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

Hanlim Pharm

Status and phase: Completed; Phase 3

Conditions: Complex-dyslipidemia

Treatments: Drug: HL-PIF cap.160/2mg + Placebo; Drug: Livalo tab. 2mg + Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03618797

HL-PIF-301

Details and patient eligibility

About

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

Full 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.

Enrollment: 347 patients

Sex: All

Ages: 19 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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347 participants in 2 patient groups

HL-PIF cap.160/2mg + Placebo

Experimental group

Description:

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

Treatment:

Drug: HL-PIF cap.160/2mg + Placebo

Livalo tab. 2mg + Placebo

Active Comparator group

Description:

Pitavastatin ca 2mg once a day

Treatment:

Drug: Livalo tab. 2mg + Placebo