Clinical trial NCT01974297: Comparison of the Efficacy and Safety of AtorVastatin mOnotherapy vs. Combination Atorvastatin/Fenofibric Acid
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mixed Hyperlipidemia
Keywords: Hyperlipidemia
Atorvastatin
Fenofibric acid
combination
monotherapy
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2013-11-01
Enrollment: 194
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Changes of non-HDL cholesterol
timeFrame: at screening and after 12 weeks
measure: levelresponse rate of non-HDL cholesterol level < 130mg/dL
timeFrame: at screening and after 12 weeks
Secondary outcomes:
measure: changes of TC,HDL-C,LDL-C,TG,Apo B/A1
timeFrame: at screening and after 12 weeks
measure: Changes of Glucose, HbA1c, HOMA-IR level
timeFrame: at screening and after 12 weeks
measure: Changes of hs-CRP, adiponectin, resistin level
timeFrame: at screening and after 12 weeks
Other outcomes:
measure: changes of BUN/Cr level
timeFrame: at screening and after 12 weeks
measure: Changes of Homocysteine level
timeFrame: at screening and after 12 weeks
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University College of Medicine
Study officials:
affiliation: Severance Hospital, Yonsei University College of Medicine
name: Sang-Hak Lee, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Goldberg AC, Bays HE, Ballantyne CM, Kelly MT, Buttler SM, Setze CM, Sleep DJ, Stolzenbach JC. Efficacy and safety of ABT-335 (fenofibric acid) in combination with atorvastatin in patients with mixed dyslipidemia. Am J Cardiol. 2009 Feb 15;103(4):515-22. doi: 10.1016/j.amjcard.2008.10.025. Epub 2008 Dec 26.
citation: Jones PH, Goldberg AC, Knapp HR, Kelly MT, Setze CM, Stolzenbach JC, Sleep DJ. Efficacy and safety of fenofibric acid in combination with atorvastatin and ezetimibe in patients with mixed dyslipidemia. Am Heart J. 2010 Oct;160(4):759-66. doi: 10.1016/j.ahj.2010.06.045.
citation: Mohiuddin SM, Pepine CJ, Kelly MT, Buttler SM, Setze CM, Sleep DJ, Stolzenbach JC. Efficacy and safety of ABT-335 (fenofibric acid) in combination with simvastatin in patients with mixed dyslipidemia: a phase 3, randomized, controlled study. Am Heart J. 2009 Jan;157(1):195-203. doi: 10.1016/j.ahj.2008.08.027. Epub 2008 Nov 20.
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citation: Jones PH, Davidson MH, Kashyap ML, Kelly MT, Buttler SM, Setze CM, Sleep DJ, Stolzenbach JC. Efficacy and safety of ABT-335 (fenofibric acid) in combination with rosuvastatin in patients with mixed dyslipidemia: a phase 3 study. Atherosclerosis. 2009 May;204(1):208-15. doi: 10.1016/j.atherosclerosis.2008.09.027. Epub 2008 Oct 5.
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citation: Farnier M, Ducobu J, Bryniarski L. Efficacy and safety of adding fenofibrate 160 mg in high-risk patients with mixed hyperlipidemia not controlled by pravastatin 40 mg monotherapy. Am J Cardiol. 2010 Sep 15;106(6):787-92. doi: 10.1016/j.amjcard.2010.05.005. Epub 2010 Aug 2.