HyperlipidemiaNCT02153073

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

An observational study of Hyperlipidemia, run by Takeda at 2 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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 Read more about this study

Who is it for?: Any age
Conditions the study is for: Hyperlipidemia
What is being tested?: Omega-3 fatty acid ethyl esters
Type of treatment: Pill or oral medicine
How many people: 3,084 participants
Where: 2 sitesJapan
Study dates: 29 May 2013to 31 May 2017
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Hyperlipidemia

Who may be able to join

Patients with hyperlipidemia

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

Japan2 sites

Study site
Osaka
Study site
Tokyo

Other trials in Japan

About this study

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

Read the 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.

Conditions: Hyperlipidemia
Being tested: Omega-3 fatty acid ethyl esters
Keywords: Pharmacological therapy
Medical subject headings: Hyperlipidemias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Omega-3 fatty acid ethyl estersDrug
Also called Lotriga Granular Capsules
Omega-3 fatty acid ethyl esters granular capsules

Study groups in NCT02153073
Study group	Role	What they receive
Omega-3 fatty acid ethyl esters 2 g		Omega-3 fatty acid ethyl esters 2 g, administered orally once or twice daily after meals Receives: Drug: Omega-3 fatty acid ethyl esters

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (9)

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.
Measured: Baseline, up to 12 months (Final Assessment Point)
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.
Measured: Baseline, up to 12 months (Final Assessment Point)
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.
Measured: Baseline, up to 12 months (Final Assessment Point)
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.
Measured: Baseline, up to 12 months (Final Assessment Point)
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.
Measured: Baseline, up to 12 months (Final Assessment Point)
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.
Measured: Baseline, up to 12 months (Final Assessment Point)
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.
Measured: Baseline, up to 12 months (Final Assessment Point)
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.
Measured: Baseline, up to 12 months (Final Assessment Point)
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.
Measured: Baseline, up to 12 months (Final Assessment Point)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 May 201331 May 2017

First posted2 Jun 2014 (estimated)
Study start29 May 2013
Primary completion31 May 2017
Study completion31 May 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HyperlipidemiaStudies of the same condition, open and under way.
More trials run by TakedaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 3,084 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02153073
Sponsor's protocol ID: 142-011
Other IDs: JapicCTI-142457
Status last verified: Jul 2019
First submitted: 29 May 2014
Last updated: 18 Jul 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Plasma Lipids-Dependent Vitamin E Metabolism During Dynamic Hyperlipidemia
Lipid Metabolism Disorders
Active, not recruiting
Developing a Learning COmmunity to Increase eNgagemeNt and Enrollment in Cardiovascular Clinical Trials (CONNECT)
Cardiovascular Diseases, Hypertension
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
Active, not recruitingObservational study
Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
Familial Hypercholesterolaemia

All Hyperlipidemia trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Omega-3 Fatty Acid Ethyl Esters (Lotriga) Granular Capsules Special Drug Use Surveillance (Long-term Use Survey)
ClinicalTrials.gov ID: NCT02153073
Acronym / sponsor ID: 142-011
Conditions: Hyperlipidemia
Keywords: Pharmacological therapy
Study type: Observational
Recruitment status: Completed
Enrolment: 3,084 participants (actual)
Lead sponsor: TakedaIndustry (pharma, biotech, devices)
Study start: 29 May 2013 (actual)
Primary completion: 31 May 2017 (actual)
Study completion: 31 May 2017 (actual)
First posted: 2 Jun 2014 (estimated)
Results: Posted 5 Jul 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Omega-3 fatty acid ethyl esters 2 g	–	Drug: Omega-3 fatty acid ethyl estersOmega-3 fatty acid ethyl esters 2 g, administered orally once or twice daily after meals

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Hyperlipidemia

Key inclusion criteria (1 listed)

Patients with hyperlipidemia

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Omega-3 fatty acid ethyl estersAlso: Lotriga Granular CapsulesOmega-3 fatty acid ethyl esters granular capsules	Drug	Omega-3 fatty acid ethyl esters 2 g

Primary outcome

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

9 secondary outcomes

Percent Change From Baseline in Lipid Parameters - Triglycerides (TG)
Time frame: Baseline, up to 12 months (Final Assessment Point)
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 Lipid Parameters - VLDL Cholesterol (VLDL-C)
Time frame: Baseline, up to 12 months (Final Assessment Point)
Percent Change From Baseline in Lipid Parameters - Apo-B
Time frame: Baseline, up to 12 months (Final Assessment Point)
Percent Change From Baseline in Lipid Parameters - Apo-CIII
Time frame: Baseline, up to 12 months (Final Assessment Point)
Percent Change From Baseline in Lipid Parameters - Lipoprotein
Time frame: Baseline, up to 12 months (Final Assessment Point)
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 Lipid Parameters - Total Cholesterol (TC)
Time frame: Baseline, up to 12 months (Final Assessment Point)
Percent Change From Baseline in Lipid Parameters - Non-HDL Cholesterol (Non-HDL-C)
Time frame: Baseline, up to 12 months (Final Assessment Point)

Results and safety

Results posted to the registry on 5 Jul 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Omega-3 Fatty Acid Ethyl Esters 2 g	3,084	2,786

Primary outcome: Number of Participants Who Had One or More Adverse Events (AE) and Serious Adverse Events (SAE)

Time frame: Up to Month 12. Count of participants. Unit: Participants

Measure	Omega-3 Fatty Acid Ethyl Esters 2 g n = 2786
AE	130
SAE	26

Population analysed: Safety Analysis Set; The safety analysis set was defined as all participants who completed the study.

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to Month12. Other adverse events reported at 0.2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Omega-3 Fatty Acid Ethyl Esters 2 g	26 of 2,786 (0.9%)	38 of 2,786 (1.4%)	10 of 2,786

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.

Related trials for Hyperlipidemia

Not yet recruiting
Plasma Lipids-Dependent Vitamin E Metabolism During Dynamic Hyperlipidemia
Lipid Metabolism Disorders
Active, not recruiting
Developing a Learning COmmunity to Increase eNgagemeNt and Enrollment in Cardiovascular Clinical Trials (CONNECT)
Cardiovascular Diseases, Hypertension
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
Active, not recruitingObservational study
Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
Familial Hypercholesterolaemia

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Study Director study director

Takeda

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Hyperlipidemia, run by Takeda at 2 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Who Had One or More Adverse Events (AE) and Serious Adverse Events (SAE) (time frame: Up to Month 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02153073.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2019.