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Completed

NCT Number: NCT02153073

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

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

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Key information

Conditions

Hyperlipidemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Osaka, Japan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with hyperlipidemia

Exclusion criteria

  • Patients with hemorrhage (e.g., hemophilia, capillary fragility, gastrointestinal ulcer, urinary tract hemorrhage, hemoptysis, or vitreous hemorrhage)
  • Patients with a history of hypersensitivity to ingredients in granular capsule formulation of omega-3 fatty acid ethyl esters

Treatment and study plan

Omega-3 fatty acid ethyl esters

Drug

Omega-3 fatty acid ethyl esters granular capsules

Other names: Lotriga Granular Capsules

Primary outcomes

  1. Number of Participants Who Had One or More Adverse Events (AE) and Serious Adverse Events (SAE)

    Time frame: Up to Month 12

Secondary outcomes

  1. Percent Change From Baseline in Lipid Parameters - Triglycerides (TG)

    Time frame: 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.

  2. Percent Change From Baseline in Lipid Parameters - LDL Cholesterol (LDL-C)

    Time frame: 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.

  3. Percent Change From Baseline in Lipid Parameters - VLDL Cholesterol (VLDL-C)

    Time frame: 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.

  4. Percent Change From Baseline in Lipid Parameters - Apo-B

    Time frame: 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.

  5. Percent Change From Baseline in Lipid Parameters - Apo-CIII

    Time frame: 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.

  6. Percent Change From Baseline in Lipid Parameters - Lipoprotein

    Time frame: 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.

  7. Percent Change From Baseline in Lipid Parameters -Remnant-Like Particles-Cholesterol (RLP-C)

    Time frame: 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.

  8. Percent Change From Baseline in Lipid Parameters - Total Cholesterol (TC)

    Time frame: 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.

  9. Percent Change From Baseline in Lipid Parameters - Non-HDL Cholesterol (Non-HDL-C)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Jun 2, 2014
Registry last updated
Jul 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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