Mixed Dyslipidemias
Conditions
Brief summary
Efficacy and safety of combination therapy of rosuvastatin and fenofibrate versus rosuvastatin monotherapy in mixed dyslipidemia patients: A randomized, multi-center, double-blind, phase 3 study
Interventions
DRUGRosuvastatin
Rosuvastatin 10 mg, qd, po
DRUGFenofibrate
Fenofibrate 160mg, qd, po
Sponsors
IlDong Pharmaceutical Co Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 19 \ 80 years old * High risk patient to Coronary Heart Disease * At Visit 1(Screening) 1. Treated with Rosuvastatin 10mg monotherapy 4weeks prior to this study 2. 110 mg/dl ≥ LDL-C, 200 mg/dl ≤ TG ≤ 500 mg/dl * At Visit 2 (Baseline), 110 mg/dl ≥ LDL-C, 200 mg/dl ≤ TG ≤ 500 mg/dl
Exclusion criteria
* AST or ALT \> 2X ULN * Patients with uncontrolled hyperthyroidism (TSH\>1.5X ULN) * Patients with uncontrolled diabetes (HbA1c ≥ 9%) * Patients with uncontrolled hypertension(SBP\>160mmHg or DBP\>95mmHg) * Patients with congestive heart failure(NYHA class III\ IV) or uncontrolled arrhythmia within 6 months * Patients treated with any investigational drugs within 3 months at the time consents are obtained * Not eligible to participate for the study at the discretion of investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The mean percent change of Non-HDL Cholesterol | from baseline at week 8 |
Secondary
| Measure | Time frame |
|---|---|
| The mean change, percent change of Non-LDL-C | from baseline at week 4 |
| The mean change of Non-LDL-C | from baseline at week 8 |
| The mean percent change of LDL-C, HDL-C, VLDL-C, TG, TC, Apo-AI, Apo-B | from baseline at week 4, 8 |
| The achievement rate of Non-HDL-C<130mg/dl | from baseline at week 4, 8 |
Countries
South Korea
Outcome results
None listed