Back to resultsA Clinical Trial to Evaluate the Efficacy and Safety of Pitavastatin/Fenofibrate in Complex-dyslipidemia
Primary Purpose
Complex-dyslipidemia
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
HL-PIF cap.160/2mg + Placebo
Livalo tab. 2mg + Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Complex-dyslipidemia
Eligibility Criteria
Inclusion Criteria:
- 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
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
HL-PIF cap.160/2mg + Placebo
Livalo tab. 2mg + Placebo
Arm Description
Fenofibrate pellet (as micronized fenofibrate 160mg) and Pitavastatin Ca 2mg once a day
Pitavastatin ca 2mg once a day
Outcomes
Primary Outcome Measures
The mean percentage change of Non-HDL Cholesterol
Change rate of Non-HDL-C after 8 weeks compared to baseline (%)
Secondary Outcome Measures
The mean percentage change of Non-HDL Cholesterol
Change rate of Non-HDL-C after 4 weeks compared to baseline (%)
The mean percentage change of LDL-C
Change rate of LDL-C after 4 and 8 weeks compared to baseline (%)
The mean percentage change of HDL-C
Change rate of HDL-C after 4 and 8 weeks compared to baseline (%)
The mean percentage change of LDL-C/HDL-C
Change rate of LDL-C/HDL-C after 4 and 8 weeks compared to baseline (%)
The mean percentage change of TC/HDL-C
Change rate of TC/HDL-C after 4 and 8 weeks compared to baseline (%)
The mean percentage change of non-HDL-C/HDL-C
Change rate of non-HDL-C/HDL-C after 4 and 8 weeks compared to baseline (%)
The mean percentage change of VLDL-C
Change rate of VLDL-C after 4 and 8 weeks compared to baseline (%)
The mean percentage change of TG
Change rate of TG after 4 and 8 weeks compared to baseline (%)
The mean percentage change of TC
Change rate of TC after 4 and 8 weeks compared to baseline (%)
The mean percentage change of Apo Al
Change rate of Apo Al after 4 and 8 weeks compared to baseline (%)
The mean percentage change of Apo B
Change rate of Apo B change after 4 and 8 weeks compared to baseline (%)
The mean percentage change of Apo Al/Apo B
Change rate of Apo Al/Apo B after 4 and 8 weeks compared to baseline (%)
The mean percentage change of fibrinogen
Change rate of fibrinogen after 4 and 8 weeks compared to baseline (%)
The mean percentage change of hs-CRP
Change rate of hs-CRP after 4 and 8 weeks compared to baseline (%)
Achievement rate(%) of treatment goals after 4 weeks and 8 weeks
LDL-C<100mg/dL & non-HDL-C <130mg/dL
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03618797
Brief Title
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
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
November 2015 (Actual)
Primary Completion Date
January 2018 (Actual)
Study Completion Date
May 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hanlim Pharm. Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complex-dyslipidemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
347 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HL-PIF cap.160/2mg + Placebo
Arm Type
Experimental
Arm Description
Fenofibrate pellet (as micronized fenofibrate 160mg) and Pitavastatin Ca 2mg
once a day
Arm Title
Livalo tab. 2mg + Placebo
Arm Type
Active Comparator
Arm Description
Pitavastatin ca 2mg
once a day
Intervention Type
Drug
Intervention Name(s)
HL-PIF cap.160/2mg + Placebo
Other Intervention Name(s)
Fenofibrate 160mg/Pitavastatin Ca 2mg
Intervention Description
Fenofibrate pellet (as micronized fenofibrate 160mg) and Pitavastatin Ca 2mg
Intervention Type
Drug
Intervention Name(s)
Livalo tab. 2mg + Placebo
Other Intervention Name(s)
Pitavastatin Ca 2mg
Intervention Description
Pitavastatin ca 2mg
Primary Outcome Measure Information:
Title
The mean percentage change of Non-HDL Cholesterol
Description
Change rate of Non-HDL-C after 8 weeks compared to baseline (%)
Time Frame
from baseline at week 8
Secondary Outcome Measure Information:
Title
The mean percentage change of Non-HDL Cholesterol
Description
Change rate of Non-HDL-C after 4 weeks compared to baseline (%)
Time Frame
from baseline at week 4
Title
The mean percentage change of LDL-C
Description
Change rate of LDL-C after 4 and 8 weeks compared to baseline (%)
Time Frame
from baseline at week 4,8
Title
The mean percentage change of HDL-C
Description
Change rate of HDL-C after 4 and 8 weeks compared to baseline (%)
Time Frame
from baseline at week 4,8
Title
The mean percentage change of LDL-C/HDL-C
Description
Change rate of LDL-C/HDL-C after 4 and 8 weeks compared to baseline (%)
Time Frame
from baseline at week 4,8
Title
The mean percentage change of TC/HDL-C
Description
Change rate of TC/HDL-C after 4 and 8 weeks compared to baseline (%)
Time Frame
from baseline at week 4,8
Title
The mean percentage change of non-HDL-C/HDL-C
Description
Change rate of non-HDL-C/HDL-C after 4 and 8 weeks compared to baseline (%)
Time Frame
from baseline at week 4,8
Title
The mean percentage change of VLDL-C
Description
Change rate of VLDL-C after 4 and 8 weeks compared to baseline (%)
Time Frame
from baseline at week 4,8
Title
The mean percentage change of TG
Description
Change rate of TG after 4 and 8 weeks compared to baseline (%)
Time Frame
from baseline at week 4,8
Title
The mean percentage change of TC
Description
Change rate of TC after 4 and 8 weeks compared to baseline (%)
Time Frame
from baseline at week 4,8
Title
The mean percentage change of Apo Al
Description
Change rate of Apo Al after 4 and 8 weeks compared to baseline (%)
Time Frame
from baseline at week 4,8
Title
The mean percentage change of Apo B
Description
Change rate of Apo B change after 4 and 8 weeks compared to baseline (%)
Time Frame
from baseline at week 4,8
Title
The mean percentage change of Apo Al/Apo B
Description
Change rate of Apo Al/Apo B after 4 and 8 weeks compared to baseline (%)
Time Frame
from baseline at week 4,8
Title
The mean percentage change of fibrinogen
Description
Change rate of fibrinogen after 4 and 8 weeks compared to baseline (%)
Time Frame
from baseline at week 4,8
Title
The mean percentage change of hs-CRP
Description
Change rate of hs-CRP after 4 and 8 weeks compared to baseline (%)
Time Frame
from baseline at week 4,8
Title
Achievement rate(%) of treatment goals after 4 weeks and 8 weeks
Description
LDL-C<100mg/dL & non-HDL-C <130mg/dL
Time Frame
from baseline at week 4,8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ki-Bae Seung
Organizational Affiliation
The Catholic University of Korea
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
32891418
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.
Results Reference
derived
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A Clinical Trial to Evaluate the Efficacy and Safety of Pitavastatin/Fenofibrate in Complex-dyslipidemia
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