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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03929198 -
Translation of Pritikin Program to the Community
|
N/A | |
Completed |
NCT02250105 -
Trial of ARI-3037MO to Reduce Triglyceride Levels in Adults With Severe (≥500 mg/dl) Hypertriglyceridemia
|
Phase 2 | |
Completed |
NCT02859129 -
Study to Evaluate the 2-Way Interaction Between Multiple Doses of Epanova™ and a Single Dose of Rosuvastatin (Crestor®)
|
Phase 1 | |
Completed |
NCT01455844 -
TRIal For Efficacy of Capre on hyperTriglyceridemiA
|
Phase 2 | |
Completed |
NCT01437930 -
Intervention With n-3 Polyunsaturated Fatty Acids (PUFA)-Supplemented Products in Moderate Hypertriglyceridemic Patients
|
N/A | |
Completed |
NCT01010399 -
Boosted Lexiva With Lovaza Adjunctive Therapy in Hypertriglyceridemic, HIV-Infected Subjects
|
Phase 4 | |
Completed |
NCT00959842 -
Effects of Lovaza on Lipoprotein Composition and Function in Mild Hypertriglyceridemia
|
Phase 1/Phase 2 | |
Completed |
NCT00519714 -
A Study to Evaluate the Lipid Regulating Effects of 1-Methylnicotinamide (1-MNA)
|
Phase 2/Phase 3 | |
Recruiting |
NCT00186537 -
Comparing Tricor, Avandia, or Weight Loss to Lower Cardiovascular Risk Factors in People With High Triglycerides.
|
N/A | |
Completed |
NCT00246402 -
Acipimox to Improve Hyperlipidemia and Insulin Sensitivity Associated With HIV
|
N/A | |
Completed |
NCT06020950 -
Chia Seeds Consumption in Hypertriglyceridemia
|
N/A | |
Completed |
NCT02354976 -
A Double-blind Randomized Placebo-controlled Study Comparing Epanova and Fenofibrate on Liver Fat in Overweight Subjects.
|
Phase 2 | |
Completed |
NCT04966494 -
Impact of Beans and Oats Snack Bar on Hypertriglyceridemic Women
|
N/A | |
Completed |
NCT04650152 -
Study to Assess Tricor Therapy Effectiveness in Patients With Metabolic Syndrome (TRISTAN)
|
||
Completed |
NCT04630366 -
A Phase 1, First Time in Humans Study of NST-1024
|
Phase 1 | |
Completed |
NCT02868177 -
Effect of Totum-63, Active Ingredient of Valedia, on Glucose and Lipid Homeostasis on Subjects With Prediabetes
|
Phase 2/Phase 3 | |
Completed |
NCT04756180 -
An Efficacy and Safety Study of Omega-3-acid Ethyl Ester in Chinese Subjects With Hypertriglyceridemia.
|
Phase 3 | |
Completed |
NCT01968720 -
Pilot Study To Assess CAT-2003 in Patients With Severe Hypertriglyceridemia
|
Phase 2 | |
Completed |
NCT01462877 -
A Study to Evaluate Fenofibrate Combination With Statin in Chinese Patients With Dyslipidemic
|
Phase 4 | |
Completed |
NCT01211847 -
Efficacy Study of Diazoxide Choline to Treat Hypertriglyceridemia
|
Phase 2 |