STRENGTH

A Long-Term Outcomes Study to Assess Statin Residual Risk Reduction With Epanova in High Cardiovascular Risk Patients With Hypertriglyceridemia.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222896

Enrollment

305

Registered

2015-06-26

Start date

2015-05-19

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertriglyceridemia at high risk for a future cardiovascular event

Interventions

investigational material(s) Generic name etc : Epanova INN of investigational material : omega-3 carboxylic acids Therapeutic category code : 218 Agents for hyperlipidemias Dosage and Administration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Patient must be on a stable diet and statin therapy at least 4 weeks prior to randomization (Visit 2) and meet the following criteria: a. LDL-C 50 years of age or females >60 years of age, with at least one of the risk factors defined in protocol.

Exclusion criteria

Exclusion criteria: - Allergy or intolerance to omega-3 carboxylic acids, omega-3 fatty acids, omega-3-acid ethyl esters, or corn oil. - Use of fibrates, bile acid sequestrants, or niacin or its analogues (>250 mg/day) within 4 weeks prior to Visit 2. - Statin naive at Visit 1.

Design outcomes

Primary

Measure	Time frame
efficacy -	—

Secondary

Measure	Time frame
safety efficacy -	—

Countries

Africa, Asia except Japan, Europe, Japan, North America, Oceania, South America

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026