Status:
COMPLETED
Specified Drug-use Survey of the Granular Capsule Formulation of Omega-3 Fatty Acid Ethyl Esters: OCEAN3
Lead Sponsor:
Takeda
Conditions:
Hyperlipidemia
Eligibility:
All Genders
50+ years
Brief Summary
The purpose of this survey is to determine the incidence rate of cardiovascular (CV) events associated with long-term treatment with and without omega-3 fatty acid ethyl esters (Lotriga Granular Capsu...
Detailed Description
This survey is planned to determine the incidence rate of cardiovascular (CV) events associated with long-term treatment with omega-3 fatty acid ethyl esters (Lotriga Granular Capsules) in high-risk h...
Eligibility Criteria
Inclusion
- Participants who meet all of the following criteria will be included in the survey:
- Patients with hyperlipidemia on statin therapy
- Outpatients
- Male participants aged ≥ 50 years and female participants aged ≥ 60 years
- Participants with fasting TG level ≥ 150 mg/dL (within 3 months prior to the start of the observation period)
- Participants who have at least two of the following risk factors:
- Hypertension
- Type 2 diabetes mellitus
- Chronic kidney disease
- Prior history of myocardial infarction or angina pectoris
- Prior history of cerebral infarction
- Peripheral arterial disease
Exclusion
- Participants who meet any of the following criteria will be excluded from the survey:
- Participants who have experienced coronary artery disease within 1 month prior to the start of the observation period
- Participants who have experienced cerebrovascular disease within 1 month prior to the start of the observation period
- Participants who have undergone heart surgery or revascularization surgery (including coronary artery intervention and peripheral arterial intervention) within 1 month prior to the start of the observation period
- Participants who plan to undergo heart surgery or revascularization surgery (including coronary artery intervention and peripheral arterial intervention)
- Patients with malignant tumors currently under treatment
- Participants who have received eicosapentaenoic acid (hereinafter, EPA) products within 1 month prior to the start of the observation period, or participants who plan to receive treatment with EPA products after the start of the observation period
- Patients with hemorrhage (e.g., hemophilia, capillary fragility, gastrointestinal ulcer, urinary tract hemorrhage, hemoptysis, or vitreous hemorrhage)
- Participants with prior history of hypersensitivity to any ingredients in omega-3 fatty acid ethyl esters (omega-3 fatty acid ethyl esters-treated participants only)
- Participants with prior history of treatment with omega-3 fatty acid ethyl esters
Key Trial Info
Start Date :
October 21 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 14 2020
Estimated Enrollment :
15330 Patients enrolled
Trial Details
Trial ID
NCT02285166
Start Date
October 21 2014
End Date
July 14 2020
Last Update
February 18 2022
Active Locations (2)
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1
Osaka, Japan
2
Tokyo, Japan