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Mixed HyperlipidemiaAVOCADONCT01974297

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

A study testing Atorvastatin 10mg, fenofibric acid 135mg and atorvastatin 20mg in people with Mixed Hyperlipidemia, run by Sang Hak Lee at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Mixed Hyperlipidemia
What is being tested?
Atorvastatin 10mg, fenofibric acid 135mg and atorvastatin 20mg
Could I receive a placebo?
No, everyone receives an active treatment
How many people
194 participants
Where
1 siteSouth Korea
Study dates
Jul 2013to Jul 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Allergic to HMG-CoA reductase inhibitor and fibrates
  • uncontrolled Hypertension
  • unstable angina, myocardial infarction, transient ischemic attack
  • uncontrolled diabetes
  • thyroid disease
  • myopathy, rhabdomyolysis history
Show all 11Show fewer
  • alcoholic
  • chronic diarrhea, gastrointestinal disease
  • malignant tumor
  • patients who are pregnant
  • lactating woman

Trial locations and contacts

1 site in 1 country.

South Korea1 site, 1 recruiting

  • Severance Hospital, Yonsei University College of Medicine

    Seoul

    Sang-Hak Lee, PhD, 82-2-2228-8456, SHL1106@hanmail.net

    Jiyeong Jeong, bachelor, 82-2-2228-8277, jiyoung112@yuhs.ac

    Recruiting

Other trials in South Korea

About this study

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.

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.

Read the 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.
Being tested
Atorvastatin 10mg, fenofibric acid 135mg, atorvastatin 20mg
Keywords
Hyperlipidemia, Atorvastatin, Fenofibric acid, combination, monotherapy
Medical subject headings
Hyperlipoproteinemia Type II, Hyperlipidemias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Atorvastatin 10mg, fenofibric acid 135mgDrug

    Also called Newvast 10mg, Fenocid 135mg

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

  • atorvastatin 20mgDrug

    Also called Newvast Tab. 20mg

    Atorvastatin 20mg/day PO for 12weeks

Study groups in NCT01974297
Study groupRoleWhat they receive
Atorvastatin 20mg, monotherapyActive comparatorAtorvastatin 20mg/day PO for 12weeks
Receives: Drug: atorvastatin 20mg
Atorvastatin 10mg, Fenofibric acid 135mgExperimentalAtorvastatin 10mg, Fenofibric acid 135mg per day PO for 12weeks
Receives: Drug: Atorvastatin 10mg, fenofibric acid 135mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes of non-HDL cholesterol

    -change rate : [(12nd week non-High density lipoprotein - baseline non-High density lipoprotein) / baseline non-High density lipoprotein] * 100

    Measured: at screening and after 12 weeks

  2. 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

    Measured: at screening and after 12 weeks

Secondary outcomes (3)

  1. changes of TC,HDL-C,LDL-C,TG,Apo B/A1

    Measured: at screening and after 12 weeks

  2. Changes of Glucose, HbA1c, HOMA-IR level

    HOMA-IR index = [fasting serum insulin(uU/mL) * fasting serum glucose(mmol/L)]/22.5

    Measured: at screening and after 12 weeks

  3. Changes of hs-CRP, adiponectin, resistin level

    Measured: at screening and after 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Nov 2013 (estimated)
  2. Study startJul 2013
  3. Primary completionJun 2014 (estimated)
  4. Study completionJul 2014 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
194 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01974297
Sponsor's protocol ID
AVOCADO
Acronym
AVOCADO
Status last verified
Oct 2013
First submitted
25 Oct 2013
Last updated
4 Nov 2013
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 19195513

  • 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.

    PubMed 20934572

  • 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.

    PubMed 19081418

  • 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.

    PubMed 15247520

  • 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.

    PubMed 18996523

  • 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.

    PubMed 22592524

  • 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.

    PubMed 17520105

  • 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.

    PubMed 20110022

  • 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.

    PubMed 18650989

  • 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.

    PubMed 20816118

Questions about this trial

What is this clinical trial studying?

A study testing Atorvastatin 10mg, fenofibric acid 135mg and atorvastatin 20mg in people with Mixed Hyperlipidemia, run by Sang Hak Lee at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 4 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes of non-HDL cholesterol (time frame: at screening and after 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01974297, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2013.

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