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

Mixed Hyperlipidemia Clinical Trial

— AVOCADO  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01974297
• Other study ID #: AVOCADO
• Status: Recruiting
• Phase: N/A
• First received: October 25, 2013
• Last updated: October 31, 2013
• Start date: July 2013
• Est. completion date: July 2014

Study information

• Verified date: October 2013
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug SafetyKorea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 194
• Est. completion date: July 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperlipidemia, Familial Combined
• Hyperlipidemias
• Hyperlipoproteinemia Type V
• Mixed Hyperlipidemia

Intervention

Drug:
• Atorvastatin 10mg, fenofibric acid 135mg
Atorvastatin 10mg, fenofibric acid 135mg/day PO for 12 weeks
• atorvastatin 20mg
Atorvastatin 20mg/day PO for 12weeks

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Sang Hak Lee

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (10)

Chatley P, Badyal DK, Calton R, Khosla PP. Combination therapy of low-dose atorvastatin and fenofibrate in mixed hyperlipidemia. Methods Find Exp Clin Pharmacol. 2007 Apr;29(3):217-21. — View Citation

Davidson MH, Rooney MW, Drucker J, Eugene Griffin H, Oosman S, Beckert M; LCP-AtorFen Investigators. Efficacy and tolerability of atorvastatin/fenofibrate fixed-dose combination tablet compared with atorvastatin and fenofibrate monotherapies in patients w — View 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.2010.05.00 — View Citation

Filippatos TD. A review of time courses and predictors of lipid changes with fenofibric acid-statin combination. Cardiovasc Drugs Ther. 2012 Jun;26(3):245-55. doi: 10.1007/s10557-012-6394-0. Review. — View 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. — View 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; — View 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.ah — View Citation

Kishikawa R, M-Horiuti T, Togawa A, Kondoh Y, Janzy PD, Goldblum RM, Kotoh E, Shimoda T, Shoji S, Nishima S, Brooks EG. [Juniper pollen monitoring by Burkard sampler in Galveston, Texas, USA and Japanese cedar pollen counting in Fukuoka, Japan -- introduc — View 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. 2 — View Citation

Shah HD, Parikh KH, Chag MC, Shah UG, Baxi HA, Chandarana AH, Naik AM, Shah JN, Iyer S, Shah KJ, Goyal RK. Beneficial effects of the addition of fenofibrate to statin therapy in patients with acute coronary syndrome after percutaneous coronary interventio — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	changes of BUN/Cr level		at screening and after 12 weeks	Yes
Other	Changes of Homocysteine level		at screening and after 12 weeks	No
Primary	Changes of non-HDL cholesterol	-change rate : [(12nd week non-High density lipoprotein - baseline non-High density lipoprotein) / baseline non-High density lipoprotein] * 100	at screening and after 12 weeks	No
Primary	levelresponse rate of non-HDL cholesterol level < 130mg/dL	-Response rate : (subjects who are at less than 130mg/dL of non-High density lipoprotein level / all subjects) * 100	at screening and after 12 weeks	No
Secondary	changes of TC,HDL-C,LDL-C,TG,Apo B/A1		at screening and after 12 weeks	No
Secondary	Changes of Glucose, HbA1c, HOMA-IR level	HOMA-IR index = [fasting serum insulin(uU/mL) * fasting serum glucose(mmol/L)]/22.5	at screening and after 12 weeks	No
Secondary	Changes of hs-CRP, adiponectin, resistin level		at screening and after 12 weeks	No