Phase III Study of Rosuvastatin and Fenofibrate Versus Rosuvastatin in Mixed Dyslipidemia

• Status: Completed
• Trial end date: 2017-06-01
• Target enrollment: 0
• Participant gender: All

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

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

Details

• Lead Sponsor: IlDong Pharmaceutical Co Ltd
• Treatments: Fenofibrate; Rosuvastatin Calcium

Criteria

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