NCT02153073

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,084

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2013

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 29, 2013

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

May 29, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 2, 2014

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2017

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

July 5, 2019

Completed
Last Updated

July 18, 2019

Status Verified

July 1, 2019

Enrollment Period

4 years

First QC Date

May 29, 2014

Results QC Date

May 25, 2018

Last Update Submit

July 17, 2019

Conditions

Hyperlipidemia

Keywords

Pharmacological therapy

Outcome Measures

Primary Outcomes (1)

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

    Up to Month 12

Secondary Outcomes (9)

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

    Baseline, up to 12 months (Final Assessment Point)

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

    Baseline, up to 12 months (Final Assessment Point)

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

    Baseline, up to 12 months (Final Assessment Point)

  • Percent Change From Baseline in Lipid Parameters - Apo-B

    Baseline, up to 12 months (Final Assessment Point)

  • Percent Change From Baseline in Lipid Parameters - Apo-CIII

    Baseline, up to 12 months (Final Assessment Point)

  • +4 more secondary outcomes

Study Arms (1)

Omega-3 fatty acid ethyl esters 2 g

Omega-3 fatty acid ethyl esters 2 g, administered orally once or twice daily after meals

Drug: Omega-3 fatty acid ethyl esters

Interventions

Omega-3 fatty acid ethyl estersDRUG

Omega-3 fatty acid ethyl esters granular capsules

Also known as: Lotriga Granular Capsules
Omega-3 fatty acid ethyl esters 2 g

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Hyperlipidemia

You may qualify if:

  • Patients with hyperlipidemia

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Osaka, Japan

Location

Unknown Facility

Tokyo, Japan

Location

MeSH Terms

Conditions

Hyperlipidemias

Interventions

Omacor

Condition Hierarchy (Ancestors)

DyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Results Point of Contact

Title
Medical Director
Organization
Takeda
trialdisclosures@takeda.com
+1-877-825-3327

Study Officials

  • Study Director

    Takeda

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2014

First Posted

June 2, 2014

Study Start

May 29, 2013

Primary Completion

May 31, 2017

Study Completion

May 31, 2017

Last Updated

July 18, 2019

Results First Posted

July 5, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

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.

Locations

JP(2)