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
Verified date | July 2019 |
Source | Mochida Pharmaceutical Company, Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to evaluate the efficacy and safety of MND-2119 compared to EPADEL CAPSULES 300 in participants with hypertriglyceridemia.
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. |
Country | Name | City | State |
---|---|---|---|
Japan | Mochida Investigational sites | Tokyo |
Lead Sponsor | Collaborator |
---|---|
Mochida Pharmaceutical Company, Ltd. |
Japan,
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 |
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