Clinical trial NCT03618797: A Clinical Trial to Evaluate the Efficacy and Safety of Pitavastatin/Fenofibrate in Complex-dyslipidemia
Official title: A Multicenter, Randomized, Double-blinded, Parallel, Therapeutic Confirmatory Clinical Trial to Evaluate the Efficacy and Safety of Pitavastatin Versus Pitavastatin/Fenofibrate in Complex-dyslipidemia Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Complex-dyslipidemia
Lead sponsor: Hanlim Pharm. Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-08-07
Enrollment: 347
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: The mean percentage change of Non-HDL Cholesterol
timeFrame: from baseline at week 8
Secondary outcomes:
measure: The mean percentage change of Non-HDL Cholesterol
timeFrame: from baseline at week 4
measure: The mean percentage change of LDL-C
timeFrame: from baseline at week 4,8
measure: The mean percentage change of HDL-C
timeFrame: from baseline at week 4,8
measure: The mean percentage change of LDL-C/HDL-C
timeFrame: from baseline at week 4,8
measure: The mean percentage change of TC/HDL-C
timeFrame: from baseline at week 4,8
measure: The mean percentage change of non-HDL-C/HDL-C
timeFrame: from baseline at week 4,8
measure: The mean percentage change of VLDL-C
timeFrame: from baseline at week 4,8
measure: The mean percentage change of TG
timeFrame: from baseline at week 4,8
measure: The mean percentage change of TC
timeFrame: from baseline at week 4,8
measure: The mean percentage change of Apo Al
timeFrame: from baseline at week 4,8
measure: The mean percentage change of Apo B
timeFrame: from baseline at week 4,8
measure: The mean percentage change of Apo Al/Apo B
timeFrame: from baseline at week 4,8
measure: The mean percentage change of fibrinogen
timeFrame: from baseline at week 4,8
measure: The mean percentage change of hs-CRP
timeFrame: from baseline at week 4,8
measure: Achievement rate(%) of treatment goals after 4 weeks and 8 weeks
timeFrame: from baseline at week 4,8
Other outcomes:
Locations:
Study officials:
affiliation: The Catholic University of Korea
name: Ki-Bae Seung
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ihm SH, Chung WB, Lee JM, Hwang BH, Yoo KD, Her SH, Song WH, Chae IH, Park TH, Kim JH, Jeon DW, Cho BR, Kang SH, Park SD, Lee JB, Woo JT, Lee BW, Han KA, Won KH, Kim HS, Yu JM, Chung CH, Kim HJ, Cho HC, Seung KB. Efficacy and Tolerability of Pitavastatin Versus Pitavastatin/Fenofibrate in High-risk Korean Patients with Mixed Dyslipidemia: A Multicenter, Randomized, Double-blinded, Parallel, Therapeutic Confirmatory Clinical Trial. Clin Ther. 2020 Oct;42(10):2021-2035.e3. doi: 10.1016/j.clinthera.2020.08.002. Epub 2020 Sep 2.