Comparison of the Efficacy and Safety of AtorVastatin mOnotherapy vs. Combination Atorvastatin/Fenofibric Acid
Information source: Yonsei University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Mixed Hyperlipidemia
Intervention: Atorvastatin 10mg, fenofibric acid 135mg (Drug); atorvastatin 20mg (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Sang Hak Lee Official(s) and/or principal investigator(s): Sang-Hak Lee, PhD, Principal Investigator, Affiliation: Severance Hospital, Yonsei University College of Medicine
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Changes of non-HDL cholesterollevelresponse rate of non-HDL cholesterol level < 130mg/dL
Secondary outcome: changes of TC,HDL-C,LDL-C,TG,Apo B/A1Changes of Glucose, HbA1c, HOMA-IR level Changes of hs-CRP, adiponectin, resistin level
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
Minimum age: 20 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Severance Hospital, Yonsei University College of Medicine, Seoul, Korea, Republic of; Recruiting Sang-Hak Lee, PhD, Phone: 82-2-2228-8456, Email: SHL1106@hanmail.net Jiyeong Jeong, bachelor, Phone: 82-2-2228-8277, Email: jiyoung112@yuhs.ac Sang-Hak Lee, PhD, Principal Investigator
Additional Information
Starting date: July 2013
Last updated: October 31, 2013
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