Complex-dyslipidemia
Conditions
Brief summary
The purpose of this study is to evaluate the efficacy and safety of Pitavastatin versus Pitavastatin/Fenofibrate in complex-dyslipidemia patients.
Detailed description
The purpose of this study is to demonstrate the efficacy of the Pitavastatin/Fenofibrate in complex-dyslipidemia patients by the reduction of non-HDL-Cholesterol levels compared with Pitavastatin.
Interventions
DRUGHL-PIF cap.160/2mg + Placebo
Fenofibrate pellet (as micronized fenofibrate 160mg) and Pitavastatin Ca 2mg
DRUGLivalo tab. 2mg + Placebo
Pitavastatin ca 2mg
Sponsors
Hanlim Pharm. Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* High risk patient to Coronary Heart Disease * At visit 1(Screening) 1. If treated with Pitavastatin 2mg monotherapy 4 weeks prior to this study : LDL-C\<100mg/dL and 150mg/dL≤TG\<500mg/dL, randomize without run-in period 2. If non treated with Pitavastatin 2mg monotherapy 4 weeks prior to this study : LDL-C≥100mg/dL and 150mg/dL≤TG\<500mg/dL, treatment of Pitavastatin 2mg for 4 weeks(run-in period) * LDL-C\<100mg/dL and 150mg/dL≤TG\<500mg/dL after 4 weeks of Pitavastatin 2mg monotherapy
Exclusion criteria
* Subject with acute artery disease * Subject with congestive heart failure(NYHA class III\ IV) or uncontrolled arrhythmia * Secondary or iatrogenic dyslipidemia caused by hypothyroidism, nephrotic syndrome etc. * AST or ALT \> 2XULN, Serum Creatinine \> 2.5mg/dL, Creatinine phosphokinase \> 2XULN * Subject with gall bladder disease or pancreatitis * Uncontrolled hypertension * Endocrine or metabolic disease affected on serum lipid or liprotein * Subject with medical history of myopathy or rhabdomyolysis caused by Statin treatment, hereditary myopathy or family history * Not eligible to participate for the study at the discretion of investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The mean percentage change of Non-HDL Cholesterol | from baseline at week 8 | Change rate of Non-HDL-C after 8 weeks compared to baseline (%) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The mean percentage change of LDL-C | from baseline at week 4,8 | Change rate of LDL-C after 4 and 8 weeks compared to baseline (%) |
| The mean percentage change of HDL-C | from baseline at week 4,8 | Change rate of HDL-C after 4 and 8 weeks compared to baseline (%) |
| The mean percentage change of LDL-C/HDL-C | from baseline at week 4,8 | Change rate of LDL-C/HDL-C after 4 and 8 weeks compared to baseline (%) |
| The mean percentage change of TC/HDL-C | from baseline at week 4,8 | Change rate of TC/HDL-C after 4 and 8 weeks compared to baseline (%) |
| The mean percentage change of non-HDL-C/HDL-C | from baseline at week 4,8 | Change rate of non-HDL-C/HDL-C after 4 and 8 weeks compared to baseline (%) |
| The mean percentage change of VLDL-C | from baseline at week 4,8 | Change rate of VLDL-C after 4 and 8 weeks compared to baseline (%) |
| The mean percentage change of TG | from baseline at week 4,8 | Change rate of TG after 4 and 8 weeks compared to baseline (%) |
| The mean percentage change of Non-HDL Cholesterol | from baseline at week 4 | Change rate of Non-HDL-C after 4 weeks compared to baseline (%) |
| The mean percentage change of Apo Al | from baseline at week 4,8 | Change rate of Apo Al after 4 and 8 weeks compared to baseline (%) |
| The mean percentage change of Apo B | from baseline at week 4,8 | Change rate of Apo B change after 4 and 8 weeks compared to baseline (%) |
| The mean percentage change of Apo Al/Apo B | from baseline at week 4,8 | Change rate of Apo Al/Apo B after 4 and 8 weeks compared to baseline (%) |
| The mean percentage change of fibrinogen | from baseline at week 4,8 | Change rate of fibrinogen after 4 and 8 weeks compared to baseline (%) |
| The mean percentage change of hs-CRP | from baseline at week 4,8 | Change rate of hs-CRP after 4 and 8 weeks compared to baseline (%) |
| Achievement rate(%) of treatment goals after 4 weeks and 8 weeks | from baseline at week 4,8 | LDL-C\<100mg/dL & non-HDL-C \<130mg/dL |
| The mean percentage change of TC | from baseline at week 4,8 | Change rate of TC after 4 and 8 weeks compared to baseline (%) |
Outcome results
None listed