CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 20 enrolled
Drug / intervention
Icosapent Ethyl 1000 MG [Vascepa]drug
Likely dose
Icosapent Ethyl 1000 MG [Vascepa]from 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/NCT03885661
NCT03885661Phase 1Completed
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Vascepa to Accelerate Lipoprotein Uptake and Elimination (VALUE): An Open-Label, Mechanistic, Randomized, Controlled, Single-Center Trial of AMR101 in Patients With Dyslipidemia

University of Pennsylvania·interventional·Posted Mar 21, 2019·Updated Nov 11, 2021

In Brief

A Phase 1 clinical trial evaluating Icosapent Ethyl 1000 MG [Vascepa] for Lipid Disorder and 2 related conditions. Completed, enrolled 20 participants across 1 site.

Detailed Summary

This study is a Phase 1 pilot/feasibility mechanistic experiment to help clarify the mechanism of action of an EPA-rich fish oil preparation, icosapent ethyl, on lipid changes in statin-treated patients with residual triglyceridemia.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLipid Disorder, Triglycerides High, Dyslipidemias
CountriesUnited States
CollaboratorsAmarin Pharma Inc.

Timeline

Phase 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedMar 21, 2019
Enrollment StartJan 11, 2016
Primary CompletionAug 1, 2018
Study CompletionJun 1, 2021
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 7.3 years ago

Interventions

Icosapent Ethyl 1000 MG [Vascepa]drug

Icosapent ethyl is an ethyl ester of the omega-3 fatty acid eicosapentaenoic acid (EPA). The empirical formula of icosapent ethyl is C22H34O2 and the molecular weight is 330.51. The chemical name for icosapent ethyl is ethyl all-cis-5,8,11,14,17-icosapentaenoate.