At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 243 enrolled
Drug / intervention
Placebo capsule +2 moredrug
Likely dose
EPA-E 300 mg capsulefrom 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 II Double-Blind, Placebo-Controlled Study of Two Doses of EPA-E in Patients With NASH
In Brief
A Phase 2 clinical trial evaluating Placebo capsule and EPA-E 300 mg capsule for Steatohepatitis. Completed, enrolled 243 participants across 34 sites in 2 countries.
Detailed Summary
This is a controlled study to determine the effectiveness and safety of ethyl icosapentate (EPA-E) in the treatment of adult patients with non-alcoholic steatohepatitis (NASH).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSteatohepatitis
CountriesPuerto Rico, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJun 2010
First PostedJul 2010
Primary CompletionOct 2012
TodayJul 2026
First PostedJul 1, 2010
Enrollment StartJun 1, 2010
Primary CompletionOct 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 16.0 years ago
Interventions
Placebo capsuledrug
3x Placebo capsules three times a day (TID) for 365 days
EPA-E 300 mg capsuledrug
2x 300 mg capsules + placebo capsule TID for 365 days
EPA-E 300 mg capsuledrug
3x 300 mg capsules TID for 365 days