MedTrace Logo

Specified Drug-use Survey of the Granular Capsule Formulation of Omega-3 Fatty Acid Ethyl Esters: OCEAN3

NCT02285166 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 15330

Last updated 2022-02-18

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

DRUG

Omega-3 fatty acid ethyl esters

Omega-3 fatty acid ethyl esters granular capsules

DRUG

Standard antihyperlipidemic therapy other than administration of omega-3 fatty acid ethyl esters (Lotriga).

Sponsors & Collaborators

Principal Investigators

  • Study Director · Takeda

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-21
Primary Completion
2020-07-14
Completion
2020-07-14

Countries

  • Japan

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02285166 on ClinicalTrials.gov