At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 503 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.
A Phase 3 Long-term Study of TAK-085 in Subjects With Hypertriglyceridemia
In Brief
A Phase 3 clinical trial evaluating omega-3-acid ethyl esters 90 (TAK-085) and Eicosapentaenoic acid-ethyl (EPA) for Hypertriglyceridemia. Completed, enrolled 503 participants.
Detailed Summary
The purpose of this study is to determine the safety and efficacy 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 CompletionJan 2011
First PostedMay 2011
TodayJul 2026
First PostedMay 10, 2011
Enrollment StartNov 1, 2009
Primary CompletionJan 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.2 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)drug
EPA-E capsules