Complex-dyslipidemia Clinical Trial
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
| NCT number | NCT03618797 |
| Other study ID # | HL-PIF-301 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 3 |
| First received | |
| Last updated | |
| Start date | November 2015 |
| Est. completion date | May 2018 |
| Verified date | August 2018 |
| Source | Hanlim Pharm. Co., Ltd. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to evaluate the efficacy and safety of Pitavastatin versus Pitavastatin/Fenofibrate in complex-dyslipidemia patients.
| Status | Completed |
| Enrollment | 347 |
| Est. completion date | May 2018 |
| Est. primary completion date | January 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 19 Years to 80 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Hanlim Pharm. Co., Ltd. |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The mean percentage change of Non-HDL Cholesterol | Change rate of Non-HDL-C after 8 weeks compared to baseline (%) | from baseline at week 8 | |
| Secondary | The mean percentage change of Non-HDL Cholesterol | Change rate of Non-HDL-C after 4 weeks compared to baseline (%) | from baseline at week 4 | |
| Secondary | The mean percentage change of LDL-C | Change rate of LDL-C after 4 and 8 weeks compared to baseline (%) | from baseline at week 4,8 | |
| Secondary | The mean percentage change of HDL-C | Change rate of HDL-C after 4 and 8 weeks compared to baseline (%) | from baseline at week 4,8 | |
| Secondary | The mean percentage change of LDL-C/HDL-C | Change rate of LDL-C/HDL-C after 4 and 8 weeks compared to baseline (%) | from baseline at week 4,8 | |
| Secondary | The mean percentage change of TC/HDL-C | Change rate of TC/HDL-C after 4 and 8 weeks compared to baseline (%) | from baseline at week 4,8 | |
| Secondary | 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 (%) | from baseline at week 4,8 | |
| Secondary | The mean percentage change of VLDL-C | Change rate of VLDL-C after 4 and 8 weeks compared to baseline (%) | from baseline at week 4,8 | |
| Secondary | The mean percentage change of TG | Change rate of TG after 4 and 8 weeks compared to baseline (%) | from baseline at week 4,8 | |
| Secondary | The mean percentage change of TC | Change rate of TC after 4 and 8 weeks compared to baseline (%) | from baseline at week 4,8 | |
| Secondary | The mean percentage change of Apo Al | Change rate of Apo Al after 4 and 8 weeks compared to baseline (%) | from baseline at week 4,8 | |
| Secondary | The mean percentage change of Apo B | Change rate of Apo B change after 4 and 8 weeks compared to baseline (%) | from baseline at week 4,8 | |
| Secondary | The mean percentage change of Apo Al/Apo B | Change rate of Apo Al/Apo B after 4 and 8 weeks compared to baseline (%) | from baseline at week 4,8 | |
| Secondary | The mean percentage change of fibrinogen | Change rate of fibrinogen after 4 and 8 weeks compared to baseline (%) | from baseline at week 4,8 | |
| Secondary | The mean percentage change of hs-CRP | Change rate of hs-CRP after 4 and 8 weeks compared to baseline (%) | from baseline at week 4,8 | |
| Secondary | Achievement rate(%) of treatment goals after 4 weeks and 8 weeks | LDL-C<100mg/dL & non-HDL-C <130mg/dL | from baseline at week 4,8 |