Clinical Trials List
2014-12-30 - 2019-12-31
Phase III
Terminated6
ICD-10E78.1
Pure hyperglyceridemia
ICD-9272.1
Pure hyperglyceridemia
A Long-Term Outcomes Study to Assess STatin Residual Risk Reduction with EpaNova in HiGh Cardiovascular Risk PatienTs with Hypertriglyceridemia (STRENGTH)
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Trial Applicant
IQVIA RDS Taiwan Ltd.
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Sponsor
AstraZeneca AB
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Taiwan National PI
Co-Principal Investigator
- Kang-Ling Wang 醫學研究部
- Ju-Pin Pan Division of Cardiovascular Diseases
- Shih-Hsien Sung Division of Cardiovascular Diseases
- 林幸榮 醫學研究部
- Tse-Min Lu Division of Cardiovascular Diseases
- Wen-Chung Yu Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
12 Completed
Audit
None
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
Audit
None
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
- CHIH-YUAN WANG Division of Endocrinology
The Actual Total Number of Participants Enrolled
0 Completed
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
The Composite of Major Adverse Cardiovascular Events (MACE) [ Time Frame: From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure ]
MACE components include: cardiovascular (CV) death, nonfatal myocardial infarction (MI), nonfatal stroke, emergent/elective coronary revascularization, or hospitalization for unstable angina. Participants with no observed events are censored at the earliest of withdrawal of consent date and last study contact (defined as the latest of the dates of assessments contributing to an opportunity to assess as to whether the participant has had every component of the endpoint being analyzed).
Inclution Criteria
Men or women, ≥18 years of age.
Patient must be on a stable diet and statin* therapy at least 4 weeks prior to randomization (Visit 2) and meet the following criteria:
LDL-C <100 mg/dL
TG level ≥180 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:
Any atherosclerotic CVD as defined in protocol.
History of diabetes mellitus (type 1 or 2) and ≥40 years of age for men and ≥50 years of age for women, plus one of the risk factors defined in protocol.
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
1. Allergy or intolerance to omega-3 carboxylic acids, omega-3 fatty acids, omega-3-acid ethyl esters, or corn oil. 2.Use of fibrates, bile acid sequestrants, or niacin or its analogues (>250 mg/day) within 4 weeks prior to Visit 2. 3.Statin naïve at Visit 1.
The Estimated Number of Participants
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Taiwan
53 participants
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Global
13000 participants
