A Phase III Confirmatory Study of K-877 Extended Release Tablet

JRCT ID: jRCT2051200128

Registered date:29/01/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Dyslipidemia
• Date of first enrollment: 03/03/2021
• Target sample size: 345
• Study type: Interventional

Intervention(s)

IR 0.2 mg/day group: oral doses twice daily
ER 0.2 mg/day group: oral doses once daily
ER 0.4 mg/day group: oral doses once daily

Outcome(s)

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(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

Exclude criteria

(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

Related Information

• Primary Sponsor: Tanigawa Ryohei
• Secondary ID(s): NCT04714151