Overview

This trial has been completed.

Condition hyperlipidemia
Treatment omega-3 fatty acid ethyl esters
Sponsor Takeda
Start date May 2013
End date August 2016
Trial size 3070 participants
Trial identifier NCT02153073, 142-011, JapicCTI-142457

Summary

The purpose of this study is to evaluate the safety and efficacy of long-term use of granular capsule formulation of omega-3 fatty acid ethyl esters (Lotriga Granular Capsules) in patients with hyperlipidemia in daily medical practice

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Omega-3 fatty acid ethyl esters 2 g, administered orally once or twice daily after meals
omega-3 fatty acid ethyl esters Lotriga Granular Capsules
Omega-3 fatty acid ethyl esters granular capsules

Primary Outcomes

Measure
Frequency of adverse events
time frame: For 12 months

Secondary Outcomes

Measure
Changes from baseline in lipid parameters
time frame: From Baseline and Month12

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: - Patients with hyperlipidemia Exclusion Criteria: - (1) Patients with hemorrhage (e.g., hemophilia, capillary fragility, gastrointestinal ulcer, urinary tract hemorrhage, hemoptysis, or vitreous hemorrhage) (2) Patients with a history of hypersensitivity to ingredients in Lotriga Granular Capsules

Additional Information

Official title Lotriga Granular Capsules Special Drug Use Surveillance (Long-term Use Survey)
Description This special drug use surveillance on long-term use of granular capsule formulation of omega-3 fatty acid ethyl esters (Lotriga Granular Capsules) was designed to investigate the frequency of adverse events in patients with hyperlipidemia The usual adult dosage is 2 g of omega-3 fatty acid ethyl esters administered orally once daily after meals. However, the dosage can be increased up to twice daily (at a dose of 2 g) depending on the patient's triglyceride level.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Takeda.