Efficacy and Safety of Fenofibrate Added on to Atorvastatin Compared With Atorvastatin in Mixed Hypercholesterolemic Patient: Multi Center, Randomized, Double-blind, Parallel-group, Therapeutic Confirmatory Study.
Trial Snapshot
- Phase
- Phase 3
- Enrollment
- 476
- Locations
- 30
- Primary Endpoint
- The mean percent change of Non-HDL Cholesterol
Study Overview
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of Atorvastatin and Fenofibrate compared with atorvastatin monotherapy in mixed hypercholesterolemic patients.
Detailed Description
Multi center, randomized, double-blind, parallel-group, therapeutic confirmatory study
Primary Outcome Measure:
The mean percent change of Non-HDL Cholesterol [Time Frame: from baseline at week 8]
Secondary Outcome Measures:
The achievement rate of LDL-C<100mg/dl, Non-HDL-C<130mg/dl [Time Frame: from baseline at week 8] The mean percent change of LDL-C, HDL-C, TG, TC, Apo-AI, Apo-B [Time Frame: from baseline at week 4, 8] The mean percent change of Non-LDL-C/HDL-C, TC/HDL-C, LDL-C/HDL-C, Apo-B/Apo-AI [Time Frame: from baseline at week 4, 8] The mean percent change of Fibrinogen, hs-CRP [Time Frame: from baseline at week 4, 8] Safety evaluation [Time Frame: Treatment period and Extension period]
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •>19 years old
- •High risk patient to Coronary Heart Disease (applied to 1 or more CHD risk factor listed below)
- •Patient with Coronary Heart Disease
- •Patient with carotid artery disease, peripheral blood vessel disease, abdominal aneurysm
- •Patient with diabetes(HbA1C≤9.0%)
- •10-year risk of CHD >20%(by Framingham 10-year risk score calculation)
- •At Visit 1(Screening)
- •100mg/dl≥LDL-C, 150mg/dl≤TG≤500mg/dl
- •4weeks of Atorvastatin 20mg monotherapy run-in period
- •LDL-C<100mg/dl, 150mg/dl≤TG≤500mg/dl
- •If treated with Atorvastatin 20mg monotherapy 4weeks prior to this study
- •At Visit 2(After 4weeks of Atorvastatin monotherapy run-in period)
- •LDL<100mg/dl, 150mg/dl≤TG≤500mg/dl
Exclusion Criteria
- •Patients with acute artery disease within 3 months
- •Patients with congestive heart failure(NYHA class III~IV) or uncontrolled arrhythmia within 6 months
- •Patients with uncontrolled hypertension(SBP>160mmHg or DBP>95mmHg)
- •TSH>1.5X ULN
- •Patients with myopathy, rhabdomyolysis or CK>2X ULN
- •Hypersensitive to Atorvastatin and/or Fenofibrate or had photoallergy or phototoxicity during fibrate and/or ketoprofen treatment
- •Serum Creatinine>2.5mg/dl, AST or ALT > 2X ULN
- •History of drug or alcohol abuse within 6 months
- •History of GI tract surgery or disability to drug absorption
- •Women with pregnant, breast-feeding
- •Patients with gallbladder disease
- •Patients with biliary cirrhosis
- •Patients with pancreatitis(acute pancreatitis is excluded due to severe hypertriglyceridemia)
- •Patients treated with any investigational drugs within 4 weeks at the time consents are obtained
- •History of malignant tumor including leukemia, lymphoma within 5 years
- •Patients must be treated with medications prohibited for concomitant use during study period
- •Not eligible to participate for the study at the discretion of investigator
Arms & Interventions
Atorvastatin 20mg, Fenofibrate 160mg
Atorvastatin 20mg, Fenofibrate 160mg: po, q.d.
Intervention: Atorvastatin 20mg (Drug)
Atorvastatin 20mg, Fenofibrate 160mg
Atorvastatin 20mg, Fenofibrate 160mg: po, q.d.
Intervention: Fenofibrate 160mg (Drug)
Atorvastatin 20mg, Placebo
Atorvastatin 20mg, Placebo for Fenofibrate 160mg po, q.d.
Intervention: Atorvastatin 20mg (Drug)
Atorvastatin 20mg, Placebo
Atorvastatin 20mg, Placebo for Fenofibrate 160mg po, q.d.
Intervention: Placebo (Fenofibrate 160 mg) (Other)
Outcomes
Primary Outcomes
The mean percent change of Non-HDL Cholesterol
Time Frame: from baseline at week 8
Secondary Outcomes
- The mean percent change of Non-LDL-C/HDL-C, TC/HDL-C, LDL-C/HDL-C, Apo-B/Apo-AI(from baseline at week 4, 8)
- The mean percent change of Fibrinogen, hs-CRP(from baseline at week 4, 8)
- Safety evaluation (Physical examination, Vital sign, Laboratory, AE etc.)(Treatment period (8 weeks) and Extension period (16 weeks))
- The achievement rate of LDL-C<100mg/dl, Non-HDL-C<130mg/dl(from baseline at week 8)
- The mean percent change of LDL-C, HDL-C, TG, TC, Apo-AI, Apo-B(from baseline at week 4, 8)