At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 399 enrolled
Drug / intervention
placebo +3 moredrug
Likely dose
placebo 1gfrom 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.
Efficacy and Safety of Epanova® (Omefas) in Severe Hypertriglyceridemia
In Brief
A Phase 3 clinical trial evaluating placebo and omefas for Severe Hypertriglyceridemia. Completed, enrolled 399 participants across 68 sites in 7 countries.
Detailed Summary
The primary objective of the study is to determine the efficacy of Epanova (omefas) compared to placebo in lowering serum triglycerides in subjects with severe hypertriglyceridemia.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSevere Hypertriglyceridemia
CountriesDenmark, Hungary, India, Netherlands, Russia, Ukraine, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedNov 2010
Enrollment StartJan 2011
Primary CompletionMar 2012
Study CompletionApr 2012
TodayJul 2026
First PostedNov 17, 2010
Enrollment StartJan 1, 2011
Primary CompletionMar 1, 2012
Study CompletionApr 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 15.6 years ago
Interventions
placebodrug
4 capsules (1g) daily for 12 weeks
omefasdrug
2 capsules (1g) + 2 placebo daily for 12 weeks
omefasdrug
3 capsules (1g) + 1 placebo daily for 12 weeks
omefasdrug
4 capsules (1g)daily for 12 weeks