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Efficacy of TAK-085 in Participants With Hypertriglyceridemia

NCT01350973 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 611

Last updated 2016-09-20

Study results available
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Summary

The purpose of this study was to determine the efficacy and safety of TAK-085, once daily (QD) or twice daily (BID), compared to ethyl eicosapentaenoate (EPA-E), three times daily (TID) in participants with hypertriglyceridemia undergoing lifestyle modification.

Conditions

  • Hypertriglyceridemia

Interventions

DRUG

Omega-3-acid ethyl esters 90 (TAK-085)

Omega-3-acid ethyl esters 90 (TAK-085) capsules. Each one gram of fatty acid in TAK-085 contains approximately 465 mg of EPA plus 375 mg of docosahexaenoic acid-ethyl as ethyl esters.

DRUG

Eicosapentaenoic acid-ethyl (EPA-E)

EPA-E, 0.6 g, orally, three-times daily for up to 12 weeks.

Sponsors & Collaborators

Principal Investigators

  • Associate Professor, Clinical Cell Biology and Medicine · Graduate School of Medicine, Chiba University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2010-12-31
Completion
2010-12-31

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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 NCT01350973 on ClinicalTrials.gov