Long-term Safety and Efficacy Study of MND-2119 in Patients With Hypertriglyceridemia
NCT ID: NCT04221217
Last Updated: 2021-08-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
120 participants
INTERVENTIONAL
2020-02-14
2021-07-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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MND-2119 2g
MND-2119 2 g, orally, once daily after breakfast for 52 weeks.
Icosapent
Icosapent (MND-2119) capsules.
MND-2119 4g
MND-2119 4 g, orally, once daily after breakfast for 52 weeks.
Icosapent
Icosapent (MND-2119) capsules.
Interventions
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Icosapent
Icosapent (MND-2119) capsules.
Eligibility Criteria
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Inclusion Criteria
2. Participants with values of fasting triglyceride level are 150 mg/dL or higher and less than 500 mg/dL.
Exclusion Criteria
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.
20 Years
74 Years
ALL
No
Sponsors
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Mochida Pharmaceutical Company, Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Takuya Mori
Role: STUDY_DIRECTOR
Mochida Pharmaceutical Company, Ltd.
Locations
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Mochida Investigational sites
Tokyo, , Japan
Countries
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Other Identifiers
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JapicCTI
Identifier Type: REGISTRY
Identifier Source: secondary_id
MND2119H41
Identifier Type: -
Identifier Source: org_study_id
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