Effect of Lipid Modifying Drugs on HDL Function in Patients With Hyperlipidemia

NCT ID: NCT02942602

Last Updated: 2018-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-03

Study Completion Date

2016-05-23

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

1\) to test HDL function comprehensively in healthy and diseased individuals; 2) to evaluate if this test correlates with cardiovascular risk, independent of traditional risk factors; 3) and to differentiate effects of lipid-modifying or antiatherosclerotic drugs on HDL function and composition

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hyperlipidemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Atorvastatin 20 mg

lipid lowering treatment

Group Type EXPERIMENTAL

Atorvastatin 20 mg

Intervention Type DRUG

The patients who meet the 2013 American College of Cardiology/American Heart Association criteria for receiving lipid-lowering therapy will be randomized into 5 groups.

Cholestyramine 8 g

lipid lowering treatment

Group Type EXPERIMENTAL

Cholestyramine 8 g

Intervention Type DRUG

The patients who meet the 2013 American College of Cardiology/American Heart Association criteria for receiving lipid-lowering therapy will be randomized into 5 groups.

Omega-3 (EPA+DHA) 2 g

lipid lowering treatment

Group Type EXPERIMENTAL

Omega-3 2g

Intervention Type DRUG

The patients who meet the 2013 American College of Cardiology/American Heart Association criteria for receiving lipid-lowering therapy will be randomized into 5 groups.

Atorvastatin 5 mg + Ezetimibe 10 mg

lipid lowering treatment

Group Type EXPERIMENTAL

Concurrent with Atorvastatin 5 mg + Ezetimibe 10 mg

Intervention Type DRUG

The patients who meet the 2013 American College of Cardiology/American Heart Association criteria for receiving lipid-lowering therapy will be randomized into 5 groups.

Life style modification for management of dyslipidemia

Group Type ACTIVE_COMPARATOR

Lifestyle modification

Intervention Type BEHAVIORAL

The patients who meet the 2013 American College of Cardiology/American Heart Association criteria for receiving lipid-lowering therapy will be randomized into 5 groups.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Atorvastatin 20 mg

The patients who meet the 2013 American College of Cardiology/American Heart Association criteria for receiving lipid-lowering therapy will be randomized into 5 groups.

Intervention Type DRUG

Cholestyramine 8 g

The patients who meet the 2013 American College of Cardiology/American Heart Association criteria for receiving lipid-lowering therapy will be randomized into 5 groups.

Intervention Type DRUG

Omega-3 2g

The patients who meet the 2013 American College of Cardiology/American Heart Association criteria for receiving lipid-lowering therapy will be randomized into 5 groups.

Intervention Type DRUG

Concurrent with Atorvastatin 5 mg + Ezetimibe 10 mg

The patients who meet the 2013 American College of Cardiology/American Heart Association criteria for receiving lipid-lowering therapy will be randomized into 5 groups.

Intervention Type DRUG

Lifestyle modification

The patients who meet the 2013 American College of Cardiology/American Heart Association criteria for receiving lipid-lowering therapy will be randomized into 5 groups.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* The patients who meet the 2013 American College of Cardiology/American Heart Association criteria for receiving lipid-lowering therapy
* Aged over 20
* Consent form signed

Exclusion Criteria

* pregnant or lactating women
* subjects with familial hypercholesterolemia
* uncontrolled hypertension or DM
* Thyroid dysfunction
* Active liver disease (transaminase or bilirubin \> 1.5 x NL)
* Serum creatinine \> 2 mg/dL
* Included in other clinical trials within 3 months
* using of other medication: fish oil, fibric acid derivatives, niacin, systemic corticosteroid, thiazolidinedione
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Yonsei University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Division of Cardiology, Department of Internal Medicine,

Seoul, , South Korea

Site Status

Countries

Review the countries where the study has at least one active or historical site.

South Korea

References

Explore related publications, articles, or registry entries linked to this study.

Lee CJ, Choi S, Cheon DH, Kim KY, Cheon EJ, Ann SJ, Noh HM, Park S, Kang SM, Choi D, Lee JE, Lee SH. Effect of two lipid-lowering strategies on high-density lipoprotein function and some HDL-related proteins: a randomized clinical trial. Lipids Health Dis. 2017 Feb 28;16(1):49. doi: 10.1186/s12944-017-0433-6.

Reference Type DERIVED
PMID: 28245873 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

4-2013-0281

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Lipid-lowering Therapy Individualization
NCT03604471 COMPLETED PHASE4
The HDL Particle Protection Study
NCT02125682 COMPLETED PHASE4