Dyslipidemia
Conditions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1)Patients who have been placed on dietary or exercise therapy for 12 weeks or longer prior to the initiation of treatment period (2)men or postmenopausal women (3)20 years or older at the time of informed consent etc
Exclusion criteria
Exclusion criteria: (1)Type 1 diabetes mellitus or poorly controlled Type 2 diabetes mellitus -HbA1c(NGSP): >= 8.0%(at the screening test) (2)Poorly controlled hypertension -SBP: >=160 and/or DBP: >=100 mmHg (at the screening test) (3)Poorly controlled thyroid disorder etc
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy: TG Safety: AE and ADR Efficacy: percent change from baseline Safety: incidence rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy: TC, HDL-C etc. Safety: laboratory tests, vital signs and physical examination Efficacy: percent change from baseline Safety: change in the laboratory tests, vital signs and physical examination | — |