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

NCT01956201 | Unknown Phase 3

• 1 other identifier: 146MHL13011
• Study Type: interventional
• Target: 476
• Locations: 1 country
• Sites: 30

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.

Conditions

Mixed Hyperlipidemia

Outcome Measures

Primary Outcomes (1)

• The mean percent change of Non-HDL Cholesterol

  from baseline at week 8

Secondary Outcomes (5)

• 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

• 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)

Study Arms (2)

Atorvastatin 20mg, Fenofibrate 160mg

EXPERIMENTAL

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

Drug: Atorvastatin 20mg; Drug: Fenofibrate 160mg

Atorvastatin 20mg, Placebo

ACTIVE COMPARATOR

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

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

Interventions

Atorvastatin 20mg DRUG

\[Atorvastatin Run-in Period\] 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)

Also known as: Lipilou Tab.

Atorvastatin 20mg, Fenofibrate 160mg; Atorvastatin 20mg, Placebo

Fenofibrate 160mg DRUG

Refer to Intervention Description of Atorvastatin 20mg

Atorvastatin 20mg, Fenofibrate 160mg

Placebo (Fenofibrate 160 mg) OTHER

Refer to Intervention Description of Atorvastatin 20mg

Also known as: Placebo

Atorvastatin 20mg, Placebo

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>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%)
• year risk of CHD \>20%(by Framingham 10-year risk score calculation)
• At Visit 1(Screening)
• mg/dl≥LDL-C, 150mg/dl≤TG≤500mg/dl
• weeks 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (30)

Inje University Busan Paik Hospital

Busan, South Korea

RECRUITING

Pusan National University Hospital

Busan, South Korea

RECRUITING

Kangwon University Hospital

Chuncheon, South Korea

RECRUITING

Daegu Catholic University Medical Center

Daegu, South Korea

RECRUITING

Keimyung University Dongsan Medical Center

Daegu, South Korea

RECRUITING

Konyang University Hospital

Daejeon, South Korea

RECRUITING

Chonnam National University Hospital

Gwangju, South Korea

RECRUITING

Dongguk University Ilsan Hospital

Ilsan, South Korea

RECRUITING

Inje University Ilsan Paik Hospital

Ilsan, South Korea

RECRUITING

Chonbuk National University Hospital

Jeonju, South Korea

RECRUITING

Hanyang University Guri Hospital

Kyunggi, South Korea

RECRUITING

Seoul National University Hospital, Bundang

Seongnam, South Korea

RECRUITING

Asan Medical Center

Seoul, South Korea

RECRUITING

Eulji General Hospital

Seoul, South Korea

RECRUITING

Gangnam Severance Hospital

Seoul, South Korea

RECRUITING

Kangbuk Samsung Medical Center

Seoul, South Korea

RECRUITING

Kangdong Sacred Heart Hospital

Seoul, South Korea

RECRUITING

Korea University Anam Hospital

Seoul, South Korea

RECRUITING

Korea University Huro Hospital

Seoul, South Korea

RECRUITING

Kyunghee University Hospital at Gangdong

Seoul, South Korea

RECRUITING

Kyunghee University Medical center

Seoul, South Korea

RECRUITING

Samsung Medical Center

Seoul, South Korea

RECRUITING

Seoul National University Hospital

Seoul, South Korea

RECRUITING

Severance Hospital

Seoul, South Korea

RECRUITING

SMG-SNU Boramae Medical Center

Seoul, South Korea

RECRUITING

The Catholic University of Korea, St. Mary's Hospital

Seoul, South Korea

RECRUITING

The Catholic University of Korea, Uijeongbu St. Mary's Hospital

Seoul, South Korea

RECRUITING

The Catholic University of korea, Yeouido St. Mary's Hospital

Seoul, South Korea

RECRUITING

Ajou University hospital

Suwon, South Korea

RECRUITING

Wonju Severance Christian Hospital

Wŏnju, South Korea

RECRUITING

MeSH Terms

Conditions

Hyperlipoproteinemia Type II

Interventions

Atorvastatin; Fenofibrate

Condition Hierarchy (Ancestors)

Lipid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperlipoproteinemias; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids; Fibric Acids; Isobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Phenyl Ethers; Ethers; Benzophenones; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols; Ketones

Study Officials

• MoonKyu Lee, M.D., Ph.D.

  Samsung Medical Center - Seoul

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hyun-Kyung Oh

CONTACT

82-2-2194-0469; hkoh@ckdpharm.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2013
• First Posted: October 8, 2013
• Study Start: December 1, 2013
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: February 4, 2015

Record last verified: 2015-02

Locations

KR (30)