Efficacy of MND-2119 in Participants With Hypertriglyceridemia

M

Mochida Pharmaceutical

Status and phase

Completed
Phase 3

Conditions

Hypertriglyceridemia

Treatments

Drug: Icosapent (EPADEL CAPSULES 300)
Drug: Icosapent (MND-2119)

Study type

Interventional

Funder types

Industry

Identifiers

NCT03693131
MND2119H31
JapicCTI-184130 (Registry Identifier)

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of MND-2119 compared to EPADEL CAPSULES 300 in participants with hypertriglyceridemia.

Full 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.

Enrollment

580 patients

Sex

All

Ages

20 to 74 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

580 participants in 4 patient groups

MND-2119 2 g
Experimental group
Description:
MND-2119 2 g, orally, once daily after breakfast for 12 weeks.
Treatment:
Drug: Icosapent (MND-2119)
MND-2119 4 g
Experimental group
Description:
MND-2119 4 g, orally, once daily after breakfast for 12 weeks.
Treatment:
Drug: Icosapent (MND-2119)
EPADEL CAPSULES 300 1.8 g
Active Comparator group
Description:
EPADEL CAPSULES 300 0.9 g, orally, twice daily after breakfast and dinner for 12 weeks.
Treatment:
Drug: Icosapent (EPADEL CAPSULES 300)
EPADEL CAPSULES 300 2.7 g
Active Comparator group
Description:
EPADEL CAPSULES 300 0.9 g, orally, three-times daily after each meal for 12 weeks.
Treatment:
Drug: Icosapent (EPADEL CAPSULES 300)

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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