Efficacy of Ethyl Icosapentate in Patients With Severe Hypertriglyceridemia

  • STATUS
    Recruiting
  • End date
    May 29, 2022
  • participants needed
    300
  • sponsor
    Mochida Pharmaceutical Company, Ltd.
Updated on 29 August 2021
fasting
serum triglycerides
icosapent ethyl

Summary

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

Details
Condition Hypertriglyceridemia, Hyperlipidemia, High Cholesterol (Hyperlipidemia), Elevated Triglycerides (Hypertriglyceridemia)
Treatment Placebo, Ethyl Icosapentate
Clinical Study IdentifierNCT04239950
SponsorMochida Pharmaceutical Company, Ltd.
Last Modified on29 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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
Patients who receive instructions for lifestyle improvement and are able to comply with all instructions throughout the study participation period
Patients who are 18 to < 75 years of age, regardless of sex, at the time of informed consent
Patients who have provided written consent to participate in this clinical trial
Patients whose serum TG level (fasting) is 500 mg/dL or higher and less than 2,000 mg/dL at Visit 2 (Week -2)
Patients whose serum TG level (fasting) is 500 mg/dL or higher and less than 2,000 mg/dL at Visit 3 (Week -1)
Patients in whom the difference between Visit 2 (Week -2) and Visit 3 (Week -1) in serum TG level (fasting) is not more than 50% of the higher value
Outpatients

Exclusion Criteria

Patients whose HbA1c from week -6 to week -4 is 8.0% or higher
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
Patients with, or with a history of, angina pectoris or myocardial infarction
Patients with a history of percutaneous transluminal coronary angioplasty or coronary artery bypass grafting
Patients with familial lipoprotein lipase (LPL) deficiency, familial apolipoprotein C-II (apo C-II) deficiency, or familial type III, IV hyperlipidemia
Patients with hypothyroidism, Cushing's syndrome, acromegaly, nephrotic syndrome, chronic renal failure, systemic lupus erythematosus, myeloma, or nonalcoholic steatohepatitis (NASH)
Patients with hyperlipidemia induced by drugs (e.g., corticosteroids, beta-blockers, contraceptives, interferons, retinoids, and diuretics)
Patients with, or with a history of, alcohol dependence or abuse or patients whose hyperlipidemia is presumed to be primarily caused by alcohol
Patients with aortic aneurysm or who have undergone aortic aneurysmectomy within the last 6 months
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))
Patients with, or with a history of, pancreatitis or patients suspected as pancreatitis by examination, etc
Patients with a diagnosis of complication of pancreas or bile duct-related neoplastic disease
Patients with type 1 diabetes mellitus or type 2 diabetes mellitus requiring insulin therapy
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
Patients who have taken any EPA product
Patients who have received a PCSK9 (human proprotein convertase subtilisin/kexin type
inhibitor to treat hyperlipidemia
Patients who have taken antihyperlipidemic drugs within the last 4 weeks
Pregnant, possibly pregnant, or lactating women
Patients with a history of hypersensitivity to polyunsaturated fatty acids or gelatin
Patients with, or with a history of, malignant tumor
Patients with any serious disease, including hepatic, renal, hematologic, respiratory, GI, cardiovascular, psychological, neurologic, metabolic, and electrolyte disorders, or hypersensitivity
Patients who have received any other investigational drug within the last 3 months
Patients who are judged by the principal (or sub-) investigator to be ineligible as a study subject for any other reason
Patients with a systolic blood pressure of 180 mmHg or a diastolic blood pressure of 110 mmHg at Visit 2 (Week -2))
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)
Patients with a systolic blood pressure of 180 mmHg or a diastolic blood pressure of 110 mmHg at Visit 3 (Week -1)
Patients with an HbA1c level of 8.0% at Visit 2 (Week -2)
Patients whose ALT or AST is more than 3 times the upper limit of normal at Visit 2 (Week -2)
Patients with a systolic blood pressure of 180 mmHg or a diastolic blood pressure of 110 mmHg at Visit 4 (Week 0)
Patients with an HbA1c level of 8.0% at Visit 3 (Week -1)
Patients whose ALT or AST is more than 3 times the upper limit of normal at Visit 3 (Week -1)
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