Efficacy of MND-2119 in Participants With Hypertriglyceridemia

• Status: Completed
• Trial end date: 2019-06-29
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mochida Pharmaceutical Company, Ltd.
• Treatments: Eicosapentaenoic acid ethyl ester

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.