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

Phase 3

• Conditions: Mixed Hyperlipidemia
• Interventions: Drug: Atorvastatin 20mg; Other: Placebo (Fenofibrate 160 mg); Drug: Fenofibrate 160mg

• Registration Number: NCT01956201
• Lead Sponsor: Chong Kun Dang Pharmaceutical

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 Timeline

• Study First Submitted: 2013-09-30
• Study First Submitted QC: 2013-09-30
• Study First Posted: 2013-10-08
• Study Start: 2013-12
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-02
• Last Update Posted: 2015-02-04
• Primary Completion: 2016-08
• Study Completion: 2016-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 476

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Atorvastatin 20mg, Placebo	Placebo (Fenofibrate 160 mg)	Atorvastatin 20mg, Placebo for Fenofibrate 160mg po, q.d.
Atorvastatin 20mg, Fenofibrate 160mg	Atorvastatin 20mg	Atorvastatin 20mg, Fenofibrate 160mg: po, q.d.
Atorvastatin 20mg, Fenofibrate 160mg	Fenofibrate 160mg	Atorvastatin 20mg, Fenofibrate 160mg: po, q.d.
Atorvastatin 20mg, Placebo	Atorvastatin 20mg	Atorvastatin 20mg, Placebo for Fenofibrate 160mg po, q.d.

Primary Outcome Measures

Name	Time	Method
The mean percent change of Non-HDL Cholesterol	from baseline at week 8

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (30)

Chonnam National University Hospital; 🇰🇷 Gwangju, Korea, Republic of

Inje University Busan Paik Hospital; 🇰🇷 Busan, Korea, Republic of

Daegu Catholic University Medical Center; 🇰🇷 Daegu, Korea, Republic of

Pusan National University Hospital; 🇰🇷 Busan, Korea, Republic of

Chonbuk National University Hospital; 🇰🇷 Jeonju, Korea, Republic of

Inje University Ilsan Paik Hospital; 🇰🇷 Ilsan, Korea, Republic of

Kangwon University Hospital; 🇰🇷 Chuncheon, Korea, Republic of

Hanyang University Guri Hospital; 🇰🇷 Kyunggi, Korea, Republic of

Dongguk University Ilsan Hospital; 🇰🇷 Ilsan, Korea, Republic of

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of

Konyang University Hospital; 🇰🇷 Daejeon, Korea, Republic of

The Catholic University of korea, Yeouido St. Mary's Hospital; 🇰🇷 Seoul, Korea, Republic of

Eulji General Hospital; 🇰🇷 Seoul, Korea, Republic of

Korea University Anam Hospital; 🇰🇷 Seoul, Korea, Republic of

Kyunghee University Medical center; 🇰🇷 Seoul, Korea, Republic of

Severance Hospital; 🇰🇷 Seoul, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of

The Catholic University of Korea, Uijeongbu St. Mary's Hospital; 🇰🇷 Seoul, Korea, Republic of

Wonju Severance Christian Hospital; 🇰🇷 Wonju, Korea, Republic of

Ajou University hospital; 🇰🇷 Suwon, Korea, Republic of

Keimyung University Dongsan Medical Center; 🇰🇷 Daegu, Korea, Republic of

Seoul National University Hospital, Bundang; 🇰🇷 Seongnam, Korea, Republic of

Gangnam Severance Hospital; 🇰🇷 Seoul, Korea, Republic of

Kangbuk Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of

Kyunghee University Hospital at Gangdong; 🇰🇷 Seoul, Korea, Republic of

The Catholic University of Korea, St. Mary's Hospital; 🇰🇷 Seoul, Korea, Republic of

Kangdong Sacred Heart Hospital; 🇰🇷 Seoul, Korea, Republic of

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of

Korea University Huro Hospital; 🇰🇷 Seoul, Korea, Republic of

SMG-SNU Boramae Medical Center; 🇰🇷 Seoul, Korea, Republic of