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

October 31, 2013 updated by: Sang Hak Lee

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.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

194

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Recruiting
        • Severance Hospital, Yonsei University College of Medicine
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sang-Hak Lee, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at screening and after 12 weeks
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
at screening and after 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
changes of TC,HDL-C,LDL-C,TG,Apo B/A1
Time Frame: at screening and after 12 weeks
at screening and after 12 weeks
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
at screening and after 12 weeks
Changes of hs-CRP, adiponectin, resistin level
Time Frame: at screening and after 12 weeks
at screening and after 12 weeks

Other Outcome Measures

Outcome Measure
Time Frame
changes of BUN/Cr level
Time Frame: at screening and after 12 weeks
at screening and after 12 weeks
Changes of Homocysteine level
Time Frame: at screening and after 12 weeks
at screening and after 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sang Hak Lee

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Anticipated)

June 1, 2014

Study Completion (Anticipated)

July 1, 2014

Study Registration Dates

First Submitted

October 25, 2013

First Submitted That Met QC Criteria

October 25, 2013

First Posted (Estimate)

November 1, 2013

Study Record Updates

Last Update Posted (Estimate)

November 3, 2013

Last Update Submitted That Met QC Criteria

October 31, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AVOCADO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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