STRENGTH

Phase 3

Completed

• Conditions: Hypertriglyceridemia at high risk for a future cardiovascular event

• Registration Number: JPRN-jRCT2080222896
• Lead Sponsor: AstraZeneca KK

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-06-26
• Study Completion: 2020-05-27
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 305

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 <100 mg/dL

b. TG level 180 or more and <500 mg/dL and HDL-C <42 mg/dL for men or HDL-C <47 mg/dL for women

- Patient is at high risk for a future cardiovascular event if at least one of the following criteria (3a, 3b or 3c) is present via patient history, physical exam, or medical records at the time of screening:

a. Any atherosclerotic CVD as defined in protocol.

b. History of diabetes mellitus (type 1 or 2) and 40 years of age or more for men and 50 years of age or omore for women, plus one of
the risk factors defined in protocol.

c. Male patients >50 years of age or females >60 years of age, with at least one of the risk factors defined in protocol.

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
efficacy<br>-

Secondary Outcome Measures

Name	Time	Method
safety<br>efficacy<br>-