drugset / Trial / NCT03885661

Vascepa to Accelerate Lipoprotein Uptake and Elimination

NCT03885661 ↗

RandomizedParallel-groupDouble-blindOther

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.

Timeline

Start
2016-01-11
Primary completion
2018-08
Completion
2021-06

Outcome

Missed primary endpoint

registry analysis (superiority test); Icosapent Ethyl vs Usual Care; p = 0.65; mixed effects regression NCT03885661 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject icosapent ethyl Small molecule 4 g Oral