At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 611 enrolled

Drug / intervention

Omega-3-acid ethyl esters 90 (TAK-085) +1 moredrug

Likely dose

Omega-3-acid ethyl esters 90 (TAK-085) 465 mgfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01350973

NCT01350973Phase 3Completed

Compare CT.gov

A Phase 3, Multicenter, Double-blind, Parallel-group Study to Evaluate the Efficacy and Safety of TAK-085 in Subjects With Hypertriglyceridemia.

Takeda·interventional·Posted May 10, 2011·Updated Sep 20, 2016

In Brief

A Phase 3 clinical trial evaluating Omega-3-acid ethyl esters 90 (TAK-085) and Eicosapentaenoic acid-ethyl (EPA-E) for Hypertriglyceridemia. Completed, enrolled 611 participants.

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsHypertriglyceridemia

Countries--

Collaborators--

Timeline

Phase 3CompletedFinished

20102011201220132014201520162017201820192020202120222023202420252026

Enrollment StartNov 2009

Primary CompletionDec 2010

First PostedMay 2011

TodayJul 2026

First PostedMay 10, 2011

Enrollment StartNov 1, 2009

Primary CompletionDec 1, 2010

TodayJul 2, 2026

Enrollment to primary: 1.1 yearsPosted 15.1 years ago

Interventions

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

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.

Eicosapentaenoic acid-ethyl (EPA-E)drug

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