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Efficacy of MND-2119 in Participants With Hypertriglyceridemia

Primary Purpose

Hypertriglyceridemia

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Icosapent (MND-2119)
Icosapent (EPADEL CAPSULES 300)
Sponsored by
Mochida Pharmaceutical Company, Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertriglyceridemia

Eligibility Criteria

20 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mochida Investigational sites

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Active Comparator

Arm Label

MND-2119 2 g

MND-2119 4 g

EPADEL CAPSULES 300 1.8 g

EPADEL CAPSULES 300 2.7 g

Arm Description

MND-2119 2 g, orally, once daily after breakfast for 12 weeks.

MND-2119 4 g, orally, once daily after breakfast for 12 weeks.

EPADEL CAPSULES 300 0.9 g, orally, twice daily after breakfast and dinner for 12 weeks.

EPADEL CAPSULES 300 0.9 g, orally, three-times daily after each meal for 12 weeks.

Outcomes

Primary Outcome Measures

Percentage of change from baseline in serum triglyceride level at 12 weeks after the start of study drug administration

Secondary Outcome Measures

Percentage of change from baseline in serum total cholesterol level at 12 weeks after the start of study drug administration
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
Percentage of change from baseline in serum LDL-C (indirect method) level at 12 weeks after the start of study drug administration
Percentage of change from baseline in serum high-density lipoprotein cholesterol (HDL-C) level at 12 weeks after the start of study drug administration
Percentage of change from baseline in serum non HDL-C level at 12 weeks after the start of study drug administration

Full Information

First Posted
September 30, 2018
Last Updated
July 30, 2019
Sponsor
Mochida Pharmaceutical Company, Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03693131
Brief Title
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

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
October 27, 2018 (Actual)
Primary Completion Date
June 15, 2019 (Actual)
Study Completion Date
June 29, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mochida Pharmaceutical Company, Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertriglyceridemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
580 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MND-2119 2 g
Arm Type
Experimental
Arm Description
MND-2119 2 g, orally, once daily after breakfast for 12 weeks.
Arm Title
MND-2119 4 g
Arm Type
Experimental
Arm Description
MND-2119 4 g, orally, once daily after breakfast for 12 weeks.
Arm Title
EPADEL CAPSULES 300 1.8 g
Arm Type
Active Comparator
Arm Description
EPADEL CAPSULES 300 0.9 g, orally, twice daily after breakfast and dinner for 12 weeks.
Arm Title
EPADEL CAPSULES 300 2.7 g
Arm Type
Active Comparator
Arm Description
EPADEL CAPSULES 300 0.9 g, orally, three-times daily after each meal for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Icosapent (MND-2119)
Intervention Description
Icosapent (MND-2119) capsules.
Intervention Type
Drug
Intervention Name(s)
Icosapent (EPADEL CAPSULES 300)
Intervention Description
Icosapent (EPADEL CAPSULES 300) capsules.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kohichi Hayashi
Organizational Affiliation
Mochida Pharmaceutical Company, Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Mochida Investigational sites
City
Tokyo
Country
Japan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Efficacy of MND-2119 in Participants With Hypertriglyceridemia

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