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| ID | Type | Description | Link |
|---|---|---|---|
| JapicCTI-142457 | Registry Identifier | JapicCTI |
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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
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Omega-3 fatty acid ethyl esters 2 g | Omega-3 fatty acid ethyl esters 2 g, administered orally once or twice daily after meals |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omega-3 fatty acid ethyl esters | Drug | Omega-3 fatty acid ethyl esters granular capsules |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Had One or More Adverse Events (AE) and Serious Adverse Events (SAE) | Up to Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Percent Change From Baseline in Lipid Parameters - LDL Cholesterol (LDL-C) |
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Inclusion Criteria:
Exclusion Criteria:
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Hyperlipidemia
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Osaka | Japan | |||||
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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Participants with a historical diagnosis of hyperlipidemia were enrolled. Participants received interventions as part of routine medical care.
Participants took part in the study at 570 investigative sites in Japan, from 29 May 2013 to 31 May 2017.
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| ID | Title | Description |
|---|---|---|
| FG000 | Omega-3 Fatty Acid Ethyl Esters 2 g | Oral administration with granular capsule formulation of 2 g of omega-3 fatty acid ethyl esters once daily for 12 months. Participants received interventions as part of routine medical care. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety Analysis Set; The safety analysis set was defined as all participants who completed the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Omega-3 Fatty Acid Ethyl Esters 2 g | Oral administration with granular capsule formulation of 2 g of omega-3 fatty acid ethyl esters once daily for 12 months. Participants received interventions as part of routine medical care. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Efficacy assessment population; The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. The analyzed numbers were participants who were evaluable for this outcome measure at the given time point. | Posted | Mean | Standard Deviation | Percent change | Baseline, up to 12 months (Final Assessment Point) |
|
Up to Month12
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Omega-3 Fatty Acid Ethyl Esters 2 g | Oral administration with granular capsule formulation of 2 g of omega-3 fatty acid ethyl esters once daily for 12 months. Participants received interventions as part of routine medical care. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sinusitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Takeda | +1-877-825-3327 | trialdisclosures@takeda.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 2, 2018 | Jan 10, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 22, 2017 | Jan 10, 2019 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C405603 | Omacor |
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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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| Tokyo |
| Japan |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | Participants |
|
| Healthcare Category | Participants were categorized as outpatient and inpatient. | Count of Participants | Participants |
|
| BMI | Body Mass Index = weight (kg)/[height (m)^2] | The number analyzed is the number of participants with data available for analysis. | Mean | Standard Deviation | Kilograms (kg)/meter (m)^2 |
|
| Medical Complications | Complications defined as a disease or a health condition for each participant at the start of study. Complications were classified as congenital anomalies, endocrine disorders, hematologic disorders, psychiatric and nervous system disorders, cardiovascular disorders, respiratory disorders, gastrointestinal (GI) disorders, renal disease and other complications. Other complications included all complications except for those mentioned above. | Count of Participants | Participants |
|
| Drinking Habits | Participants who answered Yes or No for a question "Drink Alcohol Almost Every Day?" were reported. | Count of Participants | Participants |
|
| Triglycerides (TG) in Fasted Condition [Milligrams (mg)/ Deciliter (dL)] | Count of Participants | Participants |
|
| TG in Non-Fasted Condition (mg/dL) | Count of Participants | Participants |
|
| Smoking Classification | Count of Participants | Participants |
|
| Predisposition to Hypersensitivity | The baseline characteristic was analyzed in participants who had a liability or tendency to suffer from hypersensitivity. | Count of Participants | Participants |
|
| Duration of Diagnosis of Hyperlipidemia | Mean duration between start of study and first time of diagnosis of hyperlipidemia was reported. | Population Analysis Description: The number analyzed is the number of participants with data available for analysis. | Mean | Standard Deviation | Years |
|
| Surgery within One Month before Dosing | Count of Participants | Participants |
|
| Pregnancy Status during the Administration Period | This baseline characteristic was analyzed only in female participants. | Count of Participants | Participants |
|
|
|
| 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. | Efficacy assessment population; The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. The analyzed numbers were participants who were evaluable for this outcome measure at the given time point. | Posted | Mean | Standard Deviation | Percent change | 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. | Efficacy assessment population; The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.The analyzed numbers were participants who were evaluable for this outcome measure at the given time point. | Posted | Mean | Standard Deviation | Percent change | 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. | Efficacy assessment population; The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. The analyzed numbers were participants who were evaluable for this outcome measure at the given time point. | Posted | Mean | Standard Deviation | Percent change | 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. | Efficacy assessment population; The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. The analyzed numbers were participants who were evaluable for this outcome measure at the given time point. | Posted | Mean | Standard Deviation | Percent change | 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. | Efficacy assessment population; The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. The analyzed numbers were participants who were evaluable for this outcome measure at the given time point. | Posted | Mean | Standard Deviation | Percent change | 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. | Efficacy assessment population; The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. The analyzed numbers were participants who were evaluable for this outcome measure at the given time point. | Posted | Mean | Standard Deviation | Percent change | 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. | Efficacy assessment population; The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. The analyzed numbers were participants who were evaluable for this outcome measure at the given time point. | Posted | Mean | Standard Deviation | Percent change | 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. | Efficacy assessment population; The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. The analyzed numbers were participants who were evaluable for this outcome measure at the given time point. | Posted | Mean | Standard Deviation | Percent change | Baseline, up to 12 months (Final Assessment Point) |
|
|
|
| Primary | Number of Participants Who Had One or More Adverse Events (AE) and Serious Adverse Events (SAE) | Safety Analysis Set; The safety analysis set was defined as all participants who completed the study. | Posted | Count of Participants | Participants | Up to Month 12 |
|
|
|
| 10 |
| 2,786 |
| 26 |
| 2,786 |
| 38 |
| 2,786 |
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
|
| Oesophageal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
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| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
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| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
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| Dementia | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
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| Transient ischaemic attack | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
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| Cardiac failure acute | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
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| Deep vein thrombosis | Vascular disorders | MedDRA 20.0 | Systematic Assessment |
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| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Rectal prolapse | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Liver injury | Hepatobiliary disorders | MedDRA 20.0 | Systematic Assessment |
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| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
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| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
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| Cystitis haemorrhagic | Renal and urinary disorders | MedDRA 20.0 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA 20.0 | Systematic Assessment |
|
| Death | General disorders | MedDRA 20.0 | Systematic Assessment | The reasons of events are not determined because assessment findings were insufficient to specify the reason. |
|
| Drowning | General disorders | MedDRA 20.0 | Systematic Assessment | The reasons of events are not determined because assessment findings were insufficient to specify the reason. |
|
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
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| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 20.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.