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

NCT02625870 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2015-12-09

No results posted yet for this study

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).

Conditions

  • Hypertriglyceridemia

Interventions

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.

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.

Sponsors & Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2016-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02625870 on ClinicalTrials.gov