CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 702 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/NCT01047501
NCT01047501Phase 3Completed
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Evaluation of the Effect of Two Doses of AMR101 (Ethyl Icosapentate) on Fasting Serum Triglyceride Levels in Patients With Persistent High Triglyceride Levels (≥ 200 mg/dL and < 500 mg/dL) Despite Statin Therapy

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 702 participants across 80 sites.

Detailed Summary

The primary objective is to determine the efficacy of AMR101 (ethyl icosapentate) compared to placebo in lowering high fasting triglyceride levels in patients with high risk for cardiovascular disease and fasting triglyceride levels ≥ 200 and \< 500 mg/dL.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypertriglyceridemia
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 13, 2010
Enrollment StartDec 1, 2009
Primary CompletionFeb 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 16.5 years ago

Interventions

AMR101 (ethyl icosapentate) - 4 g/daydrug

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

AMR101 (ethyl icosapentate) - 2 g/daydrug

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

Placebodrug

Placebo 4 capsules/day for 12 weeks