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

H

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

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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