Back to resultsLong-term Efficacy and Safety Study of TAK-085 in Participants With Hypertriglyceridemia
Primary Purpose
Hypertriglyceridemia
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
omega-3-acid ethyl esters 90 (TAK-085)
Eicosapentaenoic acid-ethyl (EPA)
Sponsored by
About this trial
This is an interventional treatment trial for Hypertriglyceridemia focused on measuring Drug Therapy
Eligibility Criteria
Inclusion Criteria:
Visit 1 (Week -4)
- Undergoing lifestyle modification.
- Triglyceride (TG) level (fasting state) 150 mg/dL or higher and less than 750 mg/dL at Visit 1 (Week -4).
- Both genders, aged from 20 to less than 75 years at the time of signing informed consent.
- Outpatient.
- Capable of understanding and complying with protocol requirements.
- Signed a written, informed consent form prior to the initiation of any study procedures.
A female with childbearing potential (premenopausal and non-sterilized) must have agreed to use routinely adequate contraception from signing of informed consent throughout the duration of the study.
Visit 2 (Week -2)
- Fasting TG level 150 mg/dL or higher and less than 750 mg/dL at Visit 2 (Week -2).
- Difference in fasting low density lipoprotein-cholesterol (LDL-C) level between Visit 1 (Week -4) and Visit 2 (Week -2) within 25% of the higher value
Exclusion Criteria:
Visit 1 (Week -4)
- Any coronary artery diseases (CAD, e.g., confirmed myocardial infarction and angina pectoris) within 6 months prior to Visit 1 (Week -4) or a history of revascularization.
- Received aortic aneurysmectomy or had had aortic aneurysm within 6 months prior to Visit 1 (Week -4).
- History or complication of a clinically significant hemorrhagic disease (e.g., hemophilia, capillary fragility illness, digestive tract ulcer, urinary tract haemorrhage, hemoptysis, vitreous haemorrhage) within 6 months prior to Visit 1 (Week -4).
- Diagnosed with pancreatitis.
- Diagnosed with lipoprotein lipase (LPL) deficiency, apolipoprotein C-II deficiency or type III familial hyperlipidemia.
- Cushing's syndrome, uremia, systemic lupus erythematosus (SLE) or serum dysproteinemia.
- Type 1 diabetes mellitus or with uncontrolled type 2 diabetes mellitus defined by glycosylated hemoglobin (HbA1C) level of 8.0% or higher at Visit 1 (Week -4).
- Stage III hypertension defined by systolic blood pressure of 180 mmHg or higher or diastolic blood pressure of 110 mmHg or higher regardless of the use of antihypertensive medication.
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level at Visit 1 (Week -4) was not less than twice the upper limit of the normal reference range.
- If female, was pregnant or lactating.
- Habitual drinking defined by an average daily alcohol intake of 100 mL or more , drug abuse or drug dependency, or a history of any of these conditions.
- Started to take any antihyperlipidemic drugs within 4 weeks prior to Visit 1 (Week -4).
- Received any investigational products (including those for post-marketing clinical study) within 12 weeks prior to Visit 1 (Week -4).
- Received TAK-085 in a clinical study.
Judged as being ineligible for study participation by the investigator or subinvestigator for any other reasons.
Visit 2 (Week -2)
- ALT or AST level at Visit 2 (Week -2) was twice the upper limit of the normal reference range or higher.
- Needed a change in the dose of antihyperlipidemic drugs or antidiabetic drugs, addition of a new drug or a change in the type of the drugs during the screening period.
Judged as being ineligible for study participation by the investigator or subinvestigator for any other reasons.
Visit 3 (Week 0)
- Needed a change in the dose of antihyperlipidemic drugs or antidiabetic drugs, addition of a new drug or a change in the type of the drugs during the screening period.
- Judged as being ineligible for study participation by the investigator or subinvestigator for any other reasons
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
TAK-085 2 g
TAK-085 4 g
EPA-E 1.8 g
Arm Description
TAK-085 2 g, orally, once daily for up to 52 weeks.
TAK-085 2 g, orally, twice daily for up to 52 weeks.
Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 52 weeks.
Outcomes
Primary Outcome Measures
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Number of Participants With TEAEs Associated With Abnormal Changes in Vital Signs
Number of Participants With TEAEs Associated With Abnormal Changes in Body Weight
Number of Participants With Clinically Significant Findings in Electrocardiogram After Study Drug Administration
Participants whose results of electrocardiograms were judged as abnormal and clinically significant by investigator after study drug administration were counted in this measure.
Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis
Secondary Outcome Measures
Percent Change From Baseline in Triglyceride Level
Percent Change From Baseline in Low-Density Lipoprotein - Cholesterol (LDL-C)
Percent Change From Baseline in Total Cholesterol
Percent Change From Baseline in High-Density Lipoprotein - Cholesterol (HDL-C)
Percent Change From Baseline in Non-High-Density Lipoprotein - Cholesterol
Non-high-density lipoprotein cholesterol was calculated by subtracting high-density lipoprotein cholesterol from total cholesterol.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01350999
Brief Title
Long-term Efficacy and Safety Study of TAK-085 in Participants With Hypertriglyceridemia
Official Title
A Phase 3 Long-term Study of TAK-085 in Subjects With Hypertriglyceridemia
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Takeda
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine the safety and efficacy of TAK-085, once daily (QD) or twice daily (BID), compared to ethyl eicosapentaenoate (EPA-E), three times daily (TID) in participants with hypertriglyceridemia undergoing lifestyle modification.
Detailed Description
TAK-085 is an oral capsule medicine licensed to Takeda Pharmaceutical Company Ltd. TAK-085 contains omega-3 fatty acid ethyl (mainly, ethyl eicosapentaenoate (EPA-E) and ethyl docosahexaenoic acid (DHA-E)).
This is a phase 3, open-label, randomized study to evaluate the efficacy and safety of TAK-085. In addition, EPA-E is also administered for 52 weeks for reference to evaluate the safety of TAK-085 in participants with hypertriglyceridemia who are undergoing lifestyle modification.
The study period is a total of 56 weeks, comprised of a 4- week screening period and 52 weeks of treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertriglyceridemia
Keywords
Drug Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
503 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TAK-085 2 g
Arm Type
Experimental
Arm Description
TAK-085 2 g, orally, once daily for up to 52 weeks.
Arm Title
TAK-085 4 g
Arm Type
Experimental
Arm Description
TAK-085 2 g, orally, twice daily for up to 52 weeks.
Arm Title
EPA-E 1.8 g
Arm Type
Active Comparator
Arm Description
Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 52 weeks.
Intervention Type
Drug
Intervention Name(s)
omega-3-acid ethyl esters 90 (TAK-085)
Other Intervention Name(s)
LOVAZA, Omacor
Intervention Description
Omega-3-acid ethyl esters 90 (TAK-085) capsules. Each one gram of fatty acid in TAK-085 contains approximately 465 mg of EPA plus 375 mg of docosahexaenoic acid-ethyl as ethyl esters.
Intervention Type
Drug
Intervention Name(s)
Eicosapentaenoic acid-ethyl (EPA)
Intervention Description
EPA-E capsules
Primary Outcome Measure Information:
Title
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time Frame
52 Weeks
Title
Number of Participants With TEAEs Associated With Abnormal Changes in Vital Signs
Time Frame
52 Weeks
Title
Number of Participants With TEAEs Associated With Abnormal Changes in Body Weight
Time Frame
52 Weeks
Title
Number of Participants With Clinically Significant Findings in Electrocardiogram After Study Drug Administration
Description
Participants whose results of electrocardiograms were judged as abnormal and clinically significant by investigator after study drug administration were counted in this measure.
Time Frame
52 Weeks
Title
Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis
Time Frame
52 Weeks
Secondary Outcome Measure Information:
Title
Percent Change From Baseline in Triglyceride Level
Time Frame
Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Title
Percent Change From Baseline in Low-Density Lipoprotein - Cholesterol (LDL-C)
Time Frame
Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Title
Percent Change From Baseline in Total Cholesterol
Time Frame
Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Title
Percent Change From Baseline in High-Density Lipoprotein - Cholesterol (HDL-C)
Time Frame
Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Title
Percent Change From Baseline in Non-High-Density Lipoprotein - Cholesterol
Description
Non-high-density lipoprotein cholesterol was calculated by subtracting high-density lipoprotein cholesterol from total cholesterol.
Time Frame
Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Visit 1 (Week -4)
Undergoing lifestyle modification.
Triglyceride (TG) level (fasting state) 150 mg/dL or higher and less than 750 mg/dL at Visit 1 (Week -4).
Both genders, aged from 20 to less than 75 years at the time of signing informed consent.
Outpatient.
Capable of understanding and complying with protocol requirements.
Signed a written, informed consent form prior to the initiation of any study procedures.
A female with childbearing potential (premenopausal and non-sterilized) must have agreed to use routinely adequate contraception from signing of informed consent throughout the duration of the study.
Visit 2 (Week -2)
Fasting TG level 150 mg/dL or higher and less than 750 mg/dL at Visit 2 (Week -2).
Difference in fasting low density lipoprotein-cholesterol (LDL-C) level between Visit 1 (Week -4) and Visit 2 (Week -2) within 25% of the higher value
Exclusion Criteria:
Visit 1 (Week -4)
Any coronary artery diseases (CAD, e.g., confirmed myocardial infarction and angina pectoris) within 6 months prior to Visit 1 (Week -4) or a history of revascularization.
Received aortic aneurysmectomy or had had aortic aneurysm within 6 months prior to Visit 1 (Week -4).
History or complication of a clinically significant hemorrhagic disease (e.g., hemophilia, capillary fragility illness, digestive tract ulcer, urinary tract haemorrhage, hemoptysis, vitreous haemorrhage) within 6 months prior to Visit 1 (Week -4).
Diagnosed with pancreatitis.
Diagnosed with lipoprotein lipase (LPL) deficiency, apolipoprotein C-II deficiency or type III familial hyperlipidemia.
Cushing's syndrome, uremia, systemic lupus erythematosus (SLE) or serum dysproteinemia.
Type 1 diabetes mellitus or with uncontrolled type 2 diabetes mellitus defined by glycosylated hemoglobin (HbA1C) level of 8.0% or higher at Visit 1 (Week -4).
Stage III hypertension defined by systolic blood pressure of 180 mmHg or higher or diastolic blood pressure of 110 mmHg or higher regardless of the use of antihypertensive medication.
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level at Visit 1 (Week -4) was not less than twice the upper limit of the normal reference range.
If female, was pregnant or lactating.
Habitual drinking defined by an average daily alcohol intake of 100 mL or more , drug abuse or drug dependency, or a history of any of these conditions.
Started to take any antihyperlipidemic drugs within 4 weeks prior to Visit 1 (Week -4).
Received any investigational products (including those for post-marketing clinical study) within 12 weeks prior to Visit 1 (Week -4).
Received TAK-085 in a clinical study.
Judged as being ineligible for study participation by the investigator or subinvestigator for any other reasons.
Visit 2 (Week -2)
ALT or AST level at Visit 2 (Week -2) was twice the upper limit of the normal reference range or higher.
Needed a change in the dose of antihyperlipidemic drugs or antidiabetic drugs, addition of a new drug or a change in the type of the drugs during the screening period.
Judged as being ineligible for study participation by the investigator or subinvestigator for any other reasons.
Visit 3 (Week 0)
Needed a change in the dose of antihyperlipidemic drugs or antidiabetic drugs, addition of a new drug or a change in the type of the drugs during the screening period.
Judged as being ineligible for study participation by the investigator or subinvestigator for any other reasons
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Associate Professor, Clinical Cell Biology and Medicine
Organizational Affiliation
Graduate School of Medicine, Chiba University
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Long-term Efficacy and Safety Study of TAK-085 in Participants With Hypertriglyceridemia
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