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

Study Status: Withdrawn
Recruit Status: Unknown status
Study Type: Interventional

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 Mon

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 Summary:

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 Ma
Sponsor: Sang Hak Lee

Current Primary Outcome:

  • 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
  • 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


Original Primary Outcome: Changes of non-HDL cholesterol level and response rate of non-HDL cholesterol level < 130mg/dL [ 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
  • response rate : (subjects who are at less than 130mg/dL of non-High density lipoprotein level / all subjects) * 100


Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: Yonsei University

Dates:
Date Received: October 25, 2013
Date Started: July 2013
Date Completion: July 2014
Last Updated: October 31, 2013
Last Verified: October 2013