Study identifier:D5881C00004
ClinicalTrials.gov identifier:NCT02104817
EudraCT identifier:2014-001069-28
CTIS identifier:N/A
A Long-Term Outcomes Study to Assess STatin Residual Risk Reduction with EpaNova in HiGh Cardiovascular Risk PatienTs with Hypertriglyceridemia (STRENGTH)
Eligible men or women considered high risk for atherosclerotic cardiovascular disease (CVD)
Phase 3
No
Epanova® (omega-3 carboxylic acids), corn oil control
All
13078
Interventional
18 Years - 99 Years
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 Aug 2021 by AstraZeneca
AstraZeneca
Cleveland Clinic Coordinating Center for Clinical Research (C5R), IQVIA RDS Inc.
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.
Location
Location
Columbus, Ohio, United States, 43210
Location
Charlotte, NC, United States, 28207
Location
Mesa, AZ, United States, 85213
Location
Oklahoma City, OK, United States, 73135
Location
Arlington Heights, IL, United States, 60005
Location
Camden, NJ, United States, 08103
Location
Avon, IN, United States, 46123
Location
Albany, NY, United States, 12211
Arms | Assigned Interventions |
---|---|
Experimental: EPANOVA Epanova + statin, once daily | Drug: Epanova® (omega-3 carboxylic acids) Adjunct to statin therapy and diet in high risk adult patients for the prevention and reduction of major adverse cardiovascular events (MACE) Other Name: omega-3 carboxylic acids |
Active Comparator: Corn oil Corn oil + Statin | Drug: corn oil control corn oil control arm Other Name: n/a |
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