Comparison of the Efficacy and Safety of AtorVastatin mOnotherapy vs. Combination Atorvastatin/Fenofibric Acid (AVOCADO)
Primary Purpose
Mixed Hyperlipidemia
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Atorvastatin 10mg, fenofibric acid 135mg
atorvastatin 20mg
Sponsored by
About this trial
This is an interventional treatment trial for Mixed Hyperlipidemia focused on measuring Hyperlipidemia, Atorvastatin, Fenofibric acid, combination, monotherapy
Eligibility Criteria
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
- Low density lipoproteins-cholesterol level < 130mg/dL
- 150mg/dL < Triglyceride level < 500mg/dL
- 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
Sites / Locations
- Severance Hospital, Yonsei University College of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Atorvastatin 20mg, monotherapy
Atorvastatin 10mg, Fenofibric acid 135mg
Arm Description
Atorvastatin 20mg/day PO for 12weeks
Atorvastatin 10mg, Fenofibric acid 135mg per day PO for 12weeks
Outcomes
Primary Outcome Measures
Changes of non-HDL cholesterol
-change rate : [(12nd week non-High density lipoprotein - baseline non-High density lipoprotein) / baseline non-High density lipoprotein] * 100
levelresponse rate of non-HDL cholesterol level < 130mg/dL
-Response rate : (subjects who are at less than 130mg/dL of non-High density lipoprotein level / all subjects) * 100
Secondary Outcome Measures
changes of TC,HDL-C,LDL-C,TG,Apo B/A1
Changes of Glucose, HbA1c, HOMA-IR level
HOMA-IR index = [fasting serum insulin(uU/mL) * fasting serum glucose(mmol/L)]/22.5
Changes of hs-CRP, adiponectin, resistin level
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01974297
Brief Title
Comparison of the Efficacy and Safety of AtorVastatin mOnotherapy vs. Combination Atorvastatin/Fenofibric Acid
Acronym
AVOCADO
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 Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Unknown status
Study Start Date
July 2013 (undefined)
Primary Completion Date
June 2014 (Anticipated)
Study Completion Date
July 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sang Hak Lee
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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
Monitoring
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mixed Hyperlipidemia
Keywords
Hyperlipidemia, Atorvastatin, Fenofibric acid, combination, monotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
194 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Atorvastatin 20mg, monotherapy
Arm Type
Active Comparator
Arm Description
Atorvastatin 20mg/day PO for 12weeks
Arm Title
Atorvastatin 10mg, Fenofibric acid 135mg
Arm Type
Experimental
Arm Description
Atorvastatin 10mg, Fenofibric acid 135mg per day PO for 12weeks
Intervention Type
Drug
Intervention Name(s)
Atorvastatin 10mg, fenofibric acid 135mg
Other Intervention Name(s)
Newvast 10mg, Fenocid 135mg
Intervention Description
Atorvastatin 10mg, fenofibric acid 135mg/day PO for 12 weeks
Intervention Type
Drug
Intervention Name(s)
atorvastatin 20mg
Other Intervention Name(s)
Newvast Tab. 20mg
Intervention Description
Atorvastatin 20mg/day PO for 12weeks
Primary Outcome Measure Information:
Title
Changes of non-HDL cholesterol
Description
-change rate : [(12nd week non-High density lipoprotein - baseline non-High density lipoprotein) / baseline non-High density lipoprotein] * 100
Time Frame
at screening and after 12 weeks
Title
levelresponse rate of non-HDL cholesterol level < 130mg/dL
Description
-Response rate : (subjects who are at less than 130mg/dL of non-High density lipoprotein level / all subjects) * 100
Time Frame
at screening and after 12 weeks
Secondary Outcome Measure Information:
Title
changes of TC,HDL-C,LDL-C,TG,Apo B/A1
Time Frame
at screening and after 12 weeks
Title
Changes of Glucose, HbA1c, HOMA-IR level
Description
HOMA-IR index = [fasting serum insulin(uU/mL) * fasting serum glucose(mmol/L)]/22.5
Time Frame
at screening and after 12 weeks
Title
Changes of hs-CRP, adiponectin, resistin level
Time Frame
at screening and after 12 weeks
Other Pre-specified Outcome Measures:
Title
changes of BUN/Cr level
Time Frame
at screening and after 12 weeks
Title
Changes of Homocysteine level
Time Frame
at screening and after 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Low density lipoproteins-cholesterol level < 130mg/dL
150mg/dL < Triglyceride level < 500mg/dL
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sang-Hak Lee, PhD
Organizational Affiliation
Severance Hospital, Yonsei University College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Severance Hospital, Yonsei University College of Medicine
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sang-Hak Lee, PhD
Phone
82-2-2228-8456
Email
SHL1106@hanmail.net
First Name & Middle Initial & Last Name & Degree
Jiyeong Jeong, bachelor
Phone
82-2-2228-8277
Email
jiyoung112@yuhs.ac
First Name & Middle Initial & Last Name & Degree
Sang-Hak Lee, PhD
12. IPD Sharing Statement
Citations:
PubMed Identifier
19195513
Citation
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Results Reference
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PubMed Identifier
20934572
Citation
Jones PH, Goldberg AC, Knapp HR, Kelly MT, Setze CM, Stolzenbach JC, Sleep DJ. Efficacy and safety of fenofibric acid in combination with atorvastatin and ezetimibe in patients with mixed dyslipidemia. Am Heart J. 2010 Oct;160(4):759-66. doi: 10.1016/j.ahj.2010.06.045.
Results Reference
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PubMed Identifier
19081418
Citation
Mohiuddin SM, Pepine CJ, Kelly MT, Buttler SM, Setze CM, Sleep DJ, Stolzenbach JC. Efficacy and safety of ABT-335 (fenofibric acid) in combination with simvastatin in patients with mixed dyslipidemia: a phase 3, randomized, controlled study. Am Heart J. 2009 Jan;157(1):195-203. doi: 10.1016/j.ahj.2008.08.027. Epub 2008 Nov 20.
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Citation
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Citation
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Citation
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Citation
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Comparison of the Efficacy and Safety of AtorVastatin mOnotherapy vs. Combination Atorvastatin/Fenofibric Acid
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