A Phase III Confirmatory Study of K-877 Extended Release Tablet-A Multicenter, Active Controlled, Randomized, Double Blind, Parallel Group Controlled Trial in Patients with dyslipidemia with high TG-

Kowa Company, Ltd.0 个研究点目标入组 345 人开始时间: 2021年3月3日最近更新: 2024年6月26日

适应症

试验速览

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•(1) Patients with dyslipidemia had to be age 20 years or older at written informed consent
•(2) Patients who have received dietary or exercise guidance from 12 weeks or more prior to Screening
•(3) Patients with the fasting serum TG >= 200 mg/dL twice consecutively at Screening

•(1) Patients with a fasting serum TG > 1000 mg/dL at Screening
•(2) Patients who require administration of prohibited drugs during the clinical trial period after written informed consent
•(3) Patients with uncontrolled thyroid disease
•(4) Patients with type 1 diabetes and uncontrolled diabetes [HbA1c(NGSP) >= 8.0 % at Screening]
•(5) Patients with uncontrolled hypertension (SBP >= 160 mmHg or DBP >= 100 mmHg)
•(6) Patients with an AST or ALT three times the upper limit at Screening
•(7) Patients with an CK five times the upper limit at Screening
•(8) Patients with cirrhosis or those with biliary obstruction
•(9) Patients with acute myocardial infarction within 3 months before obtaining informed consent
•(10) Patients with heart failure class III or higher according to NYHA cardiac function classification

Percent change from baseline in fasting serum TG at 4, 8, and 12 weeks of treatment.

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发起方