NCT02153073

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

Completed Results posted Last updated 18 July 2019

What this trial tests

trial testing Omega-3 fatty acid ethyl esters in Hyperlipidemia in 3,084 participants. Completed in 31 May 2017.

Timeline

29 May 2013

Primary endpoint
31 May 2017

31 May 2017

Quick facts

Lead sponsor	Takeda
Status	Completed
Study type	OBSERVATIONAL
Enrollment	3,084
Start date	29 May 2013
Primary completion	31 May 2017
Estimated completion	31 May 2017
Sites	2 locations across Japan

Drugs / interventions tested

• Omega-3 fatty acid ethyl esters — full drug profile →

Conditions studied

• Hyperlipidemia — all drugs for Hyperlipidemia →

Sponsor

Takeda — full company profile →

Who can join

Eligibility, any sex, with Hyperlipidemia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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

Group	Value	95% CI
Omega-3 Fatty Acid Ethyl Esters 2 g	-20.54	± 40.259

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

Group	Value	95% CI
Omega-3 Fatty Acid Ethyl Esters 2 g	7.73	± 82.486

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

Group	Value	95% CI
Omega-3 Fatty Acid Ethyl Esters 2 g	-14.15	± 57.833

Percent Change From Baseline in Lipid Parameters - Apo-B Secondary · 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.

Group	Value	95% CI
Omega-3 Fatty Acid Ethyl Esters 2 g	-7.21	± 12.979

Percent Change From Baseline in Lipid Parameters - Apo-CIII Secondary · 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.

Group	Value	95% CI
Omega-3 Fatty Acid Ethyl Esters 2 g	-5.49	± 23.117

Percent Change From Baseline in Lipid Parameters - Lipoprotein Secondary · 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.

Group	Value	95% CI
Omega-3 Fatty Acid Ethyl Esters 2 g	-2.98	± 28.385

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

Group	Value	95% CI
Omega-3 Fatty Acid Ethyl Esters 2 g	-22.42	± 94.776

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

Group	Value	95% CI
Omega-3 Fatty Acid Ethyl Esters 2 g	-4.26	± 17.488

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

Group	Value	95% CI
Omega-3 Fatty Acid Ethyl Esters 2 g	-1.42	± 23.495

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

AE

Group	Value	95% CI
Omega-3 Fatty Acid Ethyl Esters 2 g	130

SAE

Group	Value	95% CI
Omega-3 Fatty Acid Ethyl Esters 2 g	26

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to Month12. Reporting threshold: 0.2%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Omega-3 Fatty Acid Ethyl Esters 2 g

Serious: 26/2786 (1%)

Deaths: 10/2786

Serious adverse events (25 terms)

Reaction	System	Omega-3 Fatty Acid Ethyl E…
Myocardial infarction	Cardiac disorders	—
Angina pectoris	Cardiac disorders	—
Atrial fibrillation	Cardiac disorders	—
Sinusitis	Infections and infestations	—
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—
Oesophageal carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	—
Hypoalbuminaemia	Metabolism and nutrition disorders	—
Dementia	Nervous system disorders	—
Transient ischaemic attack	Nervous system disorders	—
Cardiac failure acute	Cardiac disorders	—
Deep vein thrombosis	Vascular disorders	—
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	—
Diarrhoea	Gastrointestinal disorders	—
Rectal prolapse	Gastrointestinal disorders	—
Liver injury	Hepatobiliary disorders	—
Skin ulcer	Skin and subcutaneous tissue disorders	—
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	—
Cystitis haemorrhagic	Renal and urinary disorders	—
Asthenia	General disorders	—
Death	General disorders	—
Drowning	General disorders	—
Road traffic accident	Injury, poisoning and procedural complications	—
Subdural haematoma	Injury, poisoning and procedural complications	—

Other adverse events (5 terms — click to expand)

Reaction	System	Omega-3 Fatty Acid Ethyl E…
Diarrhoea	Gastrointestinal disorders	—
Nausea	Gastrointestinal disorders	—
Hepatic function abnormal	Hepatobiliary disorders	—
Bronchitis	Infections and infestations	—
Viral upper respiratory tract infection	Infections and infestations	—

Most-reported serious reactions: Myocardial infarction, Angina pectoris, Atrial fibrillation, Sinusitis, Gastric cancer, Oesophageal carcinoma, Lung neoplasm malignant, Diabetes mellitus inadequate control.

Data from ClinicalTrials.gov NCT02153073 adverse events section.

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.