Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| JapicCTI-184130 | Registry Identifier | JapicCTI |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the efficacy and safety of MND-2119 compared to EPADEL CAPSULES 300 in participants with hypertriglyceridemia.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MND-2119 2 g | Experimental | MND-2119 2 g, orally, once daily after breakfast for 12 weeks. |
|
| MND-2119 4 g | Experimental | MND-2119 4 g, orally, once daily after breakfast for 12 weeks. |
|
| EPADEL CAPSULES 300 1.8 g | Active Comparator | EPADEL CAPSULES 300 0.9 g, orally, twice daily after breakfast and dinner for 12 weeks. |
|
| EPADEL CAPSULES 300 2.7 g | Active Comparator | EPADEL CAPSULES 300 0.9 g, orally, three-times daily after each meal for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Icosapent (MND-2119) | Drug | Icosapent (MND-2119) capsules. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of change from baseline in serum triglyceride level at 12 weeks after the start of study drug administration | Baseline and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of change from baseline in serum total cholesterol level at 12 weeks after the start of study drug administration | Baseline and 12 weeks | |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kohichi Hayashi | Mochida Pharmaceutical Company, Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mochida Investigational sites | Tokyo | Japan |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D015228 | Hypertriglyceridemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D015118 | Eicosapentaenoic Acid |
| C035276 | eicosapentaenoic acid ethyl ester |
| ID | Term |
|---|---|
| D015525 | Fatty Acids, Omega-3 |
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Icosapent (EPADEL CAPSULES 300) |
| Drug |
Icosapent (EPADEL CAPSULES 300) capsules. |
|
| Baseline and 12 weeks |
| 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 |
| 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 |
| 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 |
| D009750 |
| Nutritional and Metabolic Diseases |
| D008055 |
| Lipids |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |