The purpose of this study is to evaluate the safety and efficacy of MND-2119 at a dose of 2g/day or 4g/day for 52 weeks in patients with hypertriglyceridemia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Icosapent (MND-2119) capsules.
Mochida Investigational sites
Tokyo, Japan
Number of Participants With Adverse Events (AEs)
Time frame: 52 Weeks
Number of Participants With Adverse Drug Reactions (ADRs)
Time frame: 52 Weeks
Actual Value and Percent Change From Baseline in Triglyceride
Time frame: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Actual Value and 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
Actual Value and 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
Actual Value and 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
Actual Value and Percent Change From Baseline in Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C)
Time frame: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
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