A Clinical Trial to Evaluate the Efficacy and Safety of Pitavastatin/Fenofibrate in Complex-dyslipidemia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

347 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2018-05-31

Brief Summary

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The purpose of this study is to evaluate the efficacy and safety of Pitavastatin versus Pitavastatin/Fenofibrate in complex-dyslipidemia patients.

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Detailed Description

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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.

Conditions

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Complex-dyslipidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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HL-PIF cap.160/2mg + Placebo

* Fenofibrate pellet (as micronized fenofibrate 160mg) and Pitavastatin Ca 2mg
* once a day

Group Type EXPERIMENTAL

HL-PIF cap.160/2mg + Placebo

Intervention Type DRUG

Fenofibrate pellet (as micronized fenofibrate 160mg) and Pitavastatin Ca 2mg

Livalo tab. 2mg + Placebo

* Pitavastatin ca 2mg
* once a day

Group Type ACTIVE_COMPARATOR

Livalo tab. 2mg + Placebo

Intervention Type DRUG

Pitavastatin ca 2mg

Interventions

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HL-PIF cap.160/2mg + Placebo

Fenofibrate pellet (as micronized fenofibrate 160mg) and Pitavastatin Ca 2mg

Intervention Type DRUG

Livalo tab. 2mg + Placebo

Pitavastatin ca 2mg

Intervention Type DRUG

Other Intervention Names

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Fenofibrate 160mg/Pitavastatin Ca 2mg Pitavastatin Ca 2mg

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No