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STRENGTH: Epanova Outcomes Study
NCT02104817Phase 3
Key facts
- Status
- Completed
- Start
- Oct 2014
- Primary completion
- May 2020
- Countries
- 22
- Sponsor
- AstraZeneca
- Modality
- Small Molecules
- Conditions
- hypertriglyceridemiaatherosclerotic cardiovascular disease (ASCVD)
01
Overview
Phase 3, randomised, double-blind trial of eicosapentaenoic acid + docosahexaenoic acid in hypertriglyceridemia and atherosclerotic cardiovascular disease (ASCVD) (2 arms), sponsored by AstraZeneca. Primary endpoint: Composite of Major Adverse Cardiovascular Events at 60 months. Started Oct 2014; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Epanova
Epanova + statin once daily
Corn oil
Corn oil + statin once daily
03
Who it enrols
Adult patients with hypertriglyceridemia and low HDL who are at high risk for CVD and are on stable statin therapy.
04
Endpoints
Primary
Composite of Major Adverse Cardiovascular Events
Secondary
Composite of MACE in Subgroup with Established CVD
Composite of Cardiovascular Events
Cardiovascular Death
All-cause Mortality
05
Results
Not all primary endpoints met
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