Efficacy and Safety of Fenofibrate Added on to Atorvastatin Compared With Atorvastatin

Chong Kun Dang

Status and phase: Unknown; Phase 3

Conditions: Mixed Hyperlipidemia

Treatments: Drug: Fenofibrate 160mg; Drug: Atorvastatin 20mg; Other: Placebo (Fenofibrate 160 mg)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01956201

146MHL13011

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of Atorvastatin and Fenofibrate compared with atorvastatin monotherapy in mixed hypercholesterolemic patients.

Full 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]

Enrollment: 476 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• >19 years old

• High risk patient to Coronary Heart Disease (applied to 1 or more CHD risk factor listed below)

  1. Patient with Coronary Heart Disease
  2. Patient with carotid artery disease, peripheral blood vessel disease, abdominal aneurysm
  3. Patient with diabetes(HbA1C≤9.0%)
  4. 10-year risk of CHD >20%(by Framingham 10-year risk score calculation)

• At Visit 1(Screening)

  1. 100mg/dl≥LDL-C, 150mg/dl≤TG≤500mg/dl

     • 4weeks of Atorvastatin 20mg monotherapy run-in period

  2. 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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476 participants in 2 patient groups

Atorvastatin 20mg, Fenofibrate 160mg

Experimental group

Description:

Atorvastatin 20mg, Fenofibrate 160mg: po, q.d.

Treatment:

Drug: Atorvastatin 20mg

Drug: Fenofibrate 160mg

Atorvastatin 20mg, Placebo

Active Comparator group

Description:

Atorvastatin 20mg, Placebo for Fenofibrate 160mg po, q.d.

Treatment:

Drug: Atorvastatin 20mg

Other: Placebo (Fenofibrate 160 mg)