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

Hyperlipidemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02153073
• Other study ID #: 142-011
• Secondary ID: JapicCTI-142457
• Status: Completed
• Start date: May 29, 2013
• Est. completion date: May 31, 2017

Study information

• Verified date: July 2019
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3084
• Est. completion date: May 31, 2017
• Est. primary completion date: May 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Hyperlipidemia
• Hyperlipidemias
• Hyperlipoproteinemias

Intervention

Drug:
• Omega-3 fatty acid ethyl esters
Omega-3 fatty acid ethyl esters granular capsules

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Who Had One or More Adverse Events (AE) and Serious Adverse Events (SAE)		Up to Month 12
Secondary	Percent Change From Baseline in Lipid Parameters - Triglycerides (TG)	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.	Baseline, up to 12 months (Final Assessment Point)
Secondary	Percent Change From Baseline in Lipid Parameters - LDL Cholesterol (LDL-C)	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.	Baseline, up to 12 months (Final Assessment Point)
Secondary	Percent Change From Baseline in Lipid Parameters - VLDL Cholesterol (VLDL-C)	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.	Baseline, up to 12 months (Final Assessment Point)
Secondary	Percent Change From Baseline in Lipid Parameters - Apo-B	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.	Baseline, up to 12 months (Final Assessment Point)
Secondary	Percent Change From Baseline in Lipid Parameters - Apo-CIII	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.	Baseline, up to 12 months (Final Assessment Point)
Secondary	Percent Change From Baseline in Lipid Parameters - Lipoprotein	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.	Baseline, up to 12 months (Final Assessment Point)
Secondary	Percent Change From Baseline in Lipid Parameters -Remnant-Like Particles-Cholesterol (RLP-C)	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.	Baseline, up to 12 months (Final Assessment Point)
Secondary	Percent Change From Baseline in Lipid Parameters - Total Cholesterol (TC)	Percent change from baseline in TC values as one of lipid parameters at final assessment point (up to Month 12) was reported.	Baseline, up to 12 months (Final Assessment Point)
Secondary	Percent Change From Baseline in Lipid Parameters - Non-HDL Cholesterol (Non-HDL-C)	Percent change from baseline in Non-HDL-C values as one of lipid parameters at final assessment point (up to Month 12) was reported.	Baseline, up to 12 months (Final Assessment Point)