臨床研究等提出・公開システム

HMG-CoA還元酵素阻害薬投与中で高トリグリセライド血症を併せ持つ患者に、オメガ-3脂肪酸エチル2g（分1）又は4g（分2）を8週間投与し、血管内皮機能に及ぼす影響をFMD検査を用いて探索的に検討する多施設共同、無作為化、非盲検試験である。 投与群間でのFMDに影響を与える因子による偏りを考慮し、空腹時TG値を因子とする層別割付を行う。

This is a multicenter, collaborative, randomized, open-label study designed to explore the effects of administration of omega-3-acid ethyl esters [2 g (2 g PO QD) or 4 g (2 g PO BID) for 8 weeks] on vascular endothelial function, as measured by flow-mediated dilation (FMD), in patients receiving a hydroxymethylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor and have concurrent hypertriglyceridemia (hereinafter referred to as TG). Considering the potential bias by factors that affect FMD between treatment groups, stratified allocation will be performed with fasting TG level as a factor.

1. 高脂血症と診断され、生活習慣の改善指導を受けているもの
2. 同意取得後Visit1（被験薬投与開始前-29日～-1日）に測定したTG値（空腹時）が150 mg/dL以上500 mg/dL未満のもの
3. 同意取得時Visit1（被験薬投与開始前-29日～-1日）前4週間以上継続してHMG-CoA還元酵素阻害薬を一定の用法・用量で服用しているもの
4. 男性又は閉経後女性
5. 臨床研究の内容を理解し、それを遵守する能力があると研究責任者又は研究者が判断したもの
6. 臨床研究手順が行われる前に、文書により同意が得られるもの
7. 同意取得時Visit1（被験薬投与開始前-29日～-1日）の年齢が20歳以上であるもの

1. Patients with the diagnosis of hyperlipidemia and receiving instructions for lifestyle improvement
2. Patients with a fasting triglyceride (TG) level of 150 -499 mg/dL at Visit 1 after informed consent (Day -29 to Day -1 before start of study drug administration)
3. Patients receiving a stable dose of HMG-CoA reductase inhibitor therapy continuously for at least 4 weeks before informed consent at Visit 1 (Day -29 to Day -1 before start of study drug administration)
4. Male or postmenopausal female patients
5. Patients who, in the opinion of the principal investigator or the investigator, are capable of understanding the content of the clinical research and complying with the research protocol requirements.
6. Patients who can provide written informed consent prior to the conduction of the clinical research procedures
7. Patients aged >=20 years at the time of informed consent at Visit 1(Day -28 to Day 0 before the start of study drug administration)

1. 血管再開通術の既往歴があるもの又は、同意取得時Visit1（被験薬投与開始前-29日～-1日）前24週以内に冠動脈疾患（確定診断された心筋梗塞、狭心症）を発症したもの
2. 同意取得時Visit1（被験薬投与開始前-29日～-1日）前24週以内に大動脈瘤切除術を実施したもの又は大動脈瘤を合併しているもの
3. 同意取得時Visit1（被験薬投与開始前-29日～-1日）前24週以内に臨床上問題のある出血性の疾患（例：血友病、毛細血管脆弱病、消化管潰瘍、尿路出血、喀血、硝子体出血等）を発症したもの又は合併があるもの
4. 被験薬投与開始時Visit2（被験薬投与開始前-15日～-1日）に測定したFMD検査（空腹時）の値が0%のもの
5. 同意取得時Visit1（被験薬投与開始前-29日～-1日）前4週以内にHMG-CoA還元酵素阻害薬、糖尿病治療薬及び高血圧治療薬の種類及び用法用量を変更したもの
6. 同意取得時Visit1（被験薬投与開始前-29日～-1日）前4週以内に脂質異常症治療薬の投与を開始したもの
7. 同意取得時Visit1（被験薬投与開始前-29日～-1日）から被験薬投与開始時Visit2（被験薬投与開始前-15日～-1日）の間に脂質異常症治療薬、糖尿病治療薬、高血圧治療薬の用量の変更を必要とするもの
8. 重度の肝機能障害のあるもの
9. 高度腎機能障害のあるもの（目安としてCKD分類G3b以上、A3に該当）
10. これまでに膵炎と診断された事があるもの
11. これまでにリポ蛋白リパーゼ欠損症、アポ蛋白C-II欠損症、家族性高コレステロール血症、家族性複合型高脂血症、家族性III型高脂血症と診断された事があるもの
12. クッシング症候群、尿毒症、SLE（全身性エリテマトーデス）、血清蛋白異常症、甲状腺機能低下症を合併しているもの
13. 症候性のPeripheral Arterial Disease（末梢動脈疾患）を有するもの
14. II度以上の高血圧を合併しているもの注1）
注1：降圧薬投与の有無にかかわらず収縮期血圧が160 mmHg以上、又は拡張期血圧が100 mmHg以上のもの
15. アルコール量換算で1日平均100 mLを超える程度の飲酒を常習とするもの又は薬物の濫用、依存症並びにそれらの既往のあるもの注2）
16. オメガ-3脂肪酸エチルに対して過敏症又はアレルギーの既往があるもの
17. 喫煙者
18. 他の臨床試験に参加しているもの
19. その他、研究責任者又は研究者が当該臨床研究の研究対象者として不適当と判断したもの

1. Patients with a history of revascularization or those have had coronary artery disease (a definitive diagnosis of myocardial infarction, angina) within 24 weeks before informed consent at Visit 1 (Day -29 to Day -1 before the start of study drug administration)
2. Patients who have undergo aortic aneurysmectomy within 24 weeks prior to informed consent at Visit 1 (Day -29 to Day -1 before the start of study drug administration) or those with concurrent aortic aneurysm
3. Patients who have had clinically significant hemorrhagic disorders (e.g., hemophilia, capillary fragility, gastrointestinal ulcer, urinary tract hemorrhage, hemoptysis, and vitreous hemorrhage) within 24 weeks prior to informed consent at Visit 1 (Day -29 to Day -1 before the start of study drug administration) or those who concurrently have the above disorders
4. Patient with a fasting FMD level of 0% measured at the start of study drug administration at Visit 2 (Day -15 to Day -1 before the start of study drug administration)
5. Patients in whom the type and dosage of HMG-CoA reductase inhibitors, antidiabetic drugs and antihypertensive drugs have been changed within 4 weeks prior to informed consent at Visit 1 (Day -29 to Day -1 before the start of study drug administration)
6. Patients who have started anti dyslipidemic agents within 4 weeks prior to informed consent at Visit 1 (Day -29 to Day -1 before the start of study drug administration)
7. Patients requiring a change in the dose of dyslipidemia therapeutic, antidiabetic, or antihypertensive drugs during the period between informed consent at Visit 1 (Day -29 to Day -1 before the start of study drug administration) and the start of study drug administration at Visit 2 (Day -15 to Day -1 before the start of study drug administration)
8. Patients with severe hepatic dysfunction
9. Patients with severe renal dysfunction (as an indicator, CKD category >=G3b, equivalent to an A3)
10. Patients who have been diagnosed with pancreatitis
11. Patients who have been diagnosed with lipoprotein lipase deficiency, apoprotein C-II deficiency, familial hypercholesterolemia, familial combined hyperlipidemia, or familial type III hyperlipidemia
12. Patients with concurrent Cushing's syndrome, uremia, systemic lupus erythematosus (SLE), serum dysproteinemia, or hypothyroidism
13. Patients with symptomatic Peripheral Arterial Disease (PAD)
14. Patients with concurrent hypertension of grade II or higher Note 1)
Note 1: Patients with systolic blood pressure of >=160 mm Hg or diastolic BP of >=100 mm Hg regardless of treatment with antihypertensive drugs
15. Patients who are habitual drinkers drinking an average of over 100 mL per day (expressed in terms of quantity of alcohol) or patients with, or with a history of drug abuse or addiction Note 2)
16. Patients with a history of hypersensitivity or allergy for omega-3-acid ethyl esters-
17. Patients who smoke
18. Patients participating in other clinical studies
19. Patients who have been determined to be ineligible as subjects in the study by the principal investigator or the investigator

20歳以上

20age old over

上限なし

No limit

男性・女性

Both

試験完了

completed