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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04239950
Other study ID # MND2112H33
Secondary ID 20191474
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date May 9, 2020
Est. completion date December 2023

Study information

Verified date July 2023
Source Mochida Pharmaceutical Company, Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of ethyl icosapentate in Chinese patients with severe hypertriglyceridemia.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 300
Est. completion date December 2023
Est. primary completion date December 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 74 Years
Eligibility Inclusion Criteria 1. Patients whose serum Triglyceride (TG) level (fasting) from week -6 to week -4 is 500 mg/dL or higher and less than 2,000 mg/dL 2. Patients who receive instructions for lifestyle improvement and are able to comply with all instructions throughout the study participation period 3. Patients who are 18 to < 75 years of age, regardless of sex, at the time of informed consent 4. Patients who have provided written consent to participate in this clinical trial 5. Patients whose serum TG level (fasting) is less than 2,000 mg/dL at Week -2 6. Patients whose serum TG level (fasting) is less than 2,000 mg/dL at Week -1 7. Patients in whom the average of Week -2 and Week -1 in serum TG level (fasting) is 500 mg/dL or higher and less than 2,000 mg/dL 8. Outpatients Exclusion Criteria: 1. Patients whose HbA1c from week -6 to week -4 is 8.0% or higher 2. Patients whose Alanine Aminotransferase (ALT) or Aspartate aminotransferase (AST) from week -6 to week -4 is more than 3 times the upper limit of normal 3. Patients with, or with a history of, angina pectoris or myocardial infarction 4. Patients with a history of percutaneous transluminal coronary angioplasty or coronary artery bypass grafting 5. Patients with familial lipoprotein lipase (LPL) deficiency, familial apolipoprotein C-II (apo C-II) deficiency, or familial type III, IV hyperlipidemia 6. Patients with hypothyroidism, Cushing's syndrome, acromegaly, nephrotic syndrome, chronic renal failure, systemic lupus erythematosus, myeloma, or nonalcoholic steatohepatitis (NASH) 7. Patients with hyperlipidemia induced by drugs (e.g., corticosteroids, beta-blockers, contraceptives, interferons, retinoids, and diuretics) 8. Patients with, or with a history of, alcohol dependence or abuse or patients whose hyperlipidemia is presumed to be primarily caused by alcohol 9. Patients with aortic aneurysm or who have undergone aortic aneurysmectomy within the last 6 months 10. Patients with uncontrollable hypertension (patients with a systolic blood pressure of =180 mmHg or a diastolic blood pressure of =110 mmHg in a sitting position at Visit 1 (Week -4)) 11. Patients with, or with a history of, pancreatitis or patients suspected as pancreatitis by examination, etc 12. Patients with a diagnosis of complication of pancreas or bile duct-related neoplastic disease 13. Patients with type 1 diabetes mellitus or type 2 diabetes mellitus requiring insulin therapy 14. Patients with any of the following hemorrhagic findings within the last 6 months: - Patients with, or with a history of, clinically significant hemorrhagic disease (e.g., cerebral hemorrhage, hemophilia, capillary fragility, gastrointestinal [GI] ulcer, urinary tract hemorrhage, hemoptysis, vitreous hemorrhage) - Patients with clinically significant bleeding tendency (e.g., menorrhagia, frequent epistaxis) - Patients with, or with a history of, severe trauma - Patients with a history of surgery requiring blood transfusion 15. Patients who have taken any EPA product 16. Patients who have received a PCSK9 (human proprotein convertase subtilisin/kexin type 9) inhibitor to treat hyperlipidemia 17. Patients who have taken antihyperlipidemic drugs within the last 4 weeks 18. Pregnant, possibly pregnant, or lactating women 19. Patients with a history of hypersensitivity to polyunsaturated fatty acids or gelatin 20. Patients with, or with a history of, malignant tumor 21. Patients with any serious disease, including hepatic, renal, hematologic, respiratory, GI, cardiovascular, psychological, neurologic, metabolic, and electrolyte disorders, or hypersensitivity 22. Patients who have received any other investigational drug within the last 3 months 23. Patients who are judged by the principal (or sub-) investigator to be ineligible as a study subject for any other reason 24. Patients with a systolic blood pressure of =180 mmHg or a diastolic blood pressure of =110 mmHg at Visit 2 (Week -2)) 25. Patients who have changed the dosage of antidiabetic drug (except insulin) or who have switched from one drug to another since Visit 1 (Week -4) 26. Patients with a systolic blood pressure of =180 mmHg or a diastolic blood pressure of =110 mmHg at Visit 3 (Week -1) 27. Patients with an HbA1c level of =8.0% at Visit 2 (Week -2) 28. Patients whose ALT or AST is more than 3 times the upper limit of normal at Visit 2 (Week -2) 29. Patients with a systolic blood pressure of =180 mmHg or a diastolic blood pressure of =110 mmHg at Visit 4 (Week 0) 30. Patients with an HbA1c level of =8.0% at Visit 3 (Week -1) 31. Patients whose ALT or AST is more than 3 times the upper limit of normal at Visit 3 (Week -1)

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Placebo
Placebo
Ethyl Icosapentate
Ethyl Icosapentate

Locations

Country Name City State
China Mochida Investigational sites Changsha

Sponsors (2)

Lead Sponsor Collaborator
Mochida Pharmaceutical Company, Ltd. Sumitomo Pharma (Suzhou) Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

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
Primary Adverse events after the start of study drug administration 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) 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 Adverse drug reaction after the start of study drug administration 12 weeks
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