Long-term Safety and Efficacy Study of MND-2119 in Patien... | NCT04221217

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

NCT04221217

Sponsor

Mochida Pharmaceutical Company, Ltd.

Status

Completed

Last Update Posted

Aug 23, 2021Actual

Enrollment

120Actual

Phase

Phase 3

Conditions

Hypertriglyceridemia

Interventions

Icosapent

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
JapicCTI	Registry Identifier	JapicCTI-205100

Status Module

Record Verification Date

Sep 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 14, 2020Actual

Primary Completion Date

Jul 14, 2021Actual

Completion Date

Jul 14, 2021Actual

First Submitted Date

Jan 6, 2020

First Submission Date that Met QC Criteria

Jan 6, 2020

First Posted Date

Jan 9, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 19, 2021

Last Update Posted Date

Aug 23, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MND-2119 2g	Experimental	MND-2119 2 g, orally, once daily after breakfast for 52 weeks.	Drug: Icosapent
MND-2119 4g	Experimental	MND-2119 4 g, orally, once daily after breakfast for 52 weeks.	Drug: Icosapent

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Icosapent	Drug	Icosapent (MND-2119) capsules.	MND-2119 2g MND-2119 4g

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Adverse Events (AEs)		52 Weeks

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants With Adverse Drug Reactions (ADRs)		52 Weeks
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participants diagnosed with hypertriglyceridemia.
Participants with values of fasting triglyceride level are 150 mg/dL or higher and less than 500 mg/dL.

Exclusion Criteria:

Participants who have confirmed myocardial infarction and angina pectoris within 6 months.
Participants who have aortic aneurysm or has received aortic aneurysmectomy within 6 months.
Participants with, or with a history of, pancreatitis.
Participants who have a history or complication of a clinically significant hemorrhagic disease within 6 months.
Participants taking both anti-coagulants and anti-platelets.
Participants receiving dual antiplatelet therapy (DAPT).
Participants taking direct oral anticoagulants (DOAC) or warfarin.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

74 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Takuya Mori	Mochida Pharmaceutical Company, Ltd.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mochida Investigational sites		Tokyo			Japan

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015228	Hypertriglyceridemia

Ancestor Terms

ID	Term
D006949	Hyperlipidemias
D050171	Dyslipidemias
D052439	Lipid Metabolism Disorders
D008659	Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015118	Eicosapentaenoic Acid

Ancestor Terms

ID	Term
D015525	Fatty Acids, Omega-3
D004042	Dietary Fats, Unsaturated
D004041	Dietary Fats
D005223	Fats

Browse Leaves

Not provided

Browse Branches

Not provided