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

NCT01974297 | Unknown

• 1 other identifier: AVOCADO
• Study Type: interventional
• Target: 194
• Locations: 1 country
• Sites: 1

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.

Conditions

Mixed Hyperlipidemia

Keywords

Hyperlipidemia; Atorvastatin; Fenofibric acid; combination; monotherapy

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (3)

• 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

• Changes of hs-CRP, adiponectin, resistin level

  at screening and after 12 weeks

Other Outcomes (2)

• changes of BUN/Cr level

  at screening and after 12 weeks

• Changes of Homocysteine level

  at screening and after 12 weeks

Study Arms (2)

Atorvastatin 20mg, monotherapy

ACTIVE COMPARATOR

Atorvastatin 20mg/day PO for 12weeks

Drug: atorvastatin 20mg

Atorvastatin 10mg, Fenofibric acid 135mg

EXPERIMENTAL

Atorvastatin 10mg, Fenofibric acid 135mg per day PO for 12weeks

Drug: Atorvastatin 10mg, fenofibric acid 135mg

Interventions

Atorvastatin 10mg, fenofibric acid 135mg DRUG

Atorvastatin 10mg, fenofibric acid 135mg/day PO for 12 weeks

Also known as: Newvast 10mg, Fenocid 135mg

Atorvastatin 10mg, Fenofibric acid 135mg

atorvastatin 20mg DRUG

Atorvastatin 20mg/day PO for 12weeks

Also known as: Newvast Tab. 20mg

Atorvastatin 20mg, monotherapy

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• mg/dL \< Triglyceride level \< 500mg/dL
• HDL-cholesterol level \< 45mg/dL
• patients who consent for the consent before enrolling the study

You may not qualify if:

• 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

Sponsors & Collaborators

• Sang Hak Lee: lead

Study Sites (1)

Severance Hospital, Yonsei University College of Medicine

Seoul, South Korea

RECRUITING

Related Publications (10)

• 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.

  PMID: 19195513 RESULT

• 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.

  PMID: 20934572 RESULT

• 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.

  PMID: 19081418 RESULT

• 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 -- introduction of Pan American Aerobiology Association protocol counting technique]. Arerugi. 2004 Jun;53(6):582-8. Japanese.

  PMID: 15247520 RESULT

• 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.

  PMID: 18996523 RESULT

• 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.

  PMID: 22592524 RESULT

• 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. doi: 10.1358/mf.2007.29.3.1075363.

  PMID: 17520105 RESULT

• 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 with dyslipidemia: a 12-week, multicenter, double-blind, randomized, parallel-group study. Clin Ther. 2009 Dec;31(12):2824-38. doi: 10.1016/j.clinthera.2009.12.007.

  PMID: 20110022 RESULT

• 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 interventions. Exp Clin Cardiol. 2007 Summer;12(2):91-6.

  PMID: 18650989 RESULT

• 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.

  PMID: 20816118 RESULT

MeSH Terms

Conditions

Hyperlipoproteinemia Type II; Hyperlipidemias

Interventions

Atorvastatin; fenofibric acid

Condition Hierarchy (Ancestors)

Lipid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperlipoproteinemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Sang-Hak Lee, PhD

  Severance Hospital, Yonsei University College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor in Cardiology(preventive cardiology) in Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Korea

Study Record Dates

• First Submitted: October 25, 2013
• First Posted: November 1, 2013
• Study Start: July 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: July 1, 2014
• Last Updated: November 4, 2013

Record last verified: 2013-10

Locations

KR (1)