Clinical trial NCT01350973: Efficacy of TAK-085 in Participants With Hypertriglyceridemia
Official title: A Phase 3, Multicenter, Double-blind, Parallel-group Study to Evaluate the Efficacy and Safety of TAK-085 in Subjects With Hypertriglyceridemia.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertriglyceridemia
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2011-05-10
Enrollment: 611
Sex: ALL
Minimum age (years): 20
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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, double-blind, randomized study to evaluate the efficacy and safety of TAK-085 compared to EPA-E in participants with hypertriglyceridemia who are undergoing lifestyle modification.

The study period is a total of 20 weeks, comprised of an 8- week screening period and 12 weeks of treatment.

Eligibility criteria: Inclusion Criteria:

1. 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.
2. 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:

1. 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.
2. Participants who received aortic aneurysmectomy or is complicated with aortic aneurysm within 6 months prior to Visit 1 (Week -8).
3. 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).
4. Participants who have been diagnosed with pancreatitis.
5. Participants who have been diagnosed with lipoprotein lipase (LPL) deficiency, apolipoprotein C-II deficiency or type III familial hyperlipidemia.
6. Participants with complication of Cushing's syndrome, uremia, systemic lupus erythematosus (SLE) or serum dysproteinemia.

Primary outcomes:
measure: Percent Change From Baseline in Triglyceride Level at the Final Visit
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Percent Change From Baseline in Triglyceride Level Over Time
timeFrame: Baseline and Weeks 4, 8, 10 and 12
measure: Percent Change From Baseline in Low-Density Lipoprotein - Cholesterol (LDL-C) Level Over Time
timeFrame: Baseline and Weeks 4, 8, 10 and 12
measure: Percent Change From Baseline in Total Cholesterol Over Time
timeFrame: Baseline and Weeks 4, 8, 10 and 12
measure: Percent Change From Baseline in High-Density Lipoprotein - Cholesterol (HDL-C) Level Over Time
timeFrame: Baseline and Weeks 4, 8, 10 and 12
measure: Percent Change From Baseline in Non-High-Density Lipoprotein - Cholesterol Level Over Time
timeFrame: Baseline and Weeks 4, 8, 10 and 12
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
timeFrame: 12 Weeks
measure: Number of Participants With TEAEs Associated With Abnormal Changes in Vital Signs
timeFrame: 12 Weeks
measure: Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis
timeFrame: 12 Weeks
measure: Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings After Study Drug Administration
timeFrame: 12 Weeks
Other outcomes:
Locations:
Study officials:
affiliation: Graduate School of Medicine, Chiba University
name: Associate Professor, Clinical Cell Biology and Medicine
role: STUDY_DIRECTOR
References: