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

IlDong Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: Mixed Dyslipidemias

Treatments: Drug: Rosuvastatin; Drug: Fenofibrate

Study type: Interventional

Funder types: Industry

Identifiers

NCT02262143

ID-ROFE-301

Details and patient eligibility

About

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

Enrollment: 362 patients

Sex: All

Ages: 19 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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362 participants in 2 patient groups

Experimental

Experimental group

Description:

Rosuvastatin 10 mg, Fenofibrate 160 mg

Treatment:

Drug: Fenofibrate

Drug: Rosuvastatin

Comparator

Active Comparator group

Description:

Rosuvastatin 10 mg

Treatment:

Drug: Rosuvastatin