Phase 3
N=611
Efficacy of TAK-085 in Participants With Hypertriglyceridemia
Hypertriglyceridemia
Bottom Line
View on ClinicalTrials.gov: NCT01350973 ↗Enrolled (actual)
611
Serious AEs
1.2%
Results posted
Sep 2016
Primary outcome: Primary: Percent Change From Baseline in Triglyceride Level at the Final Visit — -10.93; -22.65; -11.30 percent change — p=0.8760
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Omega-3-acid ethyl esters 90 (TAK-085) (Drug); Eicosapentaenoic acid-ethyl (EPA-E) (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Takeda
- Primary completion
- Dec 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Triglyceride Level at the Final Visit |
-10.93; -22.65; -11.30 | 0.8760 |
| SECONDARY Percent Change From Baseline in Triglyceride Level Over Time |
-13.085; -26.939; -11.417; -12.055; -22.501; -11.321 | — |
| SECONDARY Percent Change From Baseline in Low-Density Lipoprotein - Cholesterol (LDL-C) Level Over Time |
1.120; 2.262; -3.409; -0.846; -0.420; -3.008 | — |
| SECONDARY Percent Change From Baseline in Total Cholesterol Over Time |
-0.841; -2.707; -3.152; -1.996; -2.887; -3.097 | — |
| SECONDARY Percent Change From Baseline in High-Density Lipoprotein - Cholesterol (HDL-C) Level Over Time |
2.990; 4.075; 0.934; 1.547; 3.936; 1.826 | — |
| SECONDARY Percent Change From Baseline in Non-High-Density Lipoprotein - Cholesterol Level Over Time |
-1.955; -4.634; -4.274; -3.022; -4.931; -4.418 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (TEAEs) |
88; 76; 83 | — |
| SECONDARY Number of Participants With TEAEs Associated With Abnormal Changes in Vital Signs |
1; 0; 0 | — |
| SECONDARY Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis |
11; 11; 7 | — |
| SECONDARY Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings After Study Drug Administration |
0; 0; 0 | — |
Summary
The purpose of this study was to determine the efficacy and safety 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.
Eligibility Criteria
Inclusion Criteria
- Participants with values of fasting triglyceride level at Visit 2 (Week -4) and Visit 3 (Week -2) are 150 mg/dL or higher and less than 750 mg/dL, and the difference between these 2 values is within 30% of the higher one.
- Participants with differences between 2 values of fasting Low density lipoprotein - cholesterol level measured at Visit 2 (Week -4) and Visit 3 (Week -2) are within 25% of the higher one.
Exclusion Criteria
- Participants who have coronary artery diseases (eg, confirmed myocardial infarction and angina pectoris) within 6 months prior to Visit 1 (Week -8) or participants with a history of revascularization.
- Participants who received aortic aneurysmectomy or is complicated with aortic aneurysm within 6 months prior to Visit 1 (Week -8).
- Participants who have a history or complication of a clinically significant hemorrhagic disease (eg, hemophilia, capillary fragility illness, digestive tract ulcer, urinary tract hemorrhage, hemoptysis, vitreous haemorrhage and so forth) within 6 months prior to Visit 1 (Week -8).
- Participants who have been diagnosed with pancreatitis.
- Participants who have been diagnosed with lipoprotein lipase (LPL) deficiency, apolipoprotein C-II deficiency or type III familial hyperlipidemia.
- Participants with complication of Cushing's syndrome, uremia, systemic lupus erythematosus (SLE) or serum dysproteinemia.
Data sourced from ClinicalTrials.gov (NCT01350973). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.