Comparison of the Efficacy and Safety of AtorVastatin mOnotherapy vs. Combination Atorvastatin/Fenofibric Acid
- Conditions
- Mixed Hyperlipidemia
- Interventions
- Registration Number
- NCT01974297
- Lead Sponsor
- Sang Hak Lee
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 194
-
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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Atorvastatin 20mg, monotherapy atorvastatin 20mg Atorvastatin 20mg/day PO for 12weeks Atorvastatin 10mg, Fenofibric acid 135mg Atorvastatin 10mg, fenofibric acid 135mg Atorvastatin 10mg, Fenofibric acid 135mg per day PO for 12weeks
- Primary Outcome Measures
Name Time Method 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
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
- Secondary Outcome Measures
Name Time Method changes of TC,HDL-C,LDL-C,TG,Apo B/A1 at screening and after 12 weeks 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
Changes of hs-CRP, adiponectin, resistin level at screening and after 12 weeks
Trial Locations
- Locations (1)
Severance Hospital, Yonsei University College of Medicine
🇰🇷Seoul, Korea, Republic of