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Efficacy of MND-2119 in Participants With Hypertriglyceridemia

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ClinicalTrials.gov Identifier: NCT03693131
Recruitment Status : Recruiting
First Posted : October 2, 2018
Last Update Posted : November 1, 2018
Sponsor:
Information provided by (Responsible Party):
Mochida Pharmaceutical Company, Ltd.

Brief 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.

Condition or disease Intervention/treatment Phase
Hypertriglyceridemia Drug: Icosapent (MND-2119) Drug: Icosapent (EPADEL CAPSULES 300) Phase 3

Detailed 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 580 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : October 27, 2018
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Triglycerides

Arm Intervention/treatment
Experimental: MND-2119 2 g
MND-2119 2 g, orally, once daily after breakfast for 12 weeks.
Drug: Icosapent (MND-2119)
Icosapent (MND-2119) capsules.

Experimental: MND-2119 4 g
MND-2119 4 g, orally, once daily after breakfast for 12 weeks.
Drug: Icosapent (MND-2119)
Icosapent (MND-2119) capsules.

Active Comparator: EPADEL CAPSULES 300 1.8 g
EPADEL CAPSULES 300 0.9 g, orally, twice daily after breakfast and dinner for 12 weeks.
Drug: Icosapent (EPADEL CAPSULES 300)
Icosapent (EPADEL CAPSULES 300) capsules.

Active Comparator: EPADEL CAPSULES 300 2.7 g
EPADEL CAPSULES 300 0.9 g, orally, three-times daily after each meal for 12 weeks.
Drug: Icosapent (EPADEL CAPSULES 300)
Icosapent (EPADEL CAPSULES 300) capsules.




Primary Outcome Measures :
  1. Percentage of change from baseline in serum triglyceride level at 12 weeks after the start of study drug administration [ Time Frame: Baseline and 12 weeks ]

Secondary Outcome Measures :
  1. Percentage of change from baseline in serum total cholesterol level at 12 weeks after the start of study drug administration [ Time Frame: Baseline and 12 weeks ]
  2. 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 [ Time Frame: Baseline and 12 weeks ]
  3. Percentage of change from baseline in serum LDL-C (indirect method) level at 12 weeks after the start of study drug administration [ Time Frame: Baseline and 12 weeks ]
  4. Percentage of change from baseline in serum high-density lipoprotein cholesterol (HDL-C) level at 12 weeks after the start of study drug administration [ Time Frame: Baseline and 12 weeks ]
  5. Percentage of change from baseline in serum non HDL-C level at 12 weeks after the start of study drug administration [ Time Frame: Baseline and 12 weeks ]


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Ages Eligible for Study:   20 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03693131


Contacts
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Contact: Kazuki Furuno +81-3-3225-6332 kazuki.furuno@mochida.co.jp

Locations
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Japan
Mochida Investigational sites Recruiting
Tokyo, Japan
Sponsors and Collaborators
Mochida Pharmaceutical Company, Ltd.
Investigators
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Study Director: Kazuki Furuno Mochida Pharmaceutical Company, Ltd.

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Responsible Party: Mochida Pharmaceutical Company, Ltd.
ClinicalTrials.gov Identifier: NCT03693131     History of Changes
Other Study ID Numbers: MND2119H31
JapicCTI-184130 ( Registry Identifier: JapicCTI )
First Posted: October 2, 2018    Key Record Dates
Last Update Posted: November 1, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Hypertriglyceridemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Eicosapentaenoic acid ethyl ester
Platelet Aggregation Inhibitors