Clinical trial NCT03693131: Efficacy of MND-2119 in Participants With Hypertriglyceridemia
Official title: MND-2119 Phase 3 Study to Evaluate the Efficacy and Safety of MND-2119 Compared to EPADEL CAPSULES 300 in Patients With Hypertriglyceridemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertriglyceridemia
Lead sponsor: Mochida Pharmaceutical Company, Ltd.
Sponsor class: INDUSTRY
First posted: 2018-10-02
Enrollment: 580
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 is to evaluate the efficacy and safety of MND-2119 compared to EPADEL CAPSULES 300 in participants with hypertriglyceridemia.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Participants diagnosed with hypertriglyceridemia.
2. Participants with values of fasting triglyceride level are 150 mg/dL or higher and less than 500 mg/dL.

Exclusion Criteria:

1. Participants who have confirmed myocardial infarction and angina pectoris within 6 months.
2. Participants who have aortic aneurysm or has received aortic aneurysmectomy within 6 months.
3. Participants with, or with a history of, pancreatitis.
4. Participants who have a history or complication of a clinically significant hemorrhagic disease within 6 months.
5. Participants taking both anti-coagulants and anti-platelets.
6. Participants receiving dual antiplatelet therapy.
7. Participants taking direct oral anticoagulants.

Primary outcomes:
measure: Percentage of change from baseline in serum triglyceride level at 12 weeks after the start of study drug administration
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Percentage of change from baseline in serum total cholesterol level at 12 weeks after the start of study drug administration
timeFrame: Baseline and 12 weeks
measure: 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
timeFrame: Baseline and 12 weeks
measure: Percentage of change from baseline in serum LDL-C (indirect method) level at 12 weeks after the start of study drug administration
timeFrame: Baseline and 12 weeks
measure: Percentage of change from baseline in serum high-density lipoprotein cholesterol (HDL-C) level at 12 weeks after the start of study drug administration
timeFrame: Baseline and 12 weeks
measure: Percentage of change from baseline in serum non HDL-C level at 12 weeks after the start of study drug administration
timeFrame: Baseline and 12 weeks
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Mochida Investigational sites
Study officials:
affiliation: Mochida Pharmaceutical Company, Ltd.
name: Kohichi Hayashi
role: STUDY_DIRECTOR
References: