NCT00509574

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2007

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 29, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 31, 2007

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

December 13, 2010

Status Verified

November 1, 2010

First QC Date

July 29, 2007

Last Update Submit

December 10, 2010

Conditions

Statins, HMG-CoASingle Nucleotide Polymorphism

Keywords

Single Nucleotide Polymorphismstatinshyperlipidemia

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Hyperlipidemic patients meeting the criteria of NCEP ATPIII for drug treatment at internal medicine clinic of National Taiwan University Hospital.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

blood samples are obtained for genomic DNA extraction.

MeSH Terms

Conditions

Hyperlipidemias

Condition Hierarchy (Ancestors)

DyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Tzung-Dau Wang, MD, PhD

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tzung-Dau Wang, MD, PhD

CONTACT

886-2-2312-3456tdwang@ntu.edu.tw

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 29, 2007

First Posted

July 31, 2007

Study Start

March 1, 2007

Study Completion

February 1, 2010

Last Updated

December 13, 2010

Record last verified: 2010-11

Locations

TW(1)