JPRN-jRCT2080224854已完成2 期
A clinical pharmacology study of K-877 controlled release tablet
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •(1) Patients with dyslipidemia had to be age 20 years or older at written informed consent(ICF)
- •(2) Men and postmenopausal women.
- •(3) Patients who have received dietary or exercise guidance from 12 weeks prior to Screening.
- •(4) Patients who have clinical laboratory records with fasting serum TG => 150 mg/dL(or => 200 mg/dL if not fasting)within 6 months before written informed consent.
- •(5) Patients with a fasting serum TG => 150 mg/dL at Screening.
排除标准
- •(1) Patients with a fasting serum TG => 500 mg/dL at Screening
- •(2) Patients who require administration of prohibited drugs during the clinical trial period after written informed consent
- •(3) Patients who have malabsorption or those who have had the history, or who have undergone other surgical procedures that may affect absorption (excluding appendectomy or hernia treatment etc)
- •(4) Patients with uncontrolled thyroid disease
- •(5) Patients with uncontrolled diabetes as defined by a HbA1c(NGSP) => 8.0% at Screening
- •(6) Persons with uncontrolled hypertension (SBP => 160 mmHg or DBP => 100 mmHg)
- •(7) Patients with an AST or ALT three times the upper limit at Screening
- •(8) Patients with cirrhosis or those with biliary obstruction
- •(9) Patients with malignant tumor or those who are judged to have a high risk of recurrence
- •(10) Patients who have collected 400 mL or more of whole blood within 16 weeks, or 200 mL or more of whole blood within 4 weeks, or blood samples (plasma and platelet components) within 2 weeks before Screening
- •(11) Patients with a history of serious drug allergies (anaphylactic shock, etc.)
- •(12) Patients with a history of hypersensitivity to pemafibrate, patients who have stopped taking pemafibrate for reasons of insufficient efficacy or safety
- •(13) Patients who participate in other clinical trials at the time of written informed consent or who have received clinical trials other than placebo for less than 16 weeks
- •(14) Patients who have been determined inappropriate by the investigator or subinvestigator
研究者
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