasting conditions
    Time Frame
    12 weeks
    Title
    End-of-treatment VLDL-C percentage change from baseline under fasting conditions
    Time Frame
    12 weeks
    Title
    End-of-treatment HDL-C percentage change from baseline under fasting conditions
    Time Frame
    12 weeks
    Title
    End-of-treatment LDL-C percentage change from baseline under fasting conditions
    Time Frame
    12 weeks
    Title
    End-of-treatment LDL-C/HDL-C percentage change from baseline under fasting conditions
    Time Frame
    12 weeks
    Title
    End-of-treatment Apo A5 percentage change from baseline under fasting conditions
    Time Frame
    12 weeks
    Title
    End-of-treatment Apo C3 percentage change from baseline under fasting conditions
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: -1.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). 2.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 ". Exclusion Criteria: 1.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. 2.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. 3.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. 4.Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST)>3 times the upper limit of normal. 5.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. 12.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. 14.History in the past 12 months of drug abuse or alcohol abuse (.14 drinks per week; 1 drink was equivalent to 12 oz beer, 5 oz wine, or 1.5 oz hard liquor) was also exclusionary. 15.Exposure to any investigational product, within 30 days prior to Visit. 16.Presence of any other condition the Investigator believes would interfere the study.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Liang Ni, Graduate
    Phone
    18036618765
    Email
    niliang@hrs.com.cn

    12. IPD Sharing Statement

    Learn more about this trial

    Omega-3-Acid Ethyl Esters 90 Soft Capsules for Lowering Very High Triglycerides

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