A Phase III Long Term Study of K-877 Extended Release Tablet

JRCT ID: jRCT2031200343

Registered date:05/02/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Dyslipidemia
• Date of first enrollment: 26/02/2021
• Target sample size: 110
• Study type: Interventional

Intervention(s)

ER 0.2 mg/day morning administration group: oral doses once daily in the morning (If the efficacy is insufficient, increase the dose to 0.4 mg/day)
ER 0.4 mg/day evening administration group: oral doses once daily in the evening (If the efficacy is insufficient, increase the dose to 0.4 mg/day)

Outcome(s)

Primary Outcome

Mean of % change from baseline in fasting serum TG at the time of final evaluation* and immediately before it
* : Week 52 or at discontinuation

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 >= 150 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) >= 10.0 % 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