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

• Status: Completed
• Trial end date: 2021-07-14
• Target enrollment: 0
• Participant gender: All

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.

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

Details

• Lead Sponsor: Mochida Pharmaceutical Company, Ltd.

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 (DAPT).

7. Participants taking direct oral anticoagulants (DOAC) or warfarin.