NCT04716595已完成3 期
A Phase III Long Term Study of K-877 Extended Release Tablet-A Multicenter, Randomized, Open Label, Parallel Group Trial in Patients With Dyslipidemia With High TG-
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 121
- 试验地点
- 14
- 主要终点
- Efficacy : Mean of percent change from baseline in fasting serum TG (mg/dL) at the time of final evaluation* and immediately before it * : Week 52 or at discontinuation
研究概览
简要总结
To investigate the safety and efficacy of K-877 Extended Release (ER) once daily for 52 weeks in the morning or evening in dyslipidema.The starting dose of the ER tablet will be 0.2 mg/day. If the efficacy is insufficient, it will investigate the safety and efficacy of 0.4 mg/day.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with dyslipidemia had to be age 20 years or older at written informed consent
- •Patients who have received dietary or exercise guidance from 12 weeks or more prior to Screening
- •Patients with the fasting serum TG >= 150 mg/dL twice consecutively at Screening
排除标准
- •Patients with a fasting serum TG > 1000 mg/dL at Screening
- •Patients who require administration of prohibited drugs during the clinical trial period after written informed consent
- •Patients with uncontrolled thyroid disease
- •Patients with type 1 diabetes and uncontrolled diabetes [HbA1c(NGSP) >= 10.0 % at Screening]
- •Patients with uncontrolled hypertension (SBP >= 160 mmHg or DBP >= 100 mmHg)
- •Patients with an AST or ALT three times the upper limit at Screening
- •Patients with an CK five times the upper limit at Screening
- •Patients with cirrhosis or those with biliary obstruction
- •Patients with acute myocardial infarction within 3 months before obtaining informed consent
- •Patients with heart failure class III or higher according to NYHA cardiac function classification
- •Patients with malignant tumor or those who are judged to have a high risk of recurrence
- •Patients with a history of serious drug allergies (anaphylactic shock, etc.)
- •Pregnant women, lactating women, women planning to become pregnant or lactating during the study period, or pregnant women who do not use specific contraceptive methods
- •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
- •Patients who have received K-877 (pemafibrate)
- •Patients who participate in other clinical trials at the time of written informed consent and who received medication or who have received clinical trials other than placebo for less than 16 weeks
- •Patients who have been determined inappropriate by the investigator, etc
研究组 & 干预措施
morning administration
Experimental
K-877 ER 0.2 mg/day morning administration (once daily)
干预措施: K-877 ER 0.2 mg/day morning administration (once daily) (Drug)
evening administration
Experimental
K-877 ER 0.2 mg/day evening administration (once daily)
干预措施: K-877 ER 0.2 mg/day evening administration (once daily) (Drug)
结局指标
主要结局
Efficacy : Mean of percent change from baseline in fasting serum TG (mg/dL) at the time of final evaluation* and immediately before it * : Week 52 or at discontinuation
时间窗: Final evaluation (Week 52 or at discontinuation) and immediately before it
次要结局
- Efficacy : Mean of percent change from baseline in fasting serum Total Cholesterol (mg/dL) at the time of final evaluation* and immediately before it * : Week 52 or at discontinuation(Final evaluation (Week 52 or at discontinuation) and immediately before it)
- Efficacy : Mean of percent change from baseline in fasting serum LDL-C (mg/dL) at the time of final evaluation* and immediately before it * : Week 52 or at discontinuation(Final evaluation (Week 52 or at discontinuation) and immediately before it)
- Efficacy : Mean of percent change from baseline in fasting serum HDL-C (mg/dL) at the time of final evaluation* and immediately before it * : Week 52 or at discontinuation(Final evaluation (Week 52 or at discontinuation) and immediately before it)
- Efficacy : Mean of percent change from baseline in fasting serum non-HDL-C (mg/dL) at the time of final evaluation* and immediately before it * : Week 52 or at discontinuation(Final evaluation (Week 52 or at discontinuation) and immediately before it)
研究者
研究点 (14)
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