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Association of Genetic Polymorphisms With Lipid Lowering Effects of Statin Therapy

NCT ID: NCT00509574

Last Updated: 2010-12-13

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

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-03-31

Study Completion Date

2010-02-28

Brief Summary

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The 3-hydroxy-3-methylglutaryl-coenzyme A reductase inhibitors, also known as statins, played an important role in lipid-lowering therapy and reduction of cardiovascular risks. However, it has been observed that the response to statin therapy varies from patient to patient, and gene polymorphism could have contributed to the variation.

Detailed Description

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Hyperlipidemic patients are retrospectively screened from 2006/1/1 to 2006/12/31. The patient is included if he or she had been receiving atorvastatin or rosuvastatin for at least 3 months and did not receive other lipid-lowering medications 4 weeks before starting atorvastatin or rosuvastatin. Genomic DNA was collected from the blood sample of each patient using genomic DNA purification kit. The single nucleotide polymorphisms (SNPs) were determined afterward.

The correlation between response of statin therapy, defined as changes in lipid profiles including triglyceride, total cholesterol, high density lipoprotein cholesterol and low density lipoprotein cholesterol, and SNPs examined.

Conditions

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Statins, HMG-CoA Single Nucleotide Polymorphism

Keywords

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Single Nucleotide Polymorphism statins hyperlipidemia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* aged 21-80.
* conforms with the criteria of National Cholesterol Education Program Adult Treatment Panel III for medication therapy.
* have received atorvastatin or rosuvastatin regularly for 12 weeks or longer.
* available lipid profiles such triglyceride, total cholesterol, high density lipoprotein cholesterol and low density lipoprotein cholesterol 12-24 weeks after staring statin therapy.

Exclusion Criteria

* had been using lipid-lowering medications including statins 4 weeks before starting atorvastatin or rosuvastatin.
* received other lipid-lowering medications, erythromycin, immunosuppressant or azole antifungals concomitantly.
* pregnant, breast-feeding, or able to become pregnant.
* have a history of alcohol or substance abuse.
* liver cirrhosis or ALT exceeds the upper limit of normal range.
* untreated hypothyroidism.
* patients with malignant tumor who have received chemotherapy or radiotherapy.
* known allergy to atorvastatin, rosuvastatin or other statins.
* unwilling to provide written informed consent.
Minimum Eligible Age

21 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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National Taiwan University Hospital

Principal Investigators

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Tzung-Dau Wang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Division of Cardiology, Department of Internal Medicine, National Taiwan University Hospital

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Tzung-Dau Wang, MD, PhD

Role: CONTACT

Phone: 886-2-2312-3456

Email: [email protected]

Other Identifiers

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200702006M

Identifier Type: -

Identifier Source: org_study_id