JRCT ID: jRCT2051200128
Registered date:29/01/2021
A Phase III Confirmatory Study of K-877 Extended Release Tablet
Basic Information
Recruitment status | Complete |
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Health condition(s) or Problem(s) studied | Dyslipidemia |
Date of first enrollment | 03/03/2021 |
Target sample size | 345 |
Countries of recruitment | |
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. |
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Secondary Outcome |
Key inclusion & exclusion criteria
Age minimum | >= 20age old |
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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 |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) | NCT04714151 |
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 |
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 |
ctrdinfo@kowa.co.jp | |
Affiliation | Kowa Company, Ltd. |