Efficacy of MND-2119 in Participants With Hypertriglyceridemia

Hypertriglyceridemia Clinical Trial

Official title:

MND-2119 Phase 3 Study to Evaluate the Efficacy and Safety of MND-2119 Compared to EPADEL CAPSULES 300 in Patients With Hypertriglyceridemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03693131
• Other study ID #: MND2119H31
• Secondary ID: JapicCTI-184130
• Status: Completed
• Phase: Phase 3
• Start date: October 27, 2018
• Est. completion date: June 29, 2019

Study information

• Verified date: July 2019
• Source: Mochida Pharmaceutical Company, Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

MND-2119 is a new formulation of Icosapent. This is a phase 3 study to evaluate the efficacy and safety of MND-2119 compared to EPADEL CAPSULES 300 in subjects with hypertriglyceridemia.

The study period is a total of 22 weeks and is comprised of 8 weeks run-in period, 12 weeks treatment period and 2 weeks follow-up period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 580
• Est. completion date: June 29, 2019
• Est. primary completion date: June 15, 2019
• 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.

7. Participants taking direct oral anticoagulants.

Related Conditions & MeSH terms

• Hypertriglyceridemia

Intervention

Drug:
• Icosapent (MND-2119)
Icosapent (MND-2119) capsules.
• Icosapent (EPADEL CAPSULES 300)
Icosapent (EPADEL CAPSULES 300) 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	Percentage of change from baseline in serum triglyceride level at 12 weeks after the start of study drug administration		Baseline and 12 weeks
Secondary	Percentage of change from baseline in serum total cholesterol level at 12 weeks after the start of study drug administration		Baseline and 12 weeks
Secondary	Percentage of change from baseline in serum low-density lipoprotein cholesterol (LDL-C) (direct method) level at 12 weeks after the start of study drug administration		Baseline and 12 weeks
Secondary	Percentage of change from baseline in serum LDL-C (indirect method) level at 12 weeks after the start of study drug administration		Baseline and 12 weeks
Secondary	Percentage of change from baseline in serum high-density lipoprotein cholesterol (HDL-C) level at 12 weeks after the start of study drug administration		Baseline and 12 weeks
Secondary	Percentage of change from baseline in serum non HDL-C level at 12 weeks after the start of study drug administration		Baseline and 12 weeks