CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 229 enrolled
Drug / intervention
AMR101 (ethyl icosapentate) - 4 g/day +2 moredrug
Likely dose
AMR101 (ethyl icosapentate) - 4 g/dayfrom 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/NCT01047683
NCT01047683Phase 3Completed
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Evaluation of the Efficacy and Safety of AMR101 (Ethyl Icosapentate) in Patients With Fasting Triglyceride Levels ≥ 500 mg/dL and ≤ 2000 mg/dL

Amarin Pharma Inc.·interventional·Posted Jan 13, 2010·Updated Apr 25, 2022

In Brief

A Phase 3 clinical trial evaluating AMR101 (ethyl icosapentate) - 4 g/day, AMR101 (ethyl icosapentate) - 2 g/day, and 1 other intervention for Hypertriglyceridemia. Completed, enrolled 229 participants across 60 sites in 11 countries.

Detailed Summary

The primary objective is to determine the efficacy of AMR101 (ethyl icosapentate) compared to placebo in lowering fasting triglyceride levels in patients with very high fasting triglyceride levels ≥ 500 and ≤ 2000 mg/dL.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypertriglyceridemia
CountriesDenmark, Finland, Germany, India, Italy, Mexico, Netherlands, Russia, South Africa, Ukraine, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 13, 2010
Enrollment StartDec 1, 2009
Primary CompletionOct 1, 2010
Study CompletionJul 1, 2011
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 16.5 years ago

Interventions

AMR101 (ethyl icosapentate) - 4 g/daydrug

AMR101 (ethyl icosapentate) 4 capsules/day for 12 weeks (Weeks 1-12)

AMR101 (ethyl icosapentate) - 2 g/daydrug

AMR101 (ethyl icosapentate) 2 capsules/day with placebo 2 capsules/day for 12 weeks (Weeks 1-12)

Placebodrug

Placebo 4 capsules/day for 12 weeks (Weeks 1-12)