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

Mixed Hyperlipidemia Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01956201
• Other study ID #: 146MHL13011
• Status: Recruiting
• Phase: Phase 3
• First received: September 30, 2013
• Last updated: February 2, 2015
• Start date: December 2013
• Est. completion date: August 2016

Study information

• Verified date: February 2015
• Source: Chong Kun Dang Pharmaceutical
• Contact: Hyun-Kyung Oh
• Phone: 82-2-2194-0469
• Email: hkoh[@]ckdpharm.com
• Is FDA regulated: No
• Health authority: South Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial 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.

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]

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 476
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperlipidemia, Familial Combined
• Hyperlipidemias
• Hyperlipoproteinemia Type V
• Mixed Hyperlipidemia

Intervention

Drug:
• Atorvastatin 20mg
[Atorvastatin Run-in Period] Take Atorvastatin 20mg 1 tablet once a day (after breakfast) [Treatment Period] Take Atrovastatin 20mg/Fenofibrate 160mg or Atorvastiatin 20mg/Placebo of Finofibrate 160mg 2 tablet once a day (after breakfast) [Extension Period] Take Atrovastatin 20mg, Fenofibrate 160mg 2 tablet once a day (after breakfast)
• Fenofibrate 160mg
Refer to Intervention Description of Atorvastatin 20mg

Other:
• Placebo (Fenofibrate 160 mg)
Refer to Intervention Description of Atorvastatin 20mg

Locations

Country	Name	City	State
Korea, Republic of	Inje University Busan Paik Hospital	Busan
Korea, Republic of	Pusan National University Hospital	Busan
Korea, Republic of	Kangwon University Hospital	Chuncheon
Korea, Republic of	Daegu Catholic University Medical Center	Daegu
Korea, Republic of	Keimyung University Dongsan Medical Center	Daegu
Korea, Republic of	Konyang University Hospital	Daejeon
Korea, Republic of	Chonnam National University Hospital	Gwangju
Korea, Republic of	Dongguk University Ilsan Hospital	Ilsan
Korea, Republic of	Inje University Ilsan Paik Hospital	Ilsan
Korea, Republic of	Chonbuk National University Hospital	Jeonju
Korea, Republic of	Hanyang University Guri Hospital	Kyunggi
Korea, Republic of	Seoul National University Hospital, Bundang	Seongnam
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Eulji General Hospital	Seoul
Korea, Republic of	Gangnam Severance Hospital	Seoul
Korea, Republic of	Kangbuk Samsung Medical Center	Seoul
Korea, Republic of	Kangdong Sacred Heart Hospital	Seoul
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	Korea University Huro Hospital	Seoul
Korea, Republic of	Kyunghee University Hospital at Gangdong	Seoul
Korea, Republic of	Kyunghee University Medical center	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Severance Hospital	Seoul
Korea, Republic of	SMG-SNU Boramae Medical Center	Seoul
Korea, Republic of	The Catholic University of Korea, St. Mary's Hospital	Seoul
Korea, Republic of	The Catholic University of Korea, Uijeongbu St. Mary's Hospital	Seoul
Korea, Republic of	The Catholic University of korea, Yeouido St. Mary's Hospital	Seoul
Korea, Republic of	Ajou University hospital	Suwon
Korea, Republic of	Wonju Severance Christian Hospital	Wonju

Sponsors (1)

Lead Sponsor	Collaborator
Chong Kun Dang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The mean percent change of Non-HDL Cholesterol		from baseline at week 8	No
Secondary	The achievement rate of LDL-C<100mg/dl, Non-HDL-C<130mg/dl		from baseline at week 8	No
Secondary	The mean percent change of LDL-C, HDL-C, TG, TC, Apo-AI, Apo-B		from baseline at week 4, 8	No
Secondary	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	No
Secondary	The mean percent change of Fibrinogen, hs-CRP		from baseline at week 4, 8	No
Secondary	Safety evaluation (Physical examination, Vital sign, Laboratory, AE etc.)		Treatment period (8 weeks) and Extension period (16 weeks)	No