Clinical trial NCT02153073: Evaluation of the Safety and Efficacy of Long-term Use of Omega-3 Fatty Acid Ethyl Esters
Official title: Omega-3 Fatty Acid Ethyl Esters (Lotriga) Granular Capsules Special Drug Use Surveillance (Long-term Use Survey)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hyperlipidemia
Keywords: Pharmacological therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2014-06-02
Enrollment: 3084
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Hyperlipidemia

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.

Eligibility criteria: 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 granular capsule formulation of omega-3 fatty acid ethyl esters

Primary outcomes:
measure: Number of Participants Who Had One or More Adverse Events (AE) and Serious Adverse Events (SAE)
timeFrame: Up to Month 12
Secondary outcomes:
measure: Percent Change From Baseline in Lipid Parameters - Triglycerides (TG)
timeFrame: Baseline, up to 12 months (Final Assessment Point)
measure: Percent Change From Baseline in Lipid Parameters - LDL Cholesterol (LDL-C)
timeFrame: Baseline, up to 12 months (Final Assessment Point)
measure: Percent Change From Baseline in Lipid Parameters - VLDL Cholesterol (VLDL-C)
timeFrame: Baseline, up to 12 months (Final Assessment Point)
measure: Percent Change From Baseline in Lipid Parameters - Apo-B
timeFrame: Baseline, up to 12 months (Final Assessment Point)
measure: Percent Change From Baseline in Lipid Parameters - Apo-CIII
timeFrame: Baseline, up to 12 months (Final Assessment Point)
measure: Percent Change From Baseline in Lipid Parameters - Lipoprotein
timeFrame: Baseline, up to 12 months (Final Assessment Point)
measure: Percent Change From Baseline in Lipid Parameters -Remnant-Like Particles-Cholesterol (RLP-C)
timeFrame: Baseline, up to 12 months (Final Assessment Point)
measure: Percent Change From Baseline in Lipid Parameters - Total Cholesterol (TC)
timeFrame: Baseline, up to 12 months (Final Assessment Point)
measure: Percent Change From Baseline in Lipid Parameters - Non-HDL Cholesterol (Non-HDL-C)
timeFrame: Baseline, up to 12 months (Final Assessment Point)
Other outcomes:
Locations:
city: Osaka
country: Japan
city: Tokyo
country: Japan
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: