At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Long-Term Outcomes Study to Assess STatin Residual Risk Reduction With EpaNova in HiGh Cardiovascular Risk PatienTs With Hypertriglyceridemia (STRENGTH)
In Brief
A Phase 3 clinical trial evaluating Epanova® (omega-3 carboxylic acids) and corn oil control for Eligible Men or Women Considered High Risk for Atherosclerotic Cardiovascular Disease (CVD). Completed, enrolled 13,078 participants across 684 sites in 22 countries.
Detailed Summary
The study is a randomized, double-blind, placebo-controlled (corn oil), parallel group design that will enroll approximately 13,000 patients with hypertriglyceridemia and low HDL and high risk for CVD to be randomized 1:1 to either corn oil + statin or Epanova + statin, once daily, for approximately 3-5 years as determined when the number of MACE outcomes is reached.
Study Details
Timeline
Interventions
Adjunct to statin therapy and diet in high risk adult patients for the prevention and reduction of major adverse cardiovascular events (MACE)
corn oil control arm