CompletedPhase 3

Efficacy of Ethyl Icosapentate in Patients With Severe Hypertriglyceridemia

China316 participantsStarted 2020-05-09

Plain-language summary

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

Age range18 Years – 74 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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 less than 2,000 mg/dL at Week -2
✓. Patients whose serum TG level (fasting) is less than 2,000 mg/dL at Week -1
✓. 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
✓. Outpatients

✕. 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

Percentage of change from baseline in serum triglyceride level at 12 weeks after the start of study drug administration

Timeframe: Baseline and 12 weeks

Adverse events after the start of study drug administration

Timeframe: 12 weeks

NCT IDNCT04239950

SponsorMochida Pharmaceutical Company, Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-07-20

Who can participate

Age range18 Years – 74 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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 less than 2,000 mg/dL at Week -2
✓. Patients whose serum TG level (fasting) is less than 2,000 mg/dL at Week -1
✓. 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
✓. Outpatients

✕. 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