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NCT04221217 Clinical Trial

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

Hypertriglyceridemia Clinical Trial

Official title:
Phase 3 Long-term Study to Evaluate the Safety and Efficacy of MND-2119 in Patients With Hypertriglyceridemia

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04221217
Other study ID # MND2119H41
Secondary ID JapicCTI
Status Completed
Phase Phase 3
First received
Last updated
Start date February 14, 2020
Est. completion date July 14, 2021

Study information
Verified date September 2020
Source Mochida Pharmaceutical Company, Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 120
Est. completion date July 14, 2021
Est. primary completion date July 14, 2021
Accepts healthy volunteers No
Gender All
Age group 20 Years to 74 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Icosapent
Icosapent (MND-2119) capsules.

Locations
Country Name City State
Japan Mochida Investigational sites Tokyo

Sponsors (1)
Lead Sponsor Collaborator
Mochida Pharmaceutical Company, Ltd.

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Participants With Adverse Events (AEs) 52 Weeks
Secondary Number of Participants With Adverse Drug Reactions (ADRs) 52 Weeks
Secondary Actual Value and Percent Change From Baseline in Triglyceride Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Secondary Actual Value and Percent Change From Baseline in Total Cholesterol Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Secondary Actual Value and Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Secondary Actual Value and Percent Change From Baseline in High-Density Lipoprotein-Cholesterol (HDL-C) Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Secondary Actual Value and Percent Change From Baseline in Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
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