NCT02153073

Evaluation of the Safety and Efficacy of Long-term Use of Omega-3 Fatty Acid Ethyl Esters

Omega-3 Fatty Acid Ethyl Esters (Lotriga) Granular Capsules Special Drug Use Surveillance (Long-term Use Survey)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 3,084 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

Detailed 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 participant's triglyceride level.

Conditions

• Hyperlipidemia

Interventions

Type	Name	Description
DRUG	Omega-3 fatty acid ethyl esters	Omega-3 fatty acid ethyl esters granular capsules

Timeline

• Start date: 2013-05-29
• Primary completion: 2017-05-31
• Completion: 2017-05-31
• First posted: 2014-06-02
• Last updated: 2019-07-18
• Results posted: 2019-07-05

Locations

2 sites across 1 country: Japan