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

Sponsor
Sang Hak Lee (Other)
Overall Status
Unknown status
CT.gov ID
NCT01974297
Collaborator
(none)
194
Enrollment
1
Location
2
Arms
12
Duration (Months)
16.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Atorvastatin 10mg, fenofibric acid 135mg
  • Drug: atorvastatin 20mg
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated 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 :
Jul 1, 2013
Anticipated Primary Completion Date :
Jun 1, 2014
Anticipated Study Completion Date :
Jul 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Atorvastatin 20mg, monotherapy

Atorvastatin 20mg/day PO for 12weeks

Drug: atorvastatin 20mg
Atorvastatin 20mg/day PO for 12weeks
Other Names:
  • 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 Names:
  • Newvast 10mg, Fenocid 135mg

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Changes of non-HDL cholesterol [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 [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 [at screening and after 12 weeks]

    2. Changes of Glucose, HbA1c, HOMA-IR level [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 [at screening and after 12 weeks]

    Other Outcome Measures

    1. changes of BUN/Cr level [at screening and after 12 weeks]

    2. Changes of Homocysteine level [at screening and after 12 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Severance Hospital, Yonsei University College of Medicine Seoul Korea, Republic of

    Sponsors and Collaborators

    • Sang Hak Lee

    Investigators

    • Principal Investigator: Sang-Hak Lee, PhD, Severance Hospital, Yonsei University College of Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sang Hak Lee, Associate Professor in Cardiology(preventive cardiology) in Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Korea, Yonsei University
    ClinicalTrials.gov Identifier:
    NCT01974297
    Other Study ID Numbers:
    • AVOCADO
    First Posted:
    Nov 1, 2013
    Last Update Posted:
    Nov 3, 2013
    Last Verified:
    Oct 1, 2013
    Keywords provided by Sang Hak Lee, Associate Professor in Cardiology(preventive cardiology) in Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Korea, Yonsei University
    Hyperlipidemia
    Atorvastatin
    Fenofibric acid
    combination
    monotherapy
    Additional relevant MeSH terms:
    Hyperlipidemia, Familial Combined
    Hyperlipoproteinemia Type V
    Lipidoses
    Hyperlipidemias
    Hyperlipoproteinemias
    Atorvastatin
    Fenofibric acid

    Study Results

    No Results Posted as of Nov 3, 2013