A Phase 3 interventional study of Icosapent (MND-2119) and Icosapent (EPADEL CAPSULES 300) in Hypertriglyceridemia, sponsored by Mochida Pharmaceutical Company, Ltd.. Completed at 1 site in Japan. Open to participants aged 20 Years to 74 Years. Per ClinicalTrials.gov, last updated 2019-08-01.
Sponsored by Mochida Pharmaceutical Company, Ltd. · Phase 3, Interventional, and Treatment
The purpose of this study is to evaluate the efficacy and safety of MND-2119 compared to EPADEL CAPSULES 300 in participants with hypertriglyceridemia.
MND-2119 is a new formulation of Icosapent. This is a phase 3 study to evaluate the efficacy and safety of MND-2119 compared to EPADEL CAPSULES 300 in subjects with hypertriglyceridemia.
The study period is a total of 22 weeks and is comprised of 8 weeks run-in period, 12 weeks treatment period and 2 weeks follow-up period.
324 studies on the registry are indexed under Hypertriglyceridemia; 38 are open to participants now.
This study's enrollment of 580 is above the median of 66 across 288 interventional studies indexed under Hypertriglyceridemia.
Browse Hypertriglyceridemia studies →Mochida Pharmaceutical Company, Ltd. is the lead sponsor of 12 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MND-2119 2 g, orally, once daily after breakfast for 12 weeks.
Drug: Icosapent (MND-2119)
MND-2119 4 g, orally, once daily after breakfast for 12 weeks.
Drug: Icosapent (MND-2119)
EPADEL CAPSULES 300 0.9 g, orally, twice daily after breakfast and dinner for 12 weeks.
Drug: Icosapent (EPADEL CAPSULES 300)
EPADEL CAPSULES 300 0.9 g, orally, three-times daily after each meal for 12 weeks.
Drug: Icosapent (EPADEL CAPSULES 300)
Icosapent (MND-2119) capsules.
Icosapent (EPADEL CAPSULES 300) capsules.
Percentage of change from baseline in serum triglyceride level at 12 weeks after the start of study drug administration
Time frame: Baseline and 12 weeks
Percentage of change from baseline in serum total cholesterol level at 12 weeks after the start of study drug administration
Time frame: Baseline and 12 weeks
Percentage of change from baseline in serum low-density lipoprotein cholesterol (LDL-C) (direct method) level at 12 weeks after the start of study drug administration
Time frame: Baseline and 12 weeks
Percentage of change from baseline in serum LDL-C (indirect method) level at 12 weeks after the start of study drug administration
Time frame: Baseline and 12 weeks
Percentage of change from baseline in serum high-density lipoprotein cholesterol (HDL-C) level at 12 weeks after the start of study drug administration
Time frame: Baseline and 12 weeks
Percentage of change from baseline in serum non HDL-C level at 12 weeks after the start of study drug administration
Time frame: Baseline and 12 weeks
Plan to share: No
No publications or documents are linked to this record.
Ran from Oct 2018 to primary completion in Jun 2019, 7 months.
Of 28 industry-sponsored phase 3 interventional studies under Hypertriglyceridemia, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 31. This study's 7 months is below that.
Counting every sponsor, half of 29 studies reached it within 24 months; a quarter within 18 and three quarters within 31.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Eicosapentaenoic Acid
Mochida Pharmaceutical Company, Ltd.