A Clinical Trial to Evaluate the Efficacy and Safety of Pitavastatin/Fenofibrate in Complex-dyslipidemia
- Conditions
- Complex-dyslipidemia
- Interventions
- Drug: HL-PIF cap.160/2mg + Placebo
- Registration Number
- NCT03618797
- Lead Sponsor
- Hanlim Pharm. Co., Ltd.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 347
-
High risk patient to Coronary Heart Disease
-
At visit 1(Screening)
- 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
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description HL-PIF cap.160/2mg + Placebo HL-PIF cap.160/2mg + Placebo * Fenofibrate pellet (as micronized fenofibrate 160mg) and Pitavastatin Ca 2mg * once a day Livalo tab. 2mg + Placebo Livalo tab. 2mg + Placebo * Pitavastatin ca 2mg * once a day
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 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 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 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 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 TG from baseline at week 4,8 Change rate of TG after 4 and 8 weeks compared to baseline (%)
The mean percentage change of TC from baseline at week 4,8 Change rate of TC after 4 and 8 weeks compared to baseline (%)