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Comparison of the Efficacy and Safety of AtorVastatin mOnotherapy vs. Combination Atorvastatin/Fenofibric Acid (AVOCADO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01974297
Recruitment Status : Unknown
Verified October 2013 by Sang Hak Lee, Yonsei University.
Recruitment status was:  Recruiting
First Posted : November 1, 2013
Last Update Posted : November 4, 2013
Information provided by (Responsible Party):
Sang Hak Lee, Yonsei University

Brief Summary:
The purpose of this study is to compare combination atorvastatin/fenofibric acid 10/135mg with atorvastatin 20mg monotherapy in the mixed hyperlipidemia who were not at lipid goals with atorvastatin 10mg monotherapy.

Condition or disease Intervention/treatment Phase
Mixed Hyperlipidemia Drug: Atorvastatin 10mg, fenofibric acid 135mg Drug: atorvastatin 20mg Not Applicable

Detailed Description:

Study conduct according to the standard operating procedure

  • The sponsor, the investigator, and all other persons involved in the study at the study center or other facilities should conduct the study in accordance with the study protocol, each standard operating procedure, and Korea Good Clinical Pratice.

Data quality control

  • In order to ensure the reliability of all study-related data and their appropriate processing, the sponsor will apply quality control to each step of data handling


  • In order to confirm that the study is being conducted, recorded and reported according to the study protocol and International Conference on Harmonization Good Clinical Practice(ICH-GCP), the sponsor or CRO will perform monitoring of study procedure. In monitoring, the monitors will cross check the description in the case report form, etc. against study-related records such as source documents to confirm that the description is accurate.

Measures taken to cope with adverse events and reporting procedure

  • The investigator should notify the event to the sponsor or Contract Research Organization(CRO) immediately (within around 24 hours) after having noticed the occurence of a serioius adverse event by telephone, fax or E-mail. The investigator should complete and submit an serioius adverse event(SAE) report form containing all information to the Institutional Review Board (IRB).

Data Management

  • In this study, data will be collected in electronic Case Report Form(CRF)
  • Data validation for missing data will be managed by computer programming and manual check.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 194 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of the Efficacy and AtorVastatin 20mg mOnotherapy Versus Combination Atorvastatin/Fenofibric Acid 10/135mg in the Mixed hyperlipiDemia Who Were Not at Lipid gOals With Atorvastatin 10mg Monotherapy.
Study Start Date : July 2013
Estimated Primary Completion Date : June 2014
Estimated Study Completion Date : July 2014

Arm Intervention/treatment
Active Comparator: Atorvastatin 20mg, monotherapy
Atorvastatin 20mg/day PO for 12weeks
Drug: atorvastatin 20mg
Atorvastatin 20mg/day PO for 12weeks
Other Name: Newvast Tab. 20mg

Experimental: Atorvastatin 10mg, Fenofibric acid 135mg
Atorvastatin 10mg, Fenofibric acid 135mg per day PO for 12weeks
Drug: Atorvastatin 10mg, fenofibric acid 135mg
Atorvastatin 10mg, fenofibric acid 135mg/day PO for 12 weeks
Other Name: Newvast 10mg, Fenocid 135mg

Primary Outcome Measures :
  1. Changes of non-HDL cholesterol [ Time Frame: at screening and after 12 weeks ]
    -change rate : [(12nd week non-High density lipoprotein - baseline non-High density lipoprotein) / baseline non-High density lipoprotein] * 100

  2. levelresponse rate of non-HDL cholesterol level < 130mg/dL [ Time Frame: at screening and after 12 weeks ]
    -Response rate : (subjects who are at less than 130mg/dL of non-High density lipoprotein level / all subjects) * 100

Secondary Outcome Measures :
  1. changes of TC,HDL-C,LDL-C,TG,Apo B/A1 [ Time Frame: at screening and after 12 weeks ]
  2. Changes of Glucose, HbA1c, HOMA-IR level [ Time Frame: at screening and after 12 weeks ]
    HOMA-IR index = [fasting serum insulin(uU/mL) * fasting serum glucose(mmol/L)]/22.5

  3. Changes of hs-CRP, adiponectin, resistin level [ Time Frame: at screening and after 12 weeks ]

Other Outcome Measures:
  1. changes of BUN/Cr level [ Time Frame: at screening and after 12 weeks ]
  2. Changes of Homocysteine level [ Time Frame: at screening and after 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • patients of the age of 20years or older
  • patients who have been taking atorvastatin 10mg 1 tab per day for more than 8 weeks before screening
  • patients who meet the following criteria

    1. Low density lipoproteins-cholesterol level < 130mg/dL
    2. 150mg/dL < Triglyceride level < 500mg/dL
    3. HDL-cholesterol level < 45mg/dL
  • patients who consent for the consent before enrolling the study

Exclusion Criteria:

  • Allergic to HMG-CoA reductase inhibitor and fibrates
  • uncontrolled Hypertension
  • unstable angina, myocardial infarction, transient ischemic attack
  • uncontrolled diabetes
  • thyroid disease
  • myopathy, rhabdomyolysis history
  • alcoholic
  • chronic diarrhea, gastrointestinal disease
  • malignant tumor
  • patients who are pregnant
  • lactating woman

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01974297

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Korea, Republic of
Severance Hospital, Yonsei University College of Medicine Recruiting
Seoul, Korea, Republic of
Contact: Sang-Hak Lee, PhD    82-2-2228-8456   
Contact: Jiyeong Jeong, bachelor    82-2-2228-8277   
Principal Investigator: Sang-Hak Lee, PhD         
Sponsors and Collaborators
Sang Hak Lee
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Principal Investigator: Sang-Hak Lee, PhD Severance Hospital, Yonsei University College of Medicine

Publications of Results:

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Responsible Party: Sang Hak Lee, Associate Professor in Cardiology(preventive cardiology) in Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Korea, Yonsei University Identifier: NCT01974297     History of Changes
Other Study ID Numbers: AVOCADO
First Posted: November 1, 2013    Key Record Dates
Last Update Posted: November 4, 2013
Last Verified: October 2013
Keywords provided by Sang Hak Lee, Yonsei University:
Fenofibric acid
Additional relevant MeSH terms:
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Hyperlipidemia, Familial Combined
Hyperlipoproteinemia Type V
Lipid Metabolism Disorders
Metabolic Diseases
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Fenofibric acid
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors