A Phase III Long Term Study of K-877 Extended Release Tablet
- Conditions
- Dyslipidemia
- Registration Number
- JPRN-jRCT2031200343
- Lead Sponsor
- Tanigawa Ryohei
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 110
(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
(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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean of % change from baseline in fasting serum TG at the time of final evaluation* and immediately before it<br>* : Week 52 or at discontinuation
- Secondary Outcome Measures
Name Time Method