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

Sang Hak Lee

Status: Unknown

Conditions: Mixed Hyperlipidemia

Treatments: Drug: Atorvastatin 10mg, fenofibric acid 135mg; Drug: atorvastatin 20mg

Study type: Interventional

Funder types: Other

Identifiers

NCT01974297

AVOCADO

Details and patient eligibility

About

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.

Full 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.

Enrollment: 194 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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194 participants in 2 patient groups

Atorvastatin 20mg, monotherapy

Active Comparator group

Description:

Atorvastatin 20mg/day PO for 12weeks

Treatment:

Drug: atorvastatin 20mg

Atorvastatin 10mg, Fenofibric acid 135mg

Experimental group

Description:

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

Treatment:

Drug: Atorvastatin 10mg, fenofibric acid 135mg