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Long-term Safety and Efficacy Study of MND-2119 in Patients With Hypertriglyceridemia

Primary Purpose

Hypertriglyceridemia

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Icosapent
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 (DAPT).
  7. Participants taking direct oral anticoagulants (DOAC) or warfarin.

Sites / Locations

  • Mochida Investigational sites

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

MND-2119 2g

MND-2119 4g

Arm Description

MND-2119 2 g, orally, once daily after breakfast for 52 weeks.

MND-2119 4 g, orally, once daily after breakfast for 52 weeks.

Outcomes

Primary Outcome Measures

Number of Participants With Adverse Events (AEs)

Secondary Outcome Measures

Number of Participants With Adverse Drug Reactions (ADRs)
Actual Value and Percent Change From Baseline in Triglyceride
Actual Value and Percent Change From Baseline in Total Cholesterol
Actual Value and Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C)
Actual Value and Percent Change From Baseline in High-Density Lipoprotein-Cholesterol (HDL-C)
Actual Value and Percent Change From Baseline in Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C)

Full Information

First Posted
January 6, 2020
Last Updated
August 19, 2021
Sponsor
Mochida Pharmaceutical Company, Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04221217
Brief Title
Long-term Safety and Efficacy Study of MND-2119 in Patients With Hypertriglyceridemia
Official Title
Phase 3 Long-term Study to Evaluate the Safety and Efficacy of MND-2119 in Patients With Hypertriglyceridemia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
February 14, 2020 (Actual)
Primary Completion Date
July 14, 2021 (Actual)
Study Completion Date
July 14, 2021 (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
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

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
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MND-2119 2g
Arm Type
Experimental
Arm Description
MND-2119 2 g, orally, once daily after breakfast for 52 weeks.
Arm Title
MND-2119 4g
Arm Type
Experimental
Arm Description
MND-2119 4 g, orally, once daily after breakfast for 52 weeks.
Intervention Type
Drug
Intervention Name(s)
Icosapent
Intervention Description
Icosapent (MND-2119) capsules.
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Events (AEs)
Time Frame
52 Weeks
Secondary Outcome Measure Information:
Title
Number of Participants With Adverse Drug Reactions (ADRs)
Time Frame
52 Weeks
Title
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
Title
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
Title
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
Title
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
Title
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

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 (DAPT). Participants taking direct oral anticoagulants (DOAC) or warfarin.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Takuya Mori
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

Long-term Safety and Efficacy Study of MND-2119 in Patients With Hypertriglyceridemia

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