Trials / Completed
CompletedNCT03693131
Efficacy of MND-2119 in Participants With Hypertriglyceridemia
MND-2119 Phase 3 Study to Evaluate the Efficacy and Safety of MND-2119 Compared to EPADEL CAPSULES 300 in Patients With Hypertriglyceridemia
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 580 (actual)
- Sponsor
- Mochida Pharmaceutical Company, Ltd. · Industry
- Sex
- All
- Age
- 20 Years – 74 Years
- Healthy volunteers
- Not accepted
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.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Icosapent (MND-2119) | Icosapent (MND-2119) capsules. |
| DRUG | Icosapent (EPADEL CAPSULES 300) | Icosapent (EPADEL CAPSULES 300) capsules. |
Timeline
- Start date
- 2018-10-27
- Primary completion
- 2019-06-15
- Completion
- 2019-06-29
- First posted
- 2018-10-02
- Last updated
- 2019-08-01
Locations
1 site across 1 country: Japan
Source: ClinicalTrials.gov record NCT03693131. Inclusion in this directory is not an endorsement.