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

Completed

• Conditions: Hyperlipidemia
• Interventions: Drug: Omega-3 fatty acid ethyl esters

• Registration Number: NCT02153073
• Lead Sponsor: Takeda

Brief 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.

Study Timeline

• Study Start: 2013-05-29
• Study First Submitted: 2014-05-29
• Study First Submitted QC: 2014-05-29
• Study First Posted: 2014-06-02
• Primary Completion: 2017-05-31
• Study Completion: 2017-05-31
• Results First Submitted: 2018-05-25
• Results First Submitted QC: 2019-04-11
• Status Verified: 2019-07
• Results First Posted: 2019-07-05
• Last Update Submitted: 2019-07-17
• Last Update Posted: 2019-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3084

Inclusion Criteria

• Patients with hyperlipidemia

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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 granular capsule formulation of omega-3 fatty acid ethyl esters

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Omega-3 fatty acid ethyl esters 2 g	Omega-3 fatty acid ethyl esters	Omega-3 fatty acid ethyl esters 2 g, administered orally once or twice daily after meals

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Had One or More Adverse Events (AE) and Serious Adverse Events (SAE)	Up to Month 12

Secondary Outcome Measures

Name	Time	Method
Percent Change From Baseline in Lipid Parameters - Apo-CIII	Baseline, up to 12 months (Final Assessment Point)	Percent change from baseline in Apo-CIII values as one of lipid parameters in fasted condition at final assessment point (up to Month 12) was reported.
Percent Change From Baseline in Lipid Parameters - Non-HDL Cholesterol (Non-HDL-C)	Baseline, up to 12 months (Final Assessment Point)	Percent change from baseline in Non-HDL-C values as one of lipid parameters at final assessment point (up to Month 12) was reported.
Percent Change From Baseline in Lipid Parameters - Triglycerides (TG)	Baseline, up to 12 months (Final Assessment Point)	Percent change from baseline in TG values as one of lipid parameters in fasted condition at final assessment point (up to Month 12) was reported.
Percent Change From Baseline in Lipid Parameters - LDL Cholesterol (LDL-C)	Baseline, up to 12 months (Final Assessment Point)	Percent change from baseline in LDL-C values as one of lipid parameters in fasted condition at final assessment point (up to Month 12) was reported.
Percent Change From Baseline in Lipid Parameters - Lipoprotein	Baseline, up to 12 months (Final Assessment Point)	Percent change from baseline in Lipoprotein values as one of lipid parameters in fasted condition at final assessment point (up to Month 12) was reported.
Percent Change From Baseline in Lipid Parameters - VLDL Cholesterol (VLDL-C)	Baseline, up to 12 months (Final Assessment Point)	Percent change from baseline in VLDL-C values as one of lipid parameters in fasted condition at final assessment point (up to Month 12) was reported.
Percent Change From Baseline in Lipid Parameters - Apo-B	Baseline, up to 12 months (Final Assessment Point)	Percent change from baseline in Apo-B values as one of lipid parameters in fasted condition at final assessment point (up to Month 12) was reported.
Percent Change From Baseline in Lipid Parameters -Remnant-Like Particles-Cholesterol (RLP-C)	Baseline, up to 12 months (Final Assessment Point)	Percent change from baseline in RLP-C values as one of lipid parameters in fasted condition at final assessment point (up to Month 12) was reported.
Percent Change From Baseline in Lipid Parameters - Total Cholesterol (TC)	Baseline, up to 12 months (Final Assessment Point)	Percent change from baseline in TC values as one of lipid parameters at final assessment point (up to Month 12) was reported.