At a glance
ClinicalIndex Comparison RecordN/ACompleted· 15,330 enrolled
Drug / intervention
Omega-3 fatty acid ethyl esters +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Specified Drug-use Survey of Lotriga Granular Capsules: OCEAN3 (Outcome Prevention on Cardiovascular Events by Antihyperlipidemic Therapy With N3-fatty Acid in Japan)
In Brief
An observational study evaluating Omega-3 fatty acid ethyl esters and Standard antihyperlipidemic therapy other than administration of omega-3 fatty acid ethyl esters (Lotriga). for Hyperlipidemia. Completed, enrolled 15,330 participants across 2 sites.
Detailed 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 Capsules) in high-risk hyperlipidemic patients treated by statin in daily medical practice.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsHyperlipidemia
CountriesJapan
Collaborators--
Timeline
N/ACompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartOct 2014
First PostedNov 2014
Primary CompletionJul 2020
TodayJul 2026
First PostedNov 6, 2014
Enrollment StartOct 21, 2014
Primary CompletionJul 14, 2020
TodayJul 2, 2026
Enrollment to primary: 5.7 yearsPosted 11.7 years ago
Interventions
Omega-3 fatty acid ethyl estersdrug
Omega-3 fatty acid ethyl esters granular capsules
Standard antihyperlipidemic therapy other than administration of omega-3 fatty acid ethyl esters (Lotriga).drug