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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02153073
Recruitment Status : Completed
First Posted : June 2, 2014
Results First Posted : July 4, 2019
Last Update Posted : July 18, 2019
Sponsor:
Information provided by (Responsible Party):
Takeda

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

Condition or disease Intervention/treatment
Hyperlipidemia Drug: Omega-3 fatty acid ethyl esters

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.

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Study Type : Observational
Actual Enrollment : 3084 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Omega-3 Fatty Acid Ethyl Esters (Lotriga) Granular Capsules Special Drug Use Surveillance (Long-term Use Survey)
Actual Study Start Date : May 29, 2013
Actual Primary Completion Date : May 31, 2017
Actual Study Completion Date : May 31, 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
Omega-3 fatty acid ethyl esters granular capsules
Other Name: Lotriga Granular Capsules




Primary Outcome Measures :
  1. Number of Participants Who Had One or More Adverse Events (AE) and Serious Adverse Events (SAE) [ Time Frame: Up to Month 12 ]

Secondary Outcome Measures :
  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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Hyperlipidemia
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02153073


Locations
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Japan
Osaka, Japan
Tokyo, Japan
Sponsors and Collaborators
Takeda
Investigators
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Study Director: Study Director Takeda
  Study Documents (Full-Text)

Documents provided by Takeda:
Study Protocol  [PDF] April 2, 2018
Statistical Analysis Plan  [PDF] September 22, 2017


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Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT02153073     History of Changes
Other Study ID Numbers: 142-011
JapicCTI-142457 ( Registry Identifier: JapicCTI )
First Posted: June 2, 2014    Key Record Dates
Results First Posted: July 4, 2019
Last Update Posted: July 18, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: 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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Takeda:
Pharmacological therapy
Additional relevant MeSH terms:
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Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases