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

December 7, 2015 updated by: Jiangsu HengRui Medicine Co., Ltd.

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

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
240

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Omega-3-Acid Ethyl Esters 90 Soft Capsules
Drug: Omega-3-Acid Ethyl Esters 90 Soft Capsules
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.
Placebo Comparator: Corn Oil
Drug: Corn Oil
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
End-of-treatment Serum Triglycerides percentage change from baseline under fasting conditions
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
End-of-treatment non-HDL-C percentage change from baseline under fasting conditions
Time Frame: 12 weeks
12 weeks
End-of-treatment TC percentage change from baseline under fasting conditions
Time Frame: 12 weeks
12 weeks
End-of-treatment VLDL-C percentage change from baseline under fasting conditions
Time Frame: 12 weeks
12 weeks
End-of-treatment HDL-C percentage change from baseline under fasting conditions
Time Frame: 12 weeks
12 weeks
End-of-treatment LDL-C percentage change from baseline under fasting conditions
Time Frame: 12 weeks
12 weeks
End-of-treatment LDL-C/HDL-C percentage change from baseline under fasting conditions
Time Frame: 12 weeks
12 weeks
End-of-treatment Apo A5 percentage change from baseline under fasting conditions
Time Frame: 12 weeks
12 weeks
End-of-treatment Apo C3 percentage change from baseline under fasting conditions
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jiangsu HengRui Medicine Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2015

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 7, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 7, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 9, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 9, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 7, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HROMEE2015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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