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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Yonsei University
Sponsor:
Information provided by (Responsible Party):
Sang Hak Lee, Yonsei University
ClinicalTrials.gov Identifier:
NCT01974297
First received: October 25, 2013
Last updated: October 31, 2013
Last verified: October 2013
  Purpose

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 Intervention
Mixed Hyperlipidemia
Drug: Atorvastatin 10mg, fenofibric acid 135mg
Drug: atorvastatin 20mg

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • Changes of non-HDL cholesterol [ Time Frame: at screening and after 12 weeks ] [ Designated as safety issue: No ]
    -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 [ Time Frame: at screening and after 12 weeks ] [ Designated as safety issue: No ]
    -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 [ Time Frame: at screening and after 12 weeks ] [ Designated as safety issue: No ]
  • Changes of Glucose, HbA1c, HOMA-IR level [ Time Frame: at screening and after 12 weeks ] [ Designated as safety issue: No ]
    HOMA-IR index = [fasting serum insulin(uU/mL) * fasting serum glucose(mmol/L)]/22.5

  • Changes of hs-CRP, adiponectin, resistin level [ Time Frame: at screening and after 12 weeks ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • changes of BUN/Cr level [ Time Frame: at screening and after 12 weeks ] [ Designated as safety issue: Yes ]
  • Changes of Homocysteine level [ Time Frame: at screening and after 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 194
Study Start Date: July 2013
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

    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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01974297

Locations
Korea, Republic of
Severance Hospital, Yonsei University College of Medicine Recruiting
Seoul, Korea, Republic of
Contact: Sang-Hak Lee, PhD    82-2-2228-8456    SHL1106@hanmail.net   
Contact: Jiyeong Jeong, bachelor    82-2-2228-8277    jiyoung112@yuhs.ac   
Principal Investigator: Sang-Hak Lee, PhD         
Sponsors and Collaborators
Sang Hak Lee
Investigators
Principal Investigator: Sang-Hak Lee, PhD Severance Hospital, Yonsei University College of Medicine
  More Information

Publications:

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     History of Changes
Other Study ID Numbers: AVOCADO
Study First Received: October 25, 2013
Last Updated: October 31, 2013
Health Authority: Korea: Ministry of Food and Drug Safety
Korea: Institutional Review Board

Keywords provided by Yonsei University:
Hyperlipidemia
Atorvastatin
Fenofibric acid
combination
monotherapy

Additional relevant MeSH terms:
Hyperlipidemia, Familial Combined
Hyperlipidemias
Hyperlipoproteinemia Type V
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Hyperlipoproteinemias
Hypertriglyceridemia
Atorvastatin
Fenofibric acid
Fenofibrate
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 22, 2014