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

• Status: Completed
• Trial end date: 2018-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hanlim Pharm. Co., Ltd.
• Treatments: Fenofibrate; Pitavastatin

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