NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT2051200128

Registered date:29/01/2021

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

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedDyslipidemia
Date of first enrollment03/03/2021
Target sample size345
Countries of recruitment
Study typeInterventional
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 OutcomePercent change from baseline in fasting serum TG at 4, 8, and 12 weeks of treatment.
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
GenderBoth
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

Contact

Public contact
Name Contact for clinical trial information -
Address 4-14, Nihonbashi-honcho 3-chome, Chuo-ku, Tokyo Tokyo Japan 103-8433
Telephone +81-3-3279-7454
E-mail ctrdinfo@kowa.co.jp
Affiliation Kowa Company, Ltd.
Scientific contact
Name Ryohei Tanigawa
Address 4-14, Nihonbashi-honcho 3-chome, Chuo-ku, Tokyo Tokyo Japan 103-8433
Telephone +81-3-3279-7454
E-mail ctrdinfo@kowa.co.jp
Affiliation Kowa Company, Ltd.